GMP Mixer User Guide - newenglandsales.com
Contents
1. Print name Signature Date inspection completed NovAseptic GMP Mixer Installation and User Guide 35 Spare Parts The number of spare parts to keep on hand depends on the number of mixers in production and their application For further information please contact Millipore Millipore recommends the following equipment be kept in stock Mixing head GM 12 Male bearings GM 2 Male bearing o ting See page 9 for required tools and accessories www millipore com Troubleshooting During troubleshooting follow the instructions in this manual A correct installation is crucial to proper operation Before repair or service of the GMP Mixer personnel must study and understand the user guide Before performing maintenance on the GMP Mixer make sure that the vessel is cooled down to below 25 C 77 F e emptied of liquid and hazardous gas e free from traces of harmful products Itis the customer s responsibility to check the safety of the GMP Mixer used in a new application according to e External load Reaction forces and totque Corrosion erosion and fatigue e Decomposing of unstable liquids Possible Causes Solutions Motor mixing Inspect power supply head does not Overload protection tripped Check the setting amp rotate value and the ambient tem perature Heavy load of particles stuck Clean the unit to the magnets High amp value Ambient temperatre too high Chill the2. Vessel ID Inspection date Volume Manufacturer Date of manufacture Design pressure Design temperature Product description Viscosity www millipore com Maintenance Check Notes Complete Drive Unit Check cables for damage U yes D no Ll yes no Ll yes C no U yes D no Check the gearbox for leakage Check the geatbox for noise Check for any contact matk on Tank Plate Ec err eel shaft and outer drive head rota Ll yes O no tion and Ec err eel movement Check outer drive head for damage caused by contact with Tank Plate u yes u no Ensure bolt screws nuts and flange u yes u no are in good condition and free of damage Mixing Head Inspect the silicone carbide on the female bearing for damage Inspect the inside of the mixing head and bottom surface for damage Check that mixing head rotates easily Listen for noise Inspect bottom surface of wings for marks and scratches Inspect the magnetic body for par ticles Male Bearing Remove and inspect ceramic bearing for cracks and abnormal wear Inspect the stainless steel foot Make sure the O ring is not damaged Check for loose ceramic parts Check for thread deformation Install and ensure male bearing is tightened to proper torque metal to metal Tank Plate Inspect tank plate for scratches marks Ll yes O no and or damage Inspected by
3. Ensure electrical cables are long enough to enable the drive u u unit to be disassembled and removed from the vessel ee Install the AC Motor Complete Ll yes U no U yes U no Ea Connect the drive unit Ensure that the supply voltage and overload protection are set Ensure that the electrical cover and conduit entries are in place Ensure that the outer drive head rotates clockwise view from above Install the DC Motor Make electrical connections Make sure the electrical cover i Ll yes U no and the cable gland entries are properly in place ES Ensure that the motor rotates clockwise view from above Install the Speed Counter Optional a1 Remove the outer drive head from the drive unit Mount the speed counter on the drive unit according to the illustrations in this manual for each GMP size For GMP 2000 5000 and 10000 ensure the cable is in stalled correctly Mount the contact in the contact holder tighten the contact holder on the drive unit Collect leftover cable For GMP 50 insert an extension plate between the shaft and the outer drive head Connect the socket cable Check that the number of pulses per rotation is correct Insert the outer drive head on top of the speed counter unit U yes U no Complete U yes U no Ll yes O no U n a U yes U no NovAseptic GMP Mixer Installation and User Guide
4. GM 10 4 GM 20 4 GM 50 4 GM 1007 4 GM 2007 4 GM 300 4 Serial No See documentation for your NovAseptic GMP Mixer EC directive taken as a basis 98 37 EC Machinery Directive 73 23 EEC Low voltage Directive 89 336 EEC EMC Directive Applied harmonized standards EN ISO 12100 jefi Iso 00 2 Date Manufacturer s signature VYE X08 The undersigned Managing Director Anders Karlsson Millipore AB Head quarters Millipore AB Branch office Stockholm www mlillipore com R djans vag 7 Englundav gen 7 Box 1466 SE 449 34 N dinge SE 171 28 Solna Telefon 46 0 303 975 20 Telefon 46 0 771 200 645 Telefax 46 0 303 960 79 Telefax 46 0 771 200 644 VAT No SE556120300001 NovAseptic GMP Mixer Installation and User Guide INSPECTA EC DESIGN EXAMINATION STATEMENT Application of the Council Directive 97 23 EC of 29 May 1997 on Pressure Equipment as amended and Swedish ordinance AFS 1999 4 STATEMENT NO 07 195220 02 This Statement consists of 2 pages THIS IS TO STATE THAT THE COMPONENT WITH THE TYPE DESIGNATION Tank Plate Mixer MANUFACTURED BY Millipore AB N dinge Sweden is found to comply with the relevant parts for design examination of the requirements in Annex Essential Safety Requirements and EN 13445 The equipment has been examined with respect to the relevant parts for design examination procedure of conformity assessment as described in Module B in the AFS 19
