PDA Italy Chapter Single Use and Innovation Technologies to Face New Regulatory Challenges Event

Single use technologies - technically defined as disposables - play a prominent role in continuous growth in the development of new products and processes. Companies offering pre-assembled systems that are radiated and ready to use more and more numerous: in fact, it has been widely demonstrated that pre-assembled disposable systems reduce the risk of contamination, improve production efficiency and the Overall Equipment Efficiency (OEE). And again, thanks to their flexibility, the process transfer times, both from site to site and in case of scale up, are considerably reduced.

Although these credentials lay the foundations for a growing popularity, there are still some latent doubts and unanswered questions.

- What are the parameters that allow you to determine whether the use of the disposable in a process is convenient?
- How to foresee the interaction between plastic materials and product?
- Is it more appropriate to use a leachables or extractables solution?
- How to make sure that the disposable is sterile?
- What minimum standards should suppliers of disposable technologies be required to use in sterile applications? And for products for parenteral use?
- Are there good practices in the design of assembled and ready-to-use systems?

"Single Use and Innovation Technologies to face new Regulatory Challenges" aims to deepen these discussion points among the various themes, sharing the experience of those companies that have already processed and addressed them, implementing the disposable technology in their own production process.

Plant Tour

Site visites will be organized at the Patheon and BSP plants and will be reserved for the first 40 members of the Congress. Participants will be able to visit only one of the two establishments. It will be possible to indicate, during the registration phase, your preference which will be taken into consideration unless the places available are exhausted.