Infors HT Multifors 2 User manual

Operating Manual
2018-03-28
Multifors 2
Parallel Bench-top Bioreactor
Dok-ID: V. 04.01 - Original

Page 2 of 211 28 March 2018
Infors AG
Headoffice, Schweiz
Rittergasse 27
CH-4103 Bottmingen
T [phone]
F [phone]
[e-mail]
[e-mail]
Infors GmbH
Dachauer Str. 6
D-85254 Einsbach
T [phone]
F [phone]
[e-mail]
Infors UK Ltd
The Courtyard Business Centre
Dovers Farm, Lonesome Lane,
Reigate
Surrey, RH2 7QT, UK
T [phone]
F [phone]
[e-mail]
Infors Sarl
2, rue du Buisson aux Fraises
Bâtiment D13
F-91300 Massy
T [phone]
F [phone]
[e-mail]
www.infors-ht.fr
Infors Benelux BV
Markweg 9-A, NL-6883 JL
Velp (GLD)
P.O. Box 125, NL-6880 AC
Velp (GLD)
T [phone]
F [phone]
[e-mail]
Infors USA Inc.
9070 Junction Drive, Suite D
Annapolis Junction, MD20701
T [phone] /
T [phone] (toll-free USA)
F [phone]
[e-mail]
www.infors-ht.us
Infors Canada
8350 rue Bombardier
Anjou, Quebec
Canada H1J 1A6
T [phone]
F [phone]
[e-mail]
Infors Bio-Technology
(Beijing) Co., Ltd.
Room 505C, Building 106
Lize Zhongyuan
Wangjing New Industrial Zone
Chaoyang District, Beijing
100102 P.R. of China
T [phone]
F [phone]
[e-mail]
Infors South East Asia
16, 1st Floor, Taman City
MY-51200 Kuala Lumpur
Malaysia
T [phone]
F [phone]
[e-mail]
Infors LATAM Ltda.
Rua Dr. Alceu de Campos
Conjunto 205
CEP: 04544-000
São Paulo – SP
Brasil
T [phone]
F [phone]
[e-mail]
Contact details of our local dealers worldwide can be found
on our website.
www.infors-ht.com
Engineering and production in Switzerland

Multifors 2 - Parallel Bench-top Bioreactor
Table of Contents
28 March 2018 Page 3 of 211
1General Information ............................................................... 8
1.1 About this Manual .......................................................... 8
1.2 Symbols ......................................................................... 9
1.2.1 Safety Instructions .......................................... 9
1.2.2 Hints and Recommendations ......................... 9
1.2.3 Specific Safety Instructions .......................... 10
1.3 Limitation of Liability .................................................... 11
1.4 Copyright Protection .................................................... 11
1.5 Spare Parts .................................................................. 12
1.6 Terms of Guarantee ..................................................... 12
1.7 Customer Service ........................................................ 12
1.8 Declaration of Conformity ............................................ 12
2Safety .................................................................................... 13
2.1 Responsibility of the Operator ..................................... 13
2.2 Requirements for Qualified Personnel ......................... 14
2.2.1 Unauthorised Persons .................................. 15
2.3 Conventional Use of the Equipment ............................ 16
2.4 Personal Protective Equipment ................................... 17
2.5 Particular Hazards ....................................................... 19
2.6 Environmental Protection ............................................. 22
2.7 Adhesive Labels / Signs / Symbols ............................. 22
3Technical Data ...................................................................... 24
3.1 Equipment Dimensions ................................................ 24
3.2 Dimensions Culture Vessels and Vessel Holder ......... 25
3.3 Weights ........................................................................ 27
3.4 Service Requirements ................................................. 28
3.4.1 Electrical ....................................................... 28
3.4.2 Water IN ....................................................... 28
3.4.3 Water OUT ................................................... 28
3.4.4 Gas(es) IN .................................................... 28
3.4.5 Exit Gas ........................................................ 29
3.5 Specifications ............................................................... 30
3.5.1 Operating Unit .............................................. 30
3.5.2 Vessels ......................................................... 30
3.5.3 Stirrer Drive System bacterial Version ......... 32
3.5.4 Stirrer Drive System Cell Culture Version .... 33
3.5.5 Temperature ................................................. 35
3.5.6 Gassing Bacterial System ............................ 36
3.5.7 Gassing Cell Culture System ....................... 37
3.5.8 Antifoam ....................................................... 38
3.5.9 pH ................................................................. 38

