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Celsius® – CryoPilot C Thermal Control Unit

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1. CAUTION Under normal conditions when entry into the internal housing of the units is required ensure that power has been turned off and proper lock out tag out requirements are adhered to in accordance with company procedure and policy CAUTION Internal piping will be extremely hot following system operation Use extreme caution while working in the vicinity of uninsulated piping to prevent injury to personnel Whenever the CryoPilot C stainless steel panels are removed check internal surfaces for dust and other debris Clean and remove as necessary When removing dust be careful not to disturb any electrical connections i e electronic boards relays wires etc 9 4 Refrigeration System 1 Depending on the amount of calcium in your coolant the coolant system may be required to be decalcified at least once a year For systems operating with a controlled chilled water or glycol system decalcification should not be required unless a significant loss of heat transfer is noted in the condenser 2 Inspect all refrigerant piping for signs of refrigerant oil indicating possible refrigerant leaks There is no need to put gauges on this unit All necessary information is checked by the service monitor or via service displays 9 5 HTF Pump and Fluid System 9 5 1 Oil Leaks and Pump Shaft Seal Wear LEAK DETECTOR Figure 9 2 Pump Seal Drain Leak Detector Port 9 5 2
2. WARNING Do not operate the FT16 Plate Actuation switch with panels removed to avoid potential pinch and crush hazards from moving components CAUTION At the termination of the Freeze process the FT16 Freeze Thaw Module heat transfer plates surfaces may be 55 C or below Contact with skin may cause severe injury Ensure that appropriate personal protective equipment is used at all times 1 Unlatch the safety cable from its horizontal up position and lower to its vertical down position 2 On the Power Control Panel rotate and hold the plate actuation switch into the open position approximately 10 seconds The plates will stop automatically and the blue Plates Open light will illuminate when fully open Turn or rotate the FT16 door latch and open the front access door Disconnect the Celsius Pak RTDs for all Paks that will be removed 5 Push the transfer cart toward the FT16 visually aligning the centerline desired cart bay to be transferred with the centerline of the FT16 receiving bay Prior to contact the cart and FT16 docking features will engage Continue pushing the cart until the FT16 prohibits further movement 6 Lock both rear casters 7 Grasping the frame placement tool with two hands stand behind the Celsius Pak Frame to be loaded and position the Frame Placement Tool above the Celsius Pak Frame handle Lower the placement tool catch to straddle the frame handle 8 With the placem
3. Figure 6 5 Routing the Transfer Lines 7 The Celsius Pak and Frame Assembly are ready for placing in the transfer cart This section describes the features and use of the Celsius transfer carts The carts are an integral part of the safe and efficient handling of Celsius Paks within the Pak Frames Use of a transfer cart is recommended when transporting filling and draining and transferring Celsius Pak Frames to and from the FT16 However it is possible for an Operator to lift and move filled Celsius Pak Frames manually without the use of a cart CAUTION Because the weight of a filled Celsius Pak is heavy manual operations are inefficient and present risks of injury to the Operator if performed incorrectly and damage to a Celsius Pak Therefore manual operations are not recommended Daily Operation 51 6 2 2 1 Cart Bay Safety Cable Figure 6 6 Transfer Cart with Safety Cable 6 2 2 2 Locking and Unlocking Cart Wheels Figure 6 7 Transfer Cart Caster Locked and Unlocked Positions 6 2 3 Celsius Pak Loading Empty 52 Daily Operation Both transfer carts TC100 and TC33 have a safety cable located at the front This safety cable moves from an up fastened position which prevents inadvertent Celsius Pak removal to a down unfastened position allowing Celsius Paks loading and unloading Both transfer carts and the storage module are equipped with sw
4. button to navigate back When in Program 20 the two line LCD display appears as shown in the following example Start Temperature C End Temperature C 20 0 50 0 C Profile no Segment no Ramp End Time 1 1 2222 0 3m 4 4 1 Explanation of Terms The lower left value shows the segment being configured In this case it is segment 1 of TP1 1 1 The upper left value is the start temperature set point for the segment in C The start temperature set point for the profile is set via program 21 The upper right value is the end temperature set point for the segment in C The lower right value is the segment time set point in minutes Temperature profiles must terminate with a stop signal time 0 To do this after entering the last working segment in the profile being created call up the next segment and enter lt Time 0 Ent gt When the stop sign appears and the screen has reverted to the previous active segment press Esc Repeating Each profile has the ability to be programmed for one time or endless One time A profile is allowed to run to completion of the programmed time duration and then enters a hold period which maintains the last programmed set point of the profile itself until an operator intervenes Endless Using the endless method of profile control allows for a repeating of the profile in an endless cycle until cancelled by the operator Segment A comp
5. Sartorius biotech User Manual Celsius CryoPilot C Thermal Control Unit For the FT16 Freeze Thaw Module TEMA AL 85032 535 39 Vers 10 2013 Copyright 9 2009 Sartorius Stedim Biotech All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means for any purpose without the written permission of Sartorius Stedim Biotech Sartorius Stedim Systems Controlled Freeze Thaw 201 S Ingram Mill Rd Springfield MO 65802 417 873 9636 Sartorius Stedim Biotech and the Sartorius Stedim Biotech logo are service marks of Sartorius Stedim Biotech All other trademarks and service marks are marks or registered marks of their respective owners The use of this product may be covered by one or more of the following U S Patents 6 684 646 6 698 213 6 453 683 6 635 414 6 631 616 This product may also be covered by other pending U S and foreign patent applications Table of Contents Listof Figures icis Ete ER ERR EE RETE 4 4 System Controls Configuration ListOf Tables 0605 4 cceneed e DOR He x Ree Eres 5 4 1 Programming Overview lsluuesssesss Appendices 5i usseses tup ah bre gare PEERS RR dS 5 4 2 Control Keypad Overview ssseeeessss 4 2 1 Control Keypad Buttons 1 Introduction sssseeeeeeeeeeeeeennn 6 42 2 Flow Indication LEDs 1 1 Conventions Used in this Manual 6 4 3
6. USA Technical Service Sartorius Stedim Systems Inc 201 South Ingram Mill Rd Springfield MO 65802 Phone 800 258 9000 International 417 873 9636 Fax 417 873 9275 Central Europe Customer Support Sartorius Stedim Systems GmbH Schwarzenberger Weg 73 79 34212 Melsungen Phone 49 5661 71 3400 Fax 49 5661 71 3702 info sartorius bbi systems com Northern Europe Customer Support Sartorius Stedim UK Limited Longmead Business Park Blenheim Road Epsom Surrey KT19 900 Phone 44 1372 737159 Fax 44 1372 726171 ne customersupport sartorius stedim com Controlled Freeze Thaw Division Contact Information 77 11 1 Page Revision History 11 Detailed Revision History The following table lists updates additions and deletions to this manual CryoPilot C Thermal Control Unit User Manual Change Previous Page New Page Description Effective Number Version Number Version Number Number 16 Feb 2007 Version 1 0 All Initial Release Revision 0 05 Apr 2007 Version 1 0 12 30 41 46 51 70 1 5 2 wording change 2 7 2 1 wording change Revision 1 73 75 76 79 81 83 3 3 5 wording change 4 3 2 1 Date changed for 87 88 97 consistency Figure 4 3 indicator circle corrected 7 1 1 6 LCD changed to LED 8 2 2 Code 15 changed to 15 X 8 2 2 51 5 1 wording change 8 2 2 15 18 wording change 8 2 2 15 47 brought down changed to pulled down 8 2 2 15 71 wording change 8 2 2 73 X 74 X 78 X 79 X
7. it is recommended that a lockable local disconnect switch be mounted in line of sight of the front of the unit Refer to Section 1 5 1 8 and 1 5 2 2 for voltage and current requirements For operation in North America the CryoPilot C has been supplied with a step up transformer This transformer is rated for 208V 60Hz 36A and 3PH A 40A breaker minimum allows for proper operation with 208VAC electrical power 2 4 1 CryoPilot C The CryoPilot C unit is rated for indoor use and is shipped with a refrigerant charge thus not requiring a charge prior to use Environmental regulations require that a qualified and certified refrigeration technician perform any necessary refrigeration service A trained qualified electrician must perform electrical servicing In order to allow the compressor s oil to separate from the refrigerant it is important that time be allotted for the crankcase heater to warm the compressor A time delay relay is used to allow sufficient time for the crankcase to warm to a safe operating temperature to prevent the user from starting the compressor and causing equipment damage This time is approximately 30 minutes The CryoPilot will not start the compressor until the time delay relay duration has been satisfied During this time the message No Compr Clrance will intermittently be displayed on the LCD display 2 7 1 1 Data Recorder Wiring These instructions will guide the instal
8. segmt activated 7 The zero time segment must be input to prevent inadvertent activation of additional segments in the profile Press Time 0 Ent The message Stop Sign will be briefly displayed The segment containing this stop signal will not be displayed and the LCD will return to the configuration screen for the last active segment in this case TP1 6 8 Exit TP1 configuration by pressing Esc The Thawing Program Program 242 uses Temperature Profile 2 TP2 TP2 is shown in Figure 4 5 It consists of 6 segments where the sixth segment not shown below or displayed in Program 20 contains the stop signal and has an end time of 0 0 minutes During profile operation of TP2 an analog start signal will be sent to the FT16 to commence agitation At the end of the final segment of TP2 the FT16 agitation will stop The CryoPilot C LCD screen will intermittently display the message Thawing Complete The unit will enter an indefinite hold until such time as an operator intervenes by pressing the red stop button on the Control Keypad and acknowledging the user prompts During the final segment there is an activation of the POKO Message dry contact The dry contact can be used to drive other devices such as an audible horn or indicator lamp or to signal a supervisory system to indicate that the freeze has been completed The zero time end segment of the temperature profiles will not be displayed at any time during operati
9. 2 7 4 Celsius Pak Frame Assembly 26 6 2 5 Installing Temperature Probe into 2 7 5 CryoHose Installation ssuue 27 aiCelsius Pak rre PR pes 2 8 Control and Alarm Output Connections 29 6 2 6 Transferring Celsius Paks from a Cart 2 8 1 Dry Contacts for Remote Monitoring to the ET16 a coeseiirpe Rhe y eos and Alarms 0000 cece eee ai 29 6 27 Final Preparation for Freeze Thaw 2 8 2 Serial Interface iiwiccdetuidia dake eds ven 30 Process Initiation 0 ee eee ee 2 8 3 Data Output Connection 30 6 2 8 Transferring Celsius Paks from the FT16 to a Cart following Process 3 Preparation for Initial Startup 31 3 1 Supplies Needed for System Startup 31 7 Tempering Process Operations 3 2 FT16 Module Startup 0 0c eee eee eee 31 7 1 Performing Freeze Operations 3 3 Filling the CryoPilot C with Heat Transfer Fluid 31 7 2 Performing Thawing Operations 3 4 Data Recorder Basic Configuration 32 Table of Contents 8 Basic Troubleshooting 00 eee ee 59 8 1 Controller Text Message Warning Descriptions 59 8 2 Error Code MatriX ose nee ts 59 9 System Maintenance sssessss 71 9 1 Stainless Steel Case c ooo deci eem rer 71 9 2 Cooling System 12 sse mean x ER aes 71 9 2 1 Y Strainer Cl
10. PT intern offset act PT extern offset act ext PI setpoint pt follow LCD Pt Extern T Jacket Reactor Temperature Profiles Temperature Profile Parameters Tempering program Starting date Program tracking Time Base External control signal Date and Time Actual Date and Time TIME airpurging kompressorautom HT Start Temp AIF mode pers call System Identification Screen degassing F15 enabled Jacket Temp Reactor Temp Set parameter close valve adv control HEATfakt 0 100 COOLfakt 0 100 Fehlerreset STEPS 20 C 5 C 35 C internal 5 C On 1 0K 1 0K Ext alarmcontrl 320K 9 0 3200S 128 0 0 320085 0 0 320K 18 0 3200S 1000 0 0 3200S 0 0 0 0 K 0 0 K OFF OFF 100K No Change All return to temp stable No Change No Change minute inactive No Change No Change 70 s auto 100 C AIF OFF No Change No Change OFF OFF Standard Standard No Change No Change off 30 No Change No Change Program 84 Slaveadr 1 Program 85 HOST Baudrate 9 6 Program 86 choose Dig IF RS232 Program 90 Language Selection English Program 93 User Panel nb No Change Program 103 Cooling Set No Change Program 104 Init CHECK No Change Program 106 Pt EXT MAX check 320 C Program 107 Pt_EXT MIN check 155 C Program 108 Pt_INT MAX check 320 C Program 109 Pt_INT MIN check 155 C Program 111 air purging Air Purging OFF Program 135 Kalibr AIF I Input No Change Program 13
11. and open the front access door 4 Push the transfer cart toward the FT16 visually aligning the centerline of the cart bay to be transferred with the centerline of the FT16 receiving bay Prior to contact the cart and FT16 docking features will engage Continue pushing the cart until the FT16 prohibits further movement 5 Lock both rear casters 6 If RTDs are being used insert the RTD connector for the Celsius Pak closest to the FT16 into the FT16 RTD junction box position indicated as A 4 Repeat the process if an additional Celsius Pak is to be loaded and connect to A 3 CAUTION Prior to loading Celsius Paks into the FT16 Freeze Thaw Module ensure that the FT16 heat transfer plates have been defrosted Ensure that while sliding Celsius Pak frames into the bay that RTD wires are moved out of the way 7 Slide the Celsius Pak Frame into the FT16 Multiple Celsius Pak Frames can be loaded simultaneously by pushing the Celsius Pak Frame closest to cart rear 6 2 7 Final Preparation for Freeze Thaw Process Initiation 8 Once all Celsius Pak Frames have been transferred from the aligned cart bay unlock the cart s rear casters 9 Position Transfer Cart away from FT16 to clear FT16 door swing 10 Inspect the area between the loaded Celsius Paks and the heat transfer plates and verify there are no obstructions that impede plate movement and cause damage to the plates an
12. lt 8 gt lt 1 gt lt Ent gt 2 Verify the setting is 100 In the event that the parameters entered into the CryoPilot C are unknown or need to be set back to original factory values program 52 may be used The correction value for the Pt100 internal temperature sensor is set back to the standard value of 0 upon execution of Program 52 Use program 12 to read the offset value and record it prior to restoring defaults 1 Select program 52 Set 5 2 Ent 2 The LCD screen will ask Standard Param Press Ent to restore the factory settings System Controls Configuration 37 38 System Controls Configuration The following is a list of the default settings Program 0 Program 1 Program 2 Program 3 Program 4 Program 5 Program 6 Program 7 Program 8 Program 9 Program 12 Program 13 Program 14 Program 16 Program 18 Program 20 Program 21 Program 25 Program 26 Program 27 Program 28 Program 30431 Program 32 Program 34 Program 35 Program 36 Program 46 Program 47 Program 49 Program 55 Program 59 Program 68 Program 69 Program 71 Program 72 Program 73 Program 74 Program 75 Program 76 Program 77 Setpoint Minimum setpoint Maximum setpoint Tempmode Second setpoint Automode POKO max POKO min POKO control PID s Jacket Contr P Range max I TIME V TIME Act PID s Reactor Contr P Range max I TIME V TIME Act
13. 0 750 Screw HEX HEAD CAP 14 20 X 0 750 Bottom plate Bottom Support Rod o oO FF Y N No 2 ON JN Oo NY Top Support Rod Lay one Frame side down Place an O ring see item 2 above onto one end of the Bottom rod see item 7 Insert that rod end into its receiving hole on the Frame side as shown above Using a Phillips screwdriver fasten it with a Thick pan head screw item 4 Place another O ring onto each of the Top rods item 8 Insert each of the Top rods into their receiving holes on the same frame side as shown above Using a 7 16 inch socket fasten them with Hex head screws item 5 Insert the Bottom plate item 6 into its receiving slot on the same frame side as shown above Using a Phillips screwdriver fasten it with a Narrow pan head screw item 3 2 7 4 2 Attach the other Frame side 2 7 4 3 Celsius Pak and Celsius Pak Temperature Probe Installation 2 7 5 CryoHose Installation 1 Place an O ring item 2 onto the Bottom rod item 7 and onto each of the Top rods item 8 2 Slide on the other Frame side item 1 ensuring that the rods and the plate are all inserted into their receiving holes 3 Fasten each rod and the plate as detailed in 2 7 4 1 steps 2 through 4 Refer to Section 6 2 5 for information pertaining to the daily operation of the FT16 system The CryoPilot C standard supply and return connections are 34 inch stainless steel male National Pipe T
14. 2 in order to drain the HTF from the FT16 manifold 8 Fill the CryoPilot C system with new HTF according to the procedure in Section 3 3 2 Figure 9 3 HTF Drain Valves in Closed and Open Positions This procedure assumes that the FT16 unit is not performing any Freeze or Thaw operations the FT16 plates are in the open position and the FT16 unit power is off CAUTION The exact method you use to dry the FT16 heat transfer plates depends on the requirements at your facility Do not use anything that can scratch corrode or otherwise damage the plates Clean cloths are recommended for wiping and a rubber squeegee may also be used 1 Open the front access door on the FT16 2 Allow the FT16 heat transfer plates to come to room temperature 3 Wipe down the heat transfer plates until they are dry 9 6 2 Draining the FT16 Manifold Figure 9 4 FT16 Supply and Return Flange Couplings 9 7 Celsius Pak Frames Draining the FT16 heat transfer fluid HTF manifold is done only if required for service procedures that require disassembly of the HTF flow components It is normally not necessary to drain the HTF manifold Allow system components to come to room temperature so the heat transfer fluid temperature is also at room temperature when drained Use the following procedure to drain the HTF manifold 1 If the FT16 HTF manifold is to be drained separately from the
15. Dow Syltherm HF Recirculating Supply Return fittings 34 inch stainless steel male NPT Fittings for facilities coolant Supply Return 1 2 inch copper male BSPP Condenser cooling medium 315 L hr 83 2 gal hr 15 C 59 F and heat transfer fluid temperature at 0 C 32 F Maximum supply pressure 6 bar 87 psig Minimum Supply Return differential pressure 15 C 59 F 3 bar 43 5 psig Maximum inlet temperature 20 C 68 F Refrigerant Charge R 507 5 95 lbs 2 7 kg Ambient conditions temperature 5 C to 32 C 41 F to 89 6 F Humidity Non condensing Empty weight with transformer US 585 Ibs 266 kg Maximum weight full 662 Ibs 301 kg Empty weight without transformer EU 463 Ibs 210 kg Maximum weight full 539 Ibs 245 kg Dimensions with transformer 61 Hx35 Wx26 D 155 cmx90 cmx 67 cm Dimensions without transformer 53 Hx35 Wx26 D 135 cmx90 cmx67 cm Piping stainless steel Coolant piping copper 1 5 2 FT16 Freeze Thaw Module The FT16 Freeze Thaw Module s main function is to freeze and thaw aqueous biopharmaceutical solutions contained in high strength polymeric Celsius Paks Celsius Paks are held in Celsius Pak frames which are loaded into the FT16 module for freezing and thawing operations A thermoregulation unit the CryoPilot C controls the FT16 module s temperature profiles as well as circulates heat transfer fluid HTF though the module Th
