CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, is pleased to announce that it has completed the acquisition, installation and cGMP qualification process for a new Instron Model 68SC Universal Testing Machine. The Model 68SC, which has proven to be an essential tool in any container and package qualification testing program, features a Frame Capacity of 1kN, 500N Load Cell with a verifiable range of 0.5N to 500N, Test Speed Range of 0.00004 – 100 inches/minute and a data capture rate of up to 5000 points per second. Its range of capabilities within the container qualification process is broad and can include applications such as syringe testing, device testing, and package seal testing. The system is designed with flexibility in mind, allowing for testing a variety of package products.

Commented Chief Scientific Officer Brandon Zurawlow, “Instron testing capabilities have proven to be a critical component of many comprehensive container testing and qualification programs. We are excited to work with Instron to bring their unique and valued technology into our service offerings.”

Instron has been at the forefront of innovation within the biomedical industry through their development of instruments that help evaluate and analyze critical product performance and functionality attributes. The ability to more comprehensively test syringe break loose and glide forces as well as evaluate glass durability through failure testing are prime examples. These functional tests ultimately lead to a higher quality product entering the marketplace. In addition, Instron understands the strict regulatory requirements that FDA regulated companies must adhere to.

“One of Instron’s top priorities is helping customers address the regulatory hurdles associated with FDA 21 CRF Part 11 and IQ/OQ compliance,” shared Instron’s Senior Applications Engineer, Landon Goldfarb. “These regulations often tie up lab resources and reduce throughput, so we’ve developed an integrated Traceability compliance software package which is combined with help from our experienced service organization to enable customers like CS Analytical Laboratory to operate more effectively within a highly regulated environment. Given these tools, labs can maintain compliance while also maintaining high throughput and running a wide range of tests.”

Serving as part of its dedicated Comprehensive and Complimentary Servicing offering, the Instron testing capabilities, in conjunction with other unique functional and dimensional test program offerings, enable CS Analytical to meet a wide variety of regulatory and client specific qualification requirements across of broad spectrum of container and package types.