Flexible clinical scale sterile filling system for all containers

Flexible clinical scale sterile filling system for all containers

12-Oct-2016   Berkshire Sterile Manufacturing is implementing a cost-effective strategy using a flexible isolator-based sterile manufacturing system engineered by Fedegari. Berkshire Sterile Filling and Fedegari bring flexible isolator-based sterile manufacturing…
New Guidance issued by FDA on Quality Metrics

New Guidance issued by FDA on Quality Metrics

Berkshire Sterile Manufacturing   On September 9th, 2016 FDA released a technical reference document aimed at quality metrics in process validation and the pharma quality systems. The goal of this…
The Cleanroom of the Future

The Cleanroom of the Future

Inspired by Jeanne Moldenhauer Vice President at Excellent Pharma Consulting     At a local Northeast PDA meeting on May 18, 2016, over 130 attending, eleven BSM colleagues attended a…