Understanding the Effects of Gamma Radiation on Polymers: A Case Study Example of what Happens to Sterilized Cleanroom Garments
Jennifer Galvin and Khyati Vyas DuPont Protection Solutions Note: blog post not original At the 2016 Annual PDA conference in San Antonia, TX a poster that examined the…
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) …
Berkshire Sterile – formulation and filling of syringes, vials, cartridges and custom containers – In ISOLATORS
Berkshire Sterile Manufacturing 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…
Once you use Isolators will you ever go back?
Andrea Wagner, PhD, SVP, Business Development, BSM Less than 10 years ago you needed different filling equipment for vials, syringes, and cartridges. The ability to buy and install…
CMOs – Considerations in Evaluation
By Andrea Wagner, PhD, SVP Business Development Recently, Phil Burns wrote an article in Contract Pharma about utilizing contract manufacturing organizations (CMOs) to assist companies in reducing their…
CMOs Beware of GDUFA Fees
Berkshire Sterile Manufacturing by Andrea Wagner, PhD The FDA instituted a new program in 2013, to charge API and finish drug product facilities who manufacture generic drugs an…
BSM’s Amazing Steam Sterilizer
Berkshire Sterile Manufacturing BSM’s FEDEGARI autoclave has the capability to terminally sterilize syringes, bags, vials and ampules with a 20,000 unit load capacity. The autoclave has internal heat…
Understanding new regulations for HVAC validations
Berkshire Sterile Manufacturing by Andrea Wagner The FDA issued a new guidance document in 2011, General Principles and Practices for air filtration, which discusses the process validation of…
Sterile Connections in Non-Sterile Environments?!
Berkshire Sterile Manufacturing by Andrea Wagner Has Pall Corporation accomplished the impossible? Yes, you can perform sterile transfers of products and tangential flow in a non-sterile environment with…