16. Ensure the Celsius Pak Frames are pushed far enough within the cart to allow placing the safety cable in its up position 5 Return the safety cable to the up or horizontal position Ensure the cable is latched and secure to avoid movement during transfer cart transit 6 When ready to relocate the transfer cart unlock the transfer cart s rear casters 6 2 4 Filling the Celsius Paks Once the Celsius Paks have been loaded to the transfer cart they will be transferred to the appropriate filling location For proper filling procedures depending on intended application refer to SOP 200 0028 Non Pressurized and Pressurized 16 6L Celsius Pak General Use Procedures SOP 200 0030 Celsius Pak with KPC Filling Pressurizing and Emptying Procedure Using the FS16 M 0018 FS16 Fill Station User Manual 6 2 5 Installing Temperature Probe This section describes the basic procedures for installing the Product temperature into a Celsius Pak probes Pt100 RTD into the Celsius Pak For specific depth requirements depending gt p a TM 0030 RTD Placement for 16 6L and 8 3L Pressurized Celsius Paks 1 Fully insert the temperature probe through the locking collar Loctung Cotar Sen n RTD Moider f A X Y Vy RTD Probe m Figure 6 9 Inserting RTD Probe into Locking Collar Daily Operation 53 Figure 6 10 RTD Insertion into Celsius Pak 6 2 6 Transferring Celsius Paks from 54 a Car
17. Message 51 X flashes intermittently 51 67 Contactor K5 KM3 1 could not be actuated Safety cutoff Unit sees rapid shutdown or has dropped out Investigate in wiring conditions HTF pump stops Compressor stops diagram what could be inhibiting K5 KM3 1 Heaters de energize LCD LED blinking Possible causes Message 51 X flashes intermittently 1 Thermal overload 51 68 Loss of HTF pump pressure Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 70 Pump Contactor off tripped Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 71 Pump contactor is stuck in the ON position Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 74 Relay K4 and K5 KM3 1 are not operating Safety cutoff Unit sees rapid shutdown in a synchronized manner conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently Basic Troubleshooting 67 Message Error Codes Description Machine Actions 51 75 Unit type recognition error Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de en
18. One time TP2 18 0 40 0 Time Stable One time The Freezing Program Program 240 uses Temperature Profile 1 TP1 TP1 is shown in Figure 4 4 It consists of seven segments where the seventh segment not shown below or displayed in Program 20 contains the stop signal and has an end time of 0 0 minutes At the end of the final segment of TP1 the CryoPilot C LCD screen will intermittently display the message Freezing compl The unit will enter an indefinite hold until such time as an operator intervenes by pressing the red stop button on the Control Keypad and acknowledging the user prompts During the final segment there is an activation of the POKO Message dry contact The dry contact can be used to drive other devices such as an audible horn or indicator lamp or to signal a supervisory system to indicate that the freeze has been completed The zero time end segment of the temperature profile in this case TP1 7 will not be displayed 4 4 3 1 TP1 Configuration Procedure Segment 1 Indefinite Segment 4 Hold Segment 6 Figure 4 4 Freezing Profile Temperature Profile 1 To navigate between profile segments during configuration Press the lt Ent gt button to navigate forward and the lt gt button to navigate back 1 Enter the Edit Profile mode in accordance with Section 4 3 1 1 2 Access Program 20 Set 2 0 Ent 3 Choose Temperature Profile 1 by pressing
19. Pt100 sensor was set to 0 Offset is returned to normal 63 X During power on self test Warning only EPROM bank 0 error EPROM error in Control Keypad 64 X During power on self test Warning only EPROM bank 1 error EPROM error in Control Keypad 69 No unit recognition read X The unit was switched on with an existing fault status The index for 69 X X is the same as for code 51 X Unit not allowed to run LCD LED blinking 70 X Program 180 was changed Heating power has been limited to set percent Not applicable for normal CryoTrol applications Reset parameters 72 X Program 181 was wrongly adjusted Cooling power has been changed using program 181 Default value set 100 73 X Pt100 external high temperature error Pt100 external reading is greater than temperature set by program 106 Safety shutdown HTF pump heaters compressor turned off 74 X Pt100 external low temperature error Pt100 external reading is less than temperature set by program 107 Safety shutdown HTF pump heaters compressor turned off Basic Troubleshooting 69 Message Error Codes Description Machine Actions 78 X Pre run high temperature error Pre run temperature is greater than temperature set by Program 108 Safety shutdown HTF pump heaters compressor turned off 79 X Pre run low temperature error Pre run tempe
20. Stedim Biotech Section 10 3 Once powered on the Control Keypad and the over temperature indicator are illuminated The system performs self tests and the following series of possible messages are displayed on the Control Keypad two line LCD display Date Time Version R1 0 Hello POKO Control Ext alarmcontrl Automode on Huber Prog 90 D GB F HUBER IBI contr For CELSIUS Site Preparation 29 4 Upon completion of the initialization the LED display on the Control Keypad will display the internal temperature in a XXXX X display format The LCD screen on the Control Keypad will display the internal temperature in the upper left hand corner the maximum setpoint temperature in the upper right hand corner the manual setpoint temperature in the lower left hand corner and the minimum setpoint temperature in the lower right hand corner Check that the following screen format is displayed on the CryoPilot C LCD Internal Temp Max Setpoint Temp Manual Setpoint Temp Min Setpoint Temp 5 If the internal test was not successful the Control Keypad LED display lights blink 6 In the event that the LED display is blinking go to the Device Message Program Program 10 for information regarding the problem To select Program 10 follow the procedure in Section 4 3 10 2 7 1 3 Setting the Over temperature 1 The over temperature cutoff switch is located on the lower front panel of the Cutoff Switch CryoPilot C unit belo
21. The CryoPilot C CPC system freezes and thaws by controlling the temperature of heat transfer fluid HTF according to a predefined profile entered by the customer It monitors and records key process variables such as product temperature HTF inlet and outlet temperatures and agitation speed The CryoPilot C is a thermoregulation system complete with a microprocessor controlled low stress refrigeration circuit recirculating pump and fluid reservoir A scroll compressor is used to cool heat transfer fluid HTF and an electrical resistance heater to warm the HTF The refrigeration circuit uses all brazed construction for extra strength The major components of the CryoPilot C are the refrigeration system HTF recirculation pump electric heater HTF reservoir microprocessor based Controller and Control Keypad The refrigeration system consists of a scroll compressor a condenser an automated expansion valve and an evaporator The refrigerant used is R 507 The refrigerant condenser utilizes liquid coolant for heat removal The HTF recirculation pump circulates the heat transfer fluid through the refrigerant evaporator and the external loop including the HTF path of the FT16 Freeze Thaw Module heat transfer plates A 6 kW electric heater heats the HTF during the thaw cycle and a 100 W fine heater provides precise temperature control of the HTF Introduction 9 1 5 1 4 HTF Reservoir 1 5 1 5 Controller and Control Keypad Fi
22. then a nut onto each bolt af Co Figure 2 14 CryoPilot C Flange Assembly 9 Torque the bolts to 20 ft lb in a cross pattern Site Preparation 217 2 7 5 2 CryoHose to FT16 Connection D Use Figure 2 16 as a reference for CryoHose and fitting configuration while performing this procedure 1 Ensure that the CryoHoses are connected to the supply and return ports located on the left side of the CryoPilot C in accordance with section 2 7 5 1 2 Thread one of the flange couplings to the supply and return ports located on the left side of the FT16 3 Thread the 90 degree elbow into the other half of the flange coupling 4 Thread the male quick disconnect to the elbow and flange coupling 5 Place the flange coupling o ring into the groove on the appropriate flange face 6 Align the holes of the flanges such that the orientation of the male quick disconnect is directed 45 degrees up from the horizontal and facing in the forward direction 7 Apply food grade anti seize to the four flange bolts and insert the bolts through the holes of the flanges 8 Place a flat washer a lock washer and then a nut onto each bolt Figure 2 15 FT16 CryoHose Assembly 9 Tighten all bolts to 20 ft lb in a cross pattern 10 Thread the female quick disconnect to the ends of the CryoHoses 11 Slide two CryoWrap covers onto each CryoHose 12 Connect the CryoHoses to the FT16 manifold via the
23. volume production pharmaceutical environments 1 5 X Freeze Thaw System Components 1 5 1 CryoPilot C Thermal Control Unit 1 5 1 1 Refrigeration System 1 5 1 2 HTF Recirculation Pump 1 5 1 3 Electric Heater The CryoPilot C Freeze Thaw System is made up of several different components The configuration described in this manual includes CryoPilot C Thermal Control Unit F116 Freeze Thaw Module 8 3 Land 16 6 L capacity Celsius Paks and Celsius Pak Frame assemblies Data Recorder CryoHoses CryoWraps S16 Celsius Pak Filling Station Optional Components Include 33L capacity transfer cart TC33 100 L capacity frozen storage module SM100 The Celsius CryoPilot C system allows for linear scalability of volumes from 20 mL to 16 6 L of bulk liquid product The CryoPilot C Freeze Thaw System Figure 1 1 utilizes thermal plates and a uniquely designed polymer film containers i e Celsius Pak and frame to conduct heat from the aqueous solutions through a precisely controlled bi directional heat flux allowing for the formation and growth of dendritic ice crystals During the thawing process mixing aids through forced convection in the reduction of product hot spots thaw time and provides for complete homogeneity of the liquid product The CryoPilot C Thermal Control Unit is a self contained unit with all equipment and controls necessary for automated Freeze Thaw and Hold CryoComa operations
24. wording changes 9 3 1 Caution box Secured changed to turned off 9 5 2 wording change B 1 2 wording change 24 Jul 2009 Version 1 0 Version 1 0 Removed Stedim Biosystems logo replaced with Revision 1 Revision 2 Sartorius Stedim Biotech logo Updated Contact Information 1 5 2 2 3 phase changed to 1 phase 1 5 6 2 removed reference to SS handle PF16 and PF8 changed to CF16 and CF8 78 Detailed Revision History A 1 Definitions Acronyms and Abbreviations A Glossary Agitator A general term used to refer to the agitator inside the freeze thaw module Ambient Temperature Range This is the temperature range permissible in the area surrounding the device for the device to function properly This is the temperature range from 5 to 30 C Calibration Verification of the measured values displayed and if required recording of the values by which the displayed values deviate from the actual temperatures measured Compressor A compressor is a component of a mechanical refrigeration unit used to compress the refrigerant in vapor form and add heat energy Condenser A condenser is a component in a refrigerant system used for changing refrigerant vapor to liquid form by removing the latent heat Control Mode Internal thermoregulation The temperature measured inside the thermostat flow temperature is used as the controlled variable for thermoregulation Cooling Capacity The maximum rate at which cooling equipment
25. 1 Ent The 2 Line LCD display will read Segm Select 1 to n new n number of segments used in TP 4 Select Segment 1 by pressing 1 Ent The 2 Line LCD will read Start Temp End Temp nn n 1 1 2222 nn n C 5 Enter the appropriate values of each segment of the temperature profile for the desired application To enter temperature and time values when configuring a segment press the Temp and Time buttons on the keypad Refer to Table 4 3 for an example of standard Freeze parameters Table 4 3 shows an example of standard Sartorius Stedim Biotech application settings used during performance of Factory and Site Acceptance Testing The settings listed are only to be used as a reference for creating a profile suitable for the desired application Note that the Start Temperature in each segment is automatically taken from the previous segment s End Temperature System Controls Configuration 43 44 4 Thawing Program 44 Temperature Profile 2 System Controls Configuration Table 4 3 Example of TP1 Settings Segment Start Temp C End Temp C Time Duration min 121 20 0 30 0 0 3 1 2 30 0 30 0 30 0 1 3 30 0 40 0 90 0 1 4 40 0 50 0 60 0 1 5 50 0 54 0 90 0 1 6 54 0 54 0 0 3 1 7 54 0 54 0 0 0 6 When the final segment is reached noted by a momentary display of Last Segment reached and has been set press lt Ent gt The display will read
26. 27 0 0 3 2 2 27 0 27 0 90 0 2 3 27 0 30 0 90 0 2 4 30 0 30 0 60 0 2 5 30 0 30 0 0 3 2 6 30 0 30 0 0 0 6 When the final segment is reached noted by a momentary display of Last Segment reached and has been set press Ent The display will read segmt activated 7 The zero time segment must be input to prevent inadvertent activation of additional segments in the profile Press Time 0 Ent The message Stop Sign will be briefly displayed The segment containing this stop signal will not be displayed and the LCD will return to the configuration screen for the last active segment in this case TP2 5 8 Exit TP2 configuration by pressing Esc 4 5 Data Recorder The data recorder installed with the CryoPilot C unit is independent of the CryoPilot C Controller itself It records the profiles of the Celsius Pak Product RTD s temperature the HTF Supply and Return temperatures from the CryoPilot C and the agitation speed of the FT16 in RPM but there is no actual communication interface between the two components of the system System Controls Configuration 45 5 1 5 1 1 5 2 46 CryoPilot C Emergency Off CryoPilot C Stop Operation 5 Emergency Stop In an extreme emergency switch the black Control System Power switch on the front of the unit to the OFF position Figure 2 5 Page 27 and the red Main Power Switch on the back of the CryoPilot C Unit to the OFF position To stop the unit at a
27. 6 Kalibr AIF 4 20 mA OUTPUT Kalibr LOW Act 160 Kalibr AIF 4 20 mA OUTPUT Kalibr HIGH Act 880 Program 137 Temperature range of analog value zero line 40 0 Program 138 assign analg v V1 V2 Internal Pt100 Program 140 AIF Input Filter 0 s Program 141 analog offset 0 Program 180 HEATLIMIT 0 100 100 Program 181 COOLLIMIT 0 100 100 Program 245 Air valve No Change Program 246 pers call No Change Once the factory settings have been restored it will be necessary to manually enter the specific set up parameters required for the CryoPilot C Unit Call program 50 to enter the passcode Refer to Section 4 3 1 Enter the current date and time Refer to Section 4 3 2 1 2 3 Call program 90 to select desired language Refer to 4 3 4 4 Check the serial communication parameters by following the steps in 4 3 3 Program 84 must be set back to 1 Program 85 must be set back to 9 6 Program 86 must be set back to RS232 5 Call program 1 to set the minimum temperature set point 55 C OUS 0 Set 1 Ent 5 5 Ent Call program 2 to set the maximum temperature set point 35 C Set 2 Ent 3 5 Ent Call Program 3 to set Control Mode to Internal Set 3 Ent Call Program 5 to set Auto Mode to On Set 5 Ent Call Program 8 to set POKO function to External Alarm 3 Set 8 Ent If Program 12 Pt100 Correctio
28. At 15 C 59 F cooling medium temperature and heat transfer fluid temperature at 0 C 32 F the condenser cooling medium consumption is 315 L hr 83 2 gal hr Minimum Supply Return differential pressure 15 C 59 F 3 bar 43 5 psig The maximum supply pressure is 6 bar 87 psig with a maximum inlet temperature 20 C 68 F The coolant connections are located at the rear of the CryoPilot C Above the actual liquid coolant connections the lower rear access panel is marked with arrows that indicate the positional relation of the supply and return The downward arrow is for the supply and the upward arrow is for the coolant return The small capped line next to the coolant supply and return connections is a drain used to drain the return water line It can be used to prepare the unit for shipping or moving It also works as a bypass of the coolant regulator during system decalcification CAUTION To prevent damage to internal cooling lines ensure that proper counter torque is used when attaching the fittings Vd There is a y strainer in the coolant supply line inside the CryoPilot C unit The y strainer screen must be cleaned periodically depending upon the quality of the coolant Refer to Section 9 2 for more information 2 2 FT16 Module and Power Control Panel Assembly Figure 2 9 FT16 and Power Control Panel Leveling Feet Figure 2 10 Power Control Panel Mounting Bolts 1 Connect the
29. Celsius CryoPilot C Freeze Thaw System 8 CryoPilot C Controller Control Keypad and Data Recorder 00005 10 FT16 Power Control Panel Front View 12 TC100 Transfer Cart and SM100 Storage Module 122 sore opere 15 CryoWEaps i es pare ela ome ERR rA nn 15 8 3L and 16 6L Celsius Pak in Frames 16 Basic Installation Space Requirements 17 Transformer Drawer Power Switch 22 CryoPilot C Main Power Switch 22 CryoPilot C Main Power Breaker 22 Control System Power Switch and Over Temperature Setting Display 22 Phase Detection Relay Light F4M1 23 Manual Pump Start Switch 24 Liquid Coolant Connections and Drain 25 FT16 and Power Control Panel Leveling Feet 25 Power Control Panel Mounting Bolts 25 Power Supply Connection to Right Side Cabinet ics sesde2 ae eencddiaceotnn ly 26 Power Control Panel Power and Control Connections 2 eibti sepe RE RR ERE 26 Celsius Pak Frame Assembly 26 CryoPilot C Flange Assembly 27 FT16 CryoHose Assembly 28 Final CryoHose and Fitting Configuration 29 Data Recorder Ethernet Connection 30 Power Disconnect Switch in ON Position 31 HTF Drain Valves and Sealing Screw 31 CryoPilot HTF Vent Valve 32 Reservoir Fill Port and Sight Glass Lid 32 Control Keypad sessen ir
30. Changing the Heat Transfer Fluid 3 The unit should be checked once a year for correct refrigerant pressures on standby and full load Refer to an R 507 reference guide for temperature pressure information or See Section 10 for Customer Service and Support information Check all hoses and hose connections for fluid leaks on a regular basis The only elastomeric seal inside the unit is the seal on the pump shaft It is recommended that the pump shaft seal drain leak detector be checked prior to system operation Follow these steps to check the pump shaft seal 1 Locate the small drain plug on the back of the CryoPilot C unit labeled Drain Leak Detector 2 Unscrew the plug 3 Check for HTF leakage If there is significant leakage more than a few drops the pump seal or the pump motor kit will need to be replaced Change the heat transfer fluid at regular intervals annually is recommended for standard system usage or when a decline in heat transfer efficiency is noticed e g when the unit does not reach or maintain temperature within 3 degrees of set point temperature Always change out the entire amount of HTF If there is no improvement in heat transfer efficiency after changing the HTF call Sartorius Stedim Biotech Customer Service Section 10 If particulate or moisture contamination of the heat transfer fluid is suspected or water is visible in the HTF sight glass the HTF should be replaced as soon as pos
31. Commonly Used Programs 0000 ee ee 1 2 References aee dns cave PEDE RR E 6 4 3 1 Access Passcode Program 50 Ted Safety copre an ede Rm CER RO Ras 7 43 2 Setting Date and Time 1 3 4 General System sssslslsuuuu 7 43 3 Serial Communication Parameters 1 3 2 CryoPilot C Thermal Control Unit 7 43 4 Language Selection 000 1 3 3 FT16 Freeze Thaw Module 8 4 3 5 EPROM Version Numbers 1 3 4 Celsius Paks and Celsius Pak Frames 8 43 6 Manual Air Purge eee eee 1 4 Celsius Freeze Thaw Technology 8 43 7 Heating Capacity Setting 1 5 Freeze Thaw System Components 9 4 3 8 Cooling Capacity Setting 1 5 1 CryoPilot C Thermal Control Unit 9 4 3 9 Restoring Factory Defaults 1 5 2 FT16 Freeze Thaw Module 11 4 3 10 Device Message Review 1 5 3 ChYOHOSE iss ieacheindes pena aie 14 4 4 Programming and Configuration of 1 5 4 Transfer Carts 0 cece eee eee eee 14 Temperature Profiles sine rte 1 5 5 CryoWtap cesso Re ERR AR X eR SG 15 44 1 Explanation of Terms sues 1 5 6 Celsius Paks and Celsius Pak Frames 16 44 2 Entering Temperature Profile Operating Limits Program 21 sseeeeee 2 Site Preparation 2s ioliscesa e RE Re pus 17 44 3 Fre
