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Cell bioreactors-fermentors CGMP

KNIK BIO 35L bioreactor system for suspension cell culture

  • Description
  • Inquiry
Description

Ⅰ.Confirmation of Equipment Design :

1

Equipment

1.1

Total volume 

35L

Use       Fermentation tank   Bioreactor

 

Working volume

 

 40-70%        Quantity: 1

 

1.2

Liquid-adding container

Heat-resistant silica glass bottles 

1L : 3pcs,  2L : 1pc, 10L 1pc, 20L : 1pc

1.6

Process piping

 Enclosed installation

 Open-shelves installation

1.7

Air pretreatment

 Pressure-relief device             No

 Pre-filtration and pressure-relief devices       No

1.8

Vapor pretreatment

Industrial steam filtration, hydrophobic and stress systems   

 No

Pure steam filtration, hydrophobic and pressure relief systems required      

 No

1.9

Cooling water pretreatment

First-level screen filter

1.10

Other

Air , Nitrogen, carbon dioxide, oxygen decompression device                 No

1.11

The buyer's confirmation:

 

2

Application

2.1

Biological species

    Bacteria(bacteria)   Plant cells    Mammlian Cells

2.2

Cultivating methods

 Batch(Batch culture)   Suspension culture  

 

 Microcarrier culture

 

 Fed batch(Batch supplement culture)  

2.3

 The buyer's confirmation:

 

3

Delivery date and installation site

3.1

Equipment delivery date

90-120 working days

3.2

The installation site

Customer will install the equipments by themselves

3.3

 The buyer's confirmation:

 

4

 Reactor/fermentation tank

4.1

Tank

total volume:  35L Working volume    Full volume

Working volume: 70%

Diameter ratio:  1: 2.2-3       1: 1.5-1.8              ..........

Design tank pressure: 0.3MPa               ...3.... barg

Tank's internal bile material:      316L        304

Test report of tank materials: 3(SGS):Top cover, straight tube body, lower head      No

Internal polishing accuracy:        Ra0.2      Ra0.4    Ra0.8

Internal electropolishing    Internal pickling passivation

External surface polishing treatment:   Ra0.8   sand blasting

Internal polishing test report: 3(SGS):Top cover, straight tube body, lower head   No

Pressure vessel certificate:      provide          No

Conform to GMP standard:      Provide relevant documents            No

Viewing mirror:      Side-view mirror        Top-view mirror        No

floodlight:      Side installation      Top installation        No

Sterilization temperature: 100-130 °C,The sterilization time: 0-60min,The highest temperature: 135 °C

Sterilization mode:  In situ automatic sterilization (Can be sterilized separately for empty and full vessel)   Manual operation

Sampling valve:   Denmarkkeofitt          Bürkert        No

Sampling valve sterilization mode:Manual sterilization

Tank bottom valve:    Bürkert        GEMÜ    No

Tank bottom valve sterilization mode:Automatic sterilization

There are three optional filling liquid interfaces; A shallow aeration tube interface; A deep ventilation tube interface; A top flame inoculation interface;A side seed transfer interface

Cleaning: high pressure cleaning interface is installed at the top;

Tail gas condenser:   yes         No

Exhaust gas incinerator: yes         No 

4.2

Jacket

Design pressure: 0.35Mpa

Jacket material: 304 stainless steel

Temperature control jacket:Coverage ratio 80%,Internal optimization diversion structure

Heat preservation jacket:        yes            No

External surface treatment:      buffing Ra0.8      matt

4.3

Top cover

Flat-topped tank cover, bolt - type compaction device;

 Pneumatic open-cover mode       Electrodynamic open-cover mode

4.4

 The buyer's confirmation:

 

 

 

5

Mixing1 system

5.1

Mixing type

Mechanical seal system

 The bottom double mechanical seal,Steam sterilization treatment

The top magnetic drive is not mechanical seal, the performance is better, the cost is high.

