ISO 11607 Sterile Packaging Validation Kit

Not eligible for NQT documentation review.

A packaging gap tracker by ISO 11607-1/-2 clause number, a seal-strength workbook that flags results below your limits and calculates mean, SD and Ppk on your data, an accelerated-aging calculator (AAF and pull dates from your Q10 and temperatures), a test matrix, a routine seal-monitoring log, a revalidation trigger log, a validation master plan, a sealer IQ/OQ/PQ protocol and report, and a distribution and aging test plan.

What's inside:

- 00_Start_Here_README.pdf

- 01_ISO11607_Sterile_Packaging_Workbook.xlsx

- 02_Packaging_Validation_Master_Plan.docx

- 03_Sealer_IQ_OQ_PQ_Protocol.docx

- 04_Distribution_and_Aging_Plan.docx

Templates, not regulatory advice. Standards are paraphrased and cited by clause number only; buy them from their publishers.

Written by Matt Norman, US Navy veteran and former SpaceX Falcon 9 quality inspector and QA supervisor. (Not affiliated with or endorsed by SpaceX.) Norman Quality Tools is Veteran-Owned & Operated.

License: one company, all sites. Word/Excel 2016+, Microsoft 365, LibreOffice. No macros.

Templates, not regulatory advice. Not affiliated with or endorsed by SpaceX or any other current or former employer of the author, or any standards body or government agency. Does not guarantee certification or approval.

Not affiliated with or endorsed by ISO, ASTM International, ISTA or the U.S. FDA.

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