(ОК) Operational Qualification For Стерилизатор оксидом этилена
Операционная квалификация (ОК) is a critical phase in the validation of Ethylene Oxide (ЭО) sterilization equipment, ensuring that the chamber and its systems function according to design specifications and ИСО 11135:2014 стандарты.
OQ is the rigorous process of validating that the sterilization chamber meets all performance requirements specified in its design. It confirms that the system maintains control over key variables like temperature, давление, and vacuum levels under specified operating procedures.
The goal is to record that the installed EO sterilizer operates within its predetermined range. Key considerations include:
- Loading: There is no specific requirement for the chamber to be empty or loaded during OQ; however, parameters should be tested under various conditions.
- Parameter Stressing: It is recommended to set operating parameters that approach or slightly exceed process limits. This ensures the equipment remains stable even under extreme or challenging operational conditions.
No. Операционная квалификация (ОК) must be completed and proven before Performance Qualification (ПК). OQ verifies the equipment’s fundamental functionality. If OQ fails, it indicates the equipment is unreliable, making any subsequent PQ data invalid and unverified.
Соответствие нормативным требованиям
Adhering to ИСО 11135-1:2014, BOCON provides comprehensive OQ documentation and support to help medical device manufacturers achieve successful system validation. Our protocols ensure that every cycle is repeatable, безопасный, and fully documented for regulatory audits.
