CLIFTON, N.J., Jan. 10, 2024 /PRNewswire-PRWeb/ — CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and testing services specifically for drug product and medical device package systems, is excited to announce that it has implemented a major expansion program and capital investment for its ASTM D4169-22 and ISTA Package Distribution Testing service offering.
Currently, CS Analytical offers routine ISTA Series 2/3/6 and ASTM D4169-22 distribution testing services to their pharmaceutical, biotech, and medical device clients. With a commitment to remain at the cutting edge of industry regulatory requirements and best practices, the CS Analytical Management team has approved an extensive capital investment in a custom-made Lansmont Vibration test platform fitted with a uniquely designed Abbess Temperature, Relative Humidity and Altitude chamber. This enables comprehensive, multimodal, and real-time simulated distribution testing for unique, high-risk, or high-value product types and package systems.
As commented by Brian Mulhall, CS Analytical CEO, “To remain relevant for our client base, we must continue to offer services that enable clients to meet the ever-changing and often complicated regulatory requirements and best practices for their container and package systems. The CS Analytical Team is committed to this endeavor as evidenced by this substantial investment in a new distribution testing service offering.”
Traditionally, these environmental factors would be independently evaluated through conditioning, vibration, and altitude testing. For certain products such as cell and gene therapies, with their small-batch / high-value nature and unique shipment requirements, or proteinaceous products susceptible to aggregation, testing to current standards may risk over- or under-testing relative to what is experienced in the real world. Evaluating these factors in tandem provides a more accurate picture of the performance of the product-package under realistic transport conditions.
“Package distribution testing for these types of products can be challenging. Existing standards may result in over- or under-testing relative to real world distribution networks. For clients in this position, real-world, non-simulated testing is often performed, which is both time and cost intensive”, commented Brandon Zurawlow, CS Analytical CSO, “the ability to simulate this in the laboratory is a game-changer for efficiency, as well as science and risk-based product-package development”.
Due to the custom nature of such a test system, and the associated development and manufacturing time, installation is anticipated for Summer 2024. Once fully operational and validated, CS Analytical will be able to offer real-time simulated shipments for mRNA, cell-based and other biological products uniquely susceptible to damage in the distribution process.
Currently, many companies that require this type of testing are performing it real-time by sending actual product through existing shipment channels. This quickly becomes time and cost prohibitive, especially when design changes are required. Having a service provider that can replicate this type of testing in a laboratory setting will offer huge time and cost savings. Additionally, since the equipment is fully programmable, clients who have mapped the actual temperature, pressure, and vibratory profiles of their distribution channels can recreate them in the lab, simulating the exact stressors experienced in the field.
The CS Analytical Team currently offers complete ASTM D4169-22 and ISTA Certified testing for common or unique primary, secondary, and tertiary packaging components and systems. However, distribution testing is just one element of successful product-package development and validation. CS Analytical offers a host of support and complementary testing programs that ensure all aspects of the regulatory requirements are met for any type of container system in a comprehensive manner. Whether a traditional solid oral dose in an HDPE bottle, a unique drug delivery system, a challenging and oversized IV bag system, the CS Analytical Team has the knowledge and hands-on experience to develop a qualification test program that ensures all development goals and regulatory compliance factors are met.