Best Practices in Using Isolator Technology

Best Practices in Using Isolator Technology
“You need to have a robust system in place that provides flexibility,” said Vice President of Operations, Steve Nole. “Grand River Aseptic Manufacturing (GRAM) can use a combination of dedicated parts that are autoclaved and transferred into the isolator via rapid-transfer canisters, or preassembled and gamma-irradiated assemblies in bag-in-bag-out...

“You need to have a robust system in place that provides flexibility,” said Vice President of Operations, Steve Nole. “Grand River Aseptic Manufacturing (GRAM) can use a combination of dedicated parts that are autoclaved and transferred into the isolator via rapid-transfer canisters, or preassembled and gamma-irradiated assemblies in bag-in-bag-out with rapid-transfer ports.”

Pharmaceutical Technology featured Steve Nole alongside Richard Denk, senior consultant for Aseptic Processing & Containment at SKAN AG, to provide expert advice on using isolator technology. Nole has extensive experience in selecting equipment for CDMO facilities. When planning for GRAM’s expansion, Nole worked alongside other industry experts to determine the highest quality equipment for GRAM’s new facility. With the design-build concept, GRAM’s newest facility is built specifically around the state-of-the-art equipment chosen by Nole and the GRAM team. To ensure the equipment would work as desired to best serve GRAM’s clients, the team invested in a full wood mock-up and 3D virtual reality process to ensure the highest performance in the greenfield facility.

Isolator technology in GRAM’s facility expansion will provide flexibility, speed, and utmost safety features when serving clients of all sizes.

Read the full article here, or see it in the February issues of Pharmaceutical Technology and PharmTech Europe.

Source: www.grandriverasepticmfg.com