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3.5.10 pO2 ................................................................39
3.5.11 Pumps ...........................................................40
3.5.12 Sterile Filters .................................................41
3.6 Operating Conditions ...................................................42
3.7 Emissions .....................................................................42
3.8 Identification Plate ........................................................43
4Setup and Function ..............................................................44
4.1 Basic Unit .....................................................................44
4.1.1 Main Switch ..................................................46
4.1.2 Mains Connection .........................................46
4.1.3 Water Connections .......................................47
4.1.4 Gas Connections ..........................................47
4.1.5 Connections of the Exit Gas Cooler and
Control Valve ................................................47
4.1.6 Connection of the Sparger ............................49
4.1.7 Pumps ...........................................................50
4.2 Operating Panel ...........................................................52
4.2.1 Monitor Keys .................................................52
4.2.2 Operating Panel Connections .......................53
4.3 Vessels, Vessel holder & Transport Frame .................54
4.3.1 Vessel for bacterial Cultures .........................55
4.3.2 Vessel for Cell Cultures ................................57
4.3.3 Baffle Cage ...................................................58
4.3.4 Vessel Top Plate Ports and Configuration ...60
4.3.4.1 Top Plate with nominal Width
55/70 ............................................ 64
4.3.4.2 Vessel Top Plate with nominal
Width 70 ....................................... 65
4.3.4.3 Vessel Top Plate with nominal
Width 90 ....................................... 66
4.4 Temperature Control System .......................................67
4.5 Drive and Stirrer ...........................................................68
4.5.1 Drive Shaft for bacterial Cultures ..................68
4.5.2 Drive Shaft for Cell Cultures .........................69
4.5.3 Impellers .......................................................70
4.6 Gassing System ...........................................................71
4.6.1 Gassing Strategy ..........................................72
4.6.2 Gas Entry ......................................................72
4.6.3 Exit Gas and Exit Gas Cooler .......................76
4.7 Accessory Kit ...............................................................77
4.7.1 Antifoam Sensor ...........................................77
4.7.2 Reagent Bottles ............................................80

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4.7.3 Sampling System ......................................... 81
4.7.3.1 Super Safe Sampler, aseptic
Sampling System .......................... 81
4.7.4 Starter-Kit ..................................................... 86
4.8 Field of Application ...................................................... 87
4.9 Types ........................................................................... 87
5Transport, Packaging and Storage .................................... 88
5.1 Safety Instructions for Transport .................................. 88
5.2 Transport Inspection .................................................... 88
5.3 Packaging .................................................................... 89
5.4 Transport ...................................................................... 90
5.5 Storage ........................................................................ 91
5.5.1 Storage of the Equipment in General ........... 91
5.5.2 Storage of the Reagent Bottles and Hoses .. 92
5.5.3 Storage of Sensors ....................................... 92
6Installation and Initial Operation ........................................ 93
6.1 Safety ........................................................................... 93
6.2 Location Requirements for Installation ........................ 94
6.2.1 General Information ...................................... 94
6.2.2 Minimum Spacing ......................................... 95
6.2.3 Supply Lines ................................................. 95
6.2.3.1 Air/Gas .......................................... 95
6.2.3.2 Exit Gas ......................................... 96
6.2.3.3 Water Inlet ..................................... 97
6.2.3.4 Water outlet ................................... 97
6.2.3.5 Electric Power Supply ................... 98
6.3 Mounting the Operating Panel ..................................... 99
6.4 Connecting the Operating panel to the Basic Unit..... 100
6.5 Connecting the Master Unit with the Satellite Unit(s) 101
6.5.1 Mounting the Water Connection Set for 1 or 2
Satellite Units ............................................. 102
6.5.2 Connecting the Controller of the Master Unit
with the Controllers of the Satellite Unit(s) . 104
6.6 Test Run .................................................................... 106
7Preparations for Use .......................................................... 110
7.1 Safety ......................................................................... 110
7.2 Preparations before Sterilisation................................ 112
7.2.1 Preparing the Vessel .................................. 112
7.2.2 Preparing the Sensors ................................ 121
7.2.2.1 Calibrating the pH Sensor ........... 121