32. Configuration There are variables within each temperature profile which can be changed or adjusted via program 21 Standard parameters used are listed in Table 4 2 These parameters are Profile starting temperature Starting ramp to reach the temperature setpoint in K min Time Temperature stability Repeat setting one time or endless 1 Enter the Edit Profile mode in accordance with Section 4 3 1 1 2 Using the keypad on the control keypad press lt Set gt 2 1 Ent 3 Select desired temperature profile to program by pressing associated number example for temperature profile 1 press lt 1 gt listed in Table 4 2 4 The Select Start Tmp screen will be displayed Enter start temperature in accordance with Table 4 2 and press Ent 5 The Change Startramp screen will be displayed Enter start ramp in accordance with Table 4 2 and press Ent 6 The temp time stable screen will be displayed Select temperature stable by pressing TEMP or time stable by pressing TIME in accordance with Table 4 2 7 The times repeat screen will be displayed Select one time by pressing 1 or endless by pressing TIME in accordance with Table 4 2 8 Repeat steps 1 to 6 for TP 2 in accordance with Table 4 2 Table 4 2 Standard Temperature Profile Parameters for Program 21 Temperature Start Start Ramp Stability Repeat Profile Temperature C K min TP1 20 0 40 0 Time Stable
33. CryoPilot C disconnect the CryoHoses from the manifold at the quick disconnect couplings If the manifold is to be drained with the entire system ensure that the CryoHoses remain connected to the manifold to ensure a complete system drain 2 Remove the drip pan from under FT16 manifold fittings Place a suitable drain pan of sufficient volume under the FT16 Supply and Return flange couplings CAUTION Do not fully remove the flange bolts to prevent uncontrolled drainage from the FT16 During draining operations safety glasses should be worn at a minimum to prevent HTF splash into eyes 9 8 CryoPilot C Planned Maintenance 3 Slowly loosen the flange bolts starting with the bolts closest to the ground Loosen just enough to allow the HTF to begin draining Do not fully remove the bolts This should be done slowly as system may be pressurized 4 Let the heat transfer fluid HTF run out into the drain pan 5 When all the HTF has run out fully remove the bolts and inspect the flange faces for physical damage and replace as necessary 6 Replace the flange o ring gasket 7 Replace the flange bolts and tighten the bolts to 20 ft Ib in a cross pattern Prior to Celsius Pak Frame use ensure that all hex head and pan head screws are tightened 1 Using a 7 16 inch socket ensure that all hex head screws are tightened and are snug 2 Using a Phillips head cross head screwdriver ensure that all pan head screws a
34. LED blinking 2 Stepper motor plug socket faulty Message 51 X flashes intermittently 3 Faulty Controller 51 16 Thermal overload in high stage compressor has Safety cutoff Unit sees rapid shutdown tripped Possible causes to check conditions HTF pump stops Compressor stops 1 High ambient temperatures Heaters de energize LCD LED blinking 3 Wadeventfation Message 51 X flashes intermittently 3 Faulty compressor Docisenate lodging 51 17 High pressure compressor switched Safety cutoff Unit sees rapid shutdown on without permission or K3 KM3 is conditions HTF pump stops Compressor stops switched on wrongly Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 18 High temperature stage contactor Safety cutoff Unit sees rapid shutdown 62 Basic Troubleshooting K5 KM3 1 has failed conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently Message Error Codes Description Machine Actions 51 20 Over temperature cutoff has signaled indicating Over temperature cutoff LCD display flashing high temperature inside the heating chamber Safety cutoff Unit sees rapid shutdown Possible causes un conditions HTF pump stops Compressor stops 1 High ambient temperatures and too Heaters de energize LCD LED blinking Derek PON Message Overheat flashes intermittently 2 Pump stopped abruptly with hea
35. acement of the FT16 and power control panel 10 Remove any shipping material from the interior of the enclosure 2 4 2 5 Equipment Inventory Tools and Utilities Required for Installation When all the equipment containers are unpacked confirm that the following parts are available for installation CryoPilot C Thermal Control Unit FT16 Freeze Thaw Module Power Control Panel FT16 Drip Pan Two 2 CryoHoses Four 4 CryoWraps Celsius Paks Celsius Pak Frame Syltherm HF Heat Transfer Fluid 10 gallons or 40 liters Product RTD s Standard installations will be performed by a Sartorius Stedim Biotech representative Specific and additional tools and equipment required for installation will be supplied by Sartorius Stedim Biotech For questions contact Sartorius Stedim Biotech Customers are responsible for providing utilities and connections Electrical connections that meet the requirements listed in Sections 1 5 1 8 and 1 5 2 2 Cooling medium connections installed The CryoPilot C has 2 v2 inch male BSPP connections located at the back of the unit See Section 2 7 1 5 for more information The following tools will be used and provided by Sartorius Stedim Biotech during the installation process Plate installation platform Inter Plate Distance Measuring Tool IPDMT Snap ring pliers Complete standard socket set Assortment of cross head and flat head screw drivers Hathe
36. act with skin can cause severe injury Ensure that appropriate personal protective equipment is used at all times At a minimum gloves should be worn while working near the heat transfer plates and during the handling of frozen Celsius Paks To prevent injury or damage to equipment the FT16 must not be operated with any of the panels removed because of the moving parts The maximum allowable agitation speed for the FT16 is 90 RPM Do not autoclave the Celsius Pak frames Celsius Pak frames are used with Celsius Paks only Do not use Celsius Pak frames if any part is damaged or missing When filled Celsius Paks should be transferred using the transfer cart and or storage module to prevent injury and damage to the Celsius Pak and Celsius Pak frame Proceed with extreme caution when lifting or carrying individual Celsius Pak and Celsius Pak frames The Celsius Freeze Thaw systems have been designed to incorporate Sartorius Stedim Biotech controlled freezing thawing and storage processes into disposable applications This offers biopharmaceutical manufacturers a more robust scalable reproducible and easy to use freeze thaw solution than those using bottles carboys and existing bags A full range of scalable process development freeze thaw solutions provide tools for process development and commercial scale production The systems are designed to provide the controlled freezing and storage processes that occur in the large
37. ad screwdriver Digital Calipers 15 inch adjustable wrench X2 18 inch adjustable wrench 10 inch pipe wrench 3 inch adjustable wrench 4 foot level 0 80 ft lb torque wrench Tape measure Lifting jack Jack stands braces to secure FT16 for rocker bearing installation Electrical Terminal screwdriver 3g inch Hex Wrench Loctite 567 thread sealant for all threaded connections Food grade anti seize Site Preparation 19 2 6 2 6 1 2 6 1 1 CryoPilot C Controller and Serial Numbers CryoPilot C Keypad Serial Numbers 2 6 FT16 20 Site Preparation The following section describes the locations of important component serial numbers of the CryoPilot C It is recommended that the serial numbers be recorded for a starting reference It is important information that will be needed if there are any problems with the system that require reporting to a Sartorius Stedim Biotech Field Service Engineer The CryoPilot C serial number is located on the back of the unit on the label plate The Controller and Control Keypad each have a serial number SN The SN for the Controller is located at the top left hand of the back of the Controller The SN for the Control Keypad is normally located on the back as well If not there remove the four screws on the back and the serial number is located on the bottom right corner The Controller and Control Keypad must be removed from the CryoPilot C to gain access to the bac
38. al safety A series of messages may be shown Use Program 10 to access messages displayed in sequence Safety shutdown HTF pump heaters compressor turned off shutdown These messages can only be cancelled by turning off power at the black mains switch and turning off again 51 2 Condensation Controller Possible causes Safety cutoff Unit sees rapid shutdown 60 Basic Troubleshooting 1 Cooling medium supply pressure too low Cooling medium Y strainer dirty Sticking stepper motor Failed RTD 19h P9 conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently Message Error Codes Description Machine Actions 51 3 MOP Controller Suction evaporation Safety cutoff Unit sees rapid shutdown temperature of refrigeration circuit reached conditions HTF pump stops Compressor stops upper limit maximum with the stepper Heaters de energize LCD LED blinking motor valve fully shut Message 51 X flashes intermittently 1 If seen in conjunction with 51 4 and 51 2 possible stepper motor valve problem 2 If compressor was still running possible failure of suction pressure transducer A6 A15M3 51 4 Superheat control Minimum superheat of Safety cutoff Unit sees rapid shutdown refrigerant in refrigeration stage could not be conditions HTF pump stops Compressor stops controlled Danger of liquid in compressor exists Hea
39. ated by the date given below Sartorius Stedim Biotech GmbH reserves the right to make changes to the technology features specifications and design of the equipment without notice Status October 2013 Sartorius Stedim Biotech GmbH Goettingen Germany Printed in Germany on paper that has been bleached without any use of chlorine W4A000 KT Publication No S 6005 e13102 Ver 10 2013
40. cancelled by turning off power at the black mains switch and turning off again 51 7 High pressure cutoff in the refrigerant loop Safety cutoff Unit sees rapid shutdown has tripped Possible causes 1 Cooling medium temperature inlet too high 2 Cooling medium Y strainer blocked 3 Insufficient cooling medium flow conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently Basic Troubleshooting 61 Message Error Codes Description Machine Actions 51 10 Overload relay 1 tripped Compressor Safety cutoff Unit sees rapid shutdown Possible causes conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking 1 Improper voltage 2 Sticking contactor Message 51 X flashes intermittently 3 Excessive amperage draw on one or more phases 4 Electrical arcing 51 11 Overload relay 2 has tripped if applicable Safety cutoff Unit sees rapid shutdown Possible causes conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Jc Impropervoltage Message 51 X flashes intermittently 2 Sticking contactor 3 Excessive amperage draw on one or more phases 4 Electrical arcing 51 15 Stepper motor valve did not work correctly Safety cutoff Unit sees rapid shutdown due to conditions HTF pump stops Compressor stops 1 Ice in control valve or extension shaft Heaters de energize LCD
41. coolant supply to the left fitting when looking at the back of the unit 2 Connect the coolant return to the right fitting when looking at the back of the unit Ensure that both connections are snug Ensure that the drain line cap is installed and finger tight to avoid leakage 5 Turn on the facility coolant supply and return and confirm there are no leaks present at any of the threaded connections meg 1 Adjust the leveling feet on the FT16 so that the casters are off the floor Remove the casters and line up the wheel mounting holes with the storage rack Use the threaded fasteners to secure the wheels to the rack Use the two additional bolts to secure the rack to the FT16 frame 2 Remove the shipping spacers and replace with the rocker guides as described in the appropriate standard operating procedures 3 Adjust the leveling feet so that the product rails are 50 V 1 16 from the floor and the FT16 unit is level front to back and side to side 4 Position the Power Control Panel on the right side of the FT16 module 5 Adjust the height of the Power Control Panel leveling feet so that the Power Control Panel is level and the connection points on the electrical enclosure frame are aligned with the corresponding mounting points on the FT16 module base frame 6 Connect the Power Control Panel frame to the FT16 module base frame at the mounting points using two 12 13 x 1 4 bolts with flat washers and split lock washers Torqu
42. d or Celsius Paks 11 Close the FT16 front access door This procedure assumes that filled Celsius Pak Frames are loaded into the FT16 and the FT16 door is closed WARNING Do not operate the FT16 Plate Actuation switch with panels removed to avoid potential pinch and crush hazards from moving components CAUTION Prior to closing plates visually inspect and verify that there are no objects between the Celsius Pak and the HTF plate that may cause damage to the Pak when the plates are closed 1 On the FT16 Power Control Panel rotate and hold the plate actuation switch into the closed position approximately 10 seconds The plates will stop automatically when closed and the white Plates Closed light will illuminate 2 Verify that the amber Status light is illuminated on the Power Control Panel If the Status light is not illuminated repeat step 1 to ensure the plates are closed and the FT16 front access door is fully closed Daily Operation 55 6 2 8 Transferring Celsius Paks from the 56 FT16 to a Cart following Process Daily Operation 3 Ensure that any and all additional procedures required by company policy and procedure have been completed prior to system operation 4 FT16 and Celsius Paks are now ready for Freeze or Thaw operations This procedure describes the removal of the Celsius Pak Frames from the FT16 following the completion of a Freeze profile or a Thaw profile
43. d to indicate the completion status of the freeze or thawing CryoPilot C programs Contact Set 3 POKO Unipump The Unipump contact is used to start a booster pump Huber Unipump if installed in the HTF circulation system The contacts are closed upon start of the internally installed HTF pump POKO Unipump is not used for Sartorius Stedim Biotech applications Site Preparation 29 2 8 2 Serial Interface 2 8 3 Data Output Connection 30 Site Preparation The CryoPilot C can be monitored by an external device such as a personal computer PC via an RS232 link using the data transmission cable for maintenance and troubleshooting The internal operations of the CryoPilot C can be monitored with a diagnostic aid software program For the Chessell 6100A it is possible to interface with the recorder via Ethernet Ethernet cable may be routed through the rear of the right side panel of the CryoPilot C for connection at the rear of the 6100A Figure 2 17 See the Eurotherm Chessell Model 6100A 6180A 100 and 180 mm Paperless Graphics Recorders User Guide for more information Figure 2 17 Data Recorder Ethernet Connection 3 Preparation for Initial Startup 3 1 Supplies Needed for System Startup To aid in a successful installation the customer will provide the following 10 gallons 40 liters of Heat Transfer Fluid Dow Syltherm HF only Lightweight 10 to 20 L plastic container to be used fo
44. e FT16 Freeze Thaw Module which is controlled by the CryoPilot C chiller enables optimum freezing and thawing processes minimizing the adverse effects of uncontrolled freezing methods on biopharmaceutical products Designed to offer controlled freeze thaw operations for pilot and clinical manufacturing scales the FT16 module allows freezing and thawing of disposable 8 3 L and 16 6 L Celsius Paks The FT16 module consists of a single bay designed to hold one 16 6 L Celsius Pak or two 8 3 L Celsius Paks Heat transfer fluid HTF circulates inside heat exchange plates mounted in the bay During freezing and thawing the plates close onto the Celsius Paks ensuring optimal contact and heat transfer between the surface of the plates and the Celsius Paks The FT16 Freeze Thaw Module is comprised of a base assembly and a rocker assembly A roller guide and wheel assembly at each corner connects the rocker assembly to the base assembly The rocker assembly has a pair of heat exchanger plates A set of rails suspends the Celsius Pak in its frame which allows compression of the Celsius Pak to a controlled width by the plates As HTF is circulated though these plates the product inside the Celsius Pak is frozen or thawed depending upon the temperature of the HTF An integrated agitation system mounted to the base assembly enhances thawing of frozen product contained in the Celsius Paks The agitation consists of an electric motor and gear b
45. e energize LCD LED blinking Message 51 X flashes intermittently 64 Basic Troubleshooting Message Error Codes Description Machine Actions 51 40 Relay K5 KM3 1 does not switch on Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 41 Relay K3 KM3 does not switch on Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 42 Relay K3 KM3 or K5 KM3 1 incorrectly Safety cutoff Unit sees rapid shutdown switched on conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 43 Relay K2 KM1 does not switch on Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 44 Relay K2 KM1 does not switch on Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 47 Superheat was pulled down and could not Safety cutoff Unit sees rapid shutdown be built up on turning on the compressor conditions HTF pump stops Compressor stops Possible causes Heaters de energize LCD LED blinking 1 Th
46. e rotary disconnect on each FT16 When servicing the CryoMixer the facility power supply should be in the OFF position and the power cable disconnected from the power source DANGER Prior to any electrical servicing inside either the power box or the CryoPilot or FT16 cabinet take the Main Power Disconnect switch and the facility main breaker to the OFF position and lockout the main facility breaker The CryoPilot C is equipped with a Main Power Disconnect switch located at the rear of the unit When in the OFF position this switch can be used as a location for full system electrical power disconnect Downstream of the O1 disconnect all electrical power is removed when the Main Power Disconnect switch if in the OFF position Electrical power will still be supplied to the O1 terminals from the facility breaker Another switch exists on the transformer for units with the transformer drawer installed To ensure all power is completely isolated the facility breaker should be locked and tagged out as well The following describes how to use the integral lockout mechanism associated with the Main Power Disconnect switch 1 Ensure that if the system is connected to a facility central monitoring system that the proper division is informed of the planned electrical power disconnect 2 Turn the Main Power Disconnect switch to the OFF position 3 Oncein the OFF position perform the following Figure 11 1 CryoPilot C Pow
47. e stepper motor valve wide open Message 51 X flashes intermittently 2 Suction pressure transducer A6 A15M3 reading incorrectly 3 Evaporator outlet temperature sensor F 2 RF1 reading incorrectly 51 48 Relay of high pressure compressor Safety cutoff Unit sees rapid shutdown is chattering conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 49 Relay of low pressure compressor Safety cutoff Unit sees rapid shutdown is chattering conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 50 Relay of low pressure stage has not switched Safety cutoff Unit sees rapid shutdown on or has tripped Possible problem solution Over current relay has tripped conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently Basic Troubleshooting 65 Message Error Codes Description Machine Actions 51 51 Relay of low pressure stage will not switch off Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 52 Auxiliary contact on Relay K5 KM3 1 sends wrong signal Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blink
