Packaging Testing & Validation — Request Coordination
Tell us what is being packaged, how it ships and which standard your customer or regulator expects. Laboratory Vortex reviews the request and routes it to independent packaging laboratories — we do not test packages ourselves, and we do not certify results.
Services
- Distribution and transit simulation: Drop, vibration, compression and climatic conditioning sequences referencing ASTM D4169 or ISTA test procedures.
- Sterile barrier validation: Testing that supports ISO 11607 packaging validation for terminally sterilized devices.
- Seal strength: Peel testing of seals referencing ASTM F88/F88M.
- Package integrity and leak testing: Dye penetration (ASTM F1929), bubble (ASTM F2096) and other leak methods as applicable to the package.
- Accelerated aging: Shelf-life aging referencing ASTM F1980, followed by post-aging integrity and strength tests.
- Real-time confirmation: Run a justified real-time programme alongside accelerated aging. Aging does not establish transport, sterilization effectiveness or every device-function claim.
- Cold chain thermal qualification: Evaluate defined payloads, pack-outs, ambient profiles and temperature acceptance limits; thermal protection is separate from mechanical distribution testing.
Standards and methods
- ASTM D4169: Uses distribution cycles and assurance levels to sequence handling, vibration and compression hazards for a shipping unit.
- ISTA test procedures: A family of pre-shipment test procedures (e.g. series 1, 2, 3 and 6) of increasing realism. The applicable procedure depends on package and distribution channel.
- ISO 11607 (Parts 1 & 2): Sterile barrier system requirements and process validation; relevant only for sterile medical device packaging.
- ASTM F1980: Elevated-temperature aging to support shelf-life claims, with real-time aging confirmation.
- ASTM F88/F88M: Force required to separate a seal, reported per unit width.
- ASTM F1929: Seal leak detection for porous packaging using a dye penetrant.
- ASTM F2096: Bubble emission test for gross leaks in packages.
Seal strength vs package integrity
Accelerated vs real-time aging
Distribution and vibration scope