Environment monitoring clean room

Microbiology
1

Dear Sir,

What is the frequency of environment monitoring of non sterile (Class 100, Class 10000 and Class 100000) clean room area ?
Can we use Air petri sampler and settle plate technique in alternate in environment monitoring of clean room?

Thanks

1 Like
2

Following is the frequency of the air sampling in cleanroom area by WHO.

Source: http://www.who.int/immunization_standards/vaccine_quality/env_monitoring_cleanrooms_final.pdf

3

Thanks for your reply…

Can we use Air petri sampler and settle plate technique in alternate in environment monitoring of clean room?

4

As given in above table all should be done as per given frequency.

5

Thank you very much sir…

6

dear sir
can we incubate of plates without impression of air sampling,

7

Unable to understand because you have to take air sample for environmental monitoring.

8

But these exposures are for sterile manufacturing according to pharmacopeia.
There is no such frequencies for non sterile plants.
Can you please help for this matter.

9

thanks you so much for giving me reply
is there any requirement during routine montitorning of bolth vaible and non viable particles

10

non sterile frequensy in weekly aur once in month bec thet are manufatured in d claas area

11

The frequency for environment monitoring of non sterile areas is not mentioned in any of the guidelines currently.
The frequency mentioned above is for Sterile Vaccines and not non sterile area.

12

If we validate on technique; either air samplin or settle plate; one can be done following frequency.

13

Once in a month aal area covered by settle as well as active as air sampling

14

Non sterile facility not require environment monitoring.
Please read usp 1115

15

What is frequency of environment monitoring of Class 100 LAF in microbiology lab and Class 100 LAF in Production area.(but surrounding area is 10,000 Class in both area)