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June 02, 2012
How to avoid invisible and airborne contamination.
May 22, 2012
PDA Revises Technical Report on Sterilized Products
The Parenteral Drug Association has released guidance on the detection and mitigation of 2,4,6-tribromoanisole and 2,4,6-trichloroanisole taints and odors in pharmaceutical and healthcare products.
May 02, 2012
Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
May 01, 2012
Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.
April 11, 2012
FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.
March 01, 2012
JHS Secures Four Sterile Parenteral Products Manufacturing Contracts; Samsung Biologics, Biogen Idec Establish Biosimilars Joint Venture; and More.
February 17, 2012
PDA organizes this conference to address the technical and regulatory issues related to parenteral packaging. Chemical, physical and microbiological aspects will be considered and current regulatory challenges will be discussed. Two Training Courses on Container Closure Development or Selection and Utilization of Glass Containers in Pharmaceutical Packaging will be given.
February 15, 2012
The author discusses the relative advantages and disadvantages of lyophilization in vials and dual-chamber systems.
December 01, 2011
Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.