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Merck EMD Millipore NovAseptic Installation And User Manual

Gmp atex mixer
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Installation and User
Guide
NovAseptic
GMP ATEX Mixer
®
NovAseptic and the Vibrant M are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the
property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. © 2008-
2018 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
00105442PU Rev 5 02/2018

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Summary of Contents for Merck EMD Millipore NovAseptic

  • Page 1 GMP ATEX Mixer ® NovAseptic and the Vibrant M are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. © 2008- 2018 Merck KGaA, Darmstadt, Germany and/or its affiliates.
  • Page 2 Installation and User Guide...

  • Page 3: Table Of Contents

    NovAseptic GMP ATEX Mixer ® Contents Installation Note ..................5 Operator and Equipment Safety ..............6 Labeling ....................7 NovAseptic GMP ATEX Mixer Components ............. 8 ® Mixing Head (AX#/12#) ................ 8 Male Bearing (AX#/24#) ............... 8 Tank Plate (AX#/33) ................8 Drive Unit (AX#/41-E#) ................
  • Page 4 Installation and User Guide...

  • Page 5: Installation Note

    NovAseptic GMP ATEX Mixer ® Installation Note The ATEX mixer is designed for operation in the classification noted on the product label. The mixer must be in good working order before operating. Before using the mixer, ensure the following: • The tank plate is installed properly on the tank and concentricity and alignment have been verified to prevent any contact between the mixing head, outer rotor and tank plate.

  • Page 6: Operator And Equipment Safety

    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 operating and installation instructions could result in operator injury or damage to the equipment.

  • Page 7: Labeling

    NovAseptic GMP ATEX Mixer ® Labeling NovAseptic Mixer ® Part No: AX20/33 GMP2000 Tank Plate 316L/1.4435, ATEX ID No: JAD00388 Production year/week : 2009/26 0081 II 1/2 GD c T4 DNV-2003-OSL-ATEX-0227X Millipore SAS, 67120 Dachstein, France www.millipore.com Figure 1: Product label Number Description 0081 –...

  • Page 8: Novaseptic ® Gmp Atex Mixer Components

    Installation and User Guide NovAseptic GMP ATEX Tank Plate (AX#/33) ® Mixer Components Each tank plate is marked with the serial number and a mill stamp that corresponds to its heat number. The tank plate is welded onto Catalog numbers and specifications for the the vessel and is considered an integrated part components listed here can be found on the of the vessel.

  • Page 9: Required Tools

    NovAseptic GMP ATEX Mixer ® Installation and Required Tools The following tools are required for installation Operating Parameters of the NovAseptic GMP ATEX Mixer. The ® tools (shown below) are not included with Please refer to the appropriate product the mixer and are available from your local specification sheet for more information.

  • Page 10: Installation

    Installation and User Guide Installation Use the Installation Checklist and the Installation Qualification Checklist (in this manual) as guides for installing the mixer and initiating use. Use the Maintenance Checklist as a guide for follow up care of the mixer. For welding of the Tank Plate use GMP ATEX Welding Instructions.

  • Page 11: Mixing Head Installation

    NovAseptic GMP ATEX Mixer ® Catalog Number Torque AX05/24# AX1/24# 6 Nm (4.4 Lbft) Align the mixing head with the tank plate. AX510/24# Ensure that the mixing head rotates smoothly. AX20/24# 13 Nm (9.6 Lbft) AX50200/24# 30 Nm (22.1 Lbft) Mixing Head Installation See NovAseptic GMP Mixing Head Installation...
  • Page 12 Installation and User Guide • Store the motor in an area which is humid and weather proof. Ensure that motor is on a stable surface to prevent falling or vibration. • Remove the transport collar before installing the motor. Mount the drive unit onto the vessel following the instructions for the appropriate mixer size: GMP 50 ATEX, GMP 100 ATEX and GMP 500 ATEX...

  • Page 13: Electrical Installation

    NovAseptic GMP ATEX Mixer ® Install the drive unit onto the tank plate. Insert the locking screws into the two oval holes in the tank plate (2). Electrical Installation The mixer must be operated with a variable frequency drive to function properly.
  • Page 14 Installation and User Guide Revolution Counter Observe laws, regulations and/or standards governing the use, or intended use, of this equipment. Any alteration of this equipment from factory specification may cause unsafe conditions and will void the product warranty. The tachometer must be connected to an intrinsically safe Ensure that the supply voltage and barrier.