48. e that all air has been removed from the HTF piping to prevent poor heat transfer Program 111 is the manual air purge program During air purging operations do not leave the CryoPilot unattended Air purging must be stopped manually and if allowed to run unattended may lead to overheat conditions due to pump operations Stop air purging operations if the internal temperature approaches the Over temperature Cutoff setpoint 1 Select Program 111 Set 1 1 1 Ent 2 The LCD display will display Air Purging OFF Press 1 to start air purge 3 To stop air purge press the red Stop button 1 Select Program 111 Set 1 1 1 Ent 2 The LCD display will display Air Purging ON Press 0 to stop air purge Program 180 is used to set the percentage of the available heating power which should be available for use in the application The default value for this program is 100 For standard Celsius applications the CryoPilot C heating power utilizes full heating capacity 1 Select Program 180 lt Set gt lt 1 gt lt 8 gt lt 0 gt lt Ent gt 2 Verify the setting is 100 Program 181 is used to set the percentage of the available cooling capacity which should be available for use in the application The default value for this program is 100 For standard Celsius applications the CryoPilot C heating power utilizes full cooling capacity 1 Select Program 181 lt Set gt lt 1 gt
49. e to 35 ft lb Figure 2 10 Site Preparation 25 2 7 3 Signal Electrical Power Connections for System Operation Figure 2 11 Power Supply Connection to Right Side Cabinet Figure 2 12 Power Control Panel Power and Control Connections 2 7 4 Celsius Pak Frame Assembly Figure 2 13 Celsius Pak Frame Assembly 2 7 4 1 Attach rods and plate to one Frame side 26 Site Preparation Insert the RS232 Cable into the top of the Control Keypad Ensure that the power wire from the rear of the right side cabinet has been plugged into the socket labeled Power Supply at the rear of the CPC Ensure that the RTD signal wire has been connected from the FT16 to the connector labeled Product RTD at the rear of the CPC right side cabinet Ensure that the agitation communications cable has been connected from the FT16 to the connector labeled Agitator at the rear of the CPC right side cabinet Ensure that the agitation motor power conduit and the FT16 controls signal conduit connectors from the FT16 main assembly have been plugged into the back of the Power Control Panel Figure 2 12 The following assembly image shows the CF16 frame assembly the instruction steps are applicable for both the CF16 and CF8 Celsius frames CF16 Frame Assembly Component List Index Description e et m Celsius Pak Frame end with Handle Gasket O ring Screw PAN HEAD 8 32 X 0 750 Screw PAN HEAD 1 4 20 X
50. eaning 0 005 71 9 22 BDecalcification serene mnn 72 9 3 Internal Surfaces i osciet e RD eem b rene 72 933 GryoPilotG isti exams Ix 72 9 4 Refrigeration System simesissierciuienrasi ra airih 73 9 5 HTF Pump and Fluid System 005 73 9 5 1 Oil Leaks and Pump Shaft Seal Wear 73 9 5 2 Changing the Heat Transfer Fluid 73 9 6 FITS Maintenance socer er rhe pee 74 9 6 1 Drying the FT16 Heat Transfer Plates 74 9 6 2 Draining the FT16 Manifold 75 9 7 9 8 9 9 Celsius Pak Frames 000000 eee ee ee eeees 75 CryoPilot C Planned Maintenance 75 System Standard Operating Procedures 76 9 9 1 CryoPilot C Thermal Control Unit 76 9 9 FT16 Freeze Thaw Module 76 10 Controlled Freeze Thaw Division Contact Information 77 11 Detailed Revision History 005 78 4 11 1 Page Revision History Table of Contents List of Tables List of Figures Figure 1 1 Figure 1 2 Figure 1 3 Figure 1 4 Figure 1 5 Figure 1 6 Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 2 7 Figure 2 8 Figure 2 9 Figure 2 10 Figure 2 11 Figure 2 12 Figure 2 13 Figure 2 14 Figure 2 15 Figure 2 16 Figure 2 17 Figure 3 1 Figure 3 2 Figure 3 3 Figure 3 4 Figure 4 1 Figure 4 2 Figure 4 3 Figure 4 4 Figure 4 5 Figure 5 1
51. ed for cleaning in place is eliminated Sizes 8 3 Land 16 6 L Celsius Paks Celsius Pak working volume Dependent on Celsius Pak size and application full or partial fill up to 16 6L maximum Sterilization Gamma irradiated Materials of construction Product contact layer EVAM Medical grade Ethylene Vinyl Acetate Gas and moisture barrier layer EVA EVOH EVA External robust handling layer EVA Fill and drain ports EVA Fill and drain transfer line Pt cured Silicone MPC Couplings and Plugs Polycarbonate Luerlock Polycarbonate Ysplitter Polycarbonate Double barb elbow or union Polypropylene Thermowell EVA Sizes 8 3L and 16 6L Celsius Pak Frames Temperature Range 80 C to 45 C 112 F to 113 F Materials of construction Frame End HDPE Gasket O Ring PTFE Screw PAN Head 8 32 x 34 316 Stainless Steel Screw PAN Head 1 4 20 x 34 316 Stainless Steel Screw HEX Head 1 4 20 x 34 316 Stainless Steel Bottom Plate 316 Stainless Steel Bottom Support Rod 316 Stainless Steel Top Support Rod 316 Stainless Steel 2 1 2 2 2 3 Space Requirements Load Bearing Surface Unpacking and Positioning the Equipment 2 Site Preparation The space requirement for the assembled CryoPilot C and FT16 Freeze Thaw System is approximately 97 5 s x 64 s x 61 1 4 inches or 248 x 163 x 156 centimeters Width x Depth x Height Position the system a
52. ell 6100A Data Recorder 5 SOP 200 0028 Non Pressurized and Pressurized 16 6L Celsius Pak General Use Procedures 6 SOP 200 0030 Celsius Pak with KPC Filling Pressurizing and Emptying Procedure Using the FS16 7 TM 0030 RTD Placement for 16 6 L and 8 3 L Pressurized Celsius Paks 8 Eurotherm Chessell Model 6100A 6180A 100 and 180 mm Paperless Graphics Recorders User Guide 13 Safety 1 3 1 General System 1 3 2 CryoPilot C Thermal Control Unit During operation of equipment it is imperative that warnings are observed at all times to prevent serious injury death or equipment damage Any use of the system components listed in this manual with equipment or applications for which they were not intended voids the warranty and releases Sartorius Stedim Biotech Inc from any and all liability associated with the components Ensure that all company policies regarding operational safety are followed at all times 1 The CryoPilot C uses heat transfer fluid HTF that can reach temperatures of 55 C or lower Contact with skin can cause severe injury Ensure that appropriate personal protective equipment is used at all times when working with HTF or while near exposed cold equipment surfaces 2 Ensure that when performing any maintenance requiring entry into system components proper lock out and tag out procedures are adhered to in accordance with company procedures and policy 3 The CryoPilot C contains heat transfer
53. emove the unit from the shipping crate Use safety straps or other method of securing the CryoPilot to prevent the unit from tipping 5 Verify that the CryoPilot C and contents match the packing slip and have not been physically damaged during shipping 6 Position the CryoPilot C in its in service location on the surface prepared in accordance with Section 2 2 Position the unit to facilitate connection to the utilities and to allow easy access to the front of the unit 7 Lockthe casters to prevent inadvertent movement of the CryoPilot C 1 Remove the packing slip check the crate for damage and document if necessary 2 Remove the front panel and the top panel from the shipping container remove the packaging material and any loose parts 3 Cutthe strapping material security bands and remove all the supports connecting the FT16 module to the shipping pallet 4 Guide a forklift under the side center of the unit with the aid of another person to the unit from tipping Lift slowly 5 Beattentive while unpacking and collect any parts that may have been detached from the unit prior to shipment 6 Verify that the FT16 module and all contents match the packing slip and have not been physically damaged during shipment 7 Provide a dry level surface having sufficient load bearing capacity to accommo date the loading imposed by the module The room should have a drain as close as possible to the location where the equipment is to be placed 8 P
54. ent tool catch straddling the Celsius Pak Frame handle pull the placement tool towards the transfer cart sliding the Celsius Pak Frame into the transfer cart Continue sliding until the Celsius Pak Frame cannot be pulled further TU Multiple Celsius Pak Frames can be unloaded simultaneously by pulling the Celsius Pak Frame located the farthest into FT16 the first Celsius Pak Frame that would have been loaded Pulling this frame will also pull the other frames between it and the transfer cart 9 Once all Celsius Pak Frames have been transferred to the aligned cart bay unlock the cart s rear casters 10 Position Transfer Cart away from the FT16 to clear the FT16 door and latch the transfer cart safety cable in the up or horizontal position 11 Close the FT16 front access door 7 1 Performing Freeze Operations 7 lempering Process Operations There are two main tempering operations that can be performed using the CryoPilot C Freezing and Thawing Insufficient coolant flow will result in a safety shutdown of the CryoPilot C along with the display of an error message on the 2 line LCD The message No Flow may appear intermittently until the system is full with HTF and all air has been purged No action is required by the user to clear this message CAUTION Only fully thawed Celsius Paks can be used during Freezing operations Attempting to use a pa
55. er Disconnect Switch Locking Mechanism A Note the finger tab on the top of the power disconnect handle B Pull this forward and fully out C The locking device is ready for lock insertion Allgemein 83 4 Once the locking device has been fully pulled out insert the appropriate locking device in accordance with company policy and procedure 5 As with all equipment to ensure that electrical power is completely removed from the system it is important to lock and tag out all facility breakers as appropriate B 1 2 FT16 Freeze Thaw Modules The FT16 is equipped with a Main Power Disconnect switch located on the right side of the Power Control Panel When in the OFF positions this switch can be used as a location for full system power disconnect Downstream of DS1 208 230 V disconnect all electrical power is removed when the Main Power Disconnect switch is in the OFF position Electrical power will still be supplied to the DS1 connections from the facility breaker s To ensure all power is completely isolated all facility breakers should be locked and tagged out as well The FT16 power plug should be removed from the wall receptacle or breaker as appropriate The following describes how to use the integral lockout mechanism associated with the main power switch 1 Ensure that if the system is connected to a facility central monitoring system that the proper division is informed of the planned electrical power disconnect 2 Tur
56. ergize LCD LED blinking Message 51 X flashes intermittently 51 92 Thermal contact in pump motor has tripped Safety cutoff Unit sees rapid shutdown Thermal overloading Possible causes conditions HTF pump stops Compressor stops jc Pidnedamsenriccous Heaters de energize LCD LED blinking 2 One of the three phases missing in the Message 51 X flashes intermittently mains voltage 51 94 Hot gas temperature compressor outlet Safety cutoff Unit sees rapid shutdown too hot and above threshold for too long conditions HTF pump stops Compressor stops Possible causes Heaters de energize LCD LED blinking Not enough cooling to the refrigerant stage Message 51 X flashes intermittently cooling water problem 52 X Status of Controller During re boot compressor pump and heater Controller reset Controller watchdog initiates a Controller re boot stop After reboot if successful Control Keypad continues temperature control where it left off Safety stop HTF pump heaters compressor turned off 53 X Expansion valve reset Multiple instructions given to valve This occasional message is normal When often seen message code is an Indication of possible gradual failure of the stepper motor or valve Code 60 Controller messages and warnings Analyze with Program 10 Warning only Machine does not stop 60 30 60 35 Initializing tests were not passed the None first time s
57. es Open Light Agitation Manual Start Plates Closed Light Agitation Manual Stop Figure 1 3 FT16 Power Control Panel Front View The green Power Indicator Light indicates when power is present in the FT16 208 230 VAC and 24 VDC When power is present the light is illuminated WARNING Even when the light is off one or more voltages may still be present e g 24 VDC is off 1 5 2 1 2 Status Indicator Light 1 5 2 1 3 Plates Open Light 1 5 2 1 4 Plates Closed Light 1 5 2 1 5 Emergency Stop Button 12 Introduction The amber Status Indicator light will illuminate to indicate the FT16 heat transfer plates and the front access door are in the closed position and the VFD is in a no fault condition The Status Light must be illuminated to initiate agitation The blue Plates Open light will illuminate when the FT16 heat transfer plates are in the fully open position The white Plates Closed light will illuminate when the FT16 heat transfer plates are in the fully closed position The plates must be in the fully closed position to complete the agitation interlock circuit When this light is illuminated along with the amber Status Indicator light it indicates that the FT16 is ready for freeze thaw operations The Emergency Stop button will immediately remove power from the FT16 agitator motor and plate actuator To reset the unit s controls following an Emergency Stop twist or pull out the Emer
58. et 5 0 Ent 2 A is displayed on the LCD signifying enter passcode Press 1 7 Ent 3 The system displays the message Acces when a correct passcode is entered giving the operator access to the system and Denied when an incorrect passcode is entered 4 Once this passcode has been entered it is possible to Edit the profile settings found in Program 20 and 21 4 3 1 2 Passcode Process Operation A specific passcode is required in order for a user to abort a process that is in operation prior to the completion of the full profile duration Once entered and accepted this passcode will time out after 3 minutes 1 Using the keypad on the control keypad press Set 5 0 Ent 2 A is displayed on the LCD signifying enter passcode Press 4 1 Ent 3 The system displays the message Acces when a correct passcode is entered giving the operator access to the system and Denied when an incorrect passcode is entered 4 Once this passcode has been entered it is possible to abort the currently running process 433 2 Setting Date and Time 4 3 2 1 Date The date is entered in the format YY MM DD e g 07 02 27 for February 27 2007 To set the date follow the following steps a The date format displayed with program 32 is DD MM YY e g 27 02 07 Select program 30 Set 3 0 Ent Enter the year as the last 2 digits in the current year a
59. ezing Program Temperature Profile 1 2 1 Space Requirements rernm ERR 17 44 4 Thawing Program Temperature Profile 2 2 2 Load Bearing Surface 0 cece eee eee eee 17 45 Data Recorder 2c cece eee ees 2 3 Unpacking and Positioning the Equipment 17 23 1 CRYOPIOEC sae ee ster nee ere pe pud 18 5 Emergency Stop seeded eek ER es 2 3 0 FT16 Freeze Thaw Module 18 5 1 CryoPilot C Emergency Off 20055 2 4 Equipment Inventory 00 cece eee eee 19 5 1 1 CryoPilot C Stop Operation 2 5 Tools and Utilities Required for Installation 19 5 2 FT16 Module Emergency Stop Button 2 6 Serial Numbers 2 cones cebRRR Tet gaa eR RR 20 2 6 1 CryoPlloE Cersei nep rtt doa ps 20 6 Daily Operation 0 0000 cee eee 2 6 2 FG java chee beber ei rs 20 6 1 System Startup Quick Checklist suse 2 7 Installation and Sub System Assembly 21 6 2 FT16 Use and Operations 0000005 2 1 1 CYOPIOUC coii ere bRrE raisi re mre 21 6 2 1 Loading a Celsius Pak into a 2 7 2 FT16 Module and Power Control Celsius Pak Frame ssssessssesese Panel Assembly cece ee eee 25 6 2 2 Use of Transfer Carts or Storage Modules 2 13 Signal Electrical Power Connections 6 2 3 Celsius Pak Loading Empty for System Operation 00 26 6 2 4 Filling the Celsius Paks suse
60. facility supply valves should be closed locked and tagged out The following procedure is intended to provide a basic guidance for safe system entry 1 2 Locate and close all facility coolant supply and return valves Lock and tag out facility supply and return valves in accordance with company policy and procedures The cooling system will still be under system pressure when the supply and return lines are shut off Slowly remove the coolant drain cap located at the rear of the CryoPilot C If possible ensure power to the CryoPilot has been turned OFF If quick disconnects were installed at the rear of the CryoPilot disconnect fittings Slowly loosen coolant supply and return lines from connections located on the back of the unit and allow coolant system pressure to slowly vent and drain Commencement of maintenance and or repair activities should not occur prior to system being vented and drained to the fullest extent possible Allgemein 85 Sartorius Stedim Biotech GmbH August Spindler Str 11 37079 Goettingen Germany Phone 49 551 308 0 Fax 49 551 308 32 89 www sartorius stedim com Copyright by Sartorius Stedim Biotech GmbH Goettingen Germany All rights reserved No part of this publication may be reprinted or translated in any form or by any means without the prior written permission of Sartorius Stedim Biotech GmbH The status of the information specifications and illustrations in this manual is indic
61. fluids that are slippery if spilled on the floor The use of a drip pan can be required as a means of avoiding a potentially hazardous spill around component connections during maintenance Refer to the corresponding Material Safety Data Sheet MSDS for information on handling of spills 4 Heat transfer fluids are combustible liquids and must be handled as such Refer to the corresponding MSDS provided with the HTF for information on proper handling 5 Do notstretch the CryoHoses in order to attach them to the Freeze Thaw Module This may cause leaking from the connections and damage to the CryoHoses Allow adequate slack to prevent hose kinks and to allow for motion during agitation 6 System components are heavy follow proper lifting and rigging techniques in accordance with company policy and procedures When lifting equipment two or more personnel are required to assist to prevent damage to equipment or injury to personnel 1 Only qualified personnel must perform service of the refrigeration equipment 2 Refrigerant gas is not to be vented to the atmosphere it must be handled according to regulations set by the local environmental authorities R 507 is a fluorocarbon type material and subject to environmental regulations Introduction 7 1 3 3 FT16 Freeze Thaw Module 1 3 4 Celsius Paks and Celsius Pak Frames 1 4 Celsius Freeze Thaw Technology p Figure 1 1 Celsius CryoPilot C Freeze Thaw Syste
62. gency Stop button to disengage and press the Reset button on the Power Control Panel 1 5 2 1 6 Agitation Mode Selector 1 5 2 1 7 Agitation Manual Start 1 5 2 1 8 Agitation Manual Auto Stop 1 5 2 1 9 Plate Actuation Switch 1 5 2 1 10 Power Switch 1 5 2 1 11 Reset Button 1 5 2 2 FT16 Freeze Thaw Module Specifications The Agitation Mode Selector has three modes Hand manual Off and Auto auto matic When the switch is positioned to the left the agitator is in HAND mode and its motion can be started and stopped manually When the agitator selector is in the center position it is in the OFF mode which disables the agitator When the selector is in the right position it is in the AUTO mode and the agitator is controlled by the CryoPilot C With the Agitator Mode Selector in HAND mode the manual Start button will initiate the agitator s motion to the maximum programmed RPM of 90 RPM The heat trans fer plates must be in the closed position and the access door must be closed in order to start agitation With the Agitator Mode Selector in the HAND or AUTO mode the manual Stop button will stop the agitator s motion The Plate Actuation Switch both opens and closes the FT16 heat transfer plates To open the plates rotate and continue to hold the switch to the open position until the plates automatically stop in the open position To close the plates rotate and continue to hold the switch to the closed position unti