5. Install the Control Cabinet Complete EE Select the appropriate control cabinet ea Set torque according to AC motor and DC motor EX Vetity that the correct EPM prom is installed g If the control cabinet is not supplied by Millipore install a O yes UO no frequency converter C n a 30 www millipore com Commissioning Valid Regulations Application of the AFS 1999 4 Council Directive 97 23 EC of 29 May 1997 on Pressure Equipment as amended Complete this checklist to ensure regulations are met Commissioning Gheckpomt Date eigau He emit TL Use an Gauge 1 IE Use NovAseptic Gauge 2 mc cq d stalled metal to metal Outer Drive Head turns clockwise pp Before each startup The bearings are intact aS o y onu ER UESTRE The mixing head is not running dry a SE The mixing head is always covered by liquid during operation The process medium shall be Newtonic liquids with viscosity from 1 to 800 cp Free from magnetic particles a S SE NovAseptic GMP Mixer Installation and User Guide Installation Qualification Checklist Use this installation qualification for each vessel and mixer to ensure that the correct mixer has been installed and all important information has been gathered for future use Installation Qualification Different applications require different operating parameters on the frequency converter depending on Density of liquid e Viscosity of liq
6. Socket type is series 713 M12x1 Connect the socket cable according to the following Socket Connection Socket type Series 713 MI2x1 Extension Sensor Socket Cable m Brown i 4 Signal _ Black iu Blue Check that the number of pulses per rotation is correct GMP500 4 GMP500 8 cmP3oooo 12 Control Cabinet Installation The installation must be performed by an authorized electrician The control cabinet must be installed with correct fuse Control Cabinet Installation Specifications 1 Select the appropriate control cabinet according to Product Specification Sheet SP1175ENO0 Maximum allowed current during startup is controlled and programmed See the data specification label for maximun allowed current and attached to the motor Set torque For AC motors see product specification sheet SP1004ENOO For DC motors see specification sheet SP1008ENO0 Verify that the correct EPM prom is installed according to product specification sheet If the control cabinet is not supplied by Millipore ensure that a variable frequency drive is installed Millipore supplies general information and standard parameters Perform validation for each individual process Instantaneous start may lead to a breakdown Minimum frequency feed to motor 6 Hz Maximum frequency feed to motor 50 Hz 60 Hz optional Ramp up down minimum 5 seconds Specific to each application set accordi
7. 3 clockwise view from below to the stop position approximately 10 4 Tighten the two screws 4 counter clockwise view from below with a wrench NovAseptic GMP Mixer Installation and User Guide 17 A A GMP 5000 GMP 10 000 GMP 20 000 and GMP 30 000 1 CD Tas Tut Install the drive unit into the tank plate Align the four holes in the drive unit to the threaded holes in the tank plate 2 Screw the four bolts into the tank plate and tighten them with a wrench Electrical Installation When working on live drive controllers prevent accidents by observing applicable national regulations All electric installations including the variable frequency drive must be performed by an authorized electrician The mixer must be operated with a variable frequency drive to function properly Drive units require the following speed control device 3 phase AC motor Frequency converter 1 phase DC motor Thyristor controller Before installation Ensure that all incoming power is equipped with an emergency stop and an on off switch that can be locked in both positions Ensure that the motor cables are shielded to avoid electrical disturbance Ensure that the drive unit is properly grounded Ensure that the electric cables are long enough so that the drive unit can be disassembled and removed from the vessel 18 www millipore com AC Motor Installation The AC motor in the standard NovAseptic GMP
8. environment Motor mechanically over Check all transmissions loaded Mixing head Male bearing worn out Replace male bearing scratches against Female bearing holder is Repair mixing head tank plate damaged Loose male bearing Remove male bearing Inspect male bearing and tank plate for damage If it is undamaged reinstall the bearing and check rotation direction of the mixing head Particles stuck to the magnets Remove particles Deformation after welding Review instructions for welding the tank plate and verify tolerances using ap propriate gauges NovAseptic GMP Mixer Installation and User Guide 37 Possible Causes Solutions Outer drive head Contact Millipore service scratches the tank Bent hole shaft in gearbox Contact Millipore service plate Drive unit not properly in Install drive unit correctly place Particles stuck to the magnets Remove particles Deformation of tank plate Review instructions for during welding welding the tank plate and verify tolerances using ap ptoptiate gauges Loose outer drive head Position the outer drive head onto its lower end position against the shaft and tighten Magnetic discon Review the guidelines under Operation Starting of substances dry running the Miser nection of mixing Incorrect order of addition head decoupling Unexpected viscosity density Call your Millipore repre changes sentative fot consultation Remove male bearing Inspect
