Integrator`s Reference Guide Thermo Scientific HyClone Single
Contents
1. long web sling 33601571 and a web sling shackle with screw pin 35505T3 Part Number Description Vendor 88641821 1 nylon double leg sling with hooks 33607571 2 wide x 2 long web sling 3550573 Shackle for 2 web Table 1 4 Recommended Lift Kit Remove forks from forklift to keep them from damaging tank Using eyebolts on crate attach slings to forklift While lifting the crate the forklift will need to move forward at the same time to avoid the bottom of the crate sliding back Figure 1 25 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 10 Section 1 Initial Installation Instructions Overhead Crane In most cases the overhead crane is free floating on the I beam to which Method they are mounted so for this method to work two lifts need to be used Use the same kit as defined in table 1 and choke strap This choke strap needs to be wrapped around the bottom base as shown and hooked up to the second lift as in the picture below Both lifts are raised to get the crate off the floor but the eye bolt side will be raised higher as shown The strap side will then be lowered simultaneously as the eyebolt side is raised until the crate is vertical Figure 1 26 Uncrating Continued 6 Remove straps from around the tank Be careful with the bag lift hoist while doing this to make sure it doesn t fall Remove the bag lift during this same step Figure 1 27 T2. Mixer controller does not respond to user inputs Allow speed to stabilize before using key pad interface Rapidly adjusting speed control in an excessive manner may require several seconds for speed stabilization Wait ten seconds and then attempt to adjust speed at key pad interface Users should verify the position of the input select switch of the VFD If the toggle switch is not in the middle position the controller will not be able to receive control inputs from the control keypad on the front panel Dissolved Oxygen DO readings are low or slow to respond Check physical condition of the DO probe calibration of the DO probe flow rate of gas into S U B DO probes require routine maintenance replace damaged probe or membrane Verify DO probe calibration relative to set points of zero and span Inspect line sets connected to direct sparges for restriction closed tubing clamp pinched line low supply pressure Direct membrane sparge does not seem to be working although gas is present Allow sparge membrane to purge If the S U B is filled with liquid and allowed to sit idle for extended periods of time without gas being supplied to the sparge liquid can accumulate between the membrane and check valve Various media additives may restrict the membrane temporarily Several minutes of gas pressure being supplied to the sparge should purge the membrane allowing it to function properly Certain operating conditions
3. Bag Lift Remove the spider arm from the bag lift Bubble wrap both pieces and finish with stretch wrap Figure 1 51 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 19 Section 1 Initial Installation Instructions 14 Attach bag lift frame to bottom of the small base using a cloth strap 1585122 and steel wire buckles 1958T85 You will need to staple the cloth straps to the plywood base and tension them with the wire buckles 15 Remove straps and place bag lift assembly next to tank and resting on the cradles with the small arm in vertical position Ensure the control box on the beam leaves enough clearance for the side of the crate to be installed Once in place strap the bag lift down using the same cloth strapping staples and ring buckles Figure 1 52 i bo Ne w Figure 1 54 Thermo Scientific 5 i J s m _ a 2 a P Sg i 7 Fj F q 8 7 2 Integrator s Reference Guide Single Use Bioreactor S U B 20 Section 1 Initial Installation Instructions 16 Re install tank straps but add dense card board and or thick foam between the buckle and the tank 17 Lay 1 2 dense foam along bottom inside of tank for kneeling and access to the end of the tank to prevent damaging stainless finish Insert miscellaneous parts box first followed by the motor assembly box Tip them upright as shown and run ratchet strap from eyebolt to eyebolt going through the bottom
4. S U B 54 Thermo Scientific Cell Culture amp BioProcessing 925 West 1800 South Logan Utah 84321 United States In Americas Asia 435 792 8000 435 792 8001 fax In Europe 32 53 85 71 80 432 53 85 74 31 Tax www thermoscientific com hyclone 2010 Thermo Fisher Scientific Inc All rights reserved
5. Setting Range Setting Range Setting Range Setting Range 0 5 lpm 0 5 Ipm 0 25 lpm 0 1 lpm 0 1 Ipm 0 0 5 lpm 0 25 lpm 0 1 Ipm 1 Ipm 0 30 Ipm Table 2 4 Sparge Flow Meter Recommendations Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 31 Section 2 Functional Specifications S U B Water Jacket Facility Requirements and Specifications for Installation Specifications for the S U B with water jacket are listed below The system heights are listed for overall installed height and the required overall height required for installing the drive shaft into the top mounted agitation drive system Jacket temperature range specified is wider than the batch temperature range this will allow the jacket to more efficiently transfer heat by allowing high temperature gradients between the batch and jacket temperatures during temperate shifts Do not exceed a jacket temperature of 50 C for extended periods batch temperatures above 40 C can lead to product damage and system failure Jacket flow rate varies largely depending upon the style and size of pump used in the thermo circulation system For best results jacket inlet pressure and TCU thermal capacity should meet or exceed the recommendations listed HSE System Weight System Pont System Height TER Jacket Supply E TCU S U B Requirements y 9 Print y 9 p Pressure Size Range Thermal Capacity 108 125 208 240 PE e on we w e omn mn om sp
6. Clear Lexan Cable Assembly 16 Pin Main communication cable from S U B S U M to External SV50177 110 Controller Male one end Cable Assembly 16 Pin Main communication cable from S U B S U M to External Controller Male 2 Male SV50177 113 Cable Assembly 16 Pin Main communication cable from S U B S U M to External l Controller Male one end VFD amp Temperature control only SV50177 114 Cable Assembly 3 Pin Pressure Alarm Relay cable from S U B S U M to External Controller Male 2 Male SV50177 117 Cable Assembly 4 Pin TCU Communicaiton cable Male one end Cable Assembly 4 Pin Disposable pressure sensor communication cable w Buccaneer 9V50177 118 QC Male amp Female components SV50177 119 Cable Assembly 16 Pin w 3 Pin RTD in line OC pigtail Main communication cable l from S U B S U M to External Controller Male one end amp 3 Pin QC pigtail SV50177 124 1 4 Dia Neoprene Rubber Cord 9V50177 112 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 4 Partial Spare SSS Parts List Cont Drive Shaft Assembly 2000 L S U B Four 4 Piece Integrated Design V50177 160 Motor 1 4HP 208VAC 3Ph IP65 10 1 Gear Reduction 50 L 100 L S U B s SV50177 161 Motor 1 4HP 208VAC 3Ph IP65 12 5 1 Gear Reduction 250 L S U B SV50177 162 Motor 1 2HP 208VAC 3Ph IP65 15 1 Gear Reduction 500 L 1000 L S U B s 9V50177 189 Illuminated Light Green 6VDC 9V50177
7. Otherwise must use ferrule approach Typical is 10 or shorter Overlay and Sparge Can use disposable capsule filter other than standard hydrophobic Line Filters vent filter with Emflon II Limited engineer to order customization possible such as additional Dependent on location in bag and compatibility media lines and vent filter lines Requires economic justification with hardware Vent Filters Standard is Pall Kleenpak 0 2 micron exhaust vent filter el filter heater configuration restricts ee Dig Extended filter height above the S U B bag is make to order Must be compatible with a vent filter bracket option OENE ET Choice of filters for inlets used to sterile filter incoming media or Supplement Inlets supplements Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 42 Section 5 Ordering Information 5 2 Ordering Information Hardwa re 50 L 100 L 250 Land 500 L S U B Systems Include 304 stainless Standard S U B steel outer support container with swivel caster platform variable speed agitation controller motor drive assembly with shaft PID temperature Products controller resistive only RTD sensor integrated resistive heating element or jacket probe shelf and standard tool set Part Number Description Part Number Description SV50197 01 100 L S U B Electric Resistive Heater US version 120 VAC SV50197 02 100 L S U B Electric Resistive Heater EU version 240 VAC SV50197 03 100 L S
