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,…
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 MFG The use of dry ice to ship protein products that need to be kept frozen is ever increasing but the…
The Cleanroom of the Future
By Jeanne Moldenhauer Vice President at Excellent Pharma Consulting At a local Northeast PDA meeting on 5/18/16, over 130 attending, eleven BSM colleagues attended a great meeting where the…
Assessing Risk in Sterile Manufacturing
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…
OMPI DAY!! – It doesn’t get better than this!
by Andrea Wagner - SVP, BD - BSM Located in Venice Italy, OMPI day – the 6th one held to date by a company that is head quartered in Italy and…
From Pharma Kongress in Dusseldorf, Germany
By Andrea Wagner, PhD, SVP, Business Development This week I had the pleasure of attending Pharma Kongress in Dusseldorf where there were a wide variety of talks given on pharmaceutical…
Understanding the Effects of Gamma Radiation on Polymers: A Case Study Example of what Happens to Sterilized Cleanroom Garments
Authors: Jennifer Galvin and Khyati Vyas with DuPont Protection Solutions (of poster not this blog) At the 2016 Annual PDA conference in San Antonia, TX a poster was presented that…
Container Closer Integrity of Rubber Stoppered Glass and Daikyo Crystal Zenith vails stored at Cryogenic Temperature
Authors: Eugene T. Polini, West Pharma Services, Derek Duncan, Lighthouse, Lloyd Waxman West Pharma Services and Vinod Vilivalam, West Pharma Services (authors of presented poster - not of blog) West…
Berkshire Sterile – formulation and filling of syringes, vials, cartridges and custom containers – In ISOLATORS
Did you know that 70% of the contaminants in cleanrooms are generated from people? Did you know that FDA wants all products requiring aseptic filling performed in isolators? FDA,…