9. outer drive head Optional equipment available on AC drive unit NovAseptic GMP Mixer Installation and User Guide 11 Installation and Operating Parameters Please refer to the appropriate product specification sheet for more information Tank Plate and Welding Flange Parameter Minimum Maxmum Temperature 80 C 200 C 112 F 392 F Pressure 1 barg 10 barg 14 5 psig 145 psig Mixing Head Male Bearing and Tank Plate Define the operating parameters inside the vessel GMP Mixers are designed for non explosive and non hazardous areas Parameter Minimum Temperature 5 C 135 C 41 F 275 F i P TE Media may not contain magnetic particles see Product Specification Sheet Minimum acceleration Five seconds Specific to each application set accord and deacceleration time ingly Drive Unit Defines the operating parameters inside the vessel Parameter Minimum Maximum 0 C G2 F 40 C 104 F Noise level and Vibrations Noise levels are measured according to ISO 1680 standard and are within maximum levels specified by standards CEI 2 24 TEC 34 9 Vibration falls under standard class N and is specified by standard CEI 2 23 IEC 34 14 12 Installation A www millipore com 3 FER Use the Installation Checklist and the Installation AN Qualification Checklist in this manual as guides E for installing the mixer and and initiat
10. troubleshooting section in this guide Operating Notes The mixing head must be completely covered with liquid during opertion Fill the vessel and the mixer with liquid before adding solid material Always ensure that the mixing head is always completely covered with liquid during all operation For operation during draining stop the mixer before the liquid level reaches below the top of the mixer This will ensure the mixer is not run dry If the mixer has been run dry turn off the mixer and inspect the bearings Consult the troubleshooting section Avoid buildup of large quantities of solids on the bottom of the vessel 24 www millipore com Disassembly Before dismounting the drive unit Ensure that the power supply is turned off Ensure that the vessel is empty and ventilated Ensure that the vessel is at atmospheric pressure Ensure that the vessel is cooled to below 25 C 77 F Ensure that all connected media is shut off Before entering the vessel follow the local safety precautions The drive unit may be heavy Use appropriate equipment to avoid injury Dismount the mixer in the following order to prevent personal injuries and damage to the equipment 1 Drive Unit 2 Mixing Head 3 Male Beating Storage Do not store in areas exposed to weather or humidity Always place wood or other non magnetic material between floor and product to avoid direct contact with the floor For stotage periods exce
11. 563 00 issued by Det Norske Veritas Inspection AB 2005 06 10 The dr wings stamped with DNV name and number are still valid The following has been changed Name of manufacturer has been changed from NovAseptic AB Our document has been changed from a certificate to a statement Fluid The resistance against corrosion has not been a part of this review That has to be taken into consideration in each separate case Tank plate will be welded to the bottom of a vessel and pressure tested with the vessel External loads not allowed M LNDAL 2007 05 28 Mapa Sweden AB LU A inspecta INSPECTA SWEDEN AB NEONGATAN4B 43153M LNDAL SWEDEN TEL 46 850113400 FAX 46 65011 3401 www inspecla com Page 2 of2 NovAseptic GMP Mixer Installation and User Guide Operator and Equipment Safety All installers and operators of the equipment must read and understand this installation and user manual before using this equipment Failure to follow installation and operating instructions could result in operator injury or damage to the equipment Any attempt to use the NovAseptic GMP Mixer equipment in a manner not specified by Millipore Corporation may result in damage to the equipment voiding of product warranty and possible operator injury e Any of the following can damage the mixer external load reaction forces and AN torque corrosion erosion and fatigue and decomposing of unstable liquids e Prior to opera
12. 99 4 APPLICATIONS Equipment Category IV Design Pressure min max 1 10 bar g Design Temp range 80 200 C Fluid Group 1 and 2 see limitations Further details of the product and conditions for the statement are given overleaf MOLNDAL 2007 05 28 Inspecta Sweden AB Notified rye No 0409 A Z z Pieter Jilderda Manager Design Review Nalice The statement is subject to terms and conditions if any overeat Lal reecbe orm cal gue desino bride the quality system or amendments to the AFS 1999 4 Directive 97 23 EC of Standards referenced sbove may render this statement invalid The product amp abillty rests with the manufacturer or his representative in accordance with the AFS 1989 4 Directive karajaning as Ins ecta amended INSPECTA SWEDEN AB NEONGATAN48 43153 M LNDAL SWEDEN TEL 46 85011 3400 FAX 46 85011 301 wwwinspecta com Page 1 of 2 0 Cen Earn www millipore com EC DESIGN EXAMINATION STATEMENT STATEMENT NO 07 195220 02 DESIGN APPROVAL DOCUMENTS AR 001010 REV A DATED 2005 06 08 AR 001011 REV A DATED 2005 06 08 AR 001012 REV A DATED 2005 06 08 AR 001013 REV A DATED 2005 06 08 AR 001014 REV A DATED 2005 06 08 AR 001015 REV A DATED 2005 06 08 AR 001016 REV A DATED 2005 06 08 AR 001017 REV A DATED 2005 06 08 AR 001291 REV B DATED 2005 06 08 AR 001078 REV B DATED 2005 06 08 LIMITATIONS This document is based upon and replaces EC Design Examination Certificate number 05 584
