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DDL Incorporated... who we are  what we do and
DDL - West DDL – Eden Prairie
Professional Associations <ul><li>Chairman for the ASTM Committee  D-10 on Packaging </li></ul><ul><li>Involved with ASTM ...
Testing Capabilities <ul><li>Medical Device Package Testing </li></ul><ul><li>Pharmaceutical Package Testing </li></ul><ul...
Medical Device Package Strength and Integrity Testing Bubble Leak Testing –ASTM F2096 Burst Testing - ASTM  F1140 Package ...
Dynamic Testing Equipment Resources
Thermal Package Performance Testing Stability Testing Over a 72 – 120 hour timeframe, DDL conducts a stability test and de...
Environmental Testing Equipment Resources 45 Chambers in MN 8 Chambers in CA 1 cu.ft. to 900 cu.ft. -70C to 200C
Material Testing Equipment Resources
Project Process Flow
Quality Management Process
Common Packaging Mistakes
ISO 11607 -Key Points <ul><li>Proof of sterile barrier integrity (by physical means) is  </li></ul><ul><li>sufficient to d...
ISO 11607 Key Points <ul><li>Use Standardized Test Methods. </li></ul><ul><li>Testing is performed on packages produced at...
 
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Ddl Overview 2009

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Transcript of "Ddl Overview 2009"

  1. 1. DDL Incorporated... who we are what we do and
  2. 2. DDL - West DDL – Eden Prairie
  3. 3. 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>
  4. 4. Testing Capabilities <ul><li>Medical Device Package Testing </li></ul><ul><li>Pharmaceutical Package Testing </li></ul><ul><li>Environmental Package Testing </li></ul><ul><li>Hazmat Package Certification </li></ul><ul><li>Mechanical Testing </li></ul>
  5. 5. Medical Device Package Strength and Integrity Testing Bubble Leak Testing –ASTM F2096 Burst Testing - ASTM F1140 Package Strength Tests Package Integrity Tests Seal Peel Testing –ASTM F88 Dye Penetration Leak Testing ASTM F1980
  6. 6. Dynamic Testing Equipment Resources
  7. 7. 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                                                                                                                         
  8. 8. Environmental Testing Equipment Resources 45 Chambers in MN 8 Chambers in CA 1 cu.ft. to 900 cu.ft. -70C to 200C
  9. 9. Material Testing Equipment Resources
  10. 10. Project Process Flow
  11. 11. Quality Management Process
  12. 12. Common Packaging Mistakes
  13. 13. 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>
  14. 14. 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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