The 2018 Pharmapack Symposium on Primary Packaging and Drug Delivery Trends for Injectables took place in Hyderabad on April 13th at the Taj Krishna Hotel and was chaired by Dr. Fabiano Nicoletti, Honorary President of the International Commission on Glass, and by Mrs. Ivy Luis, President of India PDA Chapter.
Focusing mainly on “Ready to use for aseptic manufacturing: Regulation, Technology and Quality challenges and opportunities”, more than 100 attendees subscribed the event and they were engaged in a deep discussion on the hot topics of injectable world.
Indian industry was represented by 40 Pharmaceutical companies, that had the chance to hear about the strict requirements necessary to serve Europe and US markets and to have an insight of the most recent updates on ISO regulation about prefilled syringes and ready to use vials and cartridges.
Sponsored by Ompi, Datwyler, Optrel, Nelson Labs, Mar and Comecer the Symposium worked out its focus through 9 presentations and a final panel discussion involving all presenters and attendees.
The first speech gave a good overview of regulatory assessments, especially in the domains of sterile formulations that has become more and more stringent increasing attention to be in compliance with new legislation (such as Annexi 1, USP, USFDA, etc.). The second presenter touched a critical point about standardization system of pharmaceutical packaging and gave an update on ISO standards for ready to use glass containers, pursuing with the presentation and illustration of the major results of the TC12 of International Commission of Glass about the proper autoclaving cycle, set according to the E.P. and U.S.P prescription for the hydrolytic resistance testing.
A great contribution was the designing of extractables/leachables studies for pre-fillable syringes, the key role of the analytical services, the development of flexible manufacturing models for bio-pharmaceuticals.
A highlight has been done about the different challenges through innovative primary packaging solutions for marketed and new biologic drug products. Starting from this issue one of the most interesting aspect has been covered: the flexibility in manufacturing, the sterile packaging applications for pharmaceutical containers, the development of a Drug Delivery System, the aseptic manufacturing of elastomeric closures for injectables, the selection of the right device for drug products injection, the automatic inspection systems for parenteral drugs.