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NovAseptic
GMP Mixer
®
Installation and User Guide
The M logo and NovAseptic are registered trademarks of trademarks of Merck KGaA, Darmstadt, Germany. All trademarks of third parties are the property of their
respective owners.
00104053PU Rev 2.0 03/2015 © 2008, 2015 EMD Millipore Corporation. All rights reserved.
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Summary of Contents for M NovAseptic GMP
- Page 1 ® Installation and User Guide The M logo and NovAseptic are registered trademarks of trademarks of Merck KGaA, Darmstadt, Germany. All trademarks of third parties are the property of their respective owners. 00104053PU Rev 2.0 03/2015 © 2008, 2015 EMD Millipore Corporation. All rights reserved.
- Page 2 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 SAS or an affiliate. Neither Millipore SAS nor any of its affiliates assumes responsibility for any errors that may appear in this document.
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Page 3: Table Of Contents
NovAseptic GMP Mixer Installation and User Guide ® Contents Operator and Equipment Safety ............................5 NovAseptic GMP Mixer Components ..........................6 ® Required Tools ..................................7 Additional Equipment ..............................7 Optional Equipment................................8 Installation and Operating Parameters ..........................9 Installation ....................................10 Male Bearing Installation ............................10 Mixing Head Installation ............................ - Page 4 www.millipore.com...
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Page 5: Operator And Equipment Safety
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. -
Page 6: Novaseptic Gmp Mixer Components
www.millipore.com NovAseptic GMP Mixer Components ® Catalog 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 material is hard and brittle. Keep the magnetic body away from any particles that may adhere to it. -
Page 7: Required Tools
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. -
Page 8: Optional Equipment
www.millipore.com Optional Equipment The following options are available. Catalog numbers and specifications for the components shown here can be found at www.emdmillipore.com. Description Purpose Number Mixing head Keeps the mixing head in place attractor when vessel is moved. Substitute for the drive unit during trans- (GT#/AW) port. -
Page 9: Installation And Operating Parameters
NovAseptic GMP Mixer Installation and User Guide ® Installation and Operating Parameters Please refer to the appropriate product specification sheet for more information. Tank Plate and Welding Flange Parameter Minimum Maximum Temperature -80 °C 200 °C (-112 °F) (392 °F) Pressure -1 barg 10 barg... -
Page 10: Installation
www.millipore.com Installation Use the Installation Checklist and the Installation Qualification Checklist (in this manual) as guides for installing the mixer and and initiating use. Use the Maintenance Checklist as a guide for followup care of the mixer. Install the GMP Mixer components in the following order: 1. -
Page 11: Mixing Head Installation
NovAseptic GMP Mixer Installation and User Guide ® 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. -
Page 12: Drive Unit Installation
www.millipore.com • Follow all local safety codes before entering the vessel. 1. 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 particles from adhering to the magnetic surface of the mixing head. 2. - Page 13 NovAseptic GMP Mixer Installation and User Guide ® 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. • There is a powerful magnetic force between the mixing head and the outer drive head.
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Page 14: Electrical Installation
www.millipore.com 3 10° 4. Tighten the two screws (4) counter clockwise (view from below) with a wrench. GMP 5000, GMP 10 000, GMP 20 000 and GMP 30 000 1. Install the drive unit into the tank plate. Align the four holes in the drive unit to the threaded holes in the tank plate. - Page 15 NovAseptic GMP Mixer Installation and User Guide ® • 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. AC Motor Installation The AC motor in the standard NovAseptic ®...
- Page 16 www.millipore.com Speed Counter Installation The speed counter may be ordered separately. Use the instructions below to install the speed counter. Speed counter kit catalog number GM#/67 1. Remove the outer drive head from the drive unit. 2. Mount the speed counter on the drive unit according to the following illustration (different procedures for different GMP sizes).
- Page 17 NovAseptic GMP Mixer Installation and User Guide ® 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.
- Page 18 www.millipore.com • Motor current higher than recommended could cause damage to the bearings through decoupling of the mixing head. 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.
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Page 19: Operation
NovAseptic GMP Mixer Installation and User Guide ® Operation • Ensure that the installation 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. -
Page 20: Disassembly
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). •... -
Page 21: Cleaning And Sterilizing Procedures
NovAseptic GMP Mixer Installation and User Guide ® 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 jethead before starting the mixer to ensure lubrication of the bearing. - Page 22 www.millipore.com • Add liquid before restarting the mixer after sterilization to secure lubrication of the bearings. • Magnetic Particles 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.) Magnetic particles are not removed from the mixing head during CIP;...
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Page 23: Installation Checklist
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 Ensure the proper position of the O-ring on the male bearing. - Page 24 www.millipore.com Ensure electrical cables are long enough to enable the drive unit to be disas- q yes q no sembled and removed from the vessel. Install the AC Motor Complete Connect the drive unit. q yes q no Ensure that the supply voltage and overload protection are set. Ensure that the electrical cover and conduit entries are in place.
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Page 25: Commissioning
NovAseptic GMP Mixer Installation and User Guide ® 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 Checkpoint Date Signature Tank plates are cylindrical inside the vessel. -
Page 26: Installation Qualification Checklist
www.millipore.com 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: •... - Page 27 NovAseptic GMP Mixer Installation and User Guide ® Original Value New Value Comments 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 I2T-limit...
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Page 28: Maintenance Checklist
www.millipore.com 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. Vessel ID _________________________________________________________________ Inspection date ____________________________________________________________ Volume __________________________________________________________________... -
Page 29: Spare Parts
NovAseptic GMP Mixer Installation and User Guide ® 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 your local representative. We recommend the following equipment be kept in stock: •... -
Page 30: Troubleshooting
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: •... - Page 31 NovAseptic GMP Mixer Installation and User Guide ® Problem Possible Causes Solutions Magnetic disconnec- Review the guidelines under “Operation/ Incorrect order of addition of tion of mixing head Starting the Mixer.” substances, dry running (decoupling) Unexpected viscosity/density Call your local representative for consulta- changes tion.
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Page 32: Standard Product Warranty
www.millipore.com Standard Product Warranty The applicable warranty for the products listed in this publication may be found at www.emdmillipore.com/terms (within the “Terms and Conditions of Sale” applicable to your purchase transaction). Technical Assistance For more information, contact the office nearest you or visit the Technical Service page at www.emdmillipore.com/techservice.
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