8. This will give the mechanism enough space to lift and rotate out of the way Figure 1 60 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 22 Section 1 Initial Installation Instructions Motor Mounting The tank motor will need to be installed When unpacking the motor assembly note that the bolts and washers will already be in the aluminum block that will mount to the tank Figure 1 61 Use these bolts to mount the aluminum block to the stainless tank Figure 1 62 Figure 1 61 Figure 1 62 Tank Tool Kit The tool holder is installed just behind the motor with two socket button head screws nuts and washers There is enough room to hold the nuts and washers inside the tank motor mount Install tools and shaft as shown Figure 1 63 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 23 Section 1 Initial Installation Instructions Bag Hoist Assembly The bag hoist assembly is mounted on the side and top of the tank Figure 1 64 Figure 1 64 First remove the eye bolt where the bag lift is going to be mounted To aid in assembly a slot is provided on the tank for a finger of the bag lift to fit into to hold the bottom of the bag lift next to the tank Figure 1 65 The bag lift also has a hook that engages the top lip of the tank Figure 1 66 Once bag lift is in position use the eye bolt to mount it securely to the top of the tank Figure 1 66
9. animal cell culture m 2000 L 1000 L 900 L m 290 L 100 L 0L em A 100 190 Rotation speed RPM Graph 2 1 U B Mixing Power Input to Volume Estimations Simulation assumes the system Is fill to rated working volume with water and Power Number Np 2 07 Integrator s Reference Guide Single Use Bioreactor S U B 28 Section 2 Functional Specifications Standard Range Mixer Standard range mixer speed for all S U B s is listed in Table 2 1 The mixer Speed of the S U B can be operated within this range of agitation speeds with fluid volumes anywhere from 50 to 110 of the rated working volume In general it is recommended as good practice to reduce the mixer speed of the impeller as the batch volume decreases in order to avoid excess shear and vortexing The high end of this range represents 0 2 hp 1000 gallons in the 50 1000 L systems and 0 1 hp 1000 gallons in the 2000 L Extended Range Mixer Extended range mixer speeds are the maximum recommended speeds for Spe ed use with the S U B but are to be used only under controlled conditions meeting the following criteria An interlock between the bioreactor controller and the reactor vessel is required to ensure reliable operation in this case the standard range of mixer speeds cannot be exceeded unless the vessel is at 90 of working volume or greater Load cells or a means to monitor batch volume should be the parameter
10. can create situations when the sparge membrane may become restricted due to insufficient line pressure from the bioreactor controller gas feed line Increasing the flow rate to 1 liter per minute or momentarily raising the pressure regulator outlet pressure to 5 psi 0 34 bar may alleviate the problem Alternatively several seconds at this higher pressure will allow the membrane to purge pores that may be blocked due to the presence of accumulated liquid Integrator s Reference Guide Single Use Bioreactor S U B 36 Thermo Scientific Symptom Remedy Symptom Remedy Symptom Remedy Section 4 Troubleshooting DO readings are erratic or unstable Adjust bioreactor controller to suite the volume of the S U B system Many different parameters can effect the ability of a bioreactor controller to effectively maintain a target setpoint during process control Modern controllers utilize computer algorithms to adjust targeted parameters the most common technique is that of tunable controller that uses variables of PID Tuning these PID values to the specific characteristics of the system dynamics will in most cases stabilize process parameters to an acceptable level It is recommended that S U B users consult the user manual of the particular bioreactor controller being used A grounding reference to the media can be created by using a grounding lead between the tank and the body of the stainless steel DO probe or to the stainle
11. oversized mixer motors with gear reductions and a removable rigid shaft typically the mixer speed for each system must be scaled based upon the size of the impeller and the liquid volume being mixed Larger impellers will transfer more power to the liquid for a given rotational speed and because the design uses an angled mixer shaft instead of baffles all systems will begin to vortex if the impeller is operated at excessive speed Excessive vortexing will reduce the performance of the S U B and can damage the drive shaft or impeller assembly particularly in the larger scale 1000 and 2000 L systems Therefore it is imperative that the mixer not be operated above nominal speed without the tank being filled to near full working volume During drain operation the mixing should be discontinued once the tank volume is below half the rated working volume Systems with integrated controllers that employ safety interlocks with the agitation system will provide the highest system reliability this should include deactivating agitation when the vessel is below half the rated working volume and limit the mixer speed ranges as listed in the matrix below Recommended mixer speed settings for all S U B s are based upon a scaled Power Input to Volume PIV ratio of 0 1 hp 1000 gallons assuming the impeller has a power number Np 2 01 These nominal mixer speeds are recommended as the process development starting point for performing suspension type
12. sensor port access to the hanging tab access holes Place high density cardboard and thick foam in between strap and all sharp corners before tensioning strap Figure 1 55 Figure 1 56 Figure 1 57 Figure 1 58 18 Double check all straps are properly tensioned and all points where straps cross sharp corners are properly padded 19 Install both long sides 20 Install end cover 21 Install top cover 22 Paint and or mark on all sides to Open top cover first and read instructions before proceeding to unpack crate Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 21 Section 1 Initial Installation Instructions 2000 L S U B Assembly Instructions Tank Bottom The tank bottom has two main access cut out plates one for the open pipe sparge and the bottom drain harvest ports and the other for three porous frit sparge ports Figure 1 59 3 Porous frit sparge ports Open pipe and bottom drain ports Figure 1 59 Place the white plastic Delrin circular plate with two slots in the center recessed hole Figure 1 59 The frit sparge tube port access rectangular plate is shown at the top of the Figure 1 59 This access plate is secured on one corner to let it rotate out of the way during installation of the disposable S U B The stud may be tightened down for shipping to keep the plate from bouncing To do this unscrew the nylock nut underneath the plate about an inch Figure 1 60
13. will be offset to the left or right using 4X 10X1 screws Use other 2X 10X1 screws to plug holes not used Figure 3 Adapter Mounting Plate 7 Secure the electrical receptacle using four supplied screw fasteners Connect power back to the electrical circuit 9 Test the circuit with multi meter prior to making any connections to the electrical receptacle Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 51 Appendix B Calibration of the AC Tech Variable Speed Drive Appendix B Calibration of the AC Tech Variable Speed Drive Calibration of the If during the verification of the mixer speed calibration it was determined AC Tech variable the displayed speed varied from the actual speed please follow these steps to calibrate the drive speed drive SCF 1 Press M on the speed controller menu SCM Models 2 If 000 appear the menu is locked To unlock the menu hold the up arrow key and select 225 then press the menu key 3 Use the arrow key to select P39 and then press M 4 Use the arrow keys to enter the correct value listed in the Table 3 1 then press M NOTE The value may need to be adjusted slightly to calibrate exactly S U B VFD Parameters for RPM Calibration 1 rpm 50 L SCF SCM P39 178 Motor rating of 1780 rom 60 Hz with gear models reduction of 10 1 1780 10 178 100 L SCF SCM P39 178 Motor rating of 1780 rom 60 Hz wit
