Dear Sir,
If online particle count is not available on filling machine of dry powder injection,can i ensure class A area is maintained during filling by taking offline particle count under LAF before and after filling activity.
Well the particulate counters for air monitoring in and on the powder filling lines under the LAF has been always debated.
In my view there should be offline particulate monitoring in powder injectable filling LAFs.
If online counting is there it will be showing very high count because of aerosol or dust generated by the powder under filling process.
Offline monitoring is always advisable for Sterile powder for Injections and regulators accept in this case.
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it means i can not ensure the grade A area during filling operation due to high particle generation.
What is your normal practice?
I have explianed what is the theory and rational behind.
I leave the question to your intelligence.
You are just blogging here to fish out details with having any practical experience.
I advice you to work,learn, read and ask.
This is a very basic question you have questioned again.
This is taught by pharmaceutical companies with in first 6 months of induction training.
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Dear Sir,
What is the procedure to collect the vials after depyrogenation for sterility testing, i mean how we can store these vials and transfer to micro department without sterility break.
My reply to your question:
Sampling is not your problem. Before I tell you any thing, ask your Quality assurance professional and Microbiologist and shopfloor supervisor to read Standard Operating procedure for Sampling, Storing and Transferring depyrogenated vials for sterility test.
Dear Sir,
We have 2 Particle counter (continous & mobile particle) the continous is always in filling room and works during the filling process. How the procedure to measure particle when worst case media fill is happen? When we use the mobile particle counter, whether during filling or only in the worst case happen?
[quote=Manoj Singh]Dear Sir,
If online particle count is not available on filling machine of dry powder injection,can i ensure class A area is maintained during filling by taking offline particle count under LAF before and after filling activity.[/quote]
I suggest you intall two particle sampling prbes.
One is located at the point of fill(working level of class A) and should monitor the air during at rest.
The other is located near the HEPA filter and should monitor the air during in operation.
The probe at the higher position is not affected by generated particle, API itself, during filling process.
Of course, the particle counter of the probe at working level has to be turn off and a top of the probe has to be closed during in operation.
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