2 replies to this topic

[zuoli]

How to validate UHT equipment? Equipment performance validation? Sterilization effect validation and process parameter compliance validation. Can you provide a document?

[zuoli]

who can help me?

[Tony-C]

Hi zuoli,

 

I normally use Tetra Pak Guidelines for Microbiological Evaluation of Commercially Sterile Products. The flow chart from the guidelines is shown below.

 

 Tetrapak Flow Chart for Microbiological Test Procedure.png   508.63KB   0 downloads

 

The protocol prescribes incubating products at 30°C and 55°C.

 

It is also a good idea to implement a system for early detection of severe failure - ATP test after 3 day’s incubation. This should be retained as normal following the sterility test.

 

You could also use ATP at 7 days if you are reducing incubation from 10 days.

 

You might find info in these topics useful:

 

Aseptic process validation

https://www.ifsqn.co...ess-validation/

 

Standard for Sterility Test UHT

https://www.ifsqn.co...ility-test-uht/

 

Kind regards,

 

Tony