I am reaching out to discuss some considerations for the manufacturing line layout of our terminally sterilized device.
As we are in the process of designing the layout, I am exploring the possibility of having different manufacturing steps occur in two distinct (in different floors) clean rooms with varying grades: ISO 8 and ISO 7. To ensure a smooth transition from ISO 8 to ISO 7, I would appreciate your guidance on whether the intermediate product must be packed in a specific packaging. If so, could you provide details regarding the recommended packaging specifications for this transfer?
Furthermore, I am also seeking clarification on whether our suppliers must manufacture all their components in a clean room environment. If this is a requirement, kindly advise on the clean room grade and any specific protocols that our suppliers should adhere to during the manufacturing process.
Any insights or recommendations you can provide would be greatly appreciated.
Thank you for your time and assistance. I look forward to your response.