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

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 document, per the FDA,…
The Cleanroom of the Future

The Cleanroom of the Future

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 meeting where…
Assessing Risk in Sterile Manufacturing

Assessing Risk in Sterile Manufacturing

Berkshire Sterile Manufacturing By Andrea Wagner, Ph.D.   In a recent training at Berkshire Sterile, the topic of risk assessment was covered. This topic is a very important one with…
OMPI Day – It doesn’t get better than this!

OMPI Day – It doesn’t get better than this!

Berkshire Sterile Manufacturing by Andrea Wagner, Ph.D.   Located in Venice Italy, the 6th OMPI day was held. OMPI, a company headquartered in Italy and started in 1949, is now…