Sterile Plant Clean Rooms

Depending on which part of the industry you are in it is best to look to the regulations.

- USP 71, USP 161, USP 797, EP2.6.1, JP14 54

- FDA - or your local equivalent of cGMP / GMP / GLP

- ISO - there is a specification set for clean area classifications 14644 13485 etc

Your company or college library may have copies of these documents as well as some are available online with a quick search.

All these are predicated on what you are making and for whom.

I am working as a microbiologist in Sterile Pharmaceutical company, I have referred to the guidlines mentioned by you, I was unable to get viable count limits in static and dynamic conditions of sterile clean rooms......this is very much required for my HVAC qualification project.

You must refer to the company-wide VMP or MVP and, establish thru the SOP for that particular area, your criteria as per the equipment involved:

1. DS for equipment Requested on your proposal.

2. User Requirements.

3. Functional Spec's

Note: Design the process analysis around the equipment spec's.

4. IQ/OQ for the particulars.

5. Historical Data

6. PQ's

7. Then Capabilty and PPQ

8. Compare to Cpk

9. Continue process improvement.

The list can go on and on...

10. If not familiar with these, then, contact an outside source or help. Sometimes it's better to pass the buck.

I think it depends on type of micro-organism and life-cycle. With HEPA filtration and a good certified AHU you are able to establish a study and analize the data gathered. Am almost positive that the AHU/HEPA system and with help from the QC dept. some sort of controls could be established.

http://www.fda.gov/cder/guidance/5882fnl.htm

From CDR, "...As provided for in the regulations, separate or defined areas of operation in an aseptic processing facility should be appropriately controlled to attain different degrees of air quality depending on the nature of the operation. Design of a given area involves satisfying microbiological and particle criteria as defined by the equipment, components, and products exposed, as well as the operational activities conducted in the area.

Clean area control parameters should be supported by microbiological and particle data obtained during qualification studies. Initial cleanroom qualification includes, in part, an assessment of air quality under as-built, static conditions. It is important for area qualification and classification to place most emphasis on data generated under dynamic conditions (i.e., with personnel present, equipment in place, and operations ongoing). An adequate aseptic processing facility monitoring program also will assess conformance with specified clean area classifications under dynamic conditions on a routine basis."

Contact:

http://www.bioteknica.com/

Tell them Ronald sent you. Who knows? I may be rehired by them to help you out!

TSI has a new product called the BioTrak which measures viable particles in real time. It is ISO-21501-4 complaint. A device like this might help to enure that your are meeting this standard or better.