Prefilled Syringe Seminar 2018

Winckler & Co., Ltd. is proud to announce our participation to Prefilled Syringe Seminar 2018 Tokyo, organized by Parenteral Drug Association- Japan Chapter.

During the seminar, Groninger will have a presentation.

We will be looking forward to seeing you there.

Date and Time ：

9:20-18:00, Tue 22 May, 2018

9:00-18:00, Wed 23 May, 2018

*Groninger’s presentation : 16:20 – 17:10, Wed 23 May, 2018

Place　　：

Sola City Conference Center（1 min walk from JR Ochanomizu Station）

Sola City Hall West（2nd floor）

Theme 　：

“PFS: The best solution for patient“ from the viewpoint of drugs, containers, devices

Purpose ：

This year, the experts in various fields will report on the topics that are investigated through the latest physical chemistry, ergonomics, manufacturing engineering, and drug regulation from the viewpoints of drugs, devices, and both. There will be a panel discussion regarding the topics as well.

Speech

Theme ：

”Challenges in flexible manufacturing of biological products in an isolator environment. How to balance product safety and production flexibility.”

Speaker ：Felix Mausolf　(groninger & co. gmbh)

Date and time ：16:20 – 17:10, Wed 23 May, 2018

Summary ：

Biological products can be very different in nature and at times complex to handle all along the manufacturing process. This starts from the beginning in the upstream manufacturing, continuing along the fill & finish operations and ends at the device integration and usage by the patient.

Because of the production complexity, these biological products are costly to produce and production losses in filling need to be kept to an absolute minimum, across all handling stations within a fill & finish machinery. The competing objective when it comes to biological products, is the low batch size resulting in low equipment usage. Here it becomes important to allow the equipment operator to be able to change over the production format in a very small time frame.

In order to fulfill these requirements, new concepts have been developed on production machinery. These concepts all contribute to overall product and production safety by incorporating quality-by-design principles from the very beginning.

The presentation will highlight and focus on the individual process steps of getting the API into the final delivery package (nested syringes, cartridges or vials). Furthermore the individual risks will be evaluated and different approaches as to risk minimization underlined by rationales and data gathered from live machine operation are presented.

Click here for the link to the seminar program .