13. Mixer Installation and User Guide 2 Turn on the motor and check that the rotor rotates clockwise A label on the motot indicates the correct rotational direction Speed Counter Installation The speed counter may be ordered separately Use the instructions below to install the speed counter Speed counter kit catalogue number GM 67 1 Remove the outet drive head from the dtive unit e qm I 19 20 www millipore com 2 Mount the speed counter on the drive unit according to the following illustration different procedures for different GMP sizes Note in which order to assemble the components and how the cable should run GMP 50 GMP 100 GMP 1000 GMP 500 GMP 2000 GMP 10000 GMP 20000 GMP 30000 3 For GMP 2000 5000 and 10000 the cable runs inside the drive unit flange Run the cable tight against the wall to prevent it from becoming entangled If the cable is long and tends to buckle place the ring inside the drive unit flange with the cable clamped between the ring and the wall 4 Usea strap to mount the contact in the contact holder Tighten the contact holder on the drive unit according to the following illustration Collect leftover cable with a strap Zy e NovAseptic GMP Mixer Installation and User Guide 21 For GMP 50 insert an extension plate between the shaft and the outer drive head Insert the outer drive head on top of the speed counter unit
14. Mixer is three phase 1 Connectthe drive unit according to the control cabinet specifications The drive unit can be Y or A connected depending on the supply voltage from the speed control device W2 U2 V2 W2 U2 V2 Q Q Q Q O 2 Ensure that the supply voltage and overload protection are set according to the motor specification data Ensure that the electrical cover and the conduit entries are properly in place Check that the outer drive head rotates clockwise Rotational Direction Label Drive Unit Thermistor All standard NovAseptic GMP drive units are equipped with a positive temperature coefficient PTC thermistor probe Millipore recommends installation of the probe Thermistor protection units continuously monitor the temperature of the motor through a probe embedded in the motor windings If the nominal operating temperature of the probe is reached a rapid increase in resistance is converted into a switching function This can be used to switch off the motor or to signal a fault Accidental breaks in the supply circuits of the thermistors are also detected Motor current higher than recommended could cause damage to the bearings through decoupling of the mixing head DC motor Installation 1 Make connections according to the following illustration Ensure that the electrical cover and the cable gland entries are properly in place NovAseptic GMP
15. P NovAseptic GMP Mixer Installation and User Guide www millipore com Notice The information in this document is subject to change without notice and should not be construed as a commitment by Millipore Corporation Millipore Corporation assumes no responsibility for any errors that may appear in this document This manual is believed to be complete and accurate at the time of publication In no event shall Millipore Corporation be liable for incidental or consequential damages in connection with or arising from the use of this manual NovAseptic GMP Mixer Installation and User Guide Contents Operator and Equipment Safety sees 7 NovAseptic GMP Mixer Components sseseeeeeeeeeee 8 iss M solle Peer PR 9 Additional EQUIPMENT asaoiatodo stie etiarn dto betae mutatae nass 9 Optional ECU NIC Nismas aa RAE 10 Installation and Operating Parameters 11 SEA NG see datione oret a t apetito dt ed 12 Male Bearing Installationen tides tendon 12 Mixing Head InstellaltOfi caca ra er tente entro 14 Dove Unit WS CaN uod oie reete aaa 15 Electrical Installation era Ebor ath ute rptu 17 Pli MT 23 Starting the i Ps NNNM RR mecetscrcestanes en senletecaeanntinemommetia 23 Disassembly eiecti oe E a 24 Storages e e ee Cea ees e band eee eee eT 24 Recycle and DIS DOS all uon aiti etter sancemcnialenernrereeddaagati
16. PORE To Place an Order or Receive Technical Assistance For additional information call your nearest Millipore office In the U S and Canada call toll free 1 800 MILLIPORE 1 800 645 5476 In the U S Canada and Puerto Rico fax orders to 1 800 MILLIFX 1 800 645 5439 On the Internet www millipore com Millipore and NovAseptic are registered trademarks of Millipore Corporation The M logo is a trademark of Millipore Corporation Mobilarma is a trademark of Mobil Oil Corporation ISO is a trademark of The International Organization for Standardization or an affiliated company 00104053PU Rev A 09 2008 2008 Millipore Corporation All rights reserved