5.2

Mixing shaft type

Single axis, micro taper high speed type

5.3

Mixing speed

Speed range: 20-200rpm, stepless speed regulation

5.4

The mixing slurry

2 grade elephant ear with 4-blade impeller or customer requirements

5.5

material

Internal tank and all contact with the material both are 316L

5.6

 The buyer's confirmation:

 

 

6

Ventilation system

6.1

Ventilation mode

bottom ventilation  top ventilation    The control interface can be selected in two modes

The bottom ring gas distributor        The bottom l-shaped gas distributor

6.2

 Filter

Air intake filter           Exhaust filter

Automatic on-position sterilization         Manual on-position sterilization

on-position integrity testing      off-position integrity testing         None

Brands:Sartorius    Domnick Hunter

6.3

Gas species

air         oxygen   nitrogen      carbon dioxide

6.4

Flow meter

Rotor flow meter + solenoid valve      Gas mass flow meter + rotor flow meter

brands:   Vogtlin   Bürkert         Cheng Feng  

6.5

The buyer's confirmation:

 

 

 

 

 

7

Feeding System

7.1

Feeding type

acid    base   antifoam  Nutrient solution 1 + feeding material  inoculation liquid

Note: usually, acid and alkali only use one peristaltic pump, the interface is optional, so the actual can only needs four peristaltic pumps.

7.2

Peristaltic pump

Intermittent type:Kolpalmer (Spirax Sarco)    Watson-Marlow

Continous type:Kolpalmer (Spirax Sarco)    Longerpump

7.3

The buyer's confirmation:

 

 

8

Inoculation and Seed transfer

8.1

Inoculation

Inoculation approach:Flame inoculation   Peristaltic pump + insert inoculation

8.2

subcultivation

Rigid tube seed transfer    hose quick coupling seed transfer       No

 

8.3

The buyer's confirmation:

 

 

9

Biological safety

9.1

Exhaust disposition

High temperature sterilizer   Chemical pool sterilization        No

9.2

Sewage treatment

Dedicated pipe discharge   mix emissions      No

9.3

The buyer's confirmation:

 

 

10

Control function

10.1

sterilization

Automatic sterilization of empty vessel or filled liquid vessel;Sterilization temperature: 100-130 ° C, sterilization time: 0-60 min;

Automatic sterilization of inlet and exhaust filters.

Allowed tolerance of sterilization temperature:±0.1°C;

Note:
After sterilization, it can automatically enter the fermentation waiting state

10.2

Fermentation temperature

PID automatic control, plate heat exchanger for heating and cooling, cooling water for cooling, with circulating system;

Control range: cooling water temperature + 5-65 ° C, control precision: + / - 0.1 ° C,


With real-time curve and historical curve, it can be tracked and controlled in sections.

10.3

pH

PID automatic control, peristaltic pump control, can choose one-way or two-way control;

Control range: 2-12ph, control accuracy: + 0.02 pH, resolution: 0.01pH

It has a real time curve and a historical curve.

10.4

DO

PID automatic control, control air and O2 through mass flow meter;


It can be controlled in association with stirring speed and intake air flow, that is, the dissolved oxygen can be adjusted by changing the stirring speed and intake air flow;

 

Control range: 0-100%, display range: 0-200%, resolution: 1%

It has a real time curve and a historical curve.

10.5

Mixing speed

PID automatic control,  stepless speed regulation control with governor;

Speed range: 20-200rpm; Control accuracy: plus or minus 0.5%, resolution: 1rpm

It has a real time curve and a historical curve and can be tracked and controlled in section.

10.6

Tank pressure

PID automatic control, pneumatic control with proportional valve;

Control range 0-0.2 MPa, steady state precision: ±0.01MPa, resolution: 0.001 MPa

It has a real time curve and a historical curve and can be tracked and controlled in section.

10.7

Ventilation flow

air  100L/min      oxygen 3L/min     nitrogen50L/min      carbon dioxide  1L/min accuracy:±2%,resolution 0.1%

10.8

Material measurement

  Yes      None

10.9

Feeding control

Digital timing quantitative control, creep pump automatic replenishing;

10.10

antifoaming control

 Yes      None

10.11

Level control

 Yes      None

10.12

Exhaust gas sterilization

  Yes     None

10.13

Weighing system

Mettler weighing module

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