14. 1 nylon 2 leg sling with sling hooks part 88641821 Mcmaster Carr or equivalent Also use a 2 wide by 2 long web sling 33601571 and a web sling shackle with screw pin 3550513 Remove forks for convenience and to avoid damaging the crate Refer to Table 1 4 for the recommended lift kit Figure 1 33 4 The 2000 L S U B can be moved in two different ways 1 a fork lift at the base and 2 using the two eye bolts located at the top of the S U B itself Figure 1 34 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 14 Section 1 Initial Installation Instructions If moving the S U B using a forklift ensure that the summing block is tipped up and moved out of the way of the fork tines Also ensure that a strap secures the tank to the fork lift for security Figure 1 35 5 The sparge plate inside the tank needs to be bubble wrapped and tied down Figure 1 36 Figure 1 37 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 15 Section 1 Initial Installation Instructions 6 The tank needs to be wrapped completely with bubble wrap followed by stretch wrap Fittings up to the tee of the jacket need to be removed as shown in Figure 1 38 7 We recommend positioning the tank using a fork lift underneath the base but the option of using the tank eye bolts is available for overhead cranes Figure 1 38 8 Orient tank as shown If necessa
15. 193 Lamp Green 120VAC Replacement for motor on off switch SV50177 233 RTD P1100 3 Wire 120 w o Quick Disconnect Connector Refer to P N TX 10324 RTD Standard PT100 3 Wire 60 With Quick Disconnect Bulgin 3 pin Connector SVOOT7 234 pater to P N TX 10289 Cable Assy Disposable Sensor Fiber Optic DO Sensor Green Body Uo Mates to SV20963 sensors Cable Assy Disposable Sensor Fiber Optic PH Sensor Blue Body aau Mates to SV20963 sensors SV50177 238 Pressure Transducer Disposable 12 length QC w 4 Wire pigtail Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 48 5 5 Ordering Instructions 5 6 Ordering Support Contact Information Technical Support Technical Service Hotline Initial Setup and Operation Training Thermo Scientific Section 5 Ordering Information Disposable and hardware components for the Single Use Bioreactor S U B can be ordered directly from your sales representative for Thermo Scientific HyClone products These items include all components that have part numbers beginning with the following two digits e SH e SV In the Americas and Asia In Europe Tel 1 435 792 8000 Tel 32 53 85 75 59 Toll free 1 800 HyClone Fax 32 53 85 74 31 Or 1 800 492 5663 perbio euromarketing thermofisher com Fax 1 435 792 8001 www thermo com perbio www thermoscientific com hyclone Info hyclone com Technical support for the Singl
16. Figure 1 65 Figure 1 66 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 24 Section 1 Initial Installation Instructions Electrical Box Mount The electrical box assembly can be mounted in two different locations on and Assembly the base Figure 1 67 and Figure 1 68 Figure 1 67 Figure 1 68 Two of the three base feet have two mounting holes for the electrical box stand Figure 1 69 Once the stand is in place the electrical box has a plate mounted on the back that matches up to the stand The top of the stand has two threaded holes that will line up with the plate Use two socket button head screws to secure the electrical box plate to the stand bl Figure 1 69 Figure 1 70 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 25 Condenser System Filter Bracket and Assembly only required if Condenser System not used External E Stop Assembly Thermo Scientific Section 1 Initial Installation Instructions For Condenser set up and use please refer to the Single Use Bioreactor User s Guide Section 2 4 beginning on page 78 When a Condenser system is not used dual filters and filter heaters must be employed The filter bracket is set up by sliding the mounts up to the collar on the shaft To do this loosen the black clamps around the shaft and then tighten back up when in position The base clamp will mount to the top of the tank by setting the clamp
17. Functional Specifications Standard Batch Standard batch temperature range defines the temperature settings Temperatu re Range that are acceptable for use with the single use S U B BPC see Table 2 2 Resistive heated hardware cannot be actively cooled below room temperature the jacketed systems can be operated down to batch temperatures of 5 C The maximum recommended upper batch temperature for either system type is 40 C Elevating the batch temperature beyond 40 C is not recommended as this reduces system reliability or may irreparably damage the S U B BPC Sparging Off gassing and Backpressure Specification Proper gas management in the S U B should be a conservative balance between providing good mass transfer while managing bubble shear force foaming and internal BPC back pressure Flow rates approaching or exceeding the suggested maximum values will likely necessitate the use of antifoam additives in the media Micro Sparge Flow Macro Sparge SUB Rate Setting Flow Rates at 100 working volume at 100 working volume Size Suggested Rated Suggested Rated Suggested Rated Suggested Rated Suggested Rated Maximum Maximum Maximum Maximum Maximum Maximum Maximum Maximum Maximum Maximum 05Ipm 251pm 25 Ipm 25 Ipm 10 lpm 25pm w tiem 5i 250m pm 0m 251pm Overlay Sparge SUB BPC Internal Flow Rates MUNI E Oa Pressure Not to Exceed 50L 4pm im f 8pm ipm 10pm 2im f 2m 50pm l
18. Integrators Reference Guide Thermo Scientific HyClone Single Use Bioreactor For use in biopharmaceutical applications Integrator s Reference Guide Thermo Scientific HyClone Single Use Bioreactor S U B UG011 Rev 1 Preface Patents and Trademarks The Thermo Scientific HyClone Single Use Bioreactor is covered under US patents USPN 7 384 783 and 7 682 067 and 7 487 688 Other US and international patents are pending Kleenpak and Pall are registered trademarks of Pall Corporation SmartSite is a registered trademark of ALARIS Medical Systems Inc C Flex and PharMed are registered trademarks of Saint Gobain Envirotainer is a registered trademark of Envirotainer AB Broadley James and BioNet are trademarks of Broadley James Corporation Applikon is a trademark of Applikon Biotechnology DeltaV is a registered trademark of Emerson Process Management TruViu is a registered trademark of Finesse Solutions LLC CelliGen and BioFlo are registered trademarks of New Brunswick Scientific BIOSTAT is a registered trademark of Sartorius BBI Systems Terumo is a registered trademark of Terumo Meical Corporation PharmPure is a registered trademark of PharmaPure Tubing All other trademarks registered trademarks or logos are properties of their respective owners NOTE The drawings used throughout this document are representative only and may change Please refer to your Equipment Turn Over Package ETP fo
19. L 20 x 1 2 button head fasteners use 5 32 hex wrench located on the strap Figure 1 11 Exact position of the bracket can be adjusted once the BPC is loaded For elevated vent filters mount the adapter piece and the extended filter bracket Figure 1 14 2 Jacketed S U B Mount bracket base first loosen the three button head fasteners allow 1 4 of space between head and plate Align the fasteners to the key hole cut outs in the tank and slide to bottom Tighten fasteners to lock the plate in position Figure 1 12 The swivel arm of the upper bracket can then be placed into the lower receiver Final position of the bracket can be adjusted once the BPC is loaded Figure 1 13 Alternatively an extended height dual filter bracket can be installed for elevated vent filters Figure 1 14 Figure 1 11 Electric Resistive Heater Figure 1 12 Water Jacket mounting mounting standard vent holder base assembly g TEE T Figure 1 13 Water Jacket Figure 1 14 Extended Dual Vent mounting standard vent holder Filter Bracket in use Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 6 Thermo Scientific Section 1 Initial Installation Instructions 3 Attach the probe shelf across the lower probe access cutout by inserting the two tabs into the slots Figure 1 15 and 1 17 and hand tightening the knobs Figure 1 16 and 1 18 Figure 1 15 Electric Resistive Figure 1 16 Electric
