Questionnaire: Bioreactor/Fermenter for Microbial and Mammalian (suspension) Cell Culture
Please answer the following questions as completely as possible.
I. Customer Information
Contact Person
Company Name
Designation
Contact Number
Department
Email Address
II. Intended Application of Bioreactor/Fermenter
1.
Application
Microbial Culture
Suspension Cell Culture
Others
2.
Type of microorganism/cells
* Please indicate organism or cell line to be cultured
Yeast
Bacteria
Fungi
Cell Line
Others
3.
Product
Secreted Protein
Biomass
Non-Secreted Virus
Non-Secreted /Inclusion body (IB) Protein
Secreted Virus
Others
4.a
Current Culture System
Spinner Flask:
ml x
Pcs
Stirred-tank Bioreactor:
ml or L
Others:
4.b
Current Culture Scale in liters (L):
III. Bioprocess Parameters
1.
Current Process Mode
Batch
Continuous
Fed-Batch
Repeated Batch
Others
2.
Reactor Size
Minimum working volume:
L
Maximum working volume:
L
Working volume:
L
3.
Agitation Speed
Range:
rpm
4.
Measurements Required
Temperature
°C to
°C
pH
to
DO
% to
%
Redox
mV to
mV
Turbidity
pCO
2
Foaming
O
2
/CO
2
in Exhaust Gas
Level
Others
IV. Bioprocess Controls
1.
Sterilization
Temperature:
°C to
°C
Period:
2.
Temperature Control
Double wall vessel
Heating Pad
Heating Jacket
Heating/Cooling Pad
Others
3.
pH Control
Addition of Base
Addition of CO
2
Addition of Acid
Others
4.
Dissolved Oxygen Control
Impeller Speed
Gas Flow Rate
Addition of O
2
Others
5.
Mixing Impeller
Rushton Impeller
Pitched blade impeller
Marine blade impeller
Others
6.
Foaming
High
Not yet determined
Low
7.
Applied Gases for Aeration
Air
Air + O
2
Air + O
2
+ N
2
Air + O
2
+ N
2
+ CO
2
Others
Gas Mixing Systems:
Yes
No
8.
Airflow
Range:
vvm to
vvm
Control:
Regulator/ Rotameter (manual)
Mass Flow Controller (Automatic)
Others
9.
Aeration Delivery
Sparger, Type:
Ring Sparger
Microsparger
Others
Overlay
Overlay and Sparger
10.
Pressure Control Requirements
Manual Control
Automatic Control
11.
Other Special Requirements
V. Bioreactor/Fermenter Hardware Requirement
1.
Vessel Material
Borosilicate Glass
SS 316L
Others
2.
Seeding/Inoculation
Needleless Seeding Port
Needle Injection Inoculation Port
Others
3.
Fluid Addition Number of Ports
1
2
3
4
5
6
4.
Number of sampling port
Number of ports
1
2
3
5.
Air Filter Housing
Filter Size:
0.2µm
Others
Integrity Test Port:
Yes
No
6.
Exhaust Filter Housing
Filter Size:
0.2µm
Others
Integrity Test Port:
Yes
No
VI. Software Requirement
1.
Software compatibility
Non-GMP
GMP (21 CFR Part 11)
Others
2.
Other requirements
Data-log
Real-time trend
Remote control
Others
