FAQ - Pharmaceutical/Life Sciences Particle Counting

Lasair II Particle Counter for Cleanrooms

Question
What is the recommended recovry time for oral solid dosge form manufacturing facility?

Answer

Solid dose manufacturing is an environment that should meet defined ISO 14644 standards; the environment is defined as ISO cleanroom class X (7 or 8). As such it should be certified annually to prove it is maintained at that condition, either at rest or in operation, this is part of your license agreement for manufacturing the product - being aware of the impact of environmental risk to finished product quality.

So the test for recovery should also come from the relevant standard (ISO 14644), Recovery test is fully described in ISO 14644-3 chapter B12.