20. L S U B Water Jacket DeviceNet Interface 240 VAC Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 44 Section 5 Ordering Information The S U B Condenser System consists of a cart and brackets a condenser chill plate a peristaltic pump and a temperature control unit TCU also referred to as a chiller Part Number Description SV50237 01 Complete Condenser System 120 V including cart chill plate and l mounting post with filter brackets TCU and pump 50239 07 Complete Condenser System 240 V including cart chill plate and l mounting post with filter brackets TCU and pump SV50232 71 Condenser assembly including chill plate and mounting post with filter brackets Option Allowing two chill plates per systems SV50232 23 Thermoflex 900 TCU 115 VAC 60 Hz with necessary plumbing 9V50232 24 Thermoflex 900 TCU 240 VAC 50 or 60 Hz with necessary plumbing SV50241 01 Bi Scientific Masterflex Pump 115 VAC 50 or 60 Hz or 230 VAC 50 or Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 45 Section 5 Ordering Information 5 3 Ordering Information Accessories PartNumber Description SV50177 17 Elevated Filter Bracket Assembly 25 5 for dual filters fits all sizes except 1000 L l jacketed S U B and 2000 L S U B S50191 01 09 Vent Filter Heater and Cord Options For use with exhaust filters when not using condenser system 9V50191 02 Standard filte
21. Resistive Heater Heater 5 Figure 1 17 Water Jacket Figure 1 18 Water Jacket Integrator s Reference Guide Single Use Bioreactor S U B 7 Section 1 Initial Installation Instructions 2000 L Hardware 1 Remove top cover Uncrating Figure 1 18 2 Remove small side cover Figure 1 19 3 Remove both long side covers Figure 1 20 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 8 Section 1 Initial Installation Instructions 4 While in the horizontal position remove both boxes miscellaneous tools kit amp motor assembly and the packaging material If this step is missed both boxes can be removed through the large access door when the tank it is vertical Figure 1 21 Figure 1 22 Figure 1 23 Figure 1 24 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 9 Section 1 Initial Installation Instructions 5 Using either a fork lift or overhead crane the unit needs to be tipped from horizontal to vertical Ensure all straps are secure before proceeding Below are descriptions of both the forklift and overhead crane methods Forklift Method The next step is to lift the crate up You will need about 10 feet of ceiling Preferred height above the crate Lift the crate to vertical using the two eye bolts on the crate end with a 1 nylon 2 leg sling with sling hooks part 88641821 Mcmaster Carr or equivalent Also use a 2 wide by 2
22. U B Water Jacket US version 120 VAC SV50197 04 100 L S U B Water Jacket EU version 240 VAC Part Number Description Part Number Description SV50200 02 500 L S U B Electric Resistive Heater US EU version 208 240 VAC SV50200 04 500 L S U B Water Jacket US EU version 208 240 VAC Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 43 Section 5 Ordering Information 1000 L S U B Systems Include 304 stainless steel outer support container with swivel caster platform variable speed agitation controller motor drive assembly with shaft PID temperature controller three load cells with summing block display and wiring RTD sensor integrated resistive heating element probe shelf and standard tool set Part Number Description Part Number Description 2000 L S U B Systems Include 304 stainless steel outer support container variable speed agitation controller motor drive assembly with four segment drive shaft RTD sensor integrated water jacket three load cells with summing block display BPC pressure monitor probe support system and standard tool set Part Number Description SV50223 11 2000 L S U B Water Jacket Modbus Plus Interface 240 VAC SV50223 12 2000 L S U B Water Jacket Allen Bradley Interface 240 VAC SV50223 13 2000 L S U B Water Jacket Analog Output Interface 240 VAC SV50223 14 2000 L S U B Water Jacket Profibus Interface 240 VAC SV50223 15 2000
23. ansported NOTE Ensure S U B is in final location as overall height with motor mounted is greater than 82 and may not fit through standard door frames Mounting of the motor requires two persons please exercise caution when working in elevated positions References to figures are shown in parentheses following each step 1 Remove the protective shipping bracket above the control panel four 3 8 bolts and store in original crate Keep the 3 8 bolts for use in mounting the motor to the tank 2 Attach the motor with mounting plate to the outside of the tank above the load cell summing block and control panel Figure 1 7 or 1 8 using four qty 4 3 8 16 x 1 fasteners from step 1 above NOTE The bottom two bolts are also used to mount the tool bracket on the Water Jacket 1000 L S U B as shown in Figure 1 8 3 Attach the motor lead to the control panel quick connect Figure 1 9 or 1 10 P a i F j l Figure 1 7 Electric Resistive Figure 1 8 Water Jacket Heater Figure 1 9 Electric Resistive Figure 1 10 Water Jacket Heater Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 5 Section 1 Initial Installation Instructions pd Additional Items for Resistive Heated S U B Attach the exhaust filter bracket fingers Installation facing toward tank center to the top strap of the tank if looking at the control panel use the strap on the left side using the two 1 4 1000
24. antifoam can be used in the S U B These serve to lower the surface tension of the media and will reduce the presence of foam High sparge rates of air can result in the presence of excessive foam Testing has shown that sparging with oxygen will typically result in dramatic reduction of foam in the headspace Integrator s Reference Guide Single Use Bioreactor S U B 40 Thermo Scientific Section 5 Ordering Information Section 5 Ordering Information This section covers the following information 5 1 5 2 5 3 5 4 5 5 5 6 II Ordering Information Disposables BPC Ordering Information Hardware Ordering Information Accessories Ordering Information Partial Spare Parts List Replacement and Spare Parts Ordering Instructions Ordering Support Contact Information Integrator s Reference Guide Single Use Bioreactor S U B 41 Section 5 Ordering Information 5 1 Ordering Information Disposables Standard BPC Products Part Number Description Additional Information 9H30774 01 50 L S U B BPC 9H30774 02 100 L S U B BPC SH30774 03 250 L S U B BPC and a porous frit sparge All SUE Aai a Custom BPC Products Category Options Capability Remarks Tubing Type C Flex platinum cured silicone PVC Pharmed PharmaPure More information in selection guide of BPC catalog Tubing Size Specific lengths of 1 8 ID to 1 ID ID limitations due to port size Luers CPC Quick Connects SIP connectors Tric
25. base on the SUB with the clamp knobs facing out Screw these knobs in to secure the clamp assembly to the tank The recommended position for the filter bracket base is 1 2 feet left of the mixer motor Figure 1 71 The purpose of the external e stop is to provide quick access to an e stop while working upon the ladder Figure 1 72 It is mounted on the top lip of the tank recommended directly above the electrical box and the cord is plugged into the side of the electrical box Figure 1 73 Figure 1 72 Figure 1 73 Integrator s Reference Guide Single Use Bioreactor S U B 26 Section 1 Initial Installation Instructions Harsh Mount Display A harsh mount display can be mounted on top of the electrical box stand Figure 1 74 The two mounting holes on top match the bolt pattern of the Harsh Mount Display Figure 1 75 Figure 1 74 Figure 1 75 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 27 2 1 S U B Technical Operating Parameters Dual Sparge Standard Product Line Recommended Mixer Thermo Scientific Speed Settings Section 2 Functional Specifications Section 2 Functional Specifications Functional performance of the S U B depends largely upon the amount of agitation used to mix the S U B and can have a direct influence upon cell growth performance of the system due to parameters of shear mixing time and heat mass transfer All S U B hardware systems have
