Validation Of Sterilization

Sterilization Validation Standards

For various sterilization methods such as steam sterilization, ethylene oxide (EO) sterilization, and alternative methods like hydrogen peroxide, the International Organization for Standardization (ISO) provides standards for sterilization validation to guide users through the validation process.

Importance of Initial Work

The beginning of any validation process is crucial, as the accuracy of the initial work directly impacts the reliability of the entire validation. The first step in a validation process involves determining what needs to be validated and sterilized.

Identifying the "Worst-Case" Scenario

In the case of multiple products, packages, and types of sterilizer loads, especially in EO validations, identifying the most challenging location for sterilization is essential. Without data, determining where to place biological indicators (BI) for validation monitoring becomes a challenge. This includes identifying the most difficult-to-sterilize location and product among the options.

Process Challenge Device (PCD) Selection

Before conducting fractional runs, selecting a process challenge device (PCD) is necessary for monitoring routine production. The PCD, as per ISO 11135-1:2007, should demonstrate defined resistance to the sterilization process and should be included in fractional runs.

Packaging Considerations

Determining the packaging that represents the worst-case load is essential. Factors such as breathing surface, gas permeability, and absorbable components should be considered. Additionally, the choice of packaging should be supported by data to ensure it meets the sterilization requirements.

Load Configurations and Dunnage

For establishments with varying load configurations, evaluating the extent to which variations affect the sterilization process is crucial. Dunnage, which represents a worst-case load for validation, can be used when assembling enough products for an initial sterilizer validation is challenging.

Protocol Development

Once the above considerations are addressed, a protocol is necessary to document how the validation will comply with all ISO 11135-1:2007 requirements. The "overkill" approach, as defined in Annex C, section C14, is commonly used, with various Technical Information Reports (TIRs) providing valuable guidance and information.

Fractional Run and Final Validation

The protocol typically begins with a fractional run to document resistance to sterilization, assess PCD performance, and conduct bioburden resistance testing of representative product samples. Following the fractional run, a minimum of three half-cycles for overkill validation, as specified in ISO 11135-1:2007, should be scheduled.

Final Reporting

A final report, including all test data, results, and any deviations, should be prepared, approved by management, and submitted as part of the validation process.

By structuring the validation process in accordance with these considerations and standards, organizations can ensure the effectiveness and compliance of their sterilization procedures.