Clean room performance qualification (pq) - How many times can I do each test?

Olgamargarita

Starting to get Involved
#1
Dear all, How many times can I perform eah test of PQ?
filter integrity,
filtration,
air changes per hour,
differential pressures,
temperature,
humidity,
counting of non-viable particles and
control of viable particles

thanks

Olga
 

Olgamargarita

Starting to get Involved
#3
It depends on ISO Class of clean room, Risk Analysis and what is outlined in your validation master plan (VMP).

See this document from World Health Organization as it relates to vaccine manufacturing - they recommend 20 days (page 40)

http://apps.who.int/iris/bitstream/handle/10665/64465/WHO_VSQ_97.02.pdf?sequence=2
.
Thank you, I am interested to know how many times I have to perfom each test (for example, how may times or during how many hours I have to monitor temperature) in order to performace to quality in Class room Class D (ISO8), please
filter integrity,
filtration,
air changes per hour,
differential pressures,
temperature,
humidity,
counting of non-viable particles and
control of viable particles
 

Ninja

Looking for Reality
Trusted
#4
Not sure what industry you are in...it would be helpful...BTW, do you mean "Grade D" which equates to ISO 8, or 100K?

For my Class 100K rooms (similar to ISO 8), we did this once per year...as directed by the outsourced company who did it.
Each room tested too about an hour stem to stern...

For a totally different industry, the risks, and thus the frequency, might be wildly different (like 20 days in Ajit's post).
I was in electronic materials, but not assembly.

Note that Temp and Humidity (and everything else you list) are not required parts of ISO8...though your process needs may have added them...they are functional means to an end...the air.
My living room in my house passes ISO8...we don't have kids or pets...
 

Olgamargarita

Starting to get Involved
#5
I work at laboratory which manufacture pharmaceutical product - solid dosage forms, this clean room is Class D, this is the same ISO 8, the only way to show is Class D is performig tests. you talk about frecuency which is set by laboratory taking into account many factor. I want to know if it is neccesary to do 1 or 3 integrity test to hepa filter which is located in UHA or ducts in order to pass performed qualification.
Thanks
Olga
 

Ninja

Looking for Reality
Trusted
#6
Got it...that's why I asked about your industry...
I am not current on requirements in Pharma or medical...only electronics and electronic assembly. The requirements are likely different outside of the base ISO8 requirements...
 

Ajit Basrur

Staff member
Admin
#7
Thank you, I am interested to know how many times I have to perfom each test (for example, how may times or during how many hours I have to monitor temperature) in order to performace to quality in Class room Class D (ISO8), please
filter integrity,
filtration,
air changes per hour,
differential pressures,
temperature,
humidity,
counting of non-viable particles and
control of viable particles
There are no hard coded requirements and you can define based on your risk analysis. Typically, 3 days intensive monitoring to cover all shifts should be satisfactory. Having covered all parameters could be part of OQ, the 3-days monitoring could cover differential pressures, temperature, humidity, non-viable and viable.
 

BradM

Staff member
Admin
#8
Hello there!

Simply, the task before you is to provide and assure clean air. So there are a lot of things mixed below:

How you provide clean air and suitable environment:
filter integrity,
filtration,
air changes per hour
differential pressures
temperature control
humidity control.

How you verify suitable environment is maintained:
counting of particles
differential pressure indicator
temperature monitoring
humidity monitoring.

So, you start with a properly engineered room with gown room. Depending on the class the room was designed for, there should be sufficient filters and adequate air changes per minute/hour.

As long as the air flow is suitable, filters work like they should, environmental system is working fine, positive air pressure is maintained, and clean room guidelines are followed, the air should be clean. The appropriate parameters are then verified with the particle counters, differential indicator, and temp/RH monitoring.

Calibration of the counters, indicator and temp/RH indicators should follow an analysis of the instrument performance. Usually I would recommend once or twice a year. They can be performed when there is a planned clean-room shutdown.

Filter maintenance can depend on a lot of factors including time since last change, how much filters are moved around and such, and cleanliness of the incoming air.

If you have continuous particle monitoring, I would perform calibration and maintenance every six months or a year, unless you can find an industry requirement that would supercede that. If you're having alarms, lose positive pressure, etc., you might have to perform it more frequently.
 

Olgamargarita

Starting to get Involved
#9
Thnak you so much BradM, your commets are very useful for me, I have acknowledgement that filter integrity must be perfom for verifying environonment once a year, it is correct? I work in manufacturing lab of tablet.
Thanks,
Olga
 

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