Navigating major challenges associated with intrinsic subvisible particles on siliconized prefillable syringes
Abizer Harianawala, US TEC site Leader
Gregory Fahs, Research Scientist, Stevanato Group US Technical Excellence Center (TEC)
Martina Marchioro, Research Scientist, SG Lab Analytics
This webinar will focus on primary packaging, where the drug product will be in direct contact with the container closure system for a substantial period of time before reaching the patients. The physico-chemical interactions between the primary packaging components and the drug play a crucial role in the generation and release of subvisible particles. These particles could affect the safety and efficacy of the drug product and not meeting global regulatory standards. To address these concerns, we would like to present the background and tools used for evaluating the release of subvisible particles such as silicone oil droplets.
We leverage our expertise as a leading drug primary packaging manufacturer and as an independent laboratory analyzing the subvisible particle release with a focus on the silicone oil droplets to present:
– State of the art characterization of the release and generation of subvisible particles, such as silicone from container closure systems.
– Regulatory requirements described in USP, EP, JP, and ISO.
– Case studies demonstrating how to approach and test subvisible particle release on prefillable syringes:
– Optimization of the siliconization process to minimize the silicone oil droplets release
– Simulation study on the siliconization downstream processes such as filling, transport stress and extrusion.
Who should attend:
– Packaging Development Engineers/Scientists
– Supply Chain/Clinical Operations
– CMC Scientists
– Quality Directors/Managers/Engineers
– Team Leaders/Directors of Drug (Formulation) Development Teams
– Drug Delivery/Combination Product Scientists and Engineers
– Analytical Scientists
About the Sponsors
Established in 1949, Stevanato Group is the world’s largest, privately-owned designer and producer of glass primary packaging for the pharmaceutical industry. From its outset, the Group has developed its own glass converting technology to ensure the highest standards of quality. The Group comprises a wide set of capabilities dedicated to serving the biopharmaceutical and diagnostic industries: from glass containers with its historic brand Ompi, to high-precision plastic diagnostic and medical components, to contract manufacturing for drug delivery devices, to vision inspection systems, assembly, and packaging equipment.
The Group also provides analytical and testing services to study container closure integrity and integration into drug delivery devices, streamlining the drug development process. Thanks to its unique approach as a one-stop-shop, Stevanato Group can offer a unique set of solutions to biopharma companies for a faster time to market and a reduced total cost of ownership.