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7.2.2.2 Mounting the pH and pO2
Sensors ...................................... 121
7.2.2.3 Mounting the Antifoam Sensor ... 125
7.2.3 Preparing the Reagent Bottles, Hoses and
Pumps .........................................................128
7.2.4 Calibrating the Pumps ................................128
7.2.5 Connecting the Reagent Bottles to the Pumps
and Vessels ................................................129
7.2.6 Preparing the Sampling System Super Safe
Sampler ......................................................132
7.2.7 Mounting the Exit Gas Cooler .....................136
7.2.8 Preparing the Port in the Vessel Top Plate for
Inoculation ..................................................137
7.2.9 Preparing the Sparger ................................139
7.2.10 Attaching the Pump Heads to the Vessel
Holder and Support Frame .........................141
7.2.11 Transport to the Autoclave .........................142
7.3 Sterilisation in the Autoclave ......................................143
7.3.1 Sterilisation Methods ..................................143
7.4 Preparations after Sterilisation ...................................146
7.4.1 Mounting the Vessel Holder with the Vessels
on the Basic Unit.........................................146
7.4.2 Filling the reagent Hoses ............................149
7.4.3 Connecting the Sparger to the Gas Supply 150
7.4.4 Connecting the Temperature Sensor .........151
7.4.5 Testing the Antifoam Pump, connecting the
Antifoam Sensor .........................................152
7.4.6 Connecting the pH and pO2 Sensors .........154
7.4.7 Polarising a (polarographic) METTLER pO2
Sensor ........................................................156
7.4.8 Calibrating the pO2 Sensor .........................156
7.4.9 Connecting the Exit Gas Cooler .................157
8Operation ............................................................................159
8.1 Safety .........................................................................159
8.2 Starting Fermentation.................................................162
8.2.1 Switching on the Equipment .......................163
8.2.2 Inoculation ..................................................164
8.2.3 Sampling .....................................................166
8.2.4 Sampling with Sampling System Super Safe
Sampler ......................................................166
8.3 Ending Fermentation ..................................................170
8.3.1 Harvest .......................................................171
8.3.2 Shutting down the System, switching off the
Equipment ...................................................173

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9Maintenance ....................................................................... 174
9.1 Safety ......................................................................... 174
9.2 Environmental Protection ........................................... 176
9.3 Maintenance Plan ...................................................... 176
9.4 Sterilising the Vessel after Fermentation ................... 178
9.5 Multifors 2 Cell: Exchanging the Ball Bearings of the
Stirrer Shaft ................................................................ 180
9.5.1 Dismantling the used Ball Bearings ........... 181
9.5.2 Mounting the new Ball Bearings ................. 185
9.6 Cleaning ..................................................................... 191
9.6.1 Vessel ......................................................... 193
9.6.2 Vessel Top Plate ........................................ 194
9.6.3 Exit Gas Cooler .......................................... 195
9.6.4 Reagent Bottles and Hoses........................ 195
9.6.5 Sensors ...................................................... 196
9.6.6 Operating Unit ............................................ 197
10 Interferences ....................................................................... 198
10.1 Safety ......................................................................... 198
10.2 Tables of Interferences .............................................. 199
10.3 Interferences Basic Unit and Operating Panel .......... 200
10.1 Interferences Drive System ....................................... 201
10.2 Interferences Temperature Control System .............. 202
10.3 Interferences pH-System ........................................... 203
10.4 Interferences pO2 System .......................................... 205
10.5 Interferences Antifoam or Level Sensor and Antifoam
Pump .......................................................................... 206
10.6 Interferences Feed and Pump ................................... 207
10.7 Returning for Repair .................................................. 208
11 Disassembly ....................................................................... 209
11.1 Safety ......................................................................... 209
11.2 Disassembly ............................................................... 210
11.3 Disposal ..................................................................... 211

