PDA conference to focus on sterility assurance
The Parenteral Drug Association (PDA) is holding its second conference on sterilisation technologies that will provide essential information on how to build and maintain appropriate sterility assurance in sterile manufacturing.
The conference, entitled Building and Maintaining Sterility Assurance, takes place in Milan, Italy, from 17–18 November 2009.
It aims to promote discussion about issues surrounding the sterility assurance of drugs and medical devices following several instances of drugs being recalled due to potential loss of sterility, mostly caused by faulty sterility assurance procedures.
Topics such as sterilisation, sanitation, disinfection and decontamination and their impact on sterility assurance will be debated, in addition to issues relating to bioburden validation.
Special attention will be given to how suppliers can add value to sterility assurance, for example when performing integrity testing of sterilising filters or employing ready-to-use stoppers. Practical examples will be given, such as the use of hydrogen peroxide to sterilise plastic materials, development and validation of a sterilisation cycle for pre-filled syringes and steam-in-place solutions.
Contact T +41 91 980 4760 {encode="eck@pda.org" title="eck@pda.org"}
