Medical Device Contract Manufacturing ♦ Medical Device Product Design & Development

  • Locations in Greater Boston & Tijuana, Mexico
  • +1 (603) 332-8900

Sterile Barrier Packaging

ISO 11607 packaging for terminally sterilized medical devices. Contract manufacturer for sterile barrier packaging

ISO 11607 governs the packaging for terminally sterilized medical devices and the ASTM standards listed below are encompassed within this directive that allows medical device companies to market their products as sterile.   There are many strategies available to reduce cost and lead time on this testing.  

Phase 2 packages devices in both flexible and rigid packaging configurations.  Approximately 90% of what we ship is terminally sterilized.  We use band, bar, and tray sealers operating within our ISO Class 8 (100,000) cleanrooms to create sterile barriers for these products.  Before we can start packaging an approved medical devices, we need complete packaging validation, which typically includes the following tests:

Package Integrity Testing

 - Dye Migration or Penetration (ASTM F1929) OR Bubble Leak (ASTM F2096)
 - Visual Inspection (ASTM F1886)

Seal Strength Testing

 - Tensile Testing (ASTM F88) - typically related to rigid packaging systems
 - Burst Testing (ASTM F2054) - typically related to flexible packaging systems

Accellerated Aging and Shelf Life Studies

 - ASTM F1980

Distribution and Transit Testing

- ASTM D4169
- ISTA 1, 2, & 3 series 

 

Learn more about ISO 11067 -1 : 2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems here

 

 

Locations

Product Development & Manufacturing
88 Airport Drive
Rochester, NH 03867

Phone Number
+1 (603) 332-8900


Mexico Manufacturing
Andador Vecinal No. 14301
Tijuana, BC CP22330

Phone Number
+1 (664) 231-3844