Qualification of Non sterile facility

Production
1

Dear All,

We are going to qualify our new facility… Almost all the areas have been declared as Class D…What tests we need to qualify this facility regarding environment qualification?? do we need to test Class D also on the basis of Particulate test for each rooms or only where products are processed and exposed…Other areas like corridors and IPC rooms which are also declared as Class D do we need to check particles as per ISO 14644-1 to qualify this rooms or no need…

Thanks in advance for your valuable comments

2

During qualification of a new facility, apart form a gamet of activities, monitoring and measuring the viable and non viable count is one of the key aspects so that they do not impose any risk of contamination to your product. Having said that contamination will occur only in area where the product is exposed to environment. As your products do not get exposed in areas like corridors those can be excluded from monitoring with proper scientific rationale

3

Thanks Mr. Sanjay…

4

coridors should also qualify because in case of cleaned coridors air enter from coridor to the mfg area.

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5

Non viable count should be monitored for all grade D area on monthly basis to ensure the particle count is under limit for all grade D area.

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6

Dear All,

What are the available guidelines for designing and commissioning of facility.

Thanks