Do you handle the necessary regulatory validation required for clean room moulded components?

Yes. We manage the full validation lifecycle for clean room moulded components. This includes comprehensive documentation of:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

These validation activities ensure that processes are controlled, repeatable, and compliant with relevant clean room injection moulding standards, providing full traceability to support regulatory submissions and audits.