17. allation and User Guide 39 standard Warranty Millipore Corporation Millipore warrants its products will meet their applicable published specifications when used in accordance with their applicable instructions for a period of one year from shipment of the products MILLIPORE MAKES NO OTHER WARRANTY EXPRESSED OR IMPLIED THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE The warranty provided herein and the data specifications and descriptions of Millipore products appearing in Millipore s published catalogues and product literature may not be altered except by express written agreement signed by an officer of Millipore Representations oral or written which are inconsistent with this warranty or such publications are not authorized and if given should not be relied upon In the event of a breach of the foregoing warranty Millipore s sole obligation shall be to repair or replace at its option the applicable product or part thereof provided the customer notifies Millipore promptly of any such breach If after exercising reasonable efforts Millipore is unable to repair or replace the product or part then Millipore shall refund to the customer all monies paid for such applicable product or part MILLIPORE SHALL NOT BE LIABLE FOR CONSEQUENTIAL INCIDENTAL SPECIAL OR ANY OTHER INDIRECT DAMAGES RESULTING FROM ECONOMIC LOSS OR PROPERTY DAMAGE SUSTAINED BY ANY CUSTOMER FROM THE USE OF ITS PRODUCTS MILLI
18. aterial is hard and brittle Keep the magnetic body away from any particles that may adhere to it gets Male Bearing GM 2 Key Number Magnetic body 3 Silicone carbide female bearing The male bearing keeps the mixing head in a correct position it mounts on the tank plate inside vessel Re o a s Gem Tank Plate GM 3 or Flanged Tank Plate GM 312 Each tank plate is marked with the serial number and a mill stamp that corresponds to its heat number The tank plate is mounted welded or flanged onto the vessel and is considered an integrated part of the vessel The tank plate must comply with your local pressure code Flanged tank plate Key Number Male bearing connection thread Welding edge 15 O ring on flanged tank plate only Ms C J OA D Welded tank plate NovAseptic GMP Mixer Installation and User Guide Drive Unit GM 4 The drive unit delivers the rotating torque to the mixing head and is mounted on the outside of the vessel The speed counter is an optional feature on standard GMP Mixer drive units Drive units with speed counter catalogue no GM 4BH Drive units without speed counter catalogue no GM 4A Key Description Number 16 Magnetic outer drive head 17 Tank plate connection flange 20 Serial number label 6 T P Geben 9 0 1 1 1 2 2 Required Tools The following tools are required for installation of th
19. e NovAseptic GMP Mixer These tools are NOT included with the mixer but are available from Millipore Catalogue numbers and specifications for the components can be found at www millipore com Purpose Multi tool Installation tool for mixing head and male bearing for GT 25 use in small vessels moie tol Installation tool for male bearing Heatsink tank plate Attached to the tank plate during welding to prevent G94 deformation NovAseptic gauge 1 G91 For verification of geometry after welding NovAseptic gauge 2 G92 10 www millipore com Additional Equipment The following additional equipment is available from Millipore Catalogue numbers and specifications for the component shown here can be found at www millipore com Control cabinet Speed control device for mixer Regulates rotation speed and ramp time for the motor This equipment is required for all installations G50 G51 Optional Equipment The following options are available from Millipore Catalogue numbers and specifications for the components shown here can be found at www millipore com Key Description Purpose Number 7 Mixing head Keeps the mixing attractor head in place when GT4 AN vessel is moved Sub stitute for the drive unit during transport Speed Speed counter instal counter kit lation kit The speed GM 67 counter indicates the rotational speed of the mixing head and the
20. eding 60 days protect all coupling surfaces such as flanges and shafts on the drive unit with a suitable anti oxidation product Mobilarma 248 or equivalent For storage periods exceeding 6 months turn the rotor outer driving head on the drive unit every 1 2 months Recycle and Disposal Recycle and dispose of equipment according to local laws and regulations NovAseptic GMP Mixer Installation and User Guide 25 Cleaning and Sterilizing Procedures Cleaning in Place CIP GMP mixers are designed for CIP using any of the following processes sprayball rotary jethead or submerged Sprayball and Rotary Jethead Cleaning Start the liquid circulation through the sprayball or x jethead before starting the mixer to ensure lubrication of the bearing AN NOTE Recommended maximum speed of the mixing head is 100 rpm Ensure that the bearings are continuously lubricated Stop the mixer before turning off the sprayball jethead function Add liquid before running the mixer after cleaning to ensure lubrication of the bearings Submerged Cleaning Introduce enough cleaning or rinsing liquid into the vessel to cover the mixing head and the male bearing NOTE e Avoid vortex Add liquid before running the mixer after cleaning to ensure lubrication of the bearings e Magnetic Particles a If presence of magnetic particles is suspected remove the mixing head Remove the particles a
