Process Validations IQ-OQ-PQ

We support you in your design and development processes, in the implementation of a new process and in the improvement and verification of your ongoing processes. In the IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) processes, we provide you with information during the validation process by making the protocol and reporting, evaluation and determination of the process, tests and periods. Some of the validated processes that you may need and that we provide services for are as follows.

• ISO 14644 Series – Cleanrooms and Associated Controlled Environments
• EN 17141 Cleanrooms and associated controlled environments – Biocontamination control
• ISO 11607 Series – Packaging For Terminally Sterilized Medical Devices
• ISO/DIS 23417 General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
• ISO 19227 Implants for surgery — Cleanliness of orthopedic implants — General requirements
• ISO 17664 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
• ISO 11135 Sterilization of health-care products — Ethylene oxide
• ISO/DIS 11137 Series – Sterilization of health care products — Radiation
• ISO 17665 Series – Sterilization of health care products — Moist heat
• ISO 20857 Sterilization of health care products — Dry heat
• ISO 22441 Sterilization of health care products — Low temperature vaporized hydrogen peroxide
• ISO 25424 Sterilization of health care products — Low temperature steam and formaldehyde
• ISO 14937 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices.