M NovAseptic GMP User manual

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.

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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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 ........................................................................................................................................... 11
Drive Unit Installation ................................................................................................................................................ 12
Electrical Installation.................................................................................................................................................. 14
Operation................................................................................................................................................................................... 20
Starting the Mixer ....................................................................................................................................................... 20
Disassembly ................................................................................................................................................................... 21
Storage............................................................................................................................................................................ 21
Recycle and Disposal................................................................................................................................................... 21
Cleaning and Sterilizing Procedures.................................................................................................................................. 22
Cleaning in Place (CIP) ............................................................................................................................................... 22
Sterilizing in Place (SIP) ............................................................................................................................................. 22
Installation Checklist ............................................................................................................................................................. 24
Commissioning ........................................................................................................................................................................ 26
Valid Regulations ......................................................................................................................................................... 26
Installation Qualification Checklist ................................................................................................................................... 27
Installation Qualification ........................................................................................................................................ 27
Check Points.................................................................................................................................................................. 27
Maintenance Checklist.......................................................................................................................................................... 29
Spare Parts................................................................................................................................................................................ 30
Troubleshooting ....................................................................................................................................................................... 31
Standard Product Warranty ................................................................................................................................................. 33
Technical Assistance............................................................................................................................................................... 34
NovAseptic®GMP Mixer Installation and User Guide 3

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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
in this manual may result in damage to the equipment, voiding of product warranty,
and possible operator injury.
• Any of the following can damage the mixer: external load; reaction forces and
torque; corrosion, erosion, and fatigue; and decomposing of unstable liquids.
• Prior to operation, the equipment must be fully assembled according to the
instructions in this manual.
• 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.
• 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 occur.
• The GMP Mixer is not classified for ATEX. Contact your local representative for
ATEX options
• Check the magnetic parts of the GMP Mixer regularly for foreign materials.
• Do not run with an empty vessel.
• 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.
!
NovAseptic®GMP Mixer Installation and User Guide 5

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.
Key Number Description
1 Magnetic body
2 Wings
3 Silicone carbide female
bearing
4 Serial number
Male Bearing (GM#/2#)
The male bearing keeps the mixing head in a correct position; it mounts on the tank
plate inside vessel.
Key Number Description
5 Stainless steel support
6 Silicone carbide bearing
7 Connection thread
8 Groove
9 O-ring
10 Serial number
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.
Key Number Description
11 Male bearing connection thread
12 Welding edge
13 Drive unit connection flange
14 Serial number
15 O-ring (on flanged tank plate only)
x
x
x
x
x
x
x
5
9
6
8
10
7
xxxxxxx
3
4
2
1
12
14
13
15
11
Flanged tank plate
11 12
14
13
Welded tank plate
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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: catalog no
GM#/4B#-#
Drive units without speed counter: catalog
no GM#/4A#-#
Key Number Description
16 Magnetic outer drive head
17 Tank plate connection flange
18 Gearbox unit
19 Motor
20 Serial number label
21 Speed Counter
Required Tools
The following tools are required for installation of the NovAseptic®GMP Mixer.
These tools are NOT included with the mixer, but are available. Catalog numbers and
specifications for the components can be found at www.emdmillipore.com.
Description Purpose
Multi tool (GT#/25) Installation tool for mixing head and male bearing for use in small vessels
Tightening tool (GT#/26) Installation tool for male bearing
Heatsink tank plate (G94-#) Attached to the tank plate during welding to prevent deformation
NovAseptic®gauge 1 (G91-#) For verification of geometry after welding
NovAseptic®gauge 2 (G92-#)
Additional Equipment
The following additional equipment is available. Catalog numbers and specifications for
the component shown here can be found at www.emdmillipore.com.
Description Purpose
Control cabinet
(G50-#, G51-#)
Speed control device for mixer. Regulates ro-
tation speed and ramp time for the motor. This
equipment is required for all installations.
16
17
18
19
20
21
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NovAseptic®GMP Mixer Installation and User Guide 7

Optional Equipment
The following options are available. Catalog numbers and specifications for the
components shown here can be found at www.emdmillipore.com.
Key
Number Description Purpose
7 Mixing head
attractor
(GT#/AW)
Keeps the mixing head in place
when vessel is moved. Substitute
for the drive unit during trans-
port.
8 Speed
counter kit
(GM#/67)
Speed counter installation kit.
The speed counter indicates the
rotational speed of the mixing
head and the outer drive head.
Optional equipment available on
AC drive unit.
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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
(-112 °F)
200 °C
(392 °F)
Pressure -1 barg
(-14.5 psig)
10 barg
(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 Maximum
Temperature 5 °C
(41 °F)
135 °C
(275 °F)
pH 1 14
Viscosity 1 cP 800 cP
Media Media may not contain magnetic particles
Rotation speed see Product Specification Sheet
Minimum acceleration and
deacceleration time
Five seconds (Specific to each application; set accordingly.
)
Drive Unit
Defines the operating parameters inside the vessel.
Parameter Minimum Maximum
Ambient temperature 0 °C (32 °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/IEC 34–9. Vibration falls under standard class N
and is specified by standard CEI 2-23/IEC 34-14.
NovAseptic®GMP Mixer Installation and User Guide 9

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. Tank plate (refer to the NovAseptic®Tank Plate
Welding Guide for 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.
• The vessel must be clean and completely dry inside.
• Do not use grip tools on bearing surfaces.
• Follow all local safety codes before entering the vessel.
• Handle the male bearing with care.
Mounting the Male Bearing
1. Ensure proper position of the O-ring on the male bearing.
2. For minimal friction, lubricate the visible part of the O-ring with a small amount of
purified water.
H2O
360°
!
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3
5
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