GMP Requirements and Challenges for RTU/RTS Material

24/25 March 2026, Wiesbaden/Germany

Objectives

Which requirements apply for GMP pre-sterilised packaging material and single-use-systems (e.g., ready-to-use (RTU), ready-to-sterilise (RTS) products)? During this conference, you will hear about all aspects of the GMP manufacture of pre-sterilised products (e.g., vials, stoppers) that influence the quality of the final product. In addition, practice-oriented presentations and case studies will guide you through the relevant requirements on qualification / validation, and controls for pre-sterilised materials, including impact of the revised EU GMP Annex 1.

Registration

Background

Currently there is a growing demand in the development of pre-sterilised packaging materials and single-use-systems (SUS) for several enhanced biotech applications. However, new GMP requirements for the sterile packaging material (e.g. regarding validation of the sterilisation procedure) apply with the revised EU GMP Annex 1 entitled “Manufacture of Sterile Medicinal Products”, which provides guidance on the approaches to sterilisation of products, equipment and packaging components. All sterilisation processes should be validated.

This event will therefore deal with the current discussions and trends in the manufacture of RTU/RTS material:

  • GMP requirements for sterilisation of packaging materials / devices / SUS
  • Selection of a suitable sterilisation method
  • Critical process parameters (CPPs) that should be considered in qualification and / or routine processing
  • Validation strategy
  • Requirements for suppliers

The presentations will be provided in a practice-oriented way from the different viewpoints of authorities, suppliers of packaging materials / devices / services (including sterilisation activities), and the pharmaceutical industry.

Target Audience

This online event is designed for employees working in the pharmaceutical industry (including drug device combination products), for suppliers of packaging materials & devices and to all who have to deal with the manufacture, control and release of packaging materials for aseptic processing. The key areas are

  • Sterile Production
  • Packaging material / Device development
  • Manufacturing / Processing / Assembling
  • Quality Control
  • Quality Assurance

Detailed Programme

GMP Aspects / Supplier Qualification / Implications of EU GMP Annex 1
Dr Rainer Kahlich, Local Government Germany

  • Regulatory expectations
  • Annex 1 requirements for RTU/RTS materials
  • GMP compliant supplier qualification
  • Issues in inspections

Fill & Finish and Mircobiological Validation
Dr Markus Lesch, Vetter Pharma-Fertigung

  • Sterilisation Technologies – Pros & Cons
  • Annex 1 & Sterilisation Validation
  • Decontamination Validation
  • Biological Indicators
  • Depyrogenation Validation

RTU Packaging for PFS
Horst Koller, HK Packaging Consulting
Katharina Golly, Novartis

  • Materials
  • Manufacturing
  • Sterilisation methods
  • Design
  • Pros and Cons

Packaging Design and Management of Pre-sterilised Packaging Material
Sergio Cuevas Luján, TevaPharma

  • Packaging materials for aseptic manufacturing
    • Safety, efficiency, sustainability in packaging design and packaging materials for aseptic processes
    • Packaging materials and CCIT (Container Closure Integrity Test) validation for aseptic manufacturing
    • New trends in packaging materials for aseptic manufacturing

Validation of a Sterilisation Procedure for Closures
Adrian Beuthner, Amphenol
Jasmin Danielle Knobe, ATEC

  • Thermal Validation using RF-Logger for Sterilization Processes
  • Introduction into Guideline (Annex 1) for thermal validation
  • Differentiation of thermal validation with wired and wireless system
  • Definition of important measurement positions regarding constructional characteristic

A Supplier's Perspective on EU GMP Annex I Requirements
Dr Ana Kuschel, West Pharmaceutical Services

  • Revised EU GMP Annex I: Strong focus on primary packaging materials
  • Appropriate primary packaging components and adequate primary packaging material selection
  • How can this support pharmaceutical companies in complying with the respective requirements laid out in EU GMP Annex I?

Decontamination of Pre-Sterilised Containers (including Case Study)
Tobias Göttler, Syntegon

  • What is the ideal process for transferring ready-to-use (RTU) vials into the fill & finish area of an isolator?
  • Effects of Vaporized Hydrogen Peroxide (VHP) on pre-sterilized glass and plastic vials
  • VHP as a technology for proper outer decontamination of RTU packaging material

Extractables & Leachables: Integrating Science and Compliance with the ICH Q3E Draft Guideline
Dr Simone Biel, Merck

The ICH Q3E draft guideline introduces a framework grounded in quality risk management principles (ICH Q9) for assessing and controlling leachables that migrate from polymeric manufacturing, storage, or packaging components/systems into drug products. This presentation will provide an overview of ICH Q3E’s holistic strategy for extractables and leachables (E&L) control. We will explore:

  • How does ICH Q3E minimize uncertainty to meet global regulatory expectations?
  • In what ways does it complement existing regional regulatory requirements, such as USP <665>?

Cleanroom Films and Bags: Protection against Contamination
Dr Christoph Strubl, STRUBL

  • Flexible plastic packaging materials for pharmaceutical / medtec applications
  • Cleanroom packaging solutions - examples and applications
    • Cleanroom flexible plastic packaging materials for APIs
    • Cleanroom PE tray for liophilisation process
    • Cleanliner for containers, hobbocks, drums
    • Bag-Systems for efficient handling in cleanroom environments
    • Cleanzipbags
    • Sterilisation of flexible PE-packaging materials  

Evaluation of the Rrisk of PFAS and Nitrosamine Contamination
Dr Farid Behboodi-Sadabad, Grünenthal

  • Impact on primary packaging of pharmaceutical products
  • High risk packaging materials and their alternatives  
  • Challenges to implement changes to the primary packaging in terms of technical and regulatory requirements
  • Sustainability aspects

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