Multifors 2 - Parallel Bench-top Bioreactor
General Information
Page 8 of 211 28 March 2018
1 General Information
1.1 About this Manual
This manual enables the safe and efficient handling of the equip-
ment.
This manual is a component part of the equipment. It must be kept
near to the equipment and must be accessible to the operators at
all times. The operators must read thoroughly and fully understand
this manual before commencement of any work.
Adhering to all the points, advice and instructions concerning
safety and operation in this operating manual is a pre-condition for
safe working.
Furthermore, local rules for accident prevention and general safety
regulations relevant to the equipment’s field of application may be
in force.
This manual contains pictures which aid general understanding
and can differ from the actual equipment as supplied.

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1.2 Symbols
1.2.1 Safety Instructions
Safety instructions are labelled using symbols. All safety instruc-
tions begin with a word that signifies the degree of hazard.
Strictly follow all safety points and act with due caution to avoid ac-
cidents, damage to equipment, personal injuries and loss of prop-
erty.
DANGER!
Points out an immediate, dangerous situation that
leads to death or severe injuries unless avoided
WARNIG!
Points out a potentially dangerous situation that
may lead to death or severe injuries unless
avoided.
CAUTION!
Points out a possibly dangerous situation that
leads to slight or minor injuries unless avoided.
CAUTION!
Points out a possibly dangerous situation that
leads to damage to property unless avoided.
1.2.2 Hints and Recommendations
NOTICE!
Highlights useful hints and recommendations as
well as information for safe and efficient use of the
equipment

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General Information
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1.2.3 Specific Safety Instructions
The following safety instructions are used to call attention to partic-
ular hazards.
DANGER!
Danger of fatal electric shock!
…signifies danger by electric current. Non-ob-
servance of safety instructions may lead to a se-
vere or fatal physical injury.
WARNING!
Danger of infectious substances!
… signifies danger by infectious substances (e.g.
liquids which contain bacteria or viruses). Non-ob-
servance of safety instructions may lead to serious
or fatal infections
WARNING!
Danger of corrosive chemicals!
… signifies danger by corrosive chemicals. Non-
observance of safety instructions may lead to se-
vere chemical burns to skin, human tissues and
eyes.
WARNING!
Danger of hot surfaces!
… signifies danger by hot surfaces. Non-ob-
servance of safety instructions may lead to burns.

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1.3 Limitation of Liability
All information and instructions in this manual comply with current
standards and regulations, as well as the current state of technol-
ogy & the manufacturer’s knowledge and experience.
The manufacturer will not be held responsible for losses arising
from:
 Non-observance of the points listed in the operating manual
 Incorrect and inappropriate use of the equipment
 Unqualified personnel using the equipment
 Arbitrary modifications
 Unauthorised technical changes
 Arbitrary repair
 Utilisation of unauthorised spare parts
The scope of delivery may differ from the explanations, descrip-
tions and figures in this operating manual due to additional options
specified on ordering and the latest technical/mechanical modifica-
tions.
Obligations stated in the delivery contract, general conditions of
contract, the manufacturer’s delivery conditions and the current
legal regulations at the time of conclusion of the contract will apply.
1.4 Copyright Protection
This operating manual is protected by copyright and exclusively
intended to be used for in-house purposes.
To pass this manual on to a third party, to copy or duplicate it – in
part or as a whole – and to exploit or communicate its content by
transmission outside the workplace is not allowed unless author-
ised in written form by the manufacturer.
Contravention will lead to liability for damages. All rights are re-
served.

