How do you determine the appropriate cleanroom classification (such as ISO 7 or ISO 8) for my product?

The necessary clean room classification is determined by your product’s intended use, risk profile, and regulatory requirements. High-risk, implantable, or critical-path medical components usually require an ISO Class 7 environment, while lower-risk or non-patient-contact components may be suitable for ISO Class 8.

To determine the right classification, we assess your product’s clean room injection molding requirements, including material selection, exposure risk, downstream sterilization, and applicable regulatory standards. This makes sure the clean room environment is appropriate without adding unnecessary complexity or cost.