21. has been performed correctly and that the parameters are correctly programmed Ensure that no one is working inside the vessel Ensure that a sufficient level of liquid covers the mixing head and the male bearing to ensure sufficient lubrication of the bearing Never work close to the drive unit while it is connected to its driving source Keep away from moving parts Regulate speed acceleration and deacceleration carefully to avoid magnetic decoupling Stop the mixer immediately if any signs of malfunction abnormal noise or smell occurs Do not exceed operation temperature of 135 C 275 F inside vessel Vessel diameter to liquid height ratio should be 1 1 1 2 when vortex for the process is required Use extra precaution because of pressure buildup when the mixer is running at high speed e When it is running with hot WFI e When it is running at atmospheric pressure e During or after steam sterilization Starting the Mixer 1 Fill the vessel to a minimum level that completely covers the mixing head and the male bearing to provide sufficient lubricaiton of the bearing Start the mixer and increase the speed slowly to a minimum speed 50 rpm Note the first time the mixer is started run it for a few seconds at this speed and check that the motor fan is turning in the correct direction Increase the speed slowly to working speed If the mixer makes a rumbling noise stop the mixer immediately and consult the
22. hly NovAseptic GMP Mixer Installation and User Guide 15 A Drive Unit Installation The drive unit may be heavy Use appropriate equipment to avoid injury e Never use the drive unit without a frequency converter See Control Cabinet in this guide e See the Electrical Installation section of this manual for electrical information Check direction of rotation Turn on the motor Verify that the drive head rotates clockwise and that the fan rotates counter clockwise A sticker on the motor indicates the correct rotation direction of the fan Mounting the Drive Unit Handle the drive unit with caution to avoid personal injury and damage to the equipment Do not make any adjustments to screws and bolts Wits WAV e There is a powerful magnetic force between the mixing head and the outer drive head Mount the drive unit onto the vessel following the instructions for the appropriate mixer size GMP 50 GMP 100 GMP 500 and GMP 50 DC 1 Install the drive unit into the tank plate Put the two studs on the tank plate into the slots on the drive unit 2 Turn the drive unit clockwise view from below to the stop position approximately 15 3 Tighten the two nuts with a wrench 16 www millipore com GMP 1000 and GMP 2000 i n 2 Install the drive unit into the tank plate Insert the locking screws into the two oval holes in the tank plate 2 3 Turn the drive unit
23. ing use Use the Maintenance Checklist as a guide for followup care of the mixer O Install the GMP Mixer components in the 1 following order Co 1 Tank plate refer to the NovAseptic COD Tank Plate Welding Guide for OF installation instructions 2 Male bearing 3 Mixing head 4 Speed counter optional installed on the drive unit 5 Drive unit Male Bearing Installation See NovAseptic Mixer GMP Male Bearing Installation Guide 00101868PU for additional information e The vessel must be clean and completely dry inside e Do not use grip tools on bearing surfaces Follow all local safety codes before entering the vessel e Handle the male bearing with care Mounting the Male Bearing 1 Ensure proper position of the O ring on the male beating 2 For minimal friction lubricate the visible part of the O ring with a small amount of purified water Y 360 o_o n NovAseptic GMP Mixer Installation and User Guide 13 3 Remove the protective cap Ensure that the thread connection in the tank plate and male bearing are clean dry and free from foreign material 4 Tighten the male bearing clockwise by hand into the thread of the tank plate making sure that it is aligned with the center line of the tank plate 5 Position the male bearing in the appropriate tightening tool or multi tool with a torque wrench Ensure that the tool fits the nut Tighten the bearing to metal to metal con
24. male bearing and tank plate for damage If it Incorrect rotational direction is undamaged reinstall the ce NEN bearing and check rotation direction of the mixing head Short acceleration retarda Increase the ramp time tion time Particles stuck to the magnets Remove particles Mixing head run Remove male bearing ning eccentrically Inspect male bearing and tank plate for damage If it MIS Daring is Bot propeHy is undamaged reinstall the in place i P bearing and check rotation direction of the mixing head Replace the male bearing Bearings worn out gno and or repair mixing head Abnormal or Reduce speed Ensure mix rumbling noise Deep vortex ing head is fully covered with liquid at all times Investigate pressure tem Cavitation cotton OOO perature speed Review the guidelines Dry running under Operation Starting the Mixer Loss of running Check the power supply speed Missing phase s AC Check the fuses 38 www millipore com Possible Causes Solutions Speed counter unit is incor Ensure that the speed Speed counter incorrect number of signals rectly mounted on the drive sensor unit is completely unit flange aligned and completely in contact with the drive unit flange without any gap in between Refer to speed counter user guide 00101788PU Speed counter no Corroded socket pins Replace speed counter signal NovAseptic GMP Mixer Inst
