Isolator Validation

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Pls tell me the details for Isolator Validation

2

For isolator validation u need to perform the following validation.

  1. Sterilizaion validation including the BI,s
  2. Pressure hold test
  3. Non viable and Viable particulate count test

No need to perform the laminarity test.

3

Thanks for replying…

But I ahving regarding why we didnt required the Laminarity test?

4

Mr. Harshal, Plz go for Laminarity test also, it is requierd to examine flow of air during in operation condition.