Recently Smithers Pira achieved ISO/IEC 17025 accreditation through A2LA for our distribution testing laboratory in Lansing, Michigan. The accreditation demonstrates that Smithers Pira meets stringent, internationally recognized lab quality standards as specified in ISO 11607, an international standard that is accepted in the European Union and is an FDA Recognized Consensus Standard in the U.S.
With this new certification, Smithers Pira aims to provide independent, high quality testing and consulting services to the healthcare industry. Michael Kuebler, Technical Director of Distribution Package Testing at Smithers Pira explains, "Our goal is to ensure that our customers' products are packaged so that their characteristics and performance during intended use are not adversely affected by transport and storage. [We have] worked with various companies to validate distribution performance for a range of medical and pharmaceutical products."
Some of the testing that Smithers conducts for the medical device and pharmaceutical clients include:
- Distribution Testing - ASTM D4169
- Dye penetration - ASTM F1929
- Bubble leak testing - ASTM F2096
- Seal strength - ASTM F88
- Visual Inspection - ASTM F1886
- Accelerated aging - ASTM F1980
- Real time aging to defined accelerated aging results
Healthcare clients who require support throughout the packaging validation process or simply have capacity restrictions in their in-house testing laboratory can partner with the experienced team at Smithers Pira to optimize their packaging at the start of the product development process. Whether it's seal strength, burst, pressure, dye penetration, or distribution and storage testing,Smithers Pira can ensure quality testing accuracy with a quick turnaround.
To learn more about Smithers Pira's package testing capabilities, click here.