Package Validation & Testing:
ISO 11607 Packaging for terminally sterilized medical devices.
This international standard specifies the requirements for single use materials and re-usable containers
for packaging of terminally sterilized medical devices. The standard outlines principal requirements for
packaging process development and validation of sterile medical device package designs.

Packages may lose their integrity as a result of the dynamic related events which occur during processing and/or distribution.
Physical test methods may be used to validate that the package integrity has been maintained throughout the packages
processing, expected shelf life, and handling.

Manufacturers must evaluate their packages ability to adequately protect their medical device through the handling and
distribution environment. Damage such as material puncture, abrasion, and seal failure may result from the dynamic events
to which packages encounter.

Contract Package Validation Services:

• Seal Validations
• Shelf Life Studies / Accelerated Aging ASTM F1980-02
• Transportation / Distribution Testing ASTM D4169-05

Testing Services Include:
Package Integrity Testing: Dye Penetration per ASTM 1929 & Bubble Leak ASTM F2096-04
Package Strength Testing: Seal/Peel Testing ASTM F88-06

Contract Sterilization & Validation Services:
Quality Tech Services assists customers with various sterilization services including designing protocols,
performing complete sterility validations, routine processing and quarterly dose audits. Our staff has established
long-term relationships with qualified contract sterilizers which have consistently met our customer's sterilization requirements

• Protocol Development
• Laboratory Testing
• Cycle Coordination (EO, E-Beam & Gamma Radiation)
• Quarterly Dose Audits