We are in discussion with a pharmaceutical manufacture for manufacture of plastic primary drug containers.
The customer wants these plastic injection molded primary containers to be molded in ISO Class 7 area as the Class 7 clean rooms have lower particulates while we feel that ISO Class 8 would suffice. The molded plastic containers would be molded, washed, and then sterilized, and the customer would fill drug product aseptically in these containers.
Are there any regulations / standards that would help me in this direction? Also are there are testing criteria for the molded plastic containers to be used exclusively by the drug industry?
Appreciate your help.
The customer wants these plastic injection molded primary containers to be molded in ISO Class 7 area as the Class 7 clean rooms have lower particulates while we feel that ISO Class 8 would suffice. The molded plastic containers would be molded, washed, and then sterilized, and the customer would fill drug product aseptically in these containers.
Are there any regulations / standards that would help me in this direction? Also are there are testing criteria for the molded plastic containers to be used exclusively by the drug industry?
Appreciate your help.
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