63. gure 1 2 CryoPilot C Controller Control Controller Keypad and Data Recorder 1 5 1 6 Microprocessor 1 5 1 7 Data Recorder 1 5 1 8 CryoPilot C Thermal Control 10 Unit Specifications Introduction The HTF reservoir serves as an expansion vessel for the HTF The reservoir is designed to hold slightly more HTF than required for filling the HTF loop The Controller is the black box located on the front top right of the CryoPilot C Figure 1 2 The control keypad is mounted on the front of the Controller and is the operator interface to the Controller The Controller contains a microprocessor that performs many of the internal control functions The Controller contains an EPROM erasable programmable read only memory chip that holds the CryoPilot C control software The CryoPilot system uses a paperless data collection device for recording the HTF supply and return temperatures Figure 1 2 The recorder operates independently of the CryoPilot C control system The standard recorder offered by Sartorius Stedim Biotech is the Eurotherm Chessell 6100A Power feed US 208V 3 596 60Hz 40A breaker minimum 3PH Power feed EU 400V 3 596 50Hz 32A breaker minimum 3PHN Fluid temperature range 55 C to 200 C 67 F to 392 F Default maximum setpoint is 35 C Temperature stability 1 C 1 8 F Heating capacity 6 kW 20 478 Btu hr Reservoir maximum volume 17 L 4 5 gal Heat transfer fluid
64. he CryoPilot C and the agitation speed of the FT16 in RPM For a basic record of parameters set refer to Manual M 0021 Basic Configuration Guide for the Eurotherm Chessell 6100A Data Recorder Additional information can be found in the Eurotherm Chessell Model 6100A 6180A 100 and 180 mm Paperless Graphics Recorders User Guide 4 1 Programming Overview 4 System Controls Configuration This chapter is intended to provide the user with an overview of the CryoPilot C Con troller and Control Keypad as well as system operational configuration and parame ters These are base instructions for verifying and changing the following CryoPilot C Controller settings Access Passcode Date and Time Serial Communication Parameters Language Controller Board and EPROM Version Numbers Manual Air Purge Heating Capacity Setting Cooling Capacity Setting Restoring Factory Defaults Device Message Review Temperature Profiles Throughout this manual instructions are given to enter a program or set a value by pressing specific keys The keys to be pressed will be listed inside the symbols less than and greater than For example the instruction to enter a temperature set point for the heat transfer fluid which requires that one enter Program 0 and then enter the set point of 20 5 will be given as follows SET 0 ENT SET 2 0 lt gt 5 ENT This shorthand notation desc
65. he HTF circuit 6 The message Check Pump will be intermittently displayed Once air is purged and pump discharge pressure interlock clears the message Check Pump OK will be displayed briefly HTF loop flow LED lights flash intermittently and stabilize once interlock clears and system enters into profile operation The refrigerant line equalization valve opens and allows for a safe compressor start up 7 The compressor initiates and system temperature control seeks start temperature of TP2 1 Times will vary depending on system starting temperature Once the Start Temperature of TP2 is achieved a possible one time message display of TP prepare may be displayed and the actual profile operation will commence 8 The audible warning horn will sound prior to the agitation operation Ensure that FT16 agitation initiates once TP2 is active 9 Allow the thaw profile to run to completion Upon completion of the thaw the FT16 agitation will stop and the thaw process will advance to the hold The message display on the LCD will intermittently read THAWING COMPLETE until an operator stops the process 10 Press the red stop button on the control keypad The 2 Line LCD display will read termin process 0 NO 1 YES 11 Press 1 to end the thawing process 12 Open the FT16 heat transfer plates fully as indicated by illumination of the blue Plates Open light 13 Open the front access door of the FT16 and usi
66. hread MNPT fitting labeled Oil Flow and Oil Return The recirculating loop is under pressure when the system is operating CAUTION Do not stretch the CryoHoses in order to attach them to the FT16 This may cause damage to the hoses resulting in leaks Allow adequate slack CAUTION During CryoHose installation ensure adherence to the minimum bend radius requirements listed in section 1 5 3 2 7 5 1 CryoHose to CryoPilot C Connection 1 Thread one of the flange couplings to the supply and return ports located on the left side of the CryoPilot Note The Supply and Return CryoHoses are different lengths The longer length CryoHose should be installed as the SUPPLY hose and the shorter is to be used as the RETURN hose 2 Thread the 90 degree elbow into the other half of the flange coupling Thread the elbow and the flange coupling to the CryoHoses 4 Using the adjustable wrench with the pipe wrench for proper counter torque ensure that the CryoHose connections are adequately tightened 5 Place the flange coupling o ring into the groove on the appropriate flange face 6 Align the holes of the flanges such that the orientation of the CryoHose is directed 45 degrees down from the horizontal and facing in the forward direction 7 Apply food grade anti seize to the four flange bolts and insert the bolts through the holes of the flanges 8 Place a flat washer a lock washer and
67. ich the Thermal Control Unit is permitted to heat cool the heat transfer fluid Over temperature Protection Each CryoPilot C unit is equipped with over temperature protection The over tem perature protection operates completely independently of the Controller i e it can not be influenced through the Controller If at least one temperature sensor reports that a temperature limit has been exceeded the thermoregulation process is stopped at once POKO Potential Free Contact The POKO is a changeover contact led through the POKO relay in the Controller The potential free contact is designed for an ohm resistive load up to 30 V and a maximum of 0 1 A Process Process is an operation in which the CryoPilot C unit is controlled according to a predefined profile Profile A user defined recipe containing one or more steps each of which specifies HTF temperature setpoint and agitator operation Program The Controller provides programs for the user to operate the thermal control unit to monitor and control statuses and processes and to modify system operational parameters R 507 The refrigerant used in the CryoPilot C R 507 or equivalent AZ 50 is a mixture of hydrofluorocarbon refrigerants It is an azeotrope nonflammable and has no ozone depletion potential Ramp This is a control of how fast the CryoPilot is allowed to change the temperature setpoint every minute in Kelvin for Sartorius Stedim Biotech applications This
68. implified scale up into commercial scale production The small scale system configurations are designed to reproduce the controlled freezing thawing and storage processes that occur in the large volume production scale Celsius Paks to allow for system characterization in the laboratory The following symbols indicate important information for users Table 1 1 Definition of Symbols Used In This Document Danger This symbol accompanies notes that alert the user to definitely hazardous situations that when not avoided will result in severe injury or death to personnel Warning This symbol accompanies notes that alert the user to potentially hazardous situations which if not avoided could result in death or serious injury Caution This symbol accompanies cautionary notes that alert of potential personnel safety hazards or of potential damage to equipment or property This symbol accompanies notes related to equipment maintenance This symbol accompanies notes that relay information The following datasheets can be referenced with this manual to provide additional information regarding Celsius Paks CryoWraps CryoHoses transfer carts and storage modules 1 Celsius Pak Disposable Containers for Controlled Freeze Thaw Datasheet 2 Celsius System Logistic Accessories Datasheet 3 M 0018 FS16 Fill Station User Manual 4 M 0021 Basic Configuration Guide for the Eurotherm Chess
69. ing Message 51 X flashes intermittently 51 54 Relay K3 KM3 and K2 KM1 falsely seated or stuck Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 55 Relay K2 KM1 pulled in but not K3 KM3 Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 58 Contactor K2 KM1 has dropped out Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 59 Contactor K2 KM1 is stuck Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 60 Contactor K2 KM1 is chattering Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 61 Contactors K3 KM3 and K2 KM1 have failed Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 62 Contactor K5 KM3 1 is vibrating Safety cutoff Unit sees rapid
70. ive HTF see Section 9 5 1 Check for system alarms Verify that all CryoHoses are installed and CryoWraps are in place Ensure communication cables are connected from the FT16 to the CryoPilot C There is approximately a 30 minute delay before the compressor can be started after switching on the CryoPilot C to allow the compressor s crankcase oil to be heated to operating temperature During this time the message No Compr Clrance will intermittently be displayed on the LCD display This section describes use and operation of the Celsius Paks and the FT16 Freeze Thaw Module CAUTION Use extreme caution when lifting or carrying individual Celsius Pak and Celsius Pak Frames to prevent injury to personnel or damage to the Celsius Pak and or Celsius Pak Frame Ensure that organizational standard safety and sanitation policies are adhered to at all times when performing the FT16 procedures described in this section When filled Celsius Paks should be preferably transferred using the Transfer Cart and Storage Module to prevent injury to personnel and damage to the Celsius Pak and Celsius Pak Frame The following procedure is illustrated using the 16 6 L Celsius Pak and CF16 Pak Frame The instruction steps are applicable to the 16 6 L Celsius Pak with CF16 and the 8 3 L Celsius Pak with CF8 CAUTION Celsius Paks and Frames are intended t
71. ivel casters and locking rear casters While only the front two casters on the TC100 and TC33 swivel all four swivel on the SM100 The casters should be locked when loading empty Celsius Pak Frames or transferring contents to and from the FT16 To lock the rear caster depress caster tab with your foot causing the tab rotation counter clockwise until motion stops To unlock the casters depress caster tab with your foot causing tab rotation clockwise until motion stops The following instruction set describes the procedure of loading an empty Celsius Pak Frame into a transfer cart The supporting images show an empty 16 6L Pak Frame being loaded into a TC100 transfer cart The basic loading sequence is identical for the TC33 and SM100 storage module 1 Lock the cart s two rear casters to prevent inadvertent cart movement during loading 2 Unlatch the safety cable from its horizontal up position and lower to its vertical down position for the SM100 remove the front panel 3 Grasp both Celsius Pak Frame handles and lift the empty Celsius Pak Frame to the height of the transfer cart receiving rails Slide the Celsius Pak Frame between the rails of the cart bay Continue sliding the Celsius Pak Frame to the back of the cart bay to provide room for additional frames if necessary Figure 6 8 Loading CF16 into TC100 4 Repeat step 3 until the desired number of Celsius Pak Frames have been loaded into the transfer cart
72. k The letters RE are normally the last two letters of the Controller serial number for identification and the letters BE are normally the last two letters of the Control Keypad serial number Use caution when removing and installing the Control Keypad from the Controller The Control Keypad has a 9 pin connection on the bottom that connects it to the CAUTION Controller Use caution when removing and installing the Controller from the CryoPilot unit caution Itself The Controller has a 96 pin connection on the bottom that connects it to the unit To remove the Controller perform the following Disconnect the RS 232 cable Remove the one 1 screw at the top of the Control Keypad holding it in place Tilt the Control Keypad slightly forward Carefully remove the Control Keypad from the Controller by lifting in the upwards direction 5 Remove the one 1 screw holding the Controller in place and carefully lift the Controller upwards taking care to prevent pin damage qup NI Ensure that when replacing the Controller and Control Keypad adequate care is taken during reinstallation to prevent pin damage The FT16 serial number is located on the front access door on the label plate 2 7 Installation and Sub System Assembly The CryoPilot C and FT16 units are delivered without plugs Due to the variation in local electrical receptacles the customer must supply the plug For the CryoPilot C
73. l the plates automatically stop in the closed position The FT16 door must be closed prior to plate actuation The Power Switch provides power to the FT16 The switch is on powering the FT16 when in the 12 o clock position and off when in the 9 o clock position The switch is located on the right side of the Power Control Panel while facing the front panel The Reset Button is used to reset the system following the use of the Emergency Stop Power Feed 208 230 V 50 60 Hz 1 phase Minimum Circuit Ampacity MCA 11 5 A Weight of the Base Frame and Rocker Assembly 1410 Ibs 639 5 kg Weight of the Power Control Panel 205 Ibs 93 kg Dry weight of complete system empty Approximately 1650 Ibs 748 kg Dry weight of individual heat transfer plate with plate yoke 107 5 Ibs 49 kg Maximum operational weight including full up configurations of Celsius Paks either one 16 6 L or two 8 3 L 1750 Ibs 794 kg Hold up volume approximately 1 gallon 3 8 liters Approximate overall size of the FT16 Module 62 Hx 72 Wx65 D 157 cmx 183 cmx 165 cm Approximate size of Power Control Panel 50 Hx29 Wx43 D 127 cmx 74 cm x 109 cm Materials of Construction Piping 316L stainless steel Insulation Polyethylene Door seals Closed Cell Foam Cord Hose flange O ring EDPM Plate yoke bushings Rulon 641 Main structural pieces and outer surfaces 304L stainless steel Plates 316L stainless steel Rocker Assemb
74. lation such that the electrical connections are performed first and then power is turned on While the crankcase heater is warming the compressor the plumbing connections can be made and the reservoir filled with fluid The CryoPilot C is shipped with the Chessell 6100A installed and wired in the factory Remove the panel from the top of the right side cabinet to verify that the supply temperature return temperature product temperatures and agitation signal wires have been properly wired For basic recorder wiring information refer to the applicable Sartorius Stedim Biotech Manual Chessell 6100A M 0021 Basic Configuration Guide for the Eurotherm Chessell 6100A Data Recorder Site Preparation 21 2 7 1 2 Electrical Power Connections With the CryoPilot C unit and FT16 plugged into their respective electrical supplies and Initial Power Up per Sections 1 5 1 8 and 1 5 2 2 and with the facility electrical service to the CryoPilot C Freeze Thaw System switched on perform the following actions These instructions guide the installation such that the electrical connections are performed first and then power is turned on While the crankcase heater is warming the compressor the plumbing connections can be made and the reservoir filled with fluid An electrical hazard exists when working on the CryoPilot C with its back panel off warenine While it is powered up Use extreme caution and do not touch any power wires as this co
75. lose all pinch clamps on the transfer lines Figure 6 1 Celsius Pak Pinch Clamps 3 Properly orient the Celsius Pak and the Celsius Pak Frame D The T shaped opening located on the bottom plate of the Celsius Pak Frame defines the front of the frame The front of the Celsius Pak is defined as the side that has the Celsius Pak imprint on it The front of the Celsius Pak must be installed in the same orientation as the front of the frame 48 Daily Operation Drain elbow oriented to the right Bottom T slot must face out Figure 6 2 Loading Orientation of the Celsius Pak and Celsius Pak Frame 4 Load the Celsius Pak into the Celsius Pak Frame Insert Celsius outer rods within frame rod guides Continue pulling Celsius Pak downward Until the rods stop on Insert Celsius Pak the frame rod stops Figure 6 3 Celsius Pak Loading Daily Operation 49 50 Daily Operation 5 Prepare the drain line for routing within the frame Position the drain elbow within the T slot STEP 5b Continue line routing first to the right then up and around the channel raduis Remove drain line management tie Figure 6 4 Drain Line Positioning 6 Route the drain and fill transfer lines 6 2 2 Use of Transfer Carts or Storage Modules STEP 6d v 4 wi 8 b e DI
76. lot C Freeze Thaw System Each Temperature Profile has up to 30 segments A starting temperature an ending temperature and time duration is specified for each segment When a main operation program is executed the CryoPilot C changes the temperature of the HTF in accordance with the temperature profiles being executed following each segment within those profiles There are specific tempering profiles utilized and accessed during the operation of the CryoPilot C system Section 7 These profiles are listed below They utilize the temperature profiles TP shown The configuration of each profile TP1 and TP2 is discussed in this section Program 240 is for freezing it uses Temperature Profile 1 TP1 Program 242 is for thawing it uses Temperature Profile 2 TP2 Program 20 is utilized to set temperature and time set points for each tempera ture profile Program 20 is called by pressing Set 2 0 Ent A passcode is required to access this program See Section 4 3 1 for information on entering a passcode Program 21 is used to change the temperature profiles from temperature stable to time stable see Section 4 4 2 and to set the profile starting temperature setpoint To enter temperature and time values when configuring a profile press the Temp and Time buttons on the keypad Figure 4 3 To navigate between profile segments during configuration Press the Ent button to navigate forward and the
77. ly roller wheels PET PE Supply Return fittings 34 male NPT Ambient Conditions Temperature Between 0 to 30 C Humidity Non condensing Introduction 13 1 5 3 CryoHose 1 5 3 1 CryoHose Specifications 1 5 4 Transfer Carts 14 Introduction Two CryoHoses are used for the supply and return of HTF to and from the CryoPilot C respectively The hose consists of a stainless steel bellows primary hose with a braided stainless steel covering This hose is covered by 1 2 13 mm thick layer of Armaflex insulation and a 0 06 0 015 mm outer layer of Peek Braid On each end of the hose there is a 304 stainless steel grip with a 1 4 6 4 mm lip at the connection designed to prevent slippage during hose connection Inside the can over the braid is a layer of shrink tube followed by another short section of shrink tube to seal the end of the can Pressure Rating 150 psig 10 3 bar Temperature Rating 70 C to 260 C 90 F to 500 F End connections 3 4 male NPT Minimum Bend Radius 6 inch 152 mm Materials of Construction Inner Hose 316L Stainless Steel Outer Braid Hose covering 304L Stainless Steel Insulation Armaflex 1 3 ID x 1 2 Wall Canned Hose End Grips 304 L Stainless Steel Outer Surface Peek Braid Shrink Tube Polyethylene The Celsius transfer system components consist of specially designed carts called the TC100 and TC33 designed for daily transfer of frozen
78. m 8 Introduction B Ua Moving parts can crush and cut warning labels have been placed near the rocker bearing assemblies and plate actuation mechanisms to warn users of hazards that exist during operation Do not operate the FT16 module agitation with rocker bearing guards removed to prevent injury to personnel Do not operate the plate actuation switch with any access panels removed to prevent injury to personnel Stand clear of the FT16 during agitation as its motion and weight can crush and cause serious bodily injury Prior to loading Celsius Paks into the FT16 Freeze Thaw Module ensure that the FT16 heat transfer plates have been defrosted and that all moisture has been removed This will aid in preventing damage to the Celsius Paks during freezing operations The exact method used to dry the FT16 heat transfer plates depends on require ments at the customer s facility Do not use anything that can scratch corrode or otherwise damage the plates Clean nonabrasive cloths are recommended for wiping and a rubber squeegee can also be used For all system configurations not utilizing quick disconnect couplings for the CryoHoses ensure that the system has been fully drained of HTF prior to CryoHose removal Extremely Cold Surface caution labels have been placed on the inside of the FT16 enclosure At the termination of the Freeze process the FT16 Freeze Thaw Module heat transfer plate surfaces can be 55 C or below and cont
