Medical Device Packaging Validation India | ASTM F88 | NABL
Auriga Research provides NABL-accredited medical device packaging validation per ISO 11607, ASTM F88, and ASTM D4169. Our testing laboratory evaluates sterile barrier system performance, seal integrity, and package durability to support CDSCO registration, FDA 510(k) submissions, and CE marking documentation for sterile medical devices.
Packaging is the last line of defence for sterile devices. Our validation programme covers seal strength, burst testing, dye penetration, microbial barrier properties, accelerated and real-time ageing, and distribution simulation — ensuring your sterile barrier system maintains integrity through manufacturing, transit, storage, and point-of-use opening.
Packaging Testing Scope
- Seal strength — peel testing per ASTM F88
- Burst testing — unrestrained (ASTM F1140) and restrained (ASTM F2054)
- Dye penetration — seal integrity per ASTM F1929
- Visual seal inspection per ASTM F1886
- Package integrity — bubble emission (ASTM F2096)
- Accelerated ageing per ASTM F1980 (Q10 method)
- Real-time ageing — concurrent shelf life validation
- Distribution simulation per ASTM D4169 / ISTA 2A/3A
- Microbial barrier testing per ISO 11607-1 Annex B
- Tyvek and film tensile strength and elongation
Who Needs Packaging Validation
- Sterile medical device manufacturers validating new packaging designs
- Companies changing packaging materials, seal parameters, or sterilisation methods
- CDSCO, FDA, or CE submissions requiring shelf life validation data
- Contract packagers establishing process qualification (IQ/OQ/PQ)
- Quality teams conducting annual packaging revalidation
Turnaround Time
Seal strength, burst testing, and dye penetration take 5-7 business days. Distribution simulation takes 10-15 business days. Accelerated ageing duration depends on the shelf life claim (38 days for 1-year, 114 days for 3-year equivalence at 55 degrees Celsius). Final reports are issued within 5 business days of test completion.