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SGS Certified for ISTA Testing Standard

SGS North America, Inc. has been certified to conduct thermal testing on insulated shipping containers used in the transport of temperature-sensitive products, such as pharmaceuticals, under the new International Safe Transit Association (ISTA) Standard 20 certification/testing procedures and Standard 7E Thermal Profiles.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

SGS North America, Inc. has been certified to conduct thermal testing on insulated shipping containers used in the transport of temperature-sensitive products, such as pharmaceuticals, under the new International Safe Transit Association (ISTA) Standard 20 certification/testing procedures and Standard 7E Thermal Profiles.

With the certification, SGS can now measure thermal performance of products, assess each package’s adherence to the new Standard 7E profiles, and submit results to ISTA to certify that the package conforms to testing under Standard 20. Testing will take place at SGS’s U.S. lab in Fairfield, NJ, which has passed an on-site audit by a Certified ISTA Thermal Transport Lab Auditor. SGS has also met the standard’s training requirements and is equipped to provide documentation of testing protocols, data packages and reports in the required Standard 20 format.

“For FDA-regulated organizations like pharmaceutical manufacturers, proof of container performance is critical for ensuring that certain products will be maintained in acceptable temperature ranges throughout the supply chain. ISTA Standard 20 provides a common global methodology for testing that performance for the first time, including standard testing profiles and protocols,” said Jason Sherrier, packaging and materials lab manager of SGS North America, Inc.

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