As an ISTA Certified Laboratory, clients can feel confident that the work we perform will help to reduce the risk of package shipment damage from the distribution cycle
CLIFTON, N.J. (PRWEB)
September 13, 2022
CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems, is pleased to announce that it has it has been certified by ISTA (International Safe Transit Association) as a qualified Transport Testing Laboratory. As outlined in the ISTA program, “ISTA Transport Testing Laboratory Certification demonstrates a strong commitment to transport packaging professionalism, as well as assuring a laboratory is properly equipped to conduct ISTA® package performance testing. This certification establishes the minimum criteria to be met for transit packaging laboratories in the areas of laboratory processes and procedures, as well as equipment qualification.”
“Achievement of ISTA certification is a testament to the commitment that the CS Analytical Team has made to ensure we are positioned to help clients meet the strict regulatory demands that manufacturers have come to expect. As an ISTA Certified Laboratory, clients can feel confident that the work we perform will help to reduce the risk of package shipment damage from the distribution cycle,” noted Brian Mulhall, CEO of CS Analytical.
Package distribution testing plays a critical role in the validation of package systems for drug products and medical devices. CS Analytical is fully equipped to assist clients with all aspects of ISTA and ASTM D4169 distribution testing within an FDA regulated, strict cGMP laboratory environment. The experienced CS Analytical Team can help define a comprehensive test program that not only include ISTA and ASTM test procedures but can also include other critical aspects based upon a holistic approach. For example, the ability to marry ISTA Distribution testing to USP 1207 Leak Testing has become a common expectation. As demonstrated in the ISTA certification process, CS Analytical meets a higher standard when it comes to package distribution testing.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world’s leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
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