1 reply to this topic

[Juna]

Hi,

 

God Morning.

 

Currently our testing for microbiological sample for LACF incubated in 10days at C35°C. Were doing a validation study reduce the number days of incubation period to 7days. Base on our result their is no significant different 10days and 7days incubation. This shorter incubation period will streamline testing processes without compromising the quality control of the product.

 

Asking if you have thoughts in this validation study.

 

Thank you.

[Tony-C]

Hi Juna,

 

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 (States optional but I always incubate at 55°C as well).

 

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

 

Standard for Sterility Test UHT

 

Kind regards,

 

Tony

Edited by Tony-C, 03 September 2024 - 03:44 AM.