Professional Associations <ul><li>Chairman for the ASTM Committee D-10 on Packaging </li></ul><ul><li>Involved with ASTM since 1981 </li></ul><ul><li>Member of the AAMI committee to draft a Technical Information Report (TIR) </li></ul><ul><li>Institute of Environmental Sciences (IES) </li></ul><ul><li>Society of Automotive Engineers (SAE) </li></ul><ul><li>ISTA Certified Lab </li></ul><ul><li>DOT Third Party Testing Lab </li></ul><ul><li>IoPP Members (8 Staff are members) </li></ul><ul><li>Member of LifeScience Alley (formerly Medical Alley) </li></ul>
Thermal Package Performance Testing Stability Testing Over a 72 – 120 hour timeframe, DDL conducts a stability test and develops a specification designed to inform pharmaceutical package testing clients of conditions that will push a thermal container out of the 2-8 centigrade (an indication that contents may lose active ingredients or even spoil) desired shipping and storage temperature. Thermal Performance over time for Profile #1 Thermal Performance over time for Profile #2 Thermocouple set-up in package
Environmental Testing Equipment Resources 45 Chambers in MN 8 Chambers in CA 1 cu.ft. to 900 cu.ft. -70C to 200C
ISO 11607 -Key Points <ul><li>Proof of sterile barrier integrity (by physical means) is </li></ul><ul><li>sufficient to demonstrate sterility of the product. </li></ul><ul><li>Medical devices with the same package system may be grouped for purposes of package system validation. </li></ul><ul><li>The worst case package configuration must be determined, documented, and used for testing for compliance…this will require performing ‘process validation’. </li></ul><ul><li>Results of the design development process shall be documented, verified and approved prior to product release. </li></ul><ul><li>Physical testing (e.g. bubble leak, dye penetration, etc.) along with microbial barrier testing of materials can be used to demonstrate sterile barrier integrity. </li></ul>
ISO 11607 Key Points <ul><li>Use Standardized Test Methods. </li></ul><ul><li>Testing is performed on packages produced at the lower limits of the process parameters established during compliance with Part 2 of this standard. </li></ul><ul><li>The package system must provide adequate protection to the product through the rigors of handling, distribution and storage. (Laboratory distribution simulation or actual ship testing). </li></ul><ul><li>Accelerated aging is sufficient evidence for expiry dates until real time aging is completed. Accelerated and real time studies should begin simultaneously. </li></ul><ul><li>Stability testing and performance testing are separate entities </li></ul>
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