Accelerated Aging Study Protocol
Plan an accelerated aging study for medical device sterile-barrier packaging with this editable protocol. It brings Q10 assumptions and exposure-time calculations together with sample plans, post-aging package evaluation and a parallel real-time aging study. Customize the plan and acceptance criteria for your device and packaging.
Included: one editable Microsoft Word (.docx) protocol, supplied in a ZIP file as a digital download.
Packaging aging study assumptions and testing
Representative product and packaging configurations, family justification and aging-related risks.
Q10, temperature and exposure-duration calculations, with material and humidity rationale.
Baseline and aged sample allocation, study endpoints and chamber-condition records.
Post-aging package integrity and seal-strength evaluation, with applicable laboratory reports.
Parallel real-time aging, confirmation of accelerated-aging conclusions and documentation of deviations.
Define and approve the shelf-life objective, storage conditions, acceleration assumptions, humidity controls or rationale, sample sizes, methods and acceptance criteria before starting. Accelerated-aging evidence requires real-time confirmation; purchasing or completing the document alone does not establish a validated shelf life.
The study protocol supports a shelf-life claim by defining the packaged product, storage conditions, proposed duration and the accelerated-aging calculation. It plans samples and testing at selected aging intervals, records results against acceptance criteria, and connects the accelerated study with real-time aging. Device and sterile-barrier requirements determine which tests and time points the team completes; the protocol should be populated with the actual packaging and stability data.
The revised document addresses ASTM F1980-21 and ISO 11607-1:2019 with Amendment 1:2023. It distinguishes aging stability from distribution and other package-performance evaluations.
The revised protocol also references ISO 13485:2016 and FDA QMSR (21 CFR Part 820).
For the broader process of defining a medical device shelf-life claim, reviewing aging evidence and approving an expiration period, see the separately sold Product Stability and Shelf-Life Procedure. This product supplies a study protocol; it does not provide a testing service or stand-alone calculator.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Shelf Life and Accelerated Aging: Define the Claim First for workflow guidance, a checklist and common mistakes.
