The Parenteral Drug Association (PDA) will hold the 'Building and Maintaining Sterility Assurance' conference in Milan, Italy from 17-18 November 2009, its second talk on sterilisation technologies.
The conference will provide information on how to build and maintain appropriate sterility assurance in sterile manufacturing.
Recently there have been several recalls of drug products due to a potential loss of sterility, mostly caused by faulty sterility assurance procedures.
This conference will promote discussion between health authorities, notified bodies and industry representatives on issues around sterility assurance of medicinal products and medical devices.
Presentations by inspectors and assessors from regulatory authorities, as well as notified bodies, will include: enablers to real-time release, sterilisation and sterility assurance technologies and related official monographs.
Industry experts will also present topics such as sterilisation, sanitation, disinfection and decontamination and their impact on sterility assurance.
Issues relating to bioburden validation, use and type of bio-indicators will also be debated.
Risk assessment and risk-management options, as introduced with Annex 20 to the EU GMP Guide, and their application, for example on facility design, will also be an important part of the programme.
Potential solutions to comply with the revised Annex 1 to the EU GMP Guide, for example at the point of fill, will be of particular interest.
A critical review of ISO 17665 and PDA's technical report on moist heat sterilisation will highlight issues for those producing medicinal products and medical devices in the same environment.
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.
