MedPack Labs

Specializing in Medical Device Package testing

 
 

 

Services

MedPack Labs specializes in medical device package testing services which evaluate the strength and integrity characteristics of a packaging system before and after simulating the anticipated distribution and storage conditions that the system may undergo.  This combination of simulation and evaluation is used by packaging professionals to validate package compliance with ASTM, ISO, ISTA and other accepted industry standards.

Assessment and execution of test protocols for package design, packaging processes validation and package shelf life testing.

MedPack Labs follows a comprehensive and rigorous test protocol in accordance with our Quality System requirements and based on ASTM standards and the essential requirements as outlined in ISO11607 for qualifying sterile barrier packaging systems. In addition, all the test methods used by MedPack Labs for the purpose of qualifying sterile barrier packaging systems are validated standardized ASTM test methods for evaluating the integrity of the sterile barrier system and are in accordance with ISO11607, ASTM and our Quality System requirements.

Package Testing Services offered at MedPack Labs include:

  •  Accelerated Aging Testing
  • Distribution Simulation Testing
  • Package Integrity Testing
  • Package Seal Strength Testing
  • Sterile Barrier System Package Validation (ISO 11607)

 

 

 

STANDARD TEST METHODS USED AT MEDPACK LABS

 

ISO 11607-1 (2009): PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES, PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

 ISO 11607-2:2006: PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES, PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES

 ASTM D4169-09: PERFORMANCE TESTING OF SHIPPING CONTAINERS AND SYSTEMS

 ASTM D4332-01(06): CONDITIONING CONTAINERS, PACKAGES, OR PACKAGING COMPONENTS FOR TESTING

 ASTM F88-09: SEAL STRENGTH OF FLEXIBLE BARRIER MATERIALS (PEEL TEST)

 ASTM F1929-12: DETECTING SEAL LEAKS IN POROUS MEDICAL PACKAGING BY DYE PENETRATION

 ASTM F2096-11: DETECTING GROSS LEAKS IN MEDICAL PACKAGING BY INTERNAL PRESSURIZATION (BUBBLE TEST)

 ASTM F2054-07(12): BURST TESTING OF FLEXIBLE PACKAGE SEALS USING INTERNAL AIR PRESSURIZATION WITHIN RESTRAINING PLATES

 ASTM F1140-07(12): INTERNAL PRESSURIZATION FAILURE RESISTANCE OF UNRESTRAINED PACKAGES

 ASTM F1886-09: DETERMINING INTEGRITY OF SEALS FOR MEDICAL PACKAGING BY VISUAL INSPECTION