Implement detailed testing procedures validating packaging integrity and device stability claims.
Standard | Title | Applicable Sections |
---|---|---|
ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements | All applicable clauses |
ISO 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements | All applicable clauses |
ASTM F1980 | Standard guide for accelerated aging of sterile barrier systems | Accelerated aging methodology |
ASTM F88 | Standard test method for seal strength of flexible barrier materials | Seal strength testing |
Study Type | Temperature | Relative Humidity | Duration | Aging Factor |
---|---|---|---|---|
Accelerated | 55°C | Ambient | 65 weeks | AAF = 4 |
Real-time | 25°C | ≤75% RH | 5 years | AAF = 1 |
Real-time (worst case) | 30°C | 75% RH | 5 years | AAF = 1.6 |
Time Point | Accelerated (55°C) | Real-time (25°C) | Real-time (30°C) | Sample Size |
---|---|---|---|---|
Initial (T0) | Week 0 | Month 0 | Month 0 | n=30 |
6 months | Week 6.5 | Month 6 | Month 6 | n=30 |
1 year | Week 13 | Month 12 | Month 12 | n=30 |
2 years | Week 26 | Month 24 | Month 24 | n=30 |
3 years | Week 39 | Month 36 | Month 36 | n=30 |
5 years | Week 65 | Month 60 | Month 60 | n=30 |
Test | Method | Sample Size | Acceptance Criteria |
---|---|---|---|
Peel Strength | ASTM F88 | n=10 per time point | 2-8 N, no channel failures |
Burst Strength | Internal method | n=10 per time point | >15 N, consistent failure mode |
Test | Method | Sample Size | Acceptance Criteria |
---|---|---|---|
Dye Penetration | ASTM F1929 | n=10 per time point | No dye penetration |
Bubble Emission | ASTM F2096 | n=10 per time point | No bubble emission |
Test | Method | Sample Size | Acceptance Criteria |
---|---|---|---|
Package Compression | ASTM D642 | n=10 per time point | No package damage |
Drop Test | ASTM D5276 | n=10 per time point | No package damage |
Parameter | Test Method | Sample Size | Acceptance Criteria |
---|---|---|---|
Tip Alignment | Dimensional measurement | n=10 per time point | Within ±0.1 mm specification |
Jaw Closure Force | Force measurement | n=10 per time point | 5-15 N closing force |
Surface Finish | Visual inspection | n=10 per time point | No corrosion or degradation |
Test | Method | Sample Size | Acceptance Criteria |
---|---|---|---|
Tensile Strength | ASTM E8 | n=5 per time point | >80% of initial value |
Hardness | ASTM E18 | n=5 per time point | Within ±10% of initial value |
Test | Method | Sample Size | Acceptance Criteria |
---|---|---|---|
Sterility Test | USP <71> | n=20 per time point | No growth in test media |
Bioburden | ISO 11737-1 | n=10 per time point | <10 CFU per package |
How do I determine the appropriate accelerated aging temperature?
What is the difference between sterile barrier systems and protective packaging?
How do I calculate aging factors for accelerated aging studies?
What sample sizes are needed for packaging and shelf-life testing?
How should I handle test failures during aging studies?
Can I use accelerated aging data alone to support shelf-life claims?