25. naded 24 Cleaning and Sterilizing Procedures 25 Gle ningin Place CP a el peste sen tah duces cet amet 25 Sterilizing in PLACE SIP antanan 26 l stallati n Checklist ssiuasscsgn ee E A 27 COMMISSIONING eea EEE EE 30 Valid R g lati nS srian EEEE EE 30 Installation Qualification Checklist 31 Installation Qualification M 31 Check PONS REN RR 32 Maintenance Cheoklisb oue tod one sae danda exu cutn teia bains 33 opare Pals ee dis ac ttr en ne eS ne iniustus Rete 35 T GUDISSDODUO siesta intense acta EEE dutedte 36 Standard Warranty useaan aaae aae tisse 39 www millipore com MILLIPORE EC Declaration of Incorporation Within the Meaning of the EC Machine Directive 98 37 EC Annex II B Herewith we Millipore R djans vag 7 SE 449 34 N dinge Sweden declare under our sole responsibility that the mixer mentioned hereafter corresponds to the relevant safety and health requirements taken as a basis of the EC directive The mixer must not be put into service until the machinery into which it has been incorporated has been declared in conformity with the Machinery Directive In case of a change or modification to the mixer which is not agreed with Millipore this declaration becomes invalid Product description Mixer for aseptic GMP Mixing application magnetic coupled Product type NovAseptic GMP Mixer GMO5 4 GM 1 4 GM 5 4
26. nd reinstall the mixing head Refer to Male Bearing Installation Mixing Head Installation and Drive Unit Installation in this manual b Magnetic particles are not removed from the mixing head during CIP they must be removed manually or by alternative cleaning Magnetic particles can cause corrosion and damage They can also cause a higher torque which may cause the mixing head to decouple and severely damage the vessel 26 www millipore com Sterilizing in Place SIP GMP mixers are designed for SIP fem Sterilization by Pressurized Steam The mixer can be intermittently operated during the initial condensate phase of the sterilization sequence up to 100 C 212 F Recommended maximum speed of the mixing head is 50 rpm for no longer than 30 seconds NOTES e Make sure that condensate lubricates the bearing surfaces e Recommended maximum speed of the mixing head during sterilization is 50 tpm e Turn the mixer off when the temperature reaches 100 C 212 F Add liquid before restarting the mixer after sterilization to secure lubrication of the bearings e Magnetic Particles a If presence of magnetic particles is suspected remove the mixing head Remove the particles and reinstall the mixing head Refer to Male Bearing Installation Mixing Head Installation and Drive Head Installation in this manual b Magnetic patticles are not removed from the mixing head during CIP the
27. ngly Motor current higher than recommended could cause damage to the bearings through decoupling of the mixing head 22 www millipore com Variable Frequency Drive A variable frequency adjustable speed drive VFD controls the rotational speed of an alternating current AC electric motor by controlling the frequency of the electrical power supplied to the motor VFDs are also known as adjustable frequency drives AFD variable speed drives VSD AC drives and inverter drives When starting a motor a VFD initially applies a low frequency and voltage to the motor A VFD increases the applied frequency and voltage at a controlled rate and accelerates the load without drawing excessive current Sine Wave Variable Mechanical Power Frequency Power Variable AC Motor Frequency Controller nam IIE Power Conversion Power Conversion ee N Operator Interface VDF system Notes Consult the parameters settings and curcuit and terminal diagrams before installing the control cabinet e Validate the current media and process conditions If the production conditions are in any way altered after commissioning of the mixer a new validation must be performed e Validate the possible maximum and minimum operating speed for each process e Set VFD unit to 100 nominal power kW and current A of the motor rating NovAseptic GMP Mixer Installation and User Guide 23 Operation A Ensure that the installation
28. t the mixing head rotates smoothly Before Installing the Drive Unit Complete Turn on the motor Verify that the drive head rotates clock i Ll yes Q no wise and that the fan rotates counterclockwise Install the Drive Unit GMP 50 GMP 100 GMP 500 Complete Install the drive unit into the tank plate put the two studs U yes U no on the tank plate into the slots on the drive unit Turn the drive unit clockwise view from below to the stop D U yes U no position 3 Tighten the two nuts with a wrench yes LI no Install the Drive Unit GMP 1000 and GMP 2000 Complete EZ Fit screws and tighten clockwise view from below Install the drive unit into the tank plate Install locking U yes D no screws into the two oval holes in the tank plate Turn the drive unit clockwise view from below to the stop a Ll yes Ld no position 4 Tighten the two screws clockwise view from below 28 www millipore com Install the Drive Unit GMP 5000 GMP 10000 GMP 20000 GMP 30000 Install the drive unit into the tank plate Align the four holes in the drive unit to the threaded holes in the tank plate 2 Screw the four bolts into the tank plate and tighten Before Installing the Electrical Components Ensure all incoming power is equipped with an emergency ses ino stop and an on off switch A Shield motor cables Ensure the drive unit is grounded
