Medical Devices Validation & Qualification

ETO Sterilizer Validation

• Installation Qualification (IQ)
• Performance Process Qualification (PPQ)
• Microbiological Performance Qualification (MPQ)

Steam Sterilizer Validation

Steam sterilization is the benchmark sterilization method for reusable medical devices and many single-use products. Our Steam Sterilizer Validation services are conducted in accordance with ISO 17665 and EN 285.

Cleanroom Validation (ISO 14644)

Cleanrooms and controlled environments are critical to maintaining product integrity during the manufacture of sterile medical devices. IETQAN conducts comprehensive HVAC and cleanroom validation in full compliance with ISO 14644.