26. d inspected and stamped with the Code U symbol per section U 1 c 2 f of the ASME Boiler and Pressure Vessel Code operating with water as the heat transfer medium temperature not exceeding 99 C 210 F under less than 300 psi 2 MPa In Europe to conform to the Pressure Equipment Directive 97 23 EC PED all S U B jacketed systems should be operated at 75 psi or less However if operating conditions require usage outside of the above recommended parameters a stamped jacket can be obtained for an additional fee Integrator s Reference Guide Single Use Bioreactor S U B 2 Hardware Shipment 50 L Thermo Scientific and Setup 100 L 250 L and 500 L Hardware Uncrating Section 1 Initial Installation Instructions Section 1 Initial Installation Instructions The Single Use Bioreactor hardware is shipped directly from the manufacturer and will arrive crated For unpacking instructions and detailed contents of the crate please refer to the instructions specific to the S U B volume Be sure to follow the unpacking instructions provided and retain all packaging materials The S U B hardware should arrive with the following items See T Outer support container platform tank and control panel Drive shaft RTD probe shelf and brackets 4 and standard tool set spanner wrench and torque wrench ETP located on CD provided with hardware Remove crate lid first Remove side wall s Remove the tie do
27. e to et 50L 10W 10W _ 285lbs 395 tbs 23 34 52 5 80 2 C_ soc 60psi 14 145 psi WOOL 10W 10W _ 372lbs 592lbs 29 5 42 56 85 2 C 50 C 60psi 14 145 psi 50L N A 10W 724lbs 1826 Ibs 39 25 52 2 70 95 2 C soc 60psi 14145psi 5 kW 40 Table 2 5 S U B Water Jacket Facility Requirements and Specifications for Installation 250L 10W 10W 440 lbs 991 tbs 26 35 60 96 2 C_ soc 60psi_ 14 145 psi 1 250 L S U B w custom 2 piece agitation shaft SH50177 41 requires 84 1000 L S U B w custom 4 piece agitation shaft SH50177 39 requires 112 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 32 Section 2 Functional Specifications Specifications for the S U B with resistive heater blanket are listed below The system heights are listed for overall installed height and also the required overall height required for installing the drive shaft into the top mounted agitation drive system The jacket temperature range is limited to temperatures at or above ambient conditions It is best practice to set up the system and operator process to reduce the likely hood of the S U B being operated improperly without the bag being loaded properly filled to at least 50 of working volume before the heater is enabled When integrating a bioreactor control system an interlock between the heater and vesse
28. e Use Bioreactor is available through a variety of formats Some or all of the following may be appropriate depending on individual experience and circumstances Contact your Thermo Scientific HyClone sales representative for general product pricing availability delivery order information and product complaints Call 1 800 HyClone US or 32 53 85 75 59 EU for direct and immediate response to overall product questions and general product technical information Technical Support You can also contact our Tech Support by email at hyc bpctechsupport thermofisher com Appropriate technical support is available to assist in the initial setup and operation of each Single Use Bioreactor system Inquire at the time of purchase Training can be provided for startup and operation of the S U B Contact your Thermo Scientific HyClone Products sales representative Integrator s Reference Guide Single Use Bioreactor S U B 49 Appendix A Electrical Receptacle Installation Instructions Appendix A Installation of Female l 102 5mm Electrical Receptacle In order complete this installation the facility must be equipped with an electrical housing of sufficient size e Typically in the U S the plug will require a two gang box when using the adapter plate supplied e For installations outside the U S an adapter plate is not supplied it is recommended that an electrical panel be modified to accommodate the cutout dimension
29. ection 2 5 Probe Assembly instructions for more information on probe calibration e A grounding reference to the media can be created by using a grounding lead between the tank and the body of the stainless steel DO probe or to the stainless steel connector if present on the sample line of the S U B BPC Symptom S U B BPC seems overly tight or overpressure Remedy Verify bag is venting and inspect for cause of overpressure e Reduce inlet gas flow rate of overlay and direct sparge Inspect exhaust filter for restriction or blockage e Excessive foaming should be avoided for several reasons If foam levels are allowed to reach the exhaust filter the filter will become restricted resulting in excessive internal pressure within the confines of the S U B This may cause product failure and impending burst of the S U B BPC Symptom Noise emitted from the BPC mixer assembly Remedy No action required The bearing port assembly supplied with the S U B is an important component in maintaining a sterile environment during cell growth The special seals used in the S U B may generate some noise during operation particularly after the first day of operation This noise may vary in intensity and frequency but generally has no significant effect upon performance or overall durability of the S U B BPC during the intended life of the product Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 38 Sec
30. eference Guide Single Use Bioreactor S U B 53 Thermo Scientific Appendix C Mettler Toledo Load Cell Calibration Instructions Calibration Refer to technical manual section beginning on page 3 8 l 10 11 12 13 14 15 16 17 Access the setup menu by pressing select and print simultaneously Press print continually until sub block 1 4 is displayed Press print again until CAL X is displayed this is the calibration mode Press select to toggle the value from 0 to 1 this will enable the calibration mode Display will show E SCAL indicating you should now empty the scale Once the scale is empty press enter this will establish the scale zero Display will show 15 CAL and begin to count down to zero If the scale is not completely steady it may fault showing E SCALE If successful the display will show Add Ld Place test calibration weight on scale and press ENTER Display will show 00000 Now enter the value of test weight Once the value is entered press enter this will establish the scale span Display will show 15 CAL and begin to count down to zero Display will show CAL d meaning calibration is done Exit setup mode if task is complete by pressing CLEAR Display will show CaL OFF Then press PRINT The Panther Display will return to normal operating mode Integrator s Reference Guide Single Use Bioreactor
31. for S U B Panther Terminal Technical Manual for specific procedures and trouble shooting methods Hardware Systems using Mettler Toledo Prior to reading these instructions confirm the following Panther Display e The Panther Display Load Cell summing block and Load Cell transducers have been specified installed and configured properly e The load cells transducer do not have the transport lock out nuts in place the load cells must be ready for use prior to calibration NOTE The calibration accuracy achieved cannot exceed the precision of the reference used for calibration e Field calibration is most often performed using calibrated reference weights or flow meter for volumetric mass reference e Factory trained technicians have the experience and tools necessary to provide the best system performance and reliability e IFIN DOUBT CONTACT THE FACTORY SERVICE REPRESENTATIVE Introduction e Setup mode is accessed by pressing the select and print keys at the same time these are the two outermost keys See section 3 of the technical manual for further detail e Pressing print is equivalent to ENTER Use this key to proceed through the sub block numbers until you find the choice of interest e Press select to toggle the values of the selected sub block e The S U B electrical schematic contains a table showing the sub blocks that have changed from the default settings Thermo Scientific Integrator s R
32. h gear models reduction of 10 1 1780 12 5 178 250 L SCF SCM P39 147 Motor rating of 1780 rom 60 Hz with gear models reduction of 12 5 1 1780 12 5 142 500 L SCF SCM P39 356 Motor rating of 1780 rom 60 Hz with gear models reduction of 5 1 1780 5 1 356 1000 L SCF SCM P39 119 Motor rating of 1780 rom 60 Hz with gear models reduction of 15 1 1780 15 119 2000 L SCF SCM P39 119 Motor rating of 1780 rom 60 Hz with gear models reduction of 15 1 1780 15 119 Table 3 1 VFD Parameters 5 The mixer output should now be scaled properly for the correct RPM displayed NOTE For users who currently operate the S U B and have not previously verified the calibration of the system the current calibration of the system should be verified so an approximate operating RPM for any previous bioreactor runs can be documented and compared to the newly calibrated system Users can then verify the parameters in the above table and change them if necessary To confirm that the parameter change provides a calibration accuracy of 1 RPM conduct a final check of the calibration refer to Section 2 2 a Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 52 Appendix C Mettler Toledo Load Cell Calibration Instructions Appendix C Mettler Toledo Load Cell Calibration Instructions Load Cell Calibration NOTE Please refer to the instructions and reference material found in the Instructions
33. hermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 11 Section 1 Initial Installation Instructions 7 Remove bag lift arms from bottom of crate 8 Remove lag bolts from the feet of the S U B unit Figure 1 28 9 Lift the tank out of the crate using either a fork lift or an overhead crane 10 Remove all packaging materials and prepare for assembly Figure 1 29 Figure 1 30 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 12 Section 1 Initial Installation Instructions NOTE This information is primarily directed toward third party firms performing integration services 2000 L Hardware 1 The crate will come assembled from the manufacturer so the top Crating cover two long sides covers and the end cover need to be detached and available The two remaining sides small base pallet and long base pallet remain together in an L shape as shown Figure 1 31 2 Attach two 8 tie downs as shown They need to be installed firmly to keep the long base from putting a lot of pressure at the corner joint after it gets tipped up Figure 1 32 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 3 Section 1 Initial Installation Instructions 3 The next step is to lift the crate up You will need about 10 feet of ceiling height above the crate Lift the crate to vertical using the two eye bolts on the end with a
34. ibration of the AC Tech Variable Speed Drive 0 52 Mettler Toledo Load Cell Calibration Instructions 0000 00 53 Warnings and Safety Warning Read and understand operator s manual before using this equipment Thermo Scientific HyClone Single Use Bioreactor is designed to be operated under traditional mammalian cell culture conditions A general before using this understanding of bioreactor systems and their operation is important prior machin to using the system for the first time A e Read and understand users manual before operating e Failure to do so could result in injury Warning Hazardous voltage inside Disconnect power before opening Service by trained personnel only Consult manual Electrical components are designed into and required for the proper function of the Single Use Bioreactor S U B The mixer motor motor controller resistive heater jacket and control panel all have electrical components A e Risk of electrical shock and injury e There is potential for static charge build up during mixing and set up of BPCs Warning Entanglement hazard Rotating parts can cause injury Keep hands away from moving parts A Warning Hot surface Do not touch The heating jacket is designed to heat the outer vessel wall Normal operating conditions generate heat and could create hot surfaces A e Hot surface inside e Contact with surfaces may cause burns e Do not to
35. ice to avoid conditions that will make the top of the S U B BPC bag appear tight gt 0 1 psi Typically the exhaust vent filters will block over time thus reduced capacity will increase pressure drop across the filter media as the run progresses Vent filter heaters are recommended in order to flash condensate that may accumulate near or on the filter media Maximum rated operating pressure is 0 5 psi exceeding this increases drive shaft wear and may result in bursting the BPC typically at a location above liquid level Applications requiring large gas flow can use the Single Use Bioreactor Condenser System to provide additional protection and reliability Sparge Flow Meter Recommendations Flow meters should be scaled for the proper vessel size depending upon the maximum or expected oxygen uptake rate OUR of the targeted cell line It is common in many process development applications to use a modular control platform to manage multiple S U B systems In this case it is good practice to consolidate the S U B s into scaled groupings 50 250 L 500 1000 L 2000 L for example and in this case select the upper flow rate listed on the standard range for the largest system specified for the bioreactor work station typically this is sufficient to provide both sparging flow rate accuracy and capacity Oxygen Carbon Dioxide Nitrogen optional Air S U B Size Recommended Standard Recommended Standard Recommended Standard Recommended Standard
36. interlock defined as 90 110 of the rated working volume The upper end of this range represents 0 25 hp 1000 gallons in the 50 1000 L S U B and 0 2 hp 1000 gallons in the 2000 L S U B Nominal Setting Standard Range Extended Range 100 Working Volume 50 110 Working Volume 90 110 Working Volume Only Recommended VFD Settings VFD Settings Mixer Speed P24 and P39 MATA TL P24 and P39 Mixer Speed 30 213 rpm 20 230 rpm 77 5 Hz Table 2 1 Agitation and Specification Matrix NOTE The recommended VFD settings will scale the analog output of the VFD according to mixer speed listed typically 0 10 VDC Recommended Batch Recommended batch temperature setting is specified for growing most Temperatu re Setting animal culture cultures typically 37 C However specific applications will vary and the set point can be adjusted within the standard batch temperature range Batch process temperature calibration should be verified on site to ensure accuracy See S U B Facility Requirements Table for more information on the TCU specifications for water jacketed systems S U B Recommended Batch Recommended Batch Standard Batch Size Volume Range Temperature Setting 100 WV Temperature Range 50L 25 55 L 5 40 C 100 L 50 110 L 5 40 C took 500 100 ae o e 20o0L 1000 22001 ye ee Table 2 2 Temperature Specification Matrix Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 29 Section 2
37. l load cells should be implemented to ensure the tank heater does not operate unless intended System Foot Print System Resistive Heater Power Requirements System Weight Temperature Range Capacity System Height 108 125 208 240 108 125 208 230 VAC VAC VAC VAC 50L 15Amps 10Ams 258 381 528 80 Ambient 40 C O4kW 04w WOK i5Amps 10Amps 372lbs 592Ips 295 42 5e 85 f Ambient 40 C f osiw o6kw 250L 20Amps 10Amps 440 Ibs 991lbs 26 3 eor 96 Ambient soc 13w 13w Table 2 6 S U B Resistive Heater Blanket Specifications for Installation 250 L S U B w custom 2 piece agitation shaft SH50177 41 requires 84 1000 L S U B w custume 4 piece agitation shaft SH50177 39 requires 112 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 33 2000 L Jacketed Volumetric Flow Thermo Scientific Section 3 Product Information Section 3 Product Information Tests were performed to demonstrate the flow rate performance and resulting pressure drop typical of the water jacket used on the 2000 L S U B hardware system Tests were conducted with a 2 hp centrifugal recirculation pump using water as the jacket circulation fluid Valves pressure gauges and flow meters were used to regulate and record the results presented in Table 3 1 A typical inlet pressure of 60 psi resulted in a jacket flow rate of 115 lpm and a pressure dr
38. lamp Kleenpak Lynx Refer to selection guide in BPC catalog for further Connectors SmartSite Clave Lynx steam thru CPC Steam Thru Gore steam information by connection type Note Only option valve Gore Mini TC BioQuate GE PAW SterilEnz end plug etc for probe port connections is Kleenpak MET Ea feet Additional ports second row of 4 for 50 L to 250 L S U Bs second ports row of 5 for 500 L and 1000 L U B s Pressure sensor Pendotech for 50 L to 250 L S U B comes standard on 500 L and 1000 L Disposable sensors DO Finesse DO and pH PreSens Availability of various other disposable sensors currently pending Addition of ports lines other than 2nd row of probe ports a Da TEET E ET Dependent on location in bag and fit with hardware Port sizes Limited customization possible as engineer to order with justification e g 1 ID port on harvest line Re arrangement of Limited customization possible e g moving sample tempwell port to oat roe SUES TTS Til ees a probe tube port or swapping overlay inlet line with supplement line Eee ee CE Ee OR Dag AT fE A A Dual sparger open pipe plus porous frit standard Can do an Sparger engineer to order for one or the other alone Make to order bags will be built around standard dual sparger chamber Din tube lines Limited customization possible Suggested use through 1 port so Length cannot interfere with impeller and shaft p this is engineer to order
