How to Validate UHT Equipment Effectively

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

who can help me?

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