79. ms ee 83 FT16 Power Disconnect Switch Locking Mechanism n dde IR eee etas 84 Lock Example for FT16 Power Disconnect 84 List of Tables Table 1 1 Definition of Symbols Used In This Document 2 cesses eus Table 4 1 Flow Diagram LED Functional Description Table 4 2 Standard Temperature Profile Parameters Tor Program 21 ceret arena ee Table 4 3 Example of TP1 Settings Table 4 4 Example of TP2 Settings suuesss Appendices A Glossary sessessssssee III A 1 Definitions Acronyms and Abbreviations B System Lock Out Tag Out B 1 Electrical System B 1 1 CryoPilot C B 1 2 FT16 Freeze Thaw Modules B 2 Coolant System List of Tables Appendices 1 1 1 2 Conventions Used in this Manual References Introduction 1 Introduction Sartorius Stedim Biotech offers comprehensive solutions using patented freeze thaw technologies for the handling storage transfer and shipping of biopharmaceuticals The systems use a proprietary heat transfer methodology to solidify aqueous solu tions Solutions are frozen with minimum concentration of the solutes due to freeze concentration thus reducing the risk of product loss due to degradation mechanisms aggregation and precipitation and thereby optimizing final yield Sartorius Stedim Biotech provides a full range of scalable freeze thaw systems provides tools for process development and pilot scale operation allowing s
80. n Internal was used to correct the internal temperature sensor reading the correction must be reentered following execution of Program 52 System Controls Configuration S9 4 3 10 Device Message Review 44 Programming and Configuration of Temperature Profiles Figure 4 3 Time and Temp Buttons on the CryoPilot C Control Keypad 40 System Controls Configuration Program 10 is used to scroll through recent system message and error codes All entries are time and date stamped In the event that the LED display is blinking utilize the Device Message Program to identify the cause s 1 Select Program 10 Set 1 0 Ent 2 Error messages are displayed as error codes in the numeric format such as 51 20 and include the time and date at which they occurred Toggle through the list of messages by pressing the following keys Ent moves forward and moves backward 3 Write down all message and or error codes with time and date The CryoPilot C is designed to dynamically regulate the temperature of the cooling media the heat transfer fluid or HTF circulating through its evaporator and electric heater Precise temperature set points and configuring temperature profiles specifies temperature ramp rates These profiles are used in the main freeze thaw operation programs to achieve the desired cooling and thawing functions There are nine possible temperature profiles Only two are implemented in the CryoPi
81. n the Main Power Disconnect switch to the OFF position 3 Once in the OFF position perform the following see Figure 11 2 Figure 11 2 FT16 Power Disconnect Switch Locking Mechanism A Note the circular tab behind the power disconnect handle B Push this forward and out C Pull the locking mechanism 4 Once the locking device has been fully pulled out insert the appropriate locking device in accordance with company policy and procedure An example of an inserted lock is shown in Figure 11 3 5 Prior to working on the system allow 15 minutes to fully discharge the capacitor located in the VFD 6 As with all equipment to ensure that electrical power is completely removed from the system it is important to lock and tag out all facility breakers and or disconnect wall receptacle plugs as appropriate Figure 11 3 Lock Example for FI 16 Power Disconnect 84 Allgemein B 2 Coolant System To function correctly each CryoPilot C unit requires an external coolant to remove heat from the refrigerant The coolant may reach supply pressures up to 6 bar 87 psi The connections are 1 2 inch male BSPP and are located at the rear of the unit No integral components are utilized with Lock out Tag out capability In the event that system maintenance and or repair is to be performed requiring system plumbing entry it is important to remove source of coolant and to ensure pressure has been vented from system All local
82. nata ccc cece eee eee 34 Flow Diagram LED display 35 Time and Temp Buttons on the CryoPilot C Control Keypad cece eee eee eee 40 Freezing Profile Temperature Profile1 43 Thawing Profile Temperature Profile 2 44 FT16 Emergency Stop Button 46 Figure 6 1 Figure 6 2 Figure 6 3 Figure 6 4 Figure 6 5 Figure 6 6 Figure 6 7 Figure 6 8 Figure 6 9 Figure 6 10 Figure 6 11 Figure 6 12 Figure 9 1 Figure 9 2 Figure 9 3 Figure 9 4 Figure 11 1 Figure 11 2 Figure 11 3 Celsius Pak Pinch Clamps LL 48 Loading Orientation of the Celsius Pak and Celsius Pak Frame 5 49 Celsius Pak Loading lsssssssssss 49 Drain Line Positioning 50 Routing the Transfer Lines 51 Transfer Cart with Safety Cable 52 Transfer Cart Caster Locked and Unlocked POSITIONS ca etc oe tamea 52 Loading CF16 into TC100 53 Inserting RTD Probe into Locking Collar 53 RTD Insertion into Celsius Pak 54 RTD Holder Installation on to Celsius Pak Frame Pc 54 FT16 RTD Junction Positions 55 Coolant Supply Y Strainer 71 Pump Seal Drain Leak Detector Port 73 HTF Drain Valves in Closed and Open Positions 74 FT16 Supply and Return Flange Couplings 75 CryoPilot C Power Disconnect Switch Locking Mechanism a aie
83. nd compressor electrical power too low 15 16 Controller electrical power too high 15 32 Pump electrical power high 15 64 Compressor electrical power too high 15196 Pump and compressor electrical power too high Machine shutdown Rapid shut down conditions HTF pump stops compressor stops heaters de energize LED display blinks and message 15 x flashes intermittently 31 X Data exchange between Control Keypad and Controller interrupted No communication between the Control Keypad and the Controller Possible causes 1 D pin connector damaged 2 Pin corrosion 3 Foreign material in the terminal ports Machine shuts down after a 30 second internal Controller watchdog timeout Machine sees rapid shut down conditions HTF pump stops Compressor stops Heating de energized 34 X A defect in data memory range for the tempering program has occurred The contents of the segments should be checked See program 20 Warning only Program X checksum error Blocks program X start 41 X No pressure in HTF circuit Possible causes 1 Pump failure 2 Low HTF level 3 Airlock in HTF Safety shutdown Unit will not operate If this code is activated LCD LED will blink Basic Troubleshooting 59 Message Error Codes Description Machine Actions 43 X Collection error A group of sensors has been grouped together and one has failed Causes are model depe
84. nd press Ent Enter the month as a 2 digit number and press Ent Enter the day as a 2 digit number and press Ent Pops Nu 4 3 2 2 Time The time is expressed in 24 hour format Hr Min e g 1 30 PM is displayed as 13 30 To set the local time use the following steps Select program 31 Set 3 1 Ent Enter the hour and press Ent Enter the minute and press Ent Select program 32 to verify that the correct date and time is displayed Set 3 2 Ent Pep Ne 4 3 3 Serial Communication Parameters Slave address must be set to 1 in program 84 Set 8 4 Ent 2 Host baud rate must be set to 9 600 or 9 6 in program 85 Set 8 5 Ent 3 RS232 serial communication must be selected in Program 86 Set 8 6 Ent The LCD display should read RS232 is active 36 System Controls Configuration 4 3 4 Language Selection 4 3 5 EPROM Version Numbers 4 3 6 Manual Air Purge 4 3 6 1 Alternate Air Purge Stop 43 7 Heating Capacity Setting 4 3 8 Cooling Capacity Setting 4 3 9 Restoring Factory Defaults Program 90 is the language selection program Set 9 0 Ent Press 1 for German Press 2 for English Press 3 for French Program 98 identifies the EPROM versions of the Controller and Control Keypad Set 9 8 Ent Manual Air Purge can be performed prior to system start up to ensur
85. ndent Machine shuts down Rapid shut down conditions HTF pump stops compressor stops heaters de energize LED display blinks message 43 x flashes intermittently on LCD display 44 X Unit type error Unit type is not recognized Found during power on self test Possible causes 1 Controller defect Control Keypad defect Control motherboard defect EPROM failure Bor cm Machine cannot be started LED display blinks Message 44 X flashes intermittently on LCD display Code 46 Sensor measurement specified by the index is outside the permitted limit 46 1 internal sensor Pt100 46 2 external sensor Pt100 46 4 condensing temperature sensor Pt100 46 8 Evaporator end sensor Pt100 46116 Pressure sensor for vapor pressure in refrigerant circuit If more than one error appears the Controller will sum the indices for example 46 6 external Pt100 and condensation sensor or condensing pressure sensor 0 30 bar Safety shutdown LCD LED blinking Error code 46 X shows intermittently on LCD display 49 79 HTF overheat When only the pump is turned on the recirculated value exceeded the maximum set point but is still under the over temperature cutoff limit Overheat may be caused during air purge due to pumping with no refrigeration Does not occur during normal operation Pump switched off to allow HTF to cool down Code 51 51 XXX Univers
86. nes 3 Remove the rear panel from the CryoPilot 4 Remove the cap from the drain line and drain the liquid coolant lines 5 Check the cap gasket for damage and replace as necessary 6 Slowly remove the hexagonal plug on the screen housing Behind this is the screen element 7 Remove the screen element and clean it with a water jet Replace it if it is broken 8 Re insert the element and replace the plug 9 Re cap the drain line 10 Clean up any residual coolant from the unit internal housing and the surrounding areas 11 Open the coolant inlet and outlet lines Check for leakage and tighten as necessary 12 Install the rear panel 13 Reconnect the electrical plug and turn the facility electrical to the ON position The small capped line next to the coolant inlet outlet connections is a drain normal ly used to prepare the unit for shipping For coolant systems having excessive calcium deposits decalcification may be periodically required if a loss of heat transfer is noted in the condenser The drain can also be used as a bypass of the coolant regulator during system decalcification if required see Section 10 for Contact Information DANGER Electrical hazards and Rotating Machinery hazards exist when working on the CryoPilot C with its panels off while it is powered up Use extreme caution and do not touch any power wires or perform any system operations as this could result in severe injury or death
87. ng a Transfer Cart or Storage Module remove the thawed Celsius Pak s and transfer to the final destination 8 1 Controller Text Message Warning Descriptions 8 Basic Troubleshooting The following section discusses possible error codes and display messages that might be encountered during normal operations The following are common messages that are displayed on the CryoPilot LCD 8 2 Error Code Matrix Message Error Codes 1 Pump running The pump continues to run after the red stop button has been depressed to allow for the removal of heat from the heating chamber 2 No compr clrance The 30 minute time delay has not been allowed to clear 3 Air purging Pump is operating intermittently on and off for a preset amount of time to allow for pump priming and the removal of air from the HTF loop prior to operation to prevent abnormal conditions imposed by air pockets 4 No Flow HTF pump discharge pressure sensor does not see enough pressure to clear the compressor lock and allow compressor operation or temperature control To access the Message and Error Codes of the system see Section 4 3 10 The following codes are identified as possible system shutdown explanations Description Machine Actions 15 X Electrical power input value different to the programmed value 1511 Controller electrical power low 15 2 Pump electrical power too low 15 4 Compressor electrical power too low 15 6 Pump a
88. ny time while running manually press the red Stop button 15 on the bottom of the CryoPilot C Control Keypad There may be a short delay while the unit prepares for a safe shutdown FI16 Module Emergency Stop Button The FT16 Emergency Stop button is located on the front of the FT16 Power Control Emergency Stop Panel located to the right of the FT16 Module itself Once the Emergency Stop is depressed the unit must be reset by pulling out or twisting the Emergency Stop button to release and then depressing the Reset button located to the right of the Emergency Stop button Figure 5 1 FT16 Emergency Stop Button 6 1 6 2 6 2 1 System Startup Quick Checklist FT16 Use and Operations Loading a Celsius Pak into a Celsius Pak Frame 6 Daily Operation The following are items that should be checked prior to commencement of daily system operation Ensure that power is supplied to the CryoPilot C and that the LCD is illuminated Ensure that power is supplied to the data recorder and that the touchscreen is illuminated Ensure that power is supplied to the FT16 Module and that the green Power light is illuminated Ensure that the Heat Transfer Fluid level is appropriate for system operation Ensure that the facility cooling supply and return valves are in the open position Visually inspect area for system leaks Check the pump seal leak detector at the rear of the unit for excess
89. o be handled only as described in this manual and in the referenced standard operating procedures Mishandling Celsius Paks can result in damage to the Freeze Thaw System the Celsius Pak or product loss Fd Prior to Celsius Pak Frame use ensure that all hex head and pan head screws are tightened Daily Operation 47 6 2 1 1 Preparation of Celsius Paks for Use This section describes the basic procedures for preparing the Celsius Paks and Celsius Pak Frames for use with the FT16 Freeze Thaw Module The use of a transfer cart is recommended for safe filling transport and freeze thaw operations Depending on the application refer to the following Sartorius Stedim Biotech references for more information SOP 200 0028 Non Pressurized and Pressurized 16 6L Celsius Pak General Use Procedures SOP 200 0030 Celsius Pak with KPC Filling Pressurizing and Emptying Procedure Using the FS16 Perform a full visual inspection of the Celsius Pak Frames to verify that no damage CAUTION exists Any Frame defect can result in damage to the Celsius Pak Exercise extreme care not to damage the Celsius Pak or associated tubing when caution Opening the pouches D Ensure that organizational standard safety and sanitation policies are adhered to at all times when performing the procedures described in this section 1 Remove the Celsius Pak from the outer protective pouches 2 C
90. o they were repeated 60 45 The circulation pump is in danger of None running dry at the start of tempering with green key 9 it was not possible to build up a stable fluid circulation Cause action see message 41 0 60 150 New start of Controller None 601151 Temporary fault on the RS232 Controller control unit 60 153 Superheat too low for longer than expected Warning only duration of time 60 154 Superheat collapsed and for a period of time was uncontrolled 601156 Suction pressure temporarily dropped 68 Basic Troubleshooting Message Error Codes Description Machine Actions 60 157 Compressor automatic status changed via program 35 60 158 Temperature measuring changed via program 68 should never be changed in CryoPilot applications 60 159 Temperature measuring changed via program 69 should never be changed in CryoPilot applications 60 165 Warning Controller reset noted Warning only 60 170 Echo Fail Communication problem between Warning only Controller and Control Keypad Command is automatically repeated 601173 This EPROM can not be used with Unistat 16X Unit will not run 61 X During power on self test correction values in Offset is returned to normal External Pt100 sensor parameter memory for the external Pt100 sensor was set to 0 62 X Internal Pt100 sensor During power on self test correction values in parameter memory for the internal
91. on TP2 Segment 4 2 Segment 2 Thawing h Complete eo Indefinite r Hold Segment 3 J Segment 5 4 Agitation Active Agitation Stops Segment 1 Figure 4 5 Thawing Profile Temperature Profile 2 4 4 4 1 TP2 Configuration Procedure Enter the Edit Profile mode in accordance with Section 4 3 1 1 Access Program 20 lt Set gt lt 2 gt lt 0 gt lt Ent gt Choose Temperature Profile 2 by pressing lt 2 gt Select Segment 1 by pressing lt 1 gt lt Ent gt Enter the appropriate values of each segment of the temperature profile for the desired application To enter temperature and time values when configuring a segment press the lt Temp gt and lt Time gt buttons on the keypad Once the desired temperature and Time values have been entered Press lt Ent gt to advance to the next segment Refer to Table 4 4 for an example of standard TP2 parameters OT ee ists Q Table 4 4 shows an example of standard Sartorius Stedim Biotech application settings used during performance of Factory and Site Acceptance Testing The settings listed are only to be used as a reference for creating a profile suitable for the desired application Note that the Start Temperature in each segment is automatically taken from the previous segment s End Temperature Table 4 4 Example of TP2 Settings Segment Start Temp C End Temp C Time Duration min 2 1 18 0
92. on will commence 8 Allow the freeze profile to run to completion Upon completion of the freeze process the message display on the LCD will intermittently read FREEZING COMPL until an operator stops the process 9 Press the red stop button on the control keypad The 2 Line LCD display will read termin process 0 NO 1 YES Tempering Process Operations 57 7 2 58 Performing Thawing Operations Tempering Process Operations 10 Press lt 1 gt to end the freezing process 11 Open the FT16 heat transfer plates fully as indicated by illumination of the blue Plates Open light 12 Open the front access door of the FT16 and using a Transfer Cart or Storage Module remove the frozen Celsius Pak s and transfer to the final destination To initiate the Thaw Process perform the following operations 1 Ensure that Celsius Pak s are loaded into the FT16 Module and that the front access door is closed 2 Ensure that the FT16 heat transfer plates are in the fully closed position as indicated by the illumination of the white Plates Closed light 3 Ensure that the amber status light is illuminated 4 Initiate Program 242 by pressing Set 2 4 2 Ent The 2 Line LCD display will read THAWING 0 NO 1 YES 5 Press 1 to initiate thawing operations The HTF Pump goes through start up sequence and any remaining air is purged automatically from t
93. onent of a Temperature Profile Start Temperature in each segment is automatically taken from the previous segment s End Temperature Each profile can have up to 30 active segments Stability This parameter will control how the unit proceeds through the profile itself Temperature Stable A profile will not be allowed to advance to the next segment until the ending temperature is reached Time Stable Once the programmed segment time has elapsed a profile will advance to the next segment regardless of temperature Start Ramp This is a control of how fast the CryoPilot is allowed to change temperature every minute in Kelvin for Sartorius Stedim Biotech applications This setting should always be set to 40 0 to ensure that the CryoPilot will utilize the maximum capacity to reach the programmed temperature setpoint Starting Temperature This is the temperature that the heat transfer fluid must reach before the profile is allowed to actually engage and begin the countdown Temperature Profile A tempering profile made up of single or multiple segments designed to achieve desired process results for individual products Temperature profiles are embedded into the process control programs Program 240 242 and 243 System Controls Configuration 41 44 2 Entering Temperature Profile 4 4 2 1 Configuring Program 21 Parameters Operating Limits Program 21 44 3 Freezing Program 42 Temperature Profile 1 System Controls