29. tact applying torque according to table below Important Ensure metal to metal contact by applying recommended torque in table below If beating is not installed properly it may come off jo CUDO Bs x Catalogue Number GM05 23 GM05 24 GM1 23 6Nm 4 4Lbft GM1 24 GM510 23 GM510 24 GM20 23 13Nm 9 6Lbft GM20 24 GM50300 23 30Nm 22 1Lbft GM50300 24 14 www millipore com Mixing Head Installation See NovAseptic GMP Mixing Head Installation Guide 00101787PU for additional information 5 Handle the mixing head with care Use extreme care when mounting the mixing head on to the male bearing mixer bearings are brittle Do not mount the drive unit before installing the mixing head The powerful magnetic force between the mixing head and the outer drive head may cause severe damage to beatings or personal injury Follow all local safety codes before entering the vessel Remove any foreign magnetic particles from the mixing head If the mixing head must be placed on a table place the female bearing downward to prevent magnetic patticles from adhering to the magnetic surface of the mixing head Remove the dtive unit Install the mixing head using the multi tool Mixing head sizes GMP 5000 30 000 must be installed by hand Carefully position the mixing head by turning it while lowering it onto the male bearing Align the mixing head with the tank plate Ensure that the mixing head rotates smoot
30. tion the equipment must be fully assembled according to the instructions in this manual e Use appropriate personal protective equipment and eye protection when operating the equipment Protect drive unit against dust Electric engine may cause sparks Do not use near flammable liquids or gasses The drive unit may be heavy Use appropriate equipment to avoid injury e Do not install components close to rotating parts of the GMP Mixer During mixing operations mixer parts may become hot to the touch Do not insert fingers into equipment pinching may occut The GMP Mixer is not classified for ATEX Contact your Millipore representative for ATEX options e Check the magnetic parts of the GMP Mixer regularly for foreign materials Do not run with an empty vessel e Check that all components in the mixer are of correct size Handle the mixing head and male bearing with care bearing material is hard and brittle Keep electrically controlled medical devices and magnetically stored media away from magnetic parts of the GMP mixer The mixing head must be completely submerged during operation to ensure sufficient lubrication The system must be properly grounded www millipore com NovAseptic GMP Mixer Components Catalogue numbers and specifications for the components listed here can be found on the appropriate specification sheet Mixing Head GM 12 Handle the mixing head with care The bearing m
31. uid Temperature of liquid e Geometry of vessel e Type of mixing required General Information Vessaumbes 1 Veiis MEE GMP ope X Vessel Maanta FGway 1 Sielomdan 1 Milipore Representave S GMP Mixer Information Serial Number Catalogue Number Notes Ei TEL EL Takpe oS Welded flange if E RN Mixing Mixing head Tura 0 s 32 www millipore com Check Points Frequency Converter Settings Standard Control Unit CE2 Configuration E2 C10 Min Frequency Hz C11 Max Frequency Hz C12 Acceleration Time sec C13 Deacceleration Time sec C14 Operation Type C16 Umin C22 Imax c20 I2T limit c42 Start after low high level Control Units G50 005 and G51 003 P10 Configuration TB 13A P23 Min Frequency Hz P24 Max Frequency Hz P19 Acceleration Time sec P20 Deacceleration Time sec P03 Operation Type P27 Umin P25 Imax P26 IZT limit Additional comments NovAseptic GMP Mixer Installation and User Guide 33 Maintenance Checklist To ensure safety and proper performance perform quarterly inspection of the GMP Mixer according to the following table Make copies of this table to use at each inspection Refer to applicable instructions within this guide Note Follow all installation recommendations cautions and warnings in this manual
32. y must be removed manually or by alternative cleaning Magnetic particles can cause corrosion and damage They can also cause a higher torque which may cause the mixing head to decouple and severely damage the vessel Other sterilization methods For information on using other sterilization methods please contact your Millipore representative for NovAseptic GMP Mixer product information Commisioning NovAseptic GMP Mixer Installation and User Guide Installation Checklist To ensure correct installation before using the mixer make sure to complete each step in this checklist and check the applicable box Note Follow all cautions and warnings in the installation section of this manual Install the Male Bearing Complete 1 Ensure the proper position of the O ring on the male bearing Lubricate the O ring with purified water a Ensure that the thread connection in the tank plate is clean dry and free from foreign material aS no Position the male bearing in the appropriate tightening tool Bees ot multi tool 5 Tighten the male bearing clockwise Ll yes Cd no Tighten the bearing to metal to metal contact use table to Ll yes Ld no determine correct torque Install the Mixing Head BE Inspect and remove any foreign magnetic particles from the mixing head 2 Remove the drive unit Install the mixing head 3 Position the mixing head and align it with the tank plate yes O no 4 Ensure tha
Download Pdf Manuals
Related Search