S
I have a question about environmental controls for a part we provide sterile. The processing is is 4 stages:
thanks for any advice
Simon
- We have a part injection moulded for us by a contract manufacturer in a qualified clean room.
- A batch of parts is shipped to us and we assemble the final product in-house.
- The product is shipped to a contract packager who packages it in a qualified clean room.
- The product is gamma sterilized by a validated process.
- only trained personnel handle the items.
- the production area is only used for the assembly task.
- production staff clean the room, their hands and production equipment before handling.
- we perform regular bio-burden monitoring of samples after packaging but before sterilization.
thanks for any advice
Simon