Fermentation Equipment Validation and Testing Items

Micro-giant BioEngineering 2012.10.10

Ⅰ.Document and Attachment

1. Document: Material Certificate, Production Control Table, Welding Record, Surface Polishing Ra     Examination Report, Pressure Testing Report, Operation Manual, Equipment Outline Chart, P&ID Chart, Layout Chart, Electrical Loop Chart, Pressure Vessel Manufacture License, 3Q……etc.
2. Attachment: Maintain tools x 1, Recent supply spare x1.

Ⅱ. Factory Acceptance Test (FAT):According to the quoted specification execute FAT to confirm the specifications.

Ⅲ. Pressurization and Sterility Testing

1. The Pressurization Test--Impose the tank body the maintain pressure test.  The tank pressure of 20psi, 24hr shall not be less than 15psi.
2. Sterile Blank Test –Pass 72hr sterile test times and medium was sterilized after cooling. Take the sample coated on petri dish then culture for 72 hours to see the colony and microscopic examination , shall not be detected. (This test in addition to the main fermentor, also containing all of the feed tank and mixed tank)
3. Thermophilles Test(Biological challenge testing)--Place the spores of the Thermophilc bacteria sterilization reagents multi-points in air sterilization filter, tanks (feed tank and mixed tank) inside and the bottom and Transfer pipe to start SIP. After SIP, culture or use interpretation machine to do rapid fluorescent interpretation, see sterilization whether completely.

Ⅳ. Function Testing (Auto Control Microbial Liquid State Culture Equipment for kL level fermentors)

1. Temp. Control:+5.0℃～60.0℃(PID),error ±0.2℃。
2. Speed Control:30～300 RPM (stepless speed change) ,error ±1 rpm。
3. pH Control:0.00～14.00 PH ，Precision Display pH ±0.01。
4. Do Control:0.0～200.0% (PID control)，Precision Display ±0.1%。
5. AF Control: Delay, ON/OFF,  ALARM.
6. AIR Flow Auto Adjustment System:0～2vvm(max. ventilation), error±0.3%L/min. Add Float Flowmeter to compare with the flow or switch to manual.
7. Pressure Control:0.00～3.00kg/cm2  ,error ±0.02 kg/cm2。

Ⅴ.Suitable Area:fermenter,fermentor,bioreactor,bioreacter.

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