(OQ) Operational Qualification For Eto Sterilizer Equipment

What is OQ?

OQ is the process of validating that the sterilization chamber meets the performance requirements specified in the design specifications.

ISO 11135-1:2014, the international standard for ethylene oxide (EO) sterilization validation.

How to do the OQ?

To validate and record that the installed eo sterilizer can operate within the predetermined range when following the operating procedures.

There is no specific requirement regarding whether the sterilization equipment should be empty or loaded with products during the OQ (Operational Qualification) process.

During the OQ process, it is important to consider the requirements of the sterilization process when setting the operating parameters. It is recommended to set the parameters to exceed or closely approach the limits defined by the process parameters. This ensures that the equipment is capable of performing within the specified range and can operate stably even under extreme or challenging conditions.

Should we do PQ first?

No, OQ should be conducted before PQ (Performance Qualification). OQ is performed to validate that the sterilization equipment meets the specified performance requirements and operates within the predetermined range. If the OQ results are not proven, it indicates that the equipment may not be functioning properly or may not meet the necessary criteria. In such cases, proceeding with PQ would be inappropriate as it would be based on unreliable or unverified equipment.