Performance qualification of RLAF

GOOD VALIDATION PRACTICE (cGVP) HVAC VALIDATION
1

Dear Experts,

Kindly give your valuable input for me to finish our sampling and dispensing booth Performance Qualification.
We have RLAF which are used for sampling and dispensing. We have finish IQ, OQ and PQ except Microbial monitoring. How many days microbial monitoring is required?
How many sampling points to be taken?
What are the Methods to be followed for sampling?

Kindly give your valuable information.

Thanking you

Pulla Reddy Karnati.

2

Dear you can perform microbial evaluation from 21 days (as per WHO) to 3-7 days.
For microbial Evaluation you have to use following methods as

  1. Settle Plate with 5 location four corner and one center may be used or as per risk assessment.
  2. Volumetric Air Sampling as per number of filter divided by 1000 L that is basic requirment
  3. Contact Plate from LHS side and RHS side or as per risk assessment.

This is purely based on industrial practice followed in general may be varied by company to company

Thanks
Nilesh Awadhiya
Validation Manager