Does anyone know for a Class 8 100,00 cleanroom what the limit is on Airborne Mircobial counts for the cleanroom? I have inhereted a procedure that has a spec of Zero units for mold and Bacteria and considering the product goes through 2 sterilization processes after this, it seems to be overkill :rolleyes:.
Thanks so much:thanx:

Since you are in USA, US FDA guidelines say that you must have <25 cfu/ cubic feet of microorganisms; or <88 cfu/ cubic meter.

WHO 2002 guidelines: <500 cfu per cubic meter

EUGMP 2002: < 200 cfu per cubic meter

hope this helps!

I would suggest you to refer United States Pharmacopeia section 1116 on "Microbiological Evaluation of Clean Rooms and Other Controlled Areas", that state ISO Class 8 Clean rooms can have limits as follows -

cfu per cubic feet of air Less than 2.5

cfu per cubic metre of air Less than 100

Pl note that these values serve only as guide and the regulators expect the manufactuere to establish their own alert and action limits based on the overall monitoring program.

Hope this helps.

Ajit,

the latest CDER published Guidance For Industry on Sterile Drugs Produced By Aseptic Processing, CGMP, September, 2004 provides the following data:

class 100,000 or ISO 8 areas:
Microbiological Active Air Action Levels: 100 cfu per cubic meter
Microbiological Settle Plates Action Levels: 50 cfu (90mm plate, 4 hours)

Of course; it is understood that these are recommendations only and you have the discretion to assign levels based on your manufacturing process and method of analysis

Are you referring to this draft guidance document - http://www.fda.gov/cder/guidance/1874dft.htm ?

I am sorry I could not get any such values there - can you pl highlight the same ?

Actually, there is one that is more recent; from September, 2004. The guidance that you referred to is from August, 2003. Nonetheless, the document that you linked has the same information in Building and Environment section; in Table I.
I have another document which summarizes clean room specs from nearly every reference body; ISO14644-1, Schedule M, FES 209E, WHO, etc. etc. which has the levels that I quoted in an earlier post.

Thanks Dash - nice summarization :)