News, Events and Insights

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…
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 - a very important subject with FDA and…
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…
From Pharma Kongress in Dusseldorf, Germany

From Pharma Kongress in Dusseldorf, Germany

by Andrea Wagner, PhD, SVP, Business Development Berkshire Sterile Manufacturing     This week I had the pleasure of attending Pharma Kongress in Dusseldorf where there were a wide variety…