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Manufacturing of Sterile Medicinal Products Enabled by RTU Packaging

2025-11-06 - 2025-11-07 | Dinkelsbühl, DE

course number: 7051

  • Liquid Dosage Forms
  • Packaging
  • Pharmaceutical Manufacturing

Workshop program / Flyer

  • 7051_Manufacturing of Sterile Medicinal Products Enabled by RTU Packaging (659 KB)

Date and venue

Start: 2025-11-06, 08:30
End: 2025-11-07, 14:30
Add appointment to calendar

Venue

Meiser Design Hotel
Neue Allee 4
91550 Dinkelsbühl
Germany

Phone: +49 98 51 52 91 70 66 70
E-mail: tagung.design@meiser-hotels.de
https://meiser-hotels.de/design/

Participants should make their own hotel reservation referring to the APV seminar and by using the reservation link:

bit.ly/4gPYta1

Target group

This seminar is tailored for professionals and leaders in the pharmaceutical
industry, including:

  • Production Managers and Engineers in sterile medicinal product manufacturing
  • Packaging Technology Specialists and Quality Management Personnel
  • Developers and Project Managers in pharmaceutical product development
  • Regulatory Affairs Experts and Compliance Specialists
  • Innovation and Technology Leaders focused on RTU packaging solutions
  • Aseptic Manufacturing and Sterilization Professionals
  • Sustainability Officers within the pharmaceutical sector

The seminar provides an invaluable platform for those looking to deepen their expertise in sterile medicinal product manufacturing and stay informed about the latest developments and standards in RTU packaging.

Objective

This seminar is designed to provide participants with a comprehensive understanding of the latest innovations and best practices in the manufacturing of sterile medicinal products, with a special focus on Ready-to-Use (RTU) packaging solutions.
Key topics include:

  • Agile Aseptic Manufacturing & Decentralized Production
    Gain insights into the benefits of decentralized manufacturing and fleet/sister site concepts, including the role of automation, alternative microbial monitoring, and regulatory considerations.
  • Annex 1 and Modern Manufacturing Techniques
    Understand the key aspects of Annex 1 (2022) and its implications for aseptic material transfer, automation, and robotics in sterile medicinal product manufacturing.
  • Interaction of Packaging Material and Machinery
    Explore critical factors influencing packaging material and machine compatibility, with a focus on pre-sterilized syringes, robotic solutions, and gloveless isolators.
  • Standardization of RTU Primary Packaging
    Learn about DIN/ISO standardization efforts for prefillable syringes, vials, and cartridges, including considerations for both glass and plastic containers.
  • Commercial Use of RTU Packaging
    Examine the current market landscape, implementation challenges, and evolving responsibilities in cGMPcompliant RTU processing versus bulk sterile manufacturing.
  • Advanced Processing and Inspection of RTU Containers
    Discover innovative processing techniques such as 100% check-weighing, specialized priming/end-of-batch programs, and unique inspection steps to maximize product yield.
  • Development of CSTD-Compliant Components
    Gain insights into the successful development of snap-on caps for robotic and non-robotic fill & finish systems in compliance with CSTD guidelines.
  • Sustainability in RTU and Reusable Device Product
    Explore sustainable strategies in RTU packaging and the development of reusable device solutions.
  • Sterilization Methods and Validation Excellence 
    Review key sterilization techniques, validation principles, and the unique challenges associated with ensuring sterility in pre-crimped RTU cartridges

This seminar aims to equip professionals with the knowledge and tools needed to navigate the complexities of sterile medicinal product manufacturing, fostering innovation and compliance in an ever-evolving industry.

Organizer(s)

APV-Office

Kurfürstenstraße 59
55118 Mainz
Germany

Dr. Martin Bornhöft
Phone: +49 6131 9769-0
E-mail: info@apv-mainz.de
https://www.apv-mainz.de

Cooperation partner(s)

SYNTEGON

Prices

Registration fee
Industry
€1,590.00
Authority/University
€795.00
Student
€240.00

All prices free of VAT

registration
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Contact

Logo: APV Mainz

APV Mainz

Kurfürstenstraße 59
55118 Mainz

+49 6131 97690
info@apv-mainz.de

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Note on data protection
We process your data on the legal basis in accordance with Art. 6 Paragraph 1 Sub-Paragraph 1 lit. b GDPR. You can object to this processing at any time.
You can find more information about the protection of your data in our data protection declaration.

Do you have questions

You can easily reach us:

+49 6131 97690
info@apv-mainz.de

Contact person

Do you have a specific request? Find your direct contact person here.

Contact person

Your direct contacts at APV Mainz e.V. will be happy to assist you further.

Dr. Martin Bornhöft

Dr. Martin Bornhöft

Managing Director APV e.V.
Managing Director APV GmbH

+49 6131-97 69 30+49 171 904 2540bornhoeft@apv-mainz.de

Dr. Katrin Kälkert

Managing Director APV GmbH
Deputy Managing Director APV GmbH

+49 6131-97 69 50+49 171 812 0138kaelkert@apv-mainz.de

Valentina Marinkova

Valentina Marinkova

Exhibition and course management

+49 6131-97 69 40+49 160 905 341 16marinkova@apv-mainz.de

Anna-Maria Pötzl

Anna-Maria Pötzl

Congresses and course management

+49 6131-97 69 10+49 160 678 9399poetzl@apv-mainz.de

Angelika Zengerle

Angelika Zengerle

Member support and registrations

+49 6131-97 69 35anmeldung@apv-mainz.de

Hasan Yasin Göksu

Accounting

+49 6131-97 69 85  goeksu@apv-mainz.de

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