Inprocess checking in sterile area

Quality Assurance
1

how in process checks performed in sterile area like volume checking its limits and other tests to be performed by quality assurance in sterile area?

2

Dear Ahmed,
Depending upon the type of sterile formulation in process checks are being carried out.
you need to be specific for your question.
The general test are as follows:

  1. Weight / fill volume should not be less than label claim or not more than 2%/3% of label claim
  2. Challenge for all sensors ex- No product no filling test.
  3. Torque test- as per INH SOP.
  4. Sealing/overprinting and embossing check- the number of sample for test shall be as per SOP.
    5.All challenge test for secondary packing for the functioning of sensors as per defined frequency in SOP.

Thanks