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Normal cleaning and verification of fermentation tanks
Data： 2020-09-02
Source：
Hits： 101
Preparation before verification
Before drafting the verification plan, it is necessary to evaluate the risk assessment according to the characteristics of the product or confirm the corresponding documents during the drafting process.
The key items identified in the risk assessment and documentation are as follows:
1. Evaluate what effect needs to be achieved after cleaning the fermentation tank to meet the production needs.
2. Evaluate whether the cleaning procedure is stable and reproducible, evaluate the hardware required for verification, and make sure that it is available.
3. Evaluate the test data of the cleaning method and confirm that the conclusion is correct.
4. Acceptance criteria for evaluating cleaning effects.
5. Evaluate whether the sampling method is operability: Generally, there are two types of sampling: surface wiping sampling and tank bottom sampling.
6. Evaluate whether the detection method can achieve the required accuracy, and there is no degradation of the detection index during the test.
Fermentation tank cleaning verification implementation
1. Full coverage of cleaning, no dead corners.
Spray riboflavin on the inner surface of the equipment, first let a group of people clean the fermentation tank according to the cleaning procedure, and then let another group of people observe with UV lamps, paying special attention to cleaning possible dead spots.
If there is a blind spot, it is necessary to confirm that it is the problem of the cleaning method specified by SOP or the problem of the implementation of the cleaning method.
If it is a problem with the cleaning method, end the verification and revise the SOP. If the cleaning staff did not follow the SOP, they must re-operate before verifying.
2. Inspection of tank wall residue
For a new tank that has not yet been fermented, it is difficult to find a way to measure the residue. The company can determine a substance that can be accurately detected according to the actual detection ability, and then spray it on different positions on the inner surface of the fermentation tank.
After cleaning, use the rubbing sampling method to detect the residue, and the residue is one thousandth Such indicators are the limit.
3. Residual cleaning agent
For the residue of cleaning agent, take samples at different moments when the last wash tank water is released, and test them one by one. Each test result is required to meet the requirements.
If the cleaning agent is water, this step can be omitted.
As a supplier of fermentation equipment, Paragon has sufficient capacity to provide fermentation equipment for global bio-industrial enterprises, and has been working hard to make new breakthroughs in the research and development of biological fermenter.
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