A new technology provides 100% real-time, non-destructive in-process weight checks for clinical scale drug product fills
Globe Newswire A new technology, developed by Colanar and Abbena, will provide 100% real-time, non-destructive in-process weight checks (IPCs) for syringes and bulk vials. The new technology will be…
Benefits of lyophilization and how to validate your aseptic process for lyophilized products
Berkshire Sterile Manufacturing by Sarah Kinney As the market moves away from small-molecule drug products and towards biologics, biosimilars, and other more complex products, the demand for lyophilization…
How sterility assurance levels differ between aseptic processing and terminal sterilization
Berkshire Sterile Manufacturing by Sarah Kinney The sterility assurance level (SAL) is a useful tool for assessing and describing the effectiveness of your sterilization process. SAL describes the probability…
Drug Product Processing and Handling Considerations How the Production Environment and Personnel affect the Sterility of your Product
Berkshire Sterile Manufacturing by Andrea Wagner, PhD. SVP, Business Development & Thomas Lewis, MBA, Project Manager When performing filling or formulations that require a “sterile” area many components…
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
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…
Want to keep a product frozen while shipping? Use dry ice BUT maybe not for proteins!
by Andrea Wagner, PhD SVP, Business Development Berkshire Sterile Manufacturing The use of dry ice to ship protein products that need to be kept frozen is ever increasing…
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
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…
