iia Presenting at PDA Week 2025
The iia will attend and present at PDA Week 2025, taking place 6 – 11 April in Palm Springs, California (USA).
Arthur Dumba, iia General Manager, poster presentation abstract:
Sterility Assurance: The Role of Supply Vendors, Contract Irradiators and Laboratories
Sterility combines two processes – irradiation and microbiological assessment. Ancillary products (e.g. container closure components, single use systems etc) used in aseptic processing and bio-processing industries must be sterile before use.
How does a drug manufacturer have confidence that suppliers of ancillary products meet this requirement?
This session will address the standards, activities, controls, logistics, and documentation chain of the processes that deliver sterile products. A panel will also discuss what microbiologists and quality unit personnel can, and should, assess to be confident that these supplies are fit for use.
- Contact Arthur: adumba@iiaglobal.com
Thomas Kroc, iia US Representative, presentation and abstract:
Low Energy Electron Beams for the Sterilization of Pharmaceutical Packaging
Low energy electrons, between 250 and 800 keV, are already used for a wide range of applications and their potential for the sterilisation of pharmaceutical packaging and medical products has also been recognised. The accelerator technology is compact and can be self-shielding, allowing in-line use, and high dose rates are available. The low penetration can be beneficial for pharmaceutical applications, enabling the decontamination of the external surfaces of products or packaging, with no impact on the contents. As well as highlighting the benefits of using low energy systems, this presentation will discuss what needs to be considered for these low energies before implementation, such as infrastructure, dosimetry, regulation and the practical use for sterilisation applications.
- Contact Thomas: tkroc@iiaglobal.com
If you are planning to attend PDA Week 2025, we encourage you to reach out to Arthur or Thomas to discuss their presentations and learn more about membership with the iia.