12-Oct-2016 EUROPE | MANUFACTURING Berkshire Sterile Manufacturing is implementing a cost-effective strategy using a flexible isolator-based sterile manufacturing system engineered by Fedegari Berkshire Sterile Filling and Fedagari bring flexible isolator-based sterile manufacturing to market Many aseptic contract manufacturing organisations face the challenges of small batch sizes, varying primary container types and sizes, and customer expectations… continue reading
By Andrea Wagner, Ph.D. SVP, Business Development, Berkshire Sterile In a recent training at Berkshire Sterile, the topic of risk assessment was covered. This topic is a very important one with FDA and others, such as clients, around the country. In this training I learned about how Berkshire Sterile assesses risk in relation to cGMP… continue reading
These are pre-nested, pre-siliconized, stoppered, crimped and nested then sterilized. This allows easy filling on a syringe filling line (with a small retro-fit) and allows companies to easily evaluate using cartridges without a dedicated line. continue reading