#USA #CS Analytical #Clifton #FDA regulated #distribution testing

CS Analytical Laboratory Expands Its Package Distribution Testing Services

CS Analytical Laboratory, recognized as the only FDA-regulated contract laboratory dedicated to providing regulatory solutions exclusively for drug product and medical device packaging, has announced a significant expansion of its package distribution testing services. This move is poised to enhance the industry's ability to ensure product reliability and compliance with complex regulatory demands.

New Testing Capabilities

The core of the expansion includes advanced ASTM D4169-22 and ISTA package distribution testing services, which are now fully operational. This has been made possible by the installation of new, state-of-the-art equipment, including a large-scale Lansmont vibration testing platform and a specialized Abbess Temperature, Relative Humidity, and Altitude chamber. These upgrades allow for comprehensive and real-time simulated distribution testing tailored for unique high-risk or high-value products currently in the market as well as those under development.

Brandon Zuralow, COO of CS Analytical, emphasized the importance of staying attuned to the evolving needs of their clients, stating, "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."

Addressing Industry Challenges

Traditionally, many environmental factors affecting product packaging, such as conditioning, vibration, and altitude, have been assessed separately. However, products like cell and gene therapies, which are characterized by their small-batch production and high value, require a more integrated testing approach to accurately evaluate their performance under realistic conditions.

Alex Goldberg, an analyst and project lead at CS Analytical, noted that the ability to simulate multiple stressors concurrently marks a transformative shift in the industry. He explained, "Existing standards may lead to over- or under-testing relative to real-world distribution networks, making actual product shipment testing time-consuming and costly. Simulation offers a more efficient solution."

Time and Cost Efficiency

The laboratory's ability to simulate realistic environmental conditions means companies no longer need to rely on real-time product shipping, which can be financially prohibitive, especially when design alterations are necessary. By replicating these conditions in a controlled environment, CS Analytical provides crucial time and cost efficiencies for companies.

With fully programmable equipment capable of mirroring specific temperature, pressure, and vibration profiles of actual distribution channels, clients can expect precise and relevant data. This innovation supports CS Analytical's commitment to ensuring their clients' products and packaging systems meet rigorous regulatory standards.

Comprehensive Testing Programs

Currently, CS Analytical offers complete testing services for ASTM D4169-22 and ISTA certified evaluations of various packaging systems, whether they involve common components or unique specifications. However, beyond distribution testing, the laboratory also provides an array of complementary services to guarantee full regulatory compliance for any type of packaging system.

From traditional solid oral dosages to complex drug delivery mechanisms and oversized IV bag systems, CS Analytical's knowledgeable team is well-equipped to develop tailored qualification programs that meet both client development goals and regulatory frameworks.

About CS Analytical Laboratory

As the only cGMP laboratory fully committed to the rigorous standards of the FDA, CS Analytical specializes in drug and medical device container and package qualifications. With a team of leading experts in all pertinent USP and EP regulations, CS Analytical is dedicated to offering comprehensive laboratory services that include basic feasibility studies, component qualification programs, advanced method development for different types of leak testing, and much more. Their commitment to innovation and precision makes them a vital resource in the ever-evolving landscape of pharmaceutical and biotech packaging.

For more information, inquiries can be directed to [email protected].