39. on The condition may exist where other electrical systems are requiring current loads beyond those allowed by the breaker S U B system should be placed on its own electrical circuit Disconnect main power cord Inspect electrical circuit breakers and fuses inside the electrical enclosure of the S U B controller Determine fault condition by visual inspection If fault condition can not be determined by visual inspection contact manufacturer Sym ptom Single Use Bioreactor temperature is below target or slow to respond Remedy Check temperature controller and sensor Thermo Scientific Verify the temperature probe RTD is not loose and has been fully inserted into the S U B BPC thermo well Verify thermo well has been filled with sufficient glycerol to aid in heat transfer Verify that temperature controller is enabled Indicator light green LED labeled C1 will illuminate when temperature controller is cycling heater to maintain target temperature Verify mixer is operating safety interlock will not allow heaters to warm without the mixer in operation Verify system is filled with sufficient volume of fluid There must be enough volume of media minimum volume in U B BPC to provide contact with the bag add more media if BPC is not touching heater area Integrator s Reference Guide Single Use Bioreactor S U B 35 Thermo Scientific Symptom Remedy Symptom Remedy Symptom Remedy Section 4 Troubleshooting
40. op of 33 psi The piping of the jacket utilized the standard 1 quick connects and was tested using the preferred parallel flow path between the top and bottom jackets This resulted in a flow distribution of 70 top and 30 bottom as seen in Graph 3 1 The total fluid volume of the top and bottom jacket is approximately 32 4 L upper jacket 29 L bottom jacket 3 5 L The total area of the top and bottom jacket is approximately 7759 7 in upper jacket 6832 7 in bottom jacket 927 in Tank Inlet Tank Outlet Pressure Drop Total Bottom Barton seen Flow Distribution Table 3 1 2000 L Jacketed Volumetric Flow at Specific PS with Head Pressure Shown 2000 L JACKETED Volumetric Flow luer po Aed f smj e Pe es a er pt eet tg e fFeteiFew Bottom p ee a eee eee Total Ipm a IH 50 60 70 80 90 100 110 120 130 140 150 Liters Per Minute Graph 3 1 2000 L Jacketed Volumetric Flow at Specific PSI Minus Head Pressure Integrator s Reference Guide Single Use Bioreactor S U B 34 Section 4 Troubleshooting Section 4 Troubleshooting Symptom Single Use Bioreactor will not operate Remedy Check power supply Verify main electrical plug connection at wall outlet verify position of main power disconnect and verify position of Emergency Stop switch Verify condition of main electrical circuit breaker of facility If protection breaker has been tripped determine fault conditi
41. r heater power cord for US Japan NEMA 5 15P w 6 lead 100 120 VAC V50191 03 Vent Filter Heater with programmable controller 200 240 VAC Dual Filter Bracket for 2000 L S U B tank when not using condenser system Accom SV50244 01 modates two vent filter heater units SV50935 01 Mobile Stairs 2000 L S U B only Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 46 SV50191 09 Custom Extension Cord for filter heater for use between heater and controller 10 100 240VAC Section 5 Ordering Information 5 4 Ordering Information Partial Spare Part Number Description Parts List 55070 SV50177 34 Drive Shaft Assembly o0 L S U B One 1 Piece Integrated Design Delrin Anodized Aluminum SV50177 35 Drive shaft Assembly 250 L S U B One 1 Piece Integrated Design Delrin Anodized Aluminum V50177 36 Drive Shaft Assembly 500 L U B Two 2 Piece Integrated Design Delrin SST 8V50177 38 Drive Shaft Assembly 1000 L S U B Three 3 Piece Integrated Design Delrin SST Drive Shaft Assembly 1000 L S U B Four 4 Piece Integrated Design Delrin SST V50177 39 ae NON Released Engineering Design SV50177 40 Drive Shaft Assembly 250 L U B One 1 Piece Integrated Design Delrin SST SV50177 41 Drive Shaft Assembly 250 L S U B Two 2 Piece Integrated Design Delrin SST SV50177 65 Frit Sparge Line Support SV50177 90 Safety Cap Drive Shaft Motor Assembly
42. r your applicable drawings A We have taken precautions to ensure this manual is accurate and complete Nevertheless readers should remain alert to the possibility of errors and omissions If any of the information in this manual seems incorrect contact Thermo Fisher Scientific for advice before proceeding This information including product specifications is subject to change without notice Because of this please take caution If extracting information from this User s Guide for use in other documentation as it will be updated with future revisions Please contact Thermo Scientific HyClone products technical support for the current revision MANUAL NUMBER 1 10 29 10 Integrator s Reference Guide for S U B REV ECR ECN Date Description Thermo Scientific iI Thermo Scientific Section 1 Section 2 Section 3 Section 4 Section 5 Appendix A Appendix B Appendix C Table of Contents Warnings and Safety 00 0 i cccccccccceeeeeeeeeeseeseeeeeeeeeeeees i Initial Installation Instructions 0 ccc cccesseeceesesteeeeesenteeeeees 3 Functional Specifications ccc cccccssscccccesssseeeceeessseeeeeeens 28 Product Information 0 ccc cccccccesseccseseeeseseeeeesneeeeseeeseseeeeens 34 Troubleshooting eer ne nee ne me er SP 35 Ordering Information 000 000 ccc cccsssseeesseeessssesseeeeeeeeeeeas 4 Electrical Receptacle Installation Instructions 0 0 50 Cal
43. ry locating boards can be removed and positioned to fit the feet Also straps may need to be loosened to let the tank pass through Figure 1 39 Figure 1 40 Figure 1 41 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 16 Section 1 Initial Installation Instructions 9 Install 12 straps around the tank using the eyebolts provided Use strips of foam underneath the straps to further protect the tank Figure 1 42 10 Ensure all straps are secure and tight 11 To tip the tank down using a fork lift the forks must first be removed This will keep them from damaging the tank We also recommend the same set up as mentioned before lifting the crate up vertically The fork lift needs to pull the crate back and lower it simultaneously to lay the crate S U B system down Figure 1 43 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 17 Section 1 Initial Installation Instructions Figure 1 44 Figure 1 46 Figure 1 47 Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 18 Section 1 Initial Installation Instructions 12 With the tank secured in a horizontal position each foot needs to have one lag screw 3 8 x 4 installed to keep the base from putting a side load on the load cells during shipment Ensure the lag screws go into the 4x4 underneath the feet Figure 1 48 Figure 1 49 Figure 1 50 Figure 1 51 13
44. s as shown below lt mm 106mm gt 81mm 85mm V N plaw jot Figure 1 Panel Cutout 2 Thermo Scientific Verify that electrical power has been disconnect and been locked out for safety Verify the holes for mounting the receptacle housing are positioned properly e Center to center of respective mounting positions is 3 35 85mm tall and 3 0 77mm wide Verify the condition of the three expose wire leads strip back to new wire if needed Connect the wire leads using the screw terminals paying strict attention to obtain the correct wiring position as it is labeled on the receptacle Green ground White common Black in the US Blue in the EU hot Integrator s Reference Guide Single Use Bioreactor S U B 50 Appendix A Electrical Receptacle Installation Instructions Figure 2 Female Receptacle 6 If using the adapter mounting plate secure it to the selected facility electrical housing as per drawing Figure 3 otherwise proceed to step 7 3 4X 10X1 screws to mount plug to adapter plate NOTE The plug will be offset to the left or right if mounting to a 2 gang box with screws in opposite corners If this is the case then one of the holes in the plug will line up with the screw will need to be used in that hole Use other 2X 10X1 screws to plug holes not used 4X 6 32X 1 1 4 screws to mount adapter plate to TYP 2 gang FS FD box NOTE The plug
