The required clean room classification is determined by your product’s intended use, risk profile, and regulatory requirements. High-risk, implantable, or critical-path medical components typically require an ISO Class 7 environment, while lower-risk or non-patient-contact components may be suitable for ISO Class 8.
To define the correct classification, we assess your product’s clean room injection moulding requirements, including material selection, exposure risk, downstream sterilisation, and applicable regulatory standards. This ensures the clean room environment is appropriate without introducing unnecessary complexity or cost.