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1.5 Spare Parts
WARNING!
Safety risk due to incorrect spare parts!
Inappropriate or faulty spare parts may impair
safety and/or may lead to damage, malfunction or
complete breakdown
Therefore:
– Use only original spare parts from the manufac-
turer.
Spare parts may be purchased from an authorised dealer or direct
from the manufacturer. See address on page 2
1.6 Terms of Guarantee
The terms of the guarantee are included in the manufacturer’s gen-
eral conditions of business contract to supply.
1.7 Customer Service
Our customer service is at your disposal for technical advice. See
contact details on page 2.
Furthermore, our colleagues are always interested in new infor-
mation and experiences resulting from user’s applications for the
equipment which may be valuable for the continued development
of our products.
1.8 Declaration of Conformity
The bench-top bioreactor Multifors complies in terms of Directive
2006 / 42 EC on machinery with the following relevant regulations:
 Directive on machinery 2006 / 42 / EC
 EMC Directive 2014 / 30 / EU

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Safety
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2 Safety
This section outlines all important safety aspects for optimal per-
sonnel protection and for the safe and error-free operation of the
equipment.
Non-observance of the operational descriptions and safety instruc-
tions listed in the operating manual may lead to serious hazards.
2.1 Responsibility of the Operator
The equipment is used in industrial domains, institutes and aca-
demic workplaces. Therefore an operator is individually liable with
regard to statutory duties relating to operational safety.
All regulations concerning health & safety, accident prevention and
environmental protection of the workplace must be complied with
alongside all safety instructions in this manual. In particular:
 The operator must be informed about the current industrial
safety regulations. He must carry out a risk assessment to
identify additional hazards due to special working conditions
related to the equipment’s area of application. They must de-
clare these hazards in the form of directives for the equip-
ment’s operation.
 The operator must ensure that these directives comply with
current legal regulations and adapt them as necessary.
 The operator must clearly regulate and define responsibility
for installation, operation, maintenance and cleaning.
 The operator must ensure that all employees using the equip-
ment have read and understood the operating manual. Be-
yond that, he must provide training and inform personnel at
regular intervals regarding potential dangers.
 The operator must provide the employees with the necessary
protective equipment.
Furthermore, the operator is responsible for the equipment’s
maintenance in correct operational condition. Therefore, the follow-
ing applies:
 The operator must ensure that the maintenance frequency, as
stated in the operating manual, is adhered to.
 The operator must ensure that all safety devices are checked
regularly for efficiency and integrity.

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2.2 Requirements for Qualified Personnel
WARNING!
Risk of injury when used by anyone inade-
quately qualified!
Inappropriate use of the equipment may lead to se-
rious physical injury and material damage.
Therefore:
– All operations must be executed by qualified
personnel only.
The following qualifications for different operations are listed in the
operating manual:
Qualified electrician
is capable of carrying out work on electrical systems, identifying
and avoiding possible hazards independently due to their profes-
sional standing, experience, skills and knowledge of relevant
standards and regulations.
The qualified electrician is familiar with the site on which they are
operating and knows the relevant standards and regulations.
Qualified personnel
are capable of carrying out the assigned work, identifying and
avoiding possible hazards independently due to their professional
standing, experience, skills and knowledge of relevant standards
and regulations.
Qualified personnel in biology, biotechnology or chemical en-
gineering
are capable of carrying out work in the field of biology, biotechnol-
ogy or chemical engineering alongside the chemical or biological
process chain due to their professional standing, experience, skills
and knowledge of relevant standards and regulations.
This includes regulations concerning health and environmental pro-
tection, safety at work, plant safety and taking quality management
into account at work. They are capable of identifying and avoiding
possible hazards independently. The qualified personnel in biology,
biotechnology or chemical engineering are familiar with the site on
which they are operating and know the relevant standards and reg-
ulations.

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2.2.1 Unauthorised Persons
WARNING!
Danger for unauthorised persons!
Unauthorised persons are those who do not fulfil
the criteria described here and so may not appreci-
ate any of the dangers related to operation.
Therefore:
– Keep unauthorised people away from the area
of operation.
– Challenge and remove any such persons from
the area of operation, if in doubt.
– Halt operation as long as unauthorised person-
nel remain in the area of operation.

