Millipore NovAseptic GMP Series User manual

NovAseptic®GMP Mixer
Installation and User Guide

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.
2www.millipore.com

Contents Operator and Equipment Safety.....................................................7
NovAseptic GMP Mixer Components.............................................8
Required Tools..........................................................................9
Additional Equipment................................................................9
Optional Equipment................................................................10
Installation and Operating Parameters......................................... 11
Installation....................................................................................12
Male Bearing Installation ........................................................12
Mixing Head Installation..........................................................14
Drive Unit Installation..............................................................15
Electrical Installation...............................................................17
Operation .....................................................................................23
Starting the Mixer....................................................................23
Disassembly ...........................................................................24
Storage...................................................................................24
Recycle and Disposal.............................................................24
Cleaning and Sterilizing Procedures............................................25
Cleaning in Place (CIP) ..........................................................25
Sterilizing in Place (SIP).........................................................26
Installation Checklist ....................................................................27
Commissioning.............................................................................30
Valid Regulations....................................................................30
Installation Qualification Checklist................................................31
Installation Qualification ........................................................31
Check Points...........................................................................32
Maintenance Checklist.................................................................33
Spare Parts..................................................................................35
Troubleshooting ...........................................................................36
Standard Warranty.......................................................................39
NovAseptic GMP Mixer Installation and User Guide 3

4www.millipore.com

NovAseptic GMP Mixer Installation and User Guide 5

6www.millipore.com

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.
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 Millipore•
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 7

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 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
8www.millipore.com

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#/4B#-#
Drive units without speed counter: catalogue 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 from Millipore.
Catalogue numbers and specifications for the components can be found at www.
millipore.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-#)
1617
18
19
20
21
NovAseptic GMP Mixer Installation and User Guide 9

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.
Description Purpose
Control cabinet
(G50-#, G51-#)
Speed control device for
mixer. Regulates rotation
speed and ramp time for the
motor. This equipment is
required for all installations.
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
Number Description Purpose
7 Mixing head
attractor
(GT#/AW)
Keeps the mixing
head in place when
vessel is moved. Sub-
stitute for the drive
unit during transport.
8 Speed
counter kit
(GM#/67)
Speed counter instal-
lation kit. The speed
counter indicates the
rotational speed of
the mixing head and
the outer drive head.
Optional equipment
available on AC drive
unit.
7
8
10 www.millipore.com

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 accord-
ingly. )
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 11

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:
Tank plate (refer to the NovAseptic1.
Tank Plate Welding Guide for
installation instructions.)
Male bearing2.
Mixing head3.
Speed counter (optional, installed on the4.
drive unit)
Drive unit5.
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
Ensure proper position of the O-ring on the male bearing.1.
For minimal friction, lubricate the visible part of the O-ring with a small amount2.
of purified water.
H2O
360°
!
2
3
5
14
12 www.millipore.com

Remove the protective cap. Ensure that the thread connection in the tank plate3.
and male bearing are clean, dry, and free from foreign material.
Tighten the male bearing clockwise by hand into the thread of the tank plate,4.
making sure that it is aligned with the center line of the tank plate.
1
2
Position the male bearing in the appropriate tightening tool or multi-tool with a5.
torque wrench. Ensure that the tool fits the nut. Tighten the bearing to metal-to-
metal contact, applying torque according to table below.
Important: Ensure metal-to-metal contact by applying recommended torque in
table below. If bearing is not installed properly it may come off.
3
4
Catalogue Number Torque
GM05/23
6Nm/4.4Lbft
GM05/24
GM1/23
GM1/24
GM510/23
GM510/24
GM20/23 13Nm/9.6Lbft
GM20/24
GM50300/23 30Nm/22.1Lbft
GM50300/24
NovAseptic GMP Mixer Installation and User Guide 13

Mixing Head Installation
See NovAseptic GMP Mixing Head Installation Guide 00101787PU for
additional information.
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 bearings or personal injury.
Follow all local safety codes before entering the vessel.•
Remove any foreign magnetic particles from the mixing head.1.
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.
Remove the drive unit.2.
Install the mixing head using the multi-tool. Mixing head sizes GMP 5000–300003.
must be installed by hand.
Carefully position the mixing head by turning it while lowering it onto the male4.
bearing.
Align the mixing head with the tank plate. Ensure that the mixing head rotates5.
smoothly.
!
14 www.millipore.com

Drive Unit Installation
The drive unit may be heavy. Use appropriate equipment to avoid injury.•
Never use the drive unit without a frequency converter. See Control Cabinet in•
this guide.
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.•
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
Install the drive unit into the tank plate. Put the two studs on the tank plate into1.
the slots on the drive unit.
Turn the drive unit clockwise (view from below) to the stop position,2.
approximately 15º.
Tighten the two nuts with a wrench.3.
15°
100, 500
!
!
NovAseptic GMP Mixer Installation and User Guide 15

GMP 1000 and GMP 2000
10°
Tighten the screws (1) in a clockwise direction (view from below).1.
1
Install the drive unit into the tank plate. Insert the locking screws into the two2.
oval holes in the tank plate (2).
310°
2
Turn the drive unit (3) clockwise (view from below) to the stop position,3.
approximately 10º.
Tighten the two screws (4) counter clockwise (view from below) with a wrench.4.
4
16 www.millipore.com

GMP 5000, GMP 10 000, GMP 20 000 and GMP 30 000
Install the drive unit into the tank plate. Align the four holes in the drive unit to1.
the threaded holes in the tank plate.
Screw the f2. our 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.
!
!
NovAseptic GMP Mixer Installation and User Guide 17

AC Motor Installation
The AC motor in the standard NovAseptic GMP Mixer is three phase.
Connect the drive unit according to the control cabinet specifications. The drive1.
unit can be Y- or ∆-connected, depending on the supply voltage from the speed
control device.
W2 U2 V2
U1
L1 L2 L3
V1 W1
W2 U2 V2
U1
L1 L2 L3
V1 W1
Ensure that the supply voltage and overload protection are set according to the2.
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
Motor
Specifications
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
Make connections according to the following illustration. Ensure that the1.
electrical cover and the cable gland entries are properly in place.
+ -
M
18 www.millipore.com

Turn on the motor and check that the rotor rotates clockwise. A label on the2.
motor 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
Remove the outer drive head from the drive unit.1.
2
1
NovAseptic GMP Mixer Installation and User Guide 19

Mount the speed counter on the drive unit according to the following illustration2.
(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 500 GMP 1000
GMP 2000 GMP 5000
GMP 10000 GMP 20000
GMP 30000
For GMP 2000, 5000, and 10000, the cable runs inside the drive unit flange. Run3.
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.
Use a strap to mount the contact in the contact holder. Tighten the contact4.
holder on the drive unit according to the following illustration. Collect leftover
cable with a strap.
20 www.millipore.com