45. ss steel connector if present on the sample line of the S U B BPC Most traditional systems utilize a condenser or exhaust vent heater to help manage condensate is this necessary for the S U B Extensive testing has found that an exhaust heater or a condenser is not typically required under normal operating conditions for S U B s 500 L or smaller However more demanding applications may warrant an exhaust vent heater which is available from your sales rep I typically use level sensors to control volume and feed rate or supplement during a bioreactor run how would I do this with the S U B Use load cells or a scale to control volumes based upon weight The S U B is not equipped with level sensors However the S U B can be setup to allow supplement feeds and volumes to be managed by weight Please refer to Section 3 for skid dimensions for sizing of scales Integrator s Reference Guide Single Use Bioreactor S U B 37 Section 4 Troubleshooting Symptom pH levels are questionable or out of range Remedy Verify calibration of probe utilize either media or gas buffers e pH levels can be managed in a similar manner to conventional bioreactors once calibration of the probe is verified by use of an off line sample Carbon dioxide gas sparged through the media or headspace biocarbonate levels in the media and the addition of liquid titrant solutions all serve to manage the pH balance of the bioreactor environment See S
46. t 01psi 05psi Pa om o 6pm S Som 251m o s 01 psi 05 psi Table 2 3 Sparging Off gassing and Backpressure Specification Matrix Micro Sparge Setting The suggested setting is based upon experience of providing good oxygen transfer without excessive shear coalescing or foam generation Macro Spa rge Setting The suggested setting is based upon experience of providing good oxygen transfer with the benefit of providing CO stripping and some improved control against foam generation Overlay Spa rge Setting The amount of overlay allowed is best set by determining the balance of gas exhaust vent flow capacity still available while keeping the internal back pressure of the S U B BPC under safe operating conditions Typical applications with the S U B will not require the use of the overlay vent if the open pipe spare is being used Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 30 Section 2 Functional Specifications Maximum Flow Ratings Maximum flow ratings are based upon the physical and mechanical limitations of each sparger flow channel of the standard BPC assembly flow restrictions related to filters check valves diffusers not to exceed a pressure drop of 10 psi In practice it is expected that most users will not operate near these maximum ratings Operating Pressure Operating Pressure must be considered as part of developing a robust cell culture process and it is good pract
47. the four internal clips are on the last set of rings Using both hands place connector flanges between index fingers and thumbs and squeeze until properly seated Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 39 Thermo Scientific Section 4 Troubleshooting Sym ptom We are not achieving the cell growth we expected in the S U B while running under our normal bioreactor agitation and sparging rates What should we do Remedy Reduce agitation and sparging rates Often low cell viability and cell growth can be attributed to excessive sparging or agitation It is recommended that users reduce their sparge rate compared to what they might use in a conventional bioreactor Gas flow rates supplied as overlay should also be reduced as much as possible Too much gas creates excess foam and higher shear conditions Provide only the level of agitation needed low viability and lysed cells reduce agitation speed cell aggregation and settling increase agitation Media formulation can also have a large affect on cell culture growth in the S U B Surfactants such as Pluronic decrease shear and increase k a but at a cost of increased foaming Thermo Scientific can offer custom media especially for the S U B and customer s specific cell line s Sym ptom Excessive foam in the bioreactor headspace Remedy Alter the liquid surface tension related to the culture media and or sparge gas A media supplement of
48. tion 4 Troubleshooting Symptom We forgot to introduce the pH and DO probes prior to media fill can we still make a sterile connection under these conditions Remedy Yes as long as the clamps were closed on the Kleenpak Connector probe ports before liquid fill The Kleenpak connectors must be dry to make the connection of the probe assemblies When media is already present in the S U B follow the probe insertion procedures as outlined in Section 2 5 Probe Assembly Some fluid may enter the bellows when the probe is inserted into a BPC already filled with media Symptom Iam not familiar with the use of the Pall Kleenpak Connectors and am concerned about making connections What can I do to ensure a successful connection using this system Remedy Familiarize yourself with the Pall Kleenpak Connector instructions found in Section 2 7 before beginning e When a connection is being made visually evaluate the status of the four locking external clips and verify they are tightly secured the snap should be audible for all four clips when pressing the connectors together Always make sure the four locking clips are fully engaged for the male female connection before removing the paper strips e Acommon cause for a leaky Kleenpak is an error in the final step of seating the tapered barrels of the male female connector There are a series of concentric rings inside the male connector 0 3 in front of the black O ring Visually verify that
49. uch while in operation Warning Burst Hazard Under normal operating conditions the S U B BPC chamber is under slight pressure Normal passive venting prevents any excess of pressure building up within the chamber Chamber pressure and inlet line pressure should be monitored for proper settings A e Contents under pressure e Do not exceed 0 5 psi 0 03 bar BPC pressure e Do not exceed 5 psi 0 34 bar inlet pressure e Assure vent filter is properly positioned and working properly Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 1 Protective Earthing Environmental Conditions Water Jacket Vessel Information Thermo Scientific Warnings and Safety Protective earthing must be verified prior to plugging the S U B into any electrical outlet Ensure the receptacle is properly earth grounded e Operating 17 C to 27 C 20 to 80 relative humidity non condensing e Storage 25 C to 65 C e Installation category II over voltage in accordance with IEC 664 e Altitude Limit 2 000 meters The Water Jacket S U B has been designed to be operated with water as the heat transfer medium with temperatures not exceeding 60 C 140 F under less than 150 psi 1 MPa operating pressure NOTE The S U B BPC operating limits for temperature are 5 to 40 C and an internal pressure of less than 0 5 psi The water jacket is not classified as a pressure vessel and is not required to be registere
50. wn straps Remove any all blocks on crate floor Remove S U B carefully using forklift manually by lifting via the bottom of the cart frame not the casters Ensure no damage occurred during shipping Contact your Sales Representative immediately if damage has occurred Integrator s Reference Guide Single Use Bioreactor S U B 3 Section 1 Initial Installation Instructions 1000 L Hardware The S U B hardware should arrive with the following items Uncrating e Outer support container platform tank and control panel main shipping container e Motor boxed located inside tank Drive shaft RTD pressure transducer cable probe shelf and brackets 5 and standard tool set 4 pieces items are located in the foam packaging within the tank Figure 1 6 ETP located on CD provided with hardware Drive shaft 3 or 4 segments RTD Open end wrench Spanner wrench Motor with mounting bracket packaged separately for jacketed version Torque wrench Probe shelf Open end wrench Pressure transducer cable Exhaust filter holder packaged separately for jacketed version Probe fingers 5 Figure 1 6 Foam packaging configuration for 1000 L U B Thermo Scientific Integrator s Reference Guide Single Use Bioreactor S U B 4 Section 1 Initial Installation Instructions Motor Mounting Please reference the following instructions to mount the S U B motor for 1000 L first time setup or if the unit is to be tr
Download Pdf Manuals
Related Search