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2.3 Conventional Use of the Equipment
The equipment is designed and constructed only for conventional
uses as described here.
The equipment is conventionally used only as a bioreactor for the
culture of:
 Microorganisms (equipment version for bacterial cultures)
 Mammalian and insect cells (equipment version for cell cul-
tures)
Conventional use of the equipment also includes following all in-
structions in this operating manual.
Each instance of non-conventional use is considered as misuse
and may lead to dangerous situations.
WARNING!
Danger by misuse!
Misuse of the equipment may lead to dangerous
situations.
In particular, desist from using the equipment in
any of the following ways:
– Producing explosive gases e.g. methane, hy-
drogen etc.
– Producing uncontrolled overpressure in the cul-
ture vessel. This applies to overpressure
caused by biologic activity as well as overpres-
sure caused by unregulated supplies (.e.g. inap-
propriate air/gas pressure etc.) or
closed/blocked outlet lines (e.g. exit gas line).
– Uncontrolled cultivation of toxic or pathogenic
organisms.
All claims due to loss or damage arising from non-conventional use
of the equipment will not be considered.

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2.4 Personal Protective Equipment
It is essential to wear personal protective equipment to minimise
health hazards
 Always wear the personal protective equipment which the par-
ticular activity requires.
 Always follow instructions available in the workplace, regard-
ing the use of personal protective equipment
Strictly to be worn
Strictly to be worn for all activities:
Protective clothes
To protect against contamination and carryover of viable organ-
isms. Must be tight-fitting and only slightly tear proof work clothes
with tight sleeves and no loose material.
Protective cap
To protect against contamination and carryover of viable organ-
isms.
Safety shoes
To protect against loose materials falling and slipping on sub-
stances coating the floor.
Wearing for a particular activity
Personal protective equipment is required when executing particu-
lar activities. This is indicated within the individual chapters of this
manual. The personal protective equipment is explained as follows:

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Safety goggles
To protect the eyes against liquid splashes
Protective gloves (chemical resistant)
To protect hands from aggressive substances.
Check gloves are impermeable before use. Clean gloves before
taking them off and store in a well-ventilated location after use
Face mask
to protect against pathogenic microbes and other harmful biological
materials.

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2.5 Particular Hazards
The following section contains additional risks which were identi-
fied on the basis of a risk assessment.
Observe all safety instructions and warning notices in this and the
following sections, in order to reduce health hazards and to avoid
dangerous situations.
Electric current
DANGER!
Danger of fatal electric shock!
There may be fatal danger by touching compo-
nents connected to a mains power supply (single or
3-phase). Damage to insulation or components
may have fatal consequences!
Therefore:
– Immediately turn off the electrical supply when
the insulation is damaged and initiate a repair.
– Only qualified electricians are allowed to make
these repairs on the electrical system.
– Disconnect electrical components from the
mains supply and check whether it is electrically
isolated before making any repairs.
– Turn off the electrical supply and lock off any
isolation switch before commencing mainte-
nance, cleaning or repairing.
– Do not bypass fuses or take them out of opera-
tion. Adhere to the correct rates (in Amps) when
replacing fuses.
– Keep components which are electrically pow-
ered away from humidity, as excessive moisture
may lead to short circuit.
– Do not expose equipment to inappropriate envi-
ronmental temperatures outside the stated op-
erating range.
– Never open the housing covers of the basic unit
and control unit when the electrical supply is
turned on.

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Biohazard
WARNING!
Biohazard!
Noncompliance with biological safety regulations
increases the health risk of the operator and the
risk of lower equipment functionality.
Therefore:
– Strictly follow all biological safety regulations
– Decontaminate and sterilise every part including
any peripheral in- and outlet that comes in con-
tact with any infectious biochemical substances
(e.g. liquids which contain bacteria or viruses).
– Dispose of medium according to the local regu-
lations – sterilised medium only!
Hot surfaces
WARNING!
Danger of scalding and burns due to contact
with hot surfaces!
Skin contact with hot surfaces can lead to severe
scalding and burns.
Therefore:
– Always wear protective clothes and heat re-
sistant gloves when working near hot devices.
– Ensure that all devices are cooled down to envi-
ronmental temperature before use.
– Always place a suitable notice e.g. "Hot".
Corrosive chemicals
WARNING!
Danger of chemical burns!
Non-compliance with directives and regulations
concerning handling of corrosive substances and
chemicals contains a high risk of chemical burns!
Therefore:
– Strictly follow directives concerning handling of
corrosive substances and chemicals
– Always wear chemical-resistant gloves, safety
goggles, face mask and protective clothing
when working with corrosive substances and
chemicals