94. or liquid filled Celsius Paks A detachable long term storage module called the SM100 is optimized for use as a frozen storage solution When used with the Celsius system the transfer carts and storage module minimize Celsius Pak Frame lifting and manual handling throughout the Celsius system process The carts and module contain Bays or Celsius Pak Frame compartments The number of bays defines the capacity of the cart or module The carts and the module physically support the Celsius Pak Frames on a surface which matches the elevation of the FT16 receiving bay allowing the Celsius Pak Frames to be trans ferred to and from the FT16 with a sliding motion without lifting In addition the transfer carts and the storage module contain docking features which align the carts and module with the corresponding FT16 receiving bay The available transfer systems The TC100 transfer cart This cart is configured with three bays Each bay capable of holding two 16 6L Celsius Pak Frames CF16 or four 8 3L Celsius Pak Frames CF8 which provides approximately 100 liters of total product carrying capacity The TC33 transfer cart This cart is configured with two bays Each bay capable of holding one 16 6L Celsius Pak Frame or two 8 3L Celsius Pak Frames which provides approximately 33 liters of total product carrying capacity The SM100 storage module The SM100 cart has the same capacity as the TC100 cart but includes pr
95. orm the following pie e e e te te Turn power to the unit OFF Unplug the unit from the facility power supply Figure 2 6 Phase Detection Relay Swap 2 phases within the plug i Light F4M1 Plug the unit back into the facility power supply Repeat steps 7 and 8 Q After swapping phase if the light is still does not illuminate contact Sartorius Stedim Biotech see Section 10 for contact information 10 Position the Control System Power switch the black rocker switch on the front panel of the CryoPilot C located below the Control Keypad to the OFF position 11 Turn the Main Power breaker to the OFF position 12 Replace the electrical panel cover at the rear of the unit 13 Turn the CryoPilot C Main Power switch to the ON position 2 7 1 2 1 Power up of Controller This section will quickly familiarize personnel with the LCD and LED displays on the front of the CryoPilot C Controller Refer to Section 4 to become familiar with the operation of the Controller 1 Position the Control System Power switch the black rocker switch on the front panel of the CryoPilot C located below the Control Keypad to the ON position Figure 2 5 2 Verify that the two line LCD and green temperature LED displays on the Control Keypad illuminate If they do not verify that power is available to the CryoPilot C unit If power is available to the CryoPilot C unit but the Controller does not come on contact Sartorius
96. osition the FT16 module so that the CryoHoses can be connected to the right of the CryoPilot C when facing the Control Keypad 9 When the FT16 is set in its permanent location level the unit using the four seismic mounting feet 10 Place related additional parts i e CryoHoses etc near the final placement of the FT16 module Remove any shipping material from the interior of the FT16 Leave the wood blocks between the heat transfer plates until such time as they are removed by a Sartorius Stedim Biotech representative 1 1 Remove the packing slip check the crate for damage and document if necessary 2 Remove the front panel and the top panel from the shipping container remove the packaging material and any loose parts 3 Cut the strapping material security bands and remove all the supports connecting the power control panel to the shipping pallet 4 Guide a forklift under the side center of the unit with the aid of another person to the unit from tipping Lift slowly 5 Remove the drip pan from the shipping container 6 Be attentive while unpacking and collect any parts that may have been detached from the unit prior to shipment 7 Verify that all contents match the packing slip and have not been physically damaged during shipment 8 Position the Power Control Panel to the right of the FT16 module in preparation for attachment 9 Place related additional parts i e Drip Pan CryoHoses etc near the final pl
97. ossible causes 1 Heater fuse blown breaker tripped 2 Solid state relay failure 3 Faulty Controller conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message heater fuse intermittently displayed Basic Troubleshooting 63 Message Error Codes Description Machine Actions 51 31 Fine heating test failure current measured Safety cutoff Unit sees rapid shutdown of actuated K1 KR1 and fine heaters too low conditions HTF pump stops Compressor stops Possible causes Heaters de energize LCD LED blinking 1 2 amp fuse in the back of the Controller blown Message 51 X flashes intermittently 2 Small K1 KR1 connection found on circuit board A4 A9 2 may not work 3 Faulty Controller 4 If current to the fine heaters found to be operating properly the cause may be faulty current transducer TR1 51 34 Suction pressure evaporation temperature Safety cutoff Unit sees rapid shutdown could not be pulled down the suction pressure conditions HTF pump stops Compressor stops measured by pressure transducer A6 A15M3 Heaters de energize LCD LED blinking does not read as expected Possible causes Message 51 X flashes intermittently 1 Possible thermo overload tripping 2 If compressor is running and an error message of 51 3 is seen prior to this error a possible defective compressor 3 Suction pressure transducer reading incorrectly 4 Steppe
98. otective outer panels which encapsulate the module contents The front panel is removable for access into the cart In addition module s can be separated from its wheeled base creating a more space efficient cold storage container Figure 1 4 TC100 Transfer Cart and SM100 Storage Module 1 5 5 CryoWrap The CryoWrap is a neoprene sleeve which when wrapped around CryoHose connections limits frost build up during FT16 module freezing Figure 1 5 CryoWraps Introduction 15 1 5 6 Celsius Paks and Celsius Pak Frames Figure 1 6 8 3 Land 16 6 L Celsius Pak in Frames 1 5 6 1 Celsius Pak 1 5 6 2 Celsius Pak Frame 16 Introduction The Celsius Frame Assembly consisting of the Celsius Pak and Pak Frame introduce greater product robustness throughout the process cycle The system utilizes the single use sterile Celsius Pak to hold the biopharmaceutical solution to be processed which is situated within the reusable structural Celsius Pak Frame allowing biopharmaceutical freeze thaw and storage The Celsius Paks and Celsius Pak Frames are available in 16 6 L and 8 3 L volumes They are offered as the 16 6 Land 8 3 L Celsius Paks and the CF16 and CF8 Pak Frames respectively All Celsius Paks used for Celsius systems are of the same material of construction and have the same freeze and thaw path lengths As Celsius Paks are intended for single use operations the ne
99. ox coupled to a crankshaft The crankshaft is attached to the rocker frame with a connecting rod The agitation system oscillates the rocker assembly during the thaw cycle The FT16 has an independent suspension system that supports the heat exchanger plates The suspension system uses an electric linear actuator mounted to a linkage to move the plates together or apart to either compress or release the Celsius Paks The linkage keeps the set of plates parallel during actuation A compliant link in this mechanism allows the plates to spread apart slightly to accommodate ice expansion during a freeze cycle and allows the plates to maintain contact with the Celsius Pak throughout the thaw cycle Flexible stainless steel hoses between the heat exchanger plates and the HTF manifold allows for relative movement during opening closing of the plates Introduction 11 1 5 2 1 FT16 Power Control Panel 1 5 2 1 1 Power On Light All operations for the FT16 module are performed via the module s Power Control Panel The power control panel provides the user control of the FT16 module s mechanical systems heat transfer plate actuation agitation controls main power and emergency stop The following information lists a description of the individual panel controls and their functionality Emergency Stop Auto Start Horn Reset Button Power On Light Status Light Plate Control Open Close Switch Agitation Control HOA Switch Plat
100. purging is intermittently displayed Allow the air purge to run for a minimum of 10 minutes The message No Flow may appear intermittently until the system is full and all air has been purged Data Recorder Basic Configuration Preparation for Initial Startup 7 Pressthe red stop button on the Control Keypad Figure 2 7 if the HTF level in the sight glass reaches the 3 0 L mark 8 If system requires additional filling fill the HTF reservoir with HTF until the level in the sight glass is at the 7 0 L mark 0 5 L Do not overfill 9 Once the purging of air from the system is complete and the message No Flow is no longer displayed intermittently continue the HTF flow through the system for about 15 minutes 10 Once the HTF level has stabilized make sure that enough HTF is in the system to maintain a minimum level of 4 0 L visible in the sight glass 11 Check all hose connections for leaks Tighten or replace as necessary 12 Turn off the HTF pump by pressing the red stop button on the control keypad Sartorius Stedim Biotech uses a standard configuration for all data recorders set during factory testing and re verified at the customer site This configuration is only a base set of parameters full functionality and programming should be determined by the end user The data recorder displays and records the data from the Celsius Pak Product RTD s temperature the HTF Supply and Return temperatures from t
101. quick disconnect Oil Flow from the CryoPilot will connect to the front FT16 connection The Oil Return to the CryoPilot will connect to the rear connection 13 Slide the CryoWrap over the connection for each hose to cover exposed metal 28 Site Preparation 2 8 2 8 1 Control and Alarm Output Connections Dry Contacts for Remote Monitoring and Alarms 34 Flange Fitting CryoPilot C eb Y 34 Elbow Supply and Return Connec tions 34 MNPT CryoHose 34 Female Quick Disconnect T 34 Male T Quick Disconnect FT16 Module Supply and yu 4 Elbow Return Connec 3 4 Flange tions 34 MNPT Fitting Figure 2 16 Final CryoHose and Fitting Configuration The CryoPilot C has three sets of normally open normally closed potential free contacts POKO for connection to external alarms or devices that allows for monitoring system operation from remote locations These are dry contacts requiring an external voltage source to power a circuit that includes them The contacts are rated at 30 VDC 0 1 A The contact groups are as follows ContactSet 1 POKO Alarm The alarm contact actuates when an error occurs and can be used to drive a visible audible alarm or an auto dialing device Contact Set 2 POKO Message The message contact actuates when freezing or thawing is complete if the system is operating manually and independently of the system s operational computer It can be use
102. r addition or removal of HTF Access to DI deionized water to fill Celsius Paks for test Freeze Thaw operations Aperistaltic pump or drum pump with silicone resistant tubing of sufficient length for adding heat transfer fluid HTF from its container to the CryoPilot C An ice water bath of 1 liter minimum for RTD temperature verification as required Ragsorother absorbent material and cleaning solvent for cleanup of HTF spills 3 2 FT16 Module Startup Perform the following steps to start the FT16 unit initially after it is installed and the facility electrical service to the FT16 is switched on 1 Ensure that the plug has been installed by a qualified electrician on to the power cord of the FT16 module 2 Ensure that all connections have been made from the CryoPilot C to the FT16 in accordance with section 2 7 3 3 Ensure that the Emergency Stop located on the front of the Power Control Panel is not depressed 4 Place the Hand Off Auto switch in the OFF position 5 Rotate the red Power Disconnect switch located on the right side of the Power Control Panel to the ON position 12 o clock 6 Verify that the green Power On light is illuminated Figure 3 1 Power Disconnect Switch in ON Position 33 Filling the CryoPilot C with It is recommended that 10 gallons 40 liters of HTF are on hand for the set up and Heat Transfer Fluid installation of the CryoPilot C unit Dow Syltherm HF is highly recommended as a heat
103. r motor cannot close possibly due to moisture frozen within the connection from motor to valve 51 35 Safety disconnect contactors failure May be in Safety cutoff Unit sees rapid shutdown conjunction with 51 30 or 51 31 so take actions conditions HTF pump stops Compressor stops appropriate to those codes Most common cause Heaters de energize LCD LED blinking is due to failure of small relay in the Controller In this case it will be necessary to replace the Message 51 X flashes intermittently Controller itself 51 36 Auxiliary contact on Relay K3 KM3 is stuck Safety cutoff Unit sees rapid shutdown or K3 KM3 has actuated incorrectly conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 37 Auxiliary contact on Relay K3 KM3 is stuck Safety cutoff Unit sees rapid shutdown or K3 KM3 is supplied with the wrong conditions HTF pump stops Compressor stops electrical power Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 38 Control signal for Relay K2 KM1 or Safety cutoff Unit sees rapid shutdown auxiliary contact is defective conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 39 Auxiliary contact on Relay K2 KM1 is stuck Safety cutoff Unit sees rapid shutdown or K2 KM1 is actuated incorrectly conditions HTF pump stops Compressor stops Heaters d
104. rature is less than temperature set by Program 109 Safety shutdown HTF pump heaters compressor turned off 80 X Special parameter error Error in purging time default value Found during power on self test Safety shutdown Unit will not run Correct the purge time and re start 153 X Overheat Controller warning 70 Basic Troubleshooting HTF over temperature May be stepper motor problem or insufficient recirculation because of high HTF viscosity or blockage Warning only System operation not affected if running 9 1 Stainless Steel Case 9 2 Cooling System 9 2 1 Y Strainer Cleaning Figure 9 1 Coolant Supply Y Strainer 9 System Maintenance Regular system maintenance must be performed on the CryoPilot C unit either by the user or by Sartorius Stedim Biotech on a service contract basis to avoid operational problems In the event of a problem first check the troubleshooting section Section 8 If the situation cannot be resolved call Customer Service Section 10 Ensure that when performing any maintenance requiring entry into system components proper lock out and tag out procedures are adhered to in accordance with company procedures and policy 1 Itis important to keep all stainless steel surfaces clean Use a commercially available stainless steel cleaning spray to lightly clean the stainless steel Freeze Thaw System surfaces at least once a month or a
105. re tightened and are snug For full procedure contact Sartorius Stedim Biotech see Section 10 System Maintenance 75 9 9 9 9 1 System Standard Operating Procedures The following is a basic listing of available SOPs additional procedures may be available Refer to Section 10 for Controlled Freeze Thaw Division Contact Information WARNING Ensure that when performing any maintenance requiring entry into system components proper lock out and tag out procedures are adhered to in accordance with company procedures and policy to prevent serious injury to personnel and damage to equipment Refer to Appendix B for Lock Out Tag Out overview CryoPilot C Thermal Control Unit 9 9 2 FT16 Freeze Thaw Module 76 System Maintenance 1 SOP 200 0055 Removal and Installation of Huber EPROMs 2 SOP 300 0001 CryoTrol PT100 Temperature Reference Verification 3 SOP 300 0002 Evaluation of the SpyLight Software Graph 4 SOP 400 0002 Heat Transfer Fluid Pump Motor Replacement 5 SOP 400 0004 Over Temperature Cutoff Board Removal and Replacement 1 SOP 200 0042 FT16 Freeze Thaw Module VFD Programming 10 Controlled Freeze Thaw Division Contact Information For complete list of contacts visit www sartorius com USA Customer Service Sartorius Stedim North America Inc 5 Orville Drive Suite 200 Bohemia NY 11716 Phone 800 368 7178 or 631 254 4249 Fax 631 253 5425 info sartorius stedim com
106. removes heat from the heat transfer fluid via heat exchangers using a cooling medium Cooling Water Water routed through the thermostat via a system of pipes for cooling the chiller It should contain only minimized amounts of lime calcium and corrosive substances that limit the life cycle of the system CryoPilot C Thermal Control Unit CPC A self contained thermoregulation unit with all equipment and controls necessary for automated Freeze Thaw and Hold CryoComa operations The CryoPilot C system freezes and thaws by controlling the temperature of heat transfer fluid HTF according to a predefined temperature profile or recipe Effective Heating Capacity The ratio of heat energy or enthalpy delivered to the heat transfer fluid by heat sources compared to the physical capacity of the fluid to absorb thermal energy EPROM Erasable programmable read only memory chip Evaporator An evaporator is a component in a refrigerant system used for changing refrigerant liquid to vapor form by taking up latent heat Glossary 79 80 Glossary Factory Default The manufacturer has set the CryoPilot C unit parameters such that the temperature range constitutes only a minimum potential hazard and that the easiest and most probable thermoregulation process can be performed Factory defaults ensure safe commissioning by the customer and can be changed using the respective programs according to the requirements of the customer All
107. ribes the sequence of key presses detailed below Function Action Enter Program 0 Press Set Press 0 Press Ent Enter setpoint of 20 5 Press 2 Press 0 Press lt gt Press 5 Press Ent System Controls Configuration 33 4 2 4 2 1 34 Control Keypad Overview Control Keypad Buttons System Controls Configuration The Control Keypad is the primary interface to the Controller Figure 4 1 Programs are accessed and set points are entered by use of the keypad Operator action confirmation prompts and other messages are displayed on the two line LCD display The LEDs on the flow diagram above the two line LCD display show the flowing status of the HTF fluid See section 4 2 2 for more information The green single line LED display above the flow diagram shows the actual HTF temperature in the CryoPilot C Flow Diagram LED Status of HTF Path Two Line LCD Explicit Messages and Settings Keypad Chessell Recorder Set key Program Stop and Pump Control Message Acknowledge Button Manual Temperature Control Figure 4 1 Control Keypad The Set button Figure 4 1 is used to access the program entry screen The Esc button cancels the current operation and the lt Ent gt button confirms data entry The three buttons on the bottom of the keypad are used to manually control program operation and equipment 2 The lo button on the left is used to man
108. rtially frozen Pak can compromise the liquid solution and damage system equipment To initiate the Freeze Process perform the following operations 1 Ensure that Celsius Pak s are loaded into the FT16 Module and that the front access door is closed 2 Ensure that the FT16 heat transfer plates are in the fully closed position as indicated by the illumination of the white Plates Closed light 3 Ensure that the amber Status light is illuminated 4 Initiate Program 240 by pressing Set 2 4 0 Ent The 2 Line LCD display will read FREEZING 0 NO 1 YES 5 Press 1 to initiate freezing operations The HTF Pump goes through start up sequence and any remaining air is purged automatically from the HTF circuit 6 The message Check Pump will be intermittently displayed Once air is purged and pump discharge pressure interlock clears the message Check Pump OK will be displayed briefly HTF loop flow LED lights flash intermittently and stabilize once interlock clears and system enters into profile operation The refrigerant line equalization valve opens and allows for a safe compressor start up 7 The compressor initiates and system temperature control seeks start temperature of TP1 1 Times will vary depending on system starting temperature Once the Start Temperature of TP1 is achieved a possible one time message display of TP prepare may be displayed and the actual profile operati