  • Page 15: Operation

    NovAseptic GMP ATEX Mixer ® Operation NOTE Consult the parameter settings and circuit and terminal diagrams before Ensure that the installation has installing the control cabinet. been performed correctly and that the parameters are correctly Validate the current media and process conditions.

  • Page 16: Operating Notes

    Installation and User Guide Operating Notes • For storage periods exceeding 60 days, protect all coupling surfaces (such as • Fill the vessel with liquid before adding solid flanges and shafts on the drive unit) with a material. suitable anti-oxidation product (Mobilarma 248 or equivalent).

  • Page 17: Cleaning And Sterilizing Procedures

    NovAseptic GMP ATEX Mixer ® Cleaning and Sterilizing and Drive Unit Installation in this manual.) Procedures Magnetic particles are not removed Cleaning in Place (CIP) from the mixing head during CIP; they must be removed manually or by GMP mixers are designed for CIP using any alternative cleaning.
  • Page 18 Installation and User Guide 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.

  • Page 19: Installation Atex Checklist

    NovAseptic GMP ATEX Mixer ® Installation ATEX 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 installation recommendations, cautions and warnings in this manual. Install the Male Bearing Complete Ensure the proper position of the O-ring on the male bearing.

  • Page 20: Install The Drive Unit - Gmp 1000 Atex And Gmp 2000 Atex

    Installation and User Guide Install the Drive Unit – GMP 1000 ATEX and GMP 2000 ATEX Complete Fit screws and tighten clockwise (view from below). q yes q no Install the drive unit into the tank plate. Install locking screws into the two oval q yes q no holes in the tank plate.

  • Page 21: Install The Vfd System

    NovAseptic GMP ATEX Mixer ® Install the VFD System Complete Select the appropriate control cabinet. q yes q no Set voltage according to the AC motor. q yes q no Set frequency according to the AC motor. q yes q no Set minimum/maximum rpm.

  • Page 22: Commissioning

    Installation and User Guide Commissioning Valid Regulations ATEX 2014/34/EU Complete this checklist and ensure ATEX regulations are met. Commissioning Checkpoint Date Signature Tank plates are cylindrical inside the vessel. Use NovAseptic Gauge 1. ® Mixing Head freewheel. Use NovAseptic Gauge 2. ®...

  • Page 23: Installation Qualification Checklist

    NovAseptic GMP ATEX Mixer ® 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 24 Installation and User Guide Additional comments Inspected by: Print name _____________________________________________________________________ Signature _______________________________________________________________________ Date inspection completed...

  • Page 25: Maintenance Checklist

    NovAseptic GMP ATEX Mixer ® Maintenance Checklist To ensure safety and proper performance, perform quarterly inspection of the GMP ATEX Mixer according to the following table. Make copies of this table to use at each inspection. Refer to applicable instructions within this guide.
  • Page 26 Installation and User Guide Component / Maintenance Check Notes Complete Mixing Head Inspect the silicone carbide on the female q yes q no bearing for damage. Inspect the inside of the mixing head and bottom surface for damage. Check that mixing q yes q no head rotates easily.

  • Page 27: Spare Parts

    NovAseptic GMP ATEX Mixer ® 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 Technical Service. The following equipment should be kept in stock: •...

  • Page 28: Troubleshooting

    Installation and User Guide Troubleshooting During troubleshooting, follow the instructions in this manual. A correct installation is crucial to proper operation. Before repair or service of the GMP ATEX Mixer, personnel must study and understand this user guide. Before performing maintenance on the GMP ATEX Mixer, make sure that the vessel is: •...
  • Page 29 NovAseptic GMP ATEX Mixer ® Problem Possible Causes Solutions Outer Bent shaft Contact Technical Service. drive head scratches the Bent hole-shaft in gearbox Contact Technical Service. tank plate Drive unit not properly in place Install drive unit correctly. Particles stuck to the magnets Remove particles.

  • Page 30: Standard Warranty

    Installation and User Guide Standard Warranty The applicable warranty for the products listed in this publication may be found at www.millipore. com/terms (within the “Terms and Conditions of Sale” applicable to your purchase transaction).
  • Page 31 NovAseptic GMP ATEX Mixer ®...
  • Page 32 Corporation with General Partners Frankfurter Str. 250 64293 Darmstadt, Germany Phone: + 49 6151-72 0 For requests from USA and Canada please contact: EMD Millipore Corporation A subsidiary of Merck KGaA, Darmstadt, Germany 400 Summit Drive Burlington, MA 01803 USA Phone: 1-800-645-5476...

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