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
6
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.
7
8
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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°
!
2
3
5
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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.
1
2
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.
1
2
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
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
Catalog 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
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.
!
NovAseptic®GMP Mixer Installation and User Guide 11

• 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. Remove the drive unit.
3. Install the mixing head using the multi-tool. Mixing head sizes GMP 5 000–30 000
must be installed by hand.
4. Carefully position the mixing head by turning it while lowering it onto the male
bearing.
5. Align the mixing head with the tank plate. Ensure that the mixing head rotates
smoothly.
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.
!
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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
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
15º.
3. Tighten the two nuts with a wrench.
15°
GMP 50,
100, 500
GMP 50,100, 500
GMP 1000 and GMP 2000
10°
GMP 1000, 2000
1. Tighten the screws (1) in a clockwise direction (view from below).
1
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 (3) clockwise (view from below) to the stop position, approximately 10º.
!
NovAseptic®GMP Mixer Installation and User Guide 13

310°
2
4. Tighten the two screws (4) counter clockwise (view from below) with a wrench.
4
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.
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).
!
!
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• 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®GMP Mixer is three phase.
1. Connect the drive unit according to the control cabinet specifications. The drive unit can
be Y- or ∆-connected, depending on the supply voltage from the speed control device.
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
Motor
Specifications
Label
Drive Unit Thermistor
All standard NovAseptic®GMP drive units are equipped with a positive temperature
coefficient (PTC) thermistor probe. We recommend 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.
2. Turn on the motor and check that the rotor rotates
clockwise. A label on the motor indicates the correct
rotational direction.
+ -
M
W2 U2 V2
U1
L1 L2 L3
V1 W1
W2 U2 V2
U1
L1 L2 L3
V1 W1
NovAseptic®GMP Mixer Installation and User Guide 15

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
1
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 500
GMP 1000
GMP 2000 GMP 5000
GMP 10000 GMP 20000
GMP 30000
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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. Use a 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.
5. For GMP 50, insert an extension plate between the shaft and the outer drive head.
6. Insert the outer drive head on top of the speed counter unit.
7. Socket type is series 713 M12x1. Connect the socket cable according to the following:
Brown
Socket type: Series 713 M12x1
Sensor
Socket Connection :
Socket Extension
Cable
(-)
Signal
(+) 1
4
3
Black
Blue
8. Check that the number of pulses per rotation is correct:
GMP 50 3 GMP 1000 5 GMP 10000 6
GMP 100 3 GMP 2000 6 GMP 20000 12
GMP 500 4 GMP 5000 8 GMP 30000 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
SP1175EN00.
Maximum allowed current during startup is controlled and programmed. See the data
specification label for maximun allowed current and. attached to the motor.
2. Set torque. For AC motors, see product specification sheet SP1004EN00. For DC
motors, see specification sheet SP1008EN00.
3. Verify that the correct EPM-prom is installed according to product specification sheet.
4. If the control cabinet is not supplied by us, ensure that a variable frequency drive is
installed. We supply 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 accordingly. )
!
NovAseptic®GMP Mixer Installation and User Guide 17

• 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. 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
Power
Operator
Interface
VDF system
Power Conversion
Variable
Frequency
Power
Variable
Frequency
Controller
Mechanical
Power
AC Motor
1540
Power Conversion
Notes
• Consult the parameters settings and curcuit and terminal diagrams before installing
the control cabinet.
• 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.
• Validate the possible maximum and minimum operating speed for each process.
• Set VFD unit to 100% nominal power (kW) and current (A) of the motor rating.
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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.
• 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 ºC (275 ºF) 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:
• When it is running with hot WFI
• When it is running at atmospheric pressure
• 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.
2. 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.
3. Increase the speed slowly to working speed. If the mixer makes a rumbling noise, stop
the mixer immediately and consult the 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
!
!
NovAseptic®GMP Mixer Installation and User Guide 19

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 Bearing
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 storage periods exceeding 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.
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