can anyone help me about this problem?
I need a sop for microbial monitoring of plastic bottles (for tables and ...). our products are NON STERILE. what is the accaptable criteria for TAMC and TYMC for plastic bottles??? should I test the specific microorganism too?
it shoud be based on USP or EP.
I can not find a method in pharmacopoiea, but I guess may these methods be approprate:
swabbing the bottles? or filling the bottles with sterile buffer and then pourplate the buffer in SCD agar? or any other method?
thanks for any guidances
Dear Sanat Myti.
thanks a lot for your advise
but my question is: there is no special description for examining the containers for drugs. when we buy a batch of plastic bottles, they are stored in company's warehouse. when dugs are manufactured in clean rooms they are filled in these plastic bottles, but before this happens, I should monitor the microbial load of these bottles in microbiology laboratory. but there is no method for this. in usp it is not mentioned about the mehod.
how ever, thank you so much
Hi I think you must develop those internally with the Microbiology lab plans. Like how we take swabs from work areas and check, similarly you can ensure that the bottles are free from microbes. Make an SOP on your own
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