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Sterilization Validation Toolkit: ISO 11135, ISO 11137, ISO 17665 Templates

Sterilization Validation Toolkit — validation plan, biological indicator protocol, SAL calculation, cycle development report, revalidation checklist, summary report.

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What's Included

Sterilization Validation Plan Template
Biological Indicator Protocol
SAL Calculation Worksheet
Cycle Development Report Template
Revalidation Trigger Checklist
Sterilization Validation Summary Report

Benefits

Covers EtO (ISO 11135), radiation (ISO 11137), and steam (ISO 17665)
SAL calculation worksheet with bioburden and overkill approaches
BI protocol aligned with ISO 11138
Revalidation trigger checklist prevents gaps after product or process changes

Is This For You?

This toolkit is designed for teams facing these challenges:

510(k) sterilization section rejected for incomplete validation data
Notified body queries on sterilization validation methodology
No documented revalidation process after product changes
SAL calculations not formally documented

Who This Is For

Sterility assurance engineers managing validation programsRA leads responsible for sterilization section of 510(k) or tech fileOperations managers overseeing contract sterilization qualificationQA professionals auditing sterilization validation packages

Frequently Asked Questions

Which sterilization methods does this cover?

The toolkit covers EtO (ISO 11135), radiation (ISO 11137), and moist heat/steam sterilization (ISO 17665) with method-specific guidance in each template.

Is this applicable for FDA 510(k) submissions?

Yes. The cycle development report and sterilization summary report are structured for FDA 510(k) sterilization sections and EU MDR technical documentation.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $297

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