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 formal installation of the PTI – Packaging Technologies & Inspection suite of leak testing instruments. The array of technologies qualified for use include the SIMS 1915+ Helium Leak Detection System, the VeriPac 465 Vacuum Decay Leak Tester and the E-Scan 655 MicroCurrent High Voltage Leak Testing Instrument. Collectively these technologies enable testing of multiple package types to include vials, ampoules, syringes, blister cards, pouches, sealed trays and glass/plastic containers across the entire product life cycle and as directed under USP〈1207〉guidelines.

“I have had a multi-year working relationship with the PTI team and they continue to develop package system qualification technologies that enable FDA regulated clients to meet the strict regulatory guidelines now required,” noted Brian Mulhall, CS Analytical Chief Executive Officer. “PTI leak testing instruments are a must have when it comes to meeting the demand for USP〈1207〉CCI testing.”

Commented Noba Ebaid, Regional Sales Manager for PTI, “We are proud to partner with CS Analytical, a team that is without a doubt, comprised of some of the most well-rounded industry experts. Now equipped with an impressive portfolio of PTI’s reliable, deterministic package quality testing solutions, the team at CS Analytical has bolstered their industry-leading knowledge with industry-leading CCIT equipment. Together, a common goal of caring for patients and consumers in need to enable a prosperous and healthy global community can be achieved by implementing sound engineering through good science.”

The PTI instruments will play a critical role in the USP〈1207〉Container Closure Integrity testing services offered by CS Analytical. The ability to offer multiple technologies is critical in the leak test method prescription process. Critical elements such as product type and package configuration play a key role in determining the optimal method for a specific product system. With PTI offering a suite of technologies to include Helium Leak Detection, Vacuum Decay and MicroCurrent High Voltage (HVLDmc) options, CS Analytical can be assured of having the best option for a client’s product and package system. In some cases, multiple methods may be applied further improving the overall quality profile of a given drug product container.