Tablet De-Duster Cleaning Validation Protocol Help

E

erniel

I need to perform a cleaning validation on a tablet de-duster. A machine that tablets are put through prior to packaging to remove excessive amounts of dust. I am not sure how to proceed with this or what might be needed in a test protocol. If anyone has a cleaning validation protocol i could use as a sample i would appreciate it. Also, can anyone recommend a testing lab that would be able to do the analytical testing on the samples and perhaps help with the protocol preparation. All thoughts are appreciated
 
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ScottK

Not out of the crisis
Leader
Super Moderator
Re: Cleaning Validation Protocol Help

Can you provide some more information?

I'm not sure what you mean by "tablet" - can you define the application
How big are they?
Are there regulatory requirements or standards you have to comply with?
Are you only looking for particulate?
Is there a documented allowable contamination level if you're not referencing a standard?
 
K

kdsaggi

Re: Cleaning Validation Protocol Help

Please go through the attached file. I am sure it is useful for you.
 

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  • Equipment Cleaning Validation.pdf
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E

erniel

Re: Cleaning Validation Protocol Help

good information - thank you
 
P

pia rose

Re: Cleaning Validation Protocol Help

Thank you kdsaggi. This information is very useful.
 
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