109. s needed 2 Theair inlet for the pump on the left side should be wiped clean of dust accumulation every 10 operating days or as required to ensure proper air flow to internal components 3 Forunits with the base transformer installed the air inlet fan at the rear of the unit should be wiped clean of dust accumulation every 10 operating days or as required to ensure proper air flow to the transformer internal components To maintain the cooling system clean the screen inside the Y strainer on the coolant supply line at least once a year and more frequently if the coolant contains solids or high levels of calcium To locate the screen open the back panel of the CryoPilot C and follow the coolant supply line copper to a Y shaped brass fitting where the screen is located Figure 9 1 The cooling system will still be under system pressure when the supply and return lines are shut off Remove the drain cap slowly to allow for a slow system pressure bleed off Ensure power to the CryoPilot C has been turned OFF For units with base transformer installed ensure that the transformer power switch is also placed in the OFF position System Maintenance 71 9 2 2 Decalcification 9 3 9 3 1 72 Internal Surfaces CryoPilot C System Maintenance Follow these steps to clean the screen 1 Turn OFF facility electrical supply to the CryoPilot and disconnect the plug 2 Shut off the coolant inlet and outlet li
110. s shown in Figure 2 1 Ensure in addition to the base footprint that adequate space is left around the system to allow for access to all controls electrical cabinets and for maintenance purposes Adequate area should also be available to facilitate easy movement of Transfer Carts and Storage Modules Installation should be in accordance with company policies and regulations 64 4 in 163 cm 248 cm Figure 2 1 Basic Installation Space Requirements Provide a dry level surface having sufficient load bearing capacity to accommodate the loading imposed by the system See Section 1 5 1 8 and 1 5 2 2 for equipment specifications Start this procedure with each unit the CryoPilot C and the FT16 in the shipping crate Follow the procedures below to unpack and move each unit to its in service location CAUTION For all of the following operations 2 or more personnel are required to assist to prevent damage to equipment or injury to personnel Site Preparation 17 2 3 1 2 3 2 FT16 Freeze Thaw Module 2 3 2 1 Power Control Panel 18 CryoPilot C Site Preparation 1 Remove the packing slip check the crate for damage and document if necessary 2 Remove the front panel of the shipping container remove the packaging material and any loose parts 3 Guide a forklift under the center of the unit and with the aid of another person to prevent the unit tipping slowly lift 4 Carefully r
111. sc or Ent keys to exit the program The system always relates to the internal calendar If the internal calendar is incorrect the passcode will not work If the passcode does not work check program 32 to verify the calendar date As the passcode is based on the day of the month it automatically expires every day just after midnight Personnel can also log out of the system to prevent unauthorized access by entering an incorrect passcode All program parameters are passcode protected A passcode is required to alter user accessible parameters in programs The passcode is entered via Program 50 as follows 1 Using the keypad on the control keypad press Set 5 0 Ent 2 A is displayed on the LCD prompting the user to enter a passcode The service passcode is comprised of the current day of the month multiplied by 7 For example the passcode on October 31 is 217 31 times 7 217 Enter the current day s passcode 3 The system displays the message ACCES when a correct passcode is entered giving the operator access to the system and DENIED when an incorrect passcode is entered System Controls Configuration 35 4 3 1 1 Passcode Edit Profile A specific passcode is required in order for a user to edit the settings used for profile configuration and operation Once entered and accepted this passcode will time out after 3 minutes 1 Using the keypad on the control keypad press S
112. setting should always be set to 40 0 This number is selected to ensure that the CryoPilot will utilize the maximum capacity to reach the programmed setpoint Refrigerant A chemical substance used in refrigeration systems which absorbs heat during evaporation at low temperature and pressure and releases heat during condensation at a higher temperature and pressure Refrigeration Controller A custom microcontroller based system that controls the refrigeration hardware Resistance Temperature Detector RTD A device used to measure temperature where resistance varies as temperature changes Serial Interface The serial interface is used to transfer data in the form of bits and bytes Segment A segment is a section of a thermoregulation program that defines the temperature setpoint during its duration Self Test Test procedure in the Controller after power on It ensures the operability of safety relevant thermostat components Glossary 81 82 Glossary Temperature Stability This term denotes half the difference in temperature between the highest and lowest temperature measured in the chiller within 30 minutes of attaining a stable value at a specific setpoint Slave Address Identification number the user assigns to a device to be able to allocate data to a device during data transfer via a bus protocol Variable Frequency Drive VFD VFD changes the speed of a motor by changing the frequency of the AC power supplied
113. shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 63 66 Basic Troubleshooting Contactors K3 KM3 and K5 KM3 1 are stuck Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently Message Error Codes Description Machine Actions 51 64 Contactor K5 KM3 1 is stuck Safety cutoff Unit sees rapid shutdown conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently 51 65 Contactor K3 KM3 could not be actuated Safety cutoff Unit sees rapid shutdown or has dropped out Possible causes conditions HTF pump stops Compressor stops 1 Phase sequence detector relay preventing Heaters de energize LCD LED blinking operation Message 51 X flashes intermittently 2 In a new un run installation possibly d Bremen electa Investigate in the wiring diagram what is PPIY inhibiting K2 KM1 3 Inan old installation either phase sequence relay faulty or electrical supply problem phases swapped by electricians 4 Overload relay 5 Pump Thermal overload 51 66 Low pressure switch of high pressure stage Safety cutoff Unit sees rapid shutdown has responded conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking
114. sible to prevent reduced heat transfer capacity due to freeze out within the evaporator 9 5 2 1 Draining the HTF from the System D Draining the FT16 heat transfer fluid HTF manifold is done only if required for service procedures that require disassembly of the HTF flow components It is normally not necessary to drain the HTF manifold Allow system components to come to room temperature so the heat transfer fluid temperature is also at room temperature when drained System Maintenance US 9 6 9 6 1 74 FT16 Maintenance Drying the FT16 Heat Transfer Plates System Maintenance 1 Check to be sure that the three 3 CryoPilot C HTF drain valves are closed The groove in the screw cap is vertically aligned when closed Turn clockwise to gain vertical position 2 Remove the sealing screw in the protruding stainless tube to the right of the HTF drain valves and connect a piece of tubing over this tube Attach securely with a hose clamp Put the end of the tubing in a container that will hold approximately 20 L of HTF 4 Open the 3 HTF drain valves by turning counter clockwise until the grooves are horizontally aligned 5 Puta suitable drain pan under the FT16 manifold connections located near the HTF hose connections 6 When finished draining close the HTF drain valves remove the tubing from the sealing screw tube and replace the sealing screw 7 Follow the procedure in section 9 6
115. t to the FT16 Daily Operation 2 Rotate the locking collar to secure the RTD probe s position Do not over tighten 3 Remove the thermowell cap from a Celsius Pak that is loaded in a Pak Frame and insert the RTD probe into the thermowell 4 Continue insertion until the RTD holder touches the rods on the top of the Pak Frame Make sure the RTD holder is perpendicular to the rods and then snap it into place Figure 6 11 RTD Holder Installation on to Celsius Pak Frame 5 Slide the RTD holder left or right as necessary to ensure the RTD probe and thermowell are vertically aligned 6 Place the RTD probe wire under the frame handle to store it until it is connected to the FT16 junction box This procedure assumes that filled Celsius Paks within frames are loaded onto a transfer cart and that the FT16 plates are defrosted WARNING Do not operate the FT16 Plate Actuation switch with panels removed to avoid potential pinch and crush hazards from moving components 1 Unlatch the safety cable from its horizontal up position and lower to its vertical down position 2 On the FT16 Power Control Panel rotate and hold the plate actuation switch into the Open position approximately 10 seconds The plates will stop automatically when fully open and the plate open light will illuminate Figure 6 12 FT16 RTD Junction Positions 3 Turn or rotate the FT16 door latch at the front of the module
116. ters energized 3 Heat addition from pump without tempering on caused the circuit to exceed setpoint 4 Poor circulation with heaters energized 51 21 Minimum suction pressure not achieved Safety cutoff Unit sees rapid shutdown Could originate following sudden loss of power conditions HTF pump stops Compressor stops during tempering Check by Cycling power Heaters de energize LCD LED blinking via the Blackerocker switch Message 51 X flashes intermittently Possible faulty compressor 51 26 Disruption of data transmission in Safety cutoff Unit sees rapid shutdown the Controller Possible causes conditions HTF pump stops Compressor stops ERA Heaters de energize LCD LED blinking 1 Loose communication cable 2 Control panel not properly seated in Message 51 X flashes intermittently the Controller 51 29 Minimum current high This test is run on Safety cutoff Unit sees rapid shutdown startup with just main safety disconnect conditions HTF pump stops Compressor stops K1 KR1 actuated with measured voltage Heaters de energize LCD LED blinking higher than expected Possible causes Message 51 X flashes intermittently 1 Individual component solid state relay failed Check components one at a time to check for affected circuit 2 Current transducer TR1 is defective and needs replacement 51 30 Main heating test failure Heater current Safety cutoff Unit sees rapid shutdown measured during startup and found to be low P
117. ters de energize LCD LED blinking HPL SHUR HOM Possible CAUSES Message 51 X flashes intermittently 1 Flow restriction poor flow 2 Stepper motor cannot close the expansion valve valve sticking 3 Evaporation Pressure transducer sensor fault 4 Evaporator outlet temperature sensor fault 51 5 Main safety disconnect contactor K1 KR1 Safety cutoff Unit sees rapid shutdown got stuck during initial power up operations conditions HTF pump stops Compressor stops Possible causes Heaters de energize LCD LED blinking 1 Power supply incorrect Message 51 X flashes intermittently 2 Defective current transducer TR1 as start up is dependent on current measurements 51 6 Minimum flow controller Minimum flow rate Safety cutoff Unit sees rapid shutdown of refrigerant represented by minimum value for the evaporation temperature could not be maintained Possible causes 1 Flow restriction of HTF or freeze out of water remnants on the evaporator wall from the HTF 2 Stepper motor cannot open expansion valve 3 Evaporator pressure transducer has a problem conditions HTF pump stops Compressor stops Heaters de energize LCD LED blinking Message 51 X flashes intermittently Code 51 51 XXX Universal safety A series of messages may be shown Use Program 10 to access messages displayed in sequence Safety shutdown HTF pump heaters compressor turned off shutdown These messages can only be
118. the factory defaults can be restored with Program 52 with the thermoregulation function switched off Flowrate The volume of fluid delivered by the circulation pump per time unit measured using water In charts the flowrate is expressed as a function of the delivery pressure backpressure Freeze Thaw Module FTM A device having one or more pairs of movable plates through which HTF is pumped Each pair of plates compresses one or more disposable containers FPT Frame Placement Tool Tool with a specially designed catch used to facilitate the easy insertion and removal of Celsius Paks from the Freeze Thaw Modules Heating Capacity The rate at which the installed heaters produce heat The heating capacity depends on the voltage of the CryoPilot C unit It is continuously controlled and reduced when the temperature approaches the programmed setpoint Heat Transfer Fluid HTF A silicone based fluid specifically manufactured for the purpose of heat transmission HP Horse power HTP Heat Transfer Plate IPD Inter Plate Distance The distances between the heat transfer plates in the Freeze Thaw Modules IPDMT Inter Plate Distance Measuring Tool A tool used to measure the distances between the heat transfer plates in the Freeze Thaw Modules Operating Temperature Range This is the temperature range that is limited by the permissible minimum and maximum operating temperature The operating temperature is the temperature to wh
119. to the motor Viscosity The characteristic of a fluid or gaseous substance that causes frictional tension at deformation in addition to the thermodynamic pressure which counteracts the displacement of fluid or gaseous particles relative to each other Viscosity of a substance increases with decreasing temperature the available cooling capacity decreases with decreasing temperature Warning Devices message that point to irregularities in the operation of the thermostat but do not cause a shutdown of the thermoregulation process Programs 10 and 11 Watchdog A watchdog is a safety device in the electronic control in which the functionality of the system is monitored through the input signals B 1 B 1 1 Electrical System CryoPilot C B System Lock Out Tag Out The following is a description of how to lock out the various components that comprise the Sartorius Stedim Biotech Freeze Thaw Systems Additionally ensure when performing any maintenance requiring entry into system components that proper lock out and tag out procedures are adhered to in accordance with company procedures and policy Hazardous Voltage danger and warning labels have been placed in the areas where there are hazardous voltages of up to 500 VAC on the components within the protective enclosures Before servicing the equipment will be disconnected from the source supply and locked out with an appropriate device a lockout device is built into th
120. transfer fluid due to low temperature heat transfer considerations pumpability at low temperatures and thermal stability For additional characteristic data refer to the Material Safety Data Sheet Q There is approximately a 30 minute delay before the compressor can be started after switching on the CryoPilot C to allow the compressor s crankcase oil to be heated to operating temperature During this time the message No Compr Clrance will intermittently be displayed on the LCD display 1 Ensure that all three drain valves are closed by turning clockwise to the vertical position and that the sealing screw on the side of the CryoPilot C is installed Figure 3 2 2 Ensure that the CryoHoses and the associated Freeze Thaw accessories are installed in accordance with Section 2 7 Closed Drain Sealing Valves Screw Figure 3 2 HTF Drain Valves and Sealing Screw Preparation for Initial Startup 31 Figure 3 4 Reservoir Fill Port and 3 Ensure that the vent valve located on the left side of the CryoPilot is in the closed horizontal position 4 Remove the fill port cap located on top of the CryoPilot C behind the sight glass Figure 3 4 5 Fill the HTF reservoir via the fill port with HTF to the 10 0 L mark 0 5 Las visible on the sight glass Do not overfill 6 Perform a manual air purge using the CryoPilot C HTF pump by using Program 111 see Section 4 3 6 and verifying that the message air
121. ually start the HTF pump The E button in the middle is used to manually start tempering control The unit will run to the displayed setpoint The Stop button n on the right is used to Stopa running or completed program Acknowledge program messages Stop the HTF pump if it was started manually 4 2 2 Flow Indication LEDs Figure 4 2 Flow Diagram LED display 4 3 4 3 1 Commonly Used Programs Access Passcode Program 50 The flow diagram on the Control Keypad contains 9 functional LED s that when illuminated indicate specific operations of the CryoPilot C system Refer to Table 4 1 and Figure 4 2 for a brief description of the LED functions Table 4 1 Flow Diagram LED Functional Description LED Color Indication 1 Red External Pt100 RTD control Not used for CryoPilot applications 2 Red Internal Pt100 RTD control System is being controlled by the temperature of the heat transfer fluid Standard control method 3 Green HTF pump is running 4 Green HTF pump is running 5 Green HTF pump is running 6 Green HTF pump is running 7 Orange Heater is activated 8 Green Refrigeration loop active 9 Green Not used 10 Green Refrigeration loop active Key programs must be verified to confirm that factory settings are correct Each program is accessed by pressing Set then keying in the program number then pressing Ent Once the value is verified press the E
122. uld result in severe injury or death 1 Ensure that the plug has been installed by a qualified electrician on to the power cord of the CryoPilot C unit 2 For units installed in North America ensure that the transformer switch located at the lower drawer assembly is in the ON position Figure 2 2 Transformer Drawer Power Switch 3 Ensure that the CryoPilot C Main Power switch is in the OFF position The switch is red and yellow and is located on the back of the CryoPilot C Figure 2 3 CryoPilot C Main Power Switch Verify that the CryoPilot C unit is plugged into the electrical supply Ensure the Control System Power switch Figure 2 5 is in the OFF position Remove the electrical panel cover at the rear of the unit Turn the Main power breaker located in the back of the CryoPilot C to the ON position Figure 2 4 DX 09 oS Figure 2 4 CryoPilot C Main Power Breaker 8 Position the Control System Power switch the black rocker switch on the front panel of the CryoPilot C located below the Control Keypad to the ON position Figure 2 5 Figure 2 5 Control System Power Switch and Over Temperature Setting Display 22 Site Preparation 9 During the Controller self initialization when contactor KR1 pulls in verify that the phase sequence detector PSD F4M1 light is illuminated Figure 2 6 For this brief period voltage will be available for the PSD If light is does not illuminate perf
123. w the keypad Figure 2 5 2 Using a soft tipped object depress the yellow up or down arrows by the label Overheat to enter an over temperature setpoint as read at the over tempera ture display Set the over temperature switch to 45 C 2 7 1 4 Checking HTF Pump Rotation The HTF pump motor must have proper rotation or rapid pump failure will occur CAUTION The HTF pump rotation is verified by jogging the motor on for a short duration e g two seconds and observing that the motor fan rotation is in the counter clockwise direction The procedure below requires two people One person to bump the pump motor a second person to observe rotation EE ec n 1 Facing the unit the motor fan will be located on the right side of the CryoPilot C E J 2 Perform a rapid jog of the pump by pressing the left green button manual pump ee a hare ters l tee Stop start button Figure 2 7 on the control keypad followed immediately by pressing Button GD Button the red stop button on the control keypad Figure 2 7 i us 3 Observe pump motor fan rotation and ensure it is in the counter clockwise direction Figure 2 7 Manual Pump Start Switch 24 Site Preparation 2 7 1 5 Liquid Coolant Connections Figure 2 8 Liquid Coolant Connections and Drain Many different coolants can be used with the CryoPilot C unit The refrigeration condenser requires a coolant delivery that removes 9 kW 30717 Btu hr of heat

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