GMP for Prefilled Syringes

Objectives

This conference track will provide you with a comprehensive understanding of the regulatory requirements for pre-fillable syringes. You will gain comprehensive insight into all aspects of the manufacturing process for pre-fillable syringes, including the elements that influence the filling process and the quality of the final product. In addition, practice-oriented case studies will guide you through the relevant production processes, simulations and controls for pre-filled syringes.

Background

There is an increasing demand for pre-fillable syringes (for example, ready-to-fill, ready-to-use, sterile, clean filling) for a number of enhanced biotech applications (i.e. for the final product, the prefilled syringe). However, new GMP requirements, also for the sterile packaging material (e.g. regarding validation of the sterilisation procedure for the syringe), apply with the EU GMP Annex 1 entitled "Manufacture of Sterile Medicinal Products".

This event will therefore deal with the current discussions and trends in the manufacture of pre-filled syringes:

• GMP requirements for pre-fillable syringes / devices
• PFS Design & Safety Systems
• Alternatives to glass
• GMP Requirements for personnel, cleanrooms, equipment & facilities
• Processing of pre-filled syringes
• Auto-injector Assembling
• Contamination Control Strategy
• Observations during GMP inspections

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 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 prefilled syringes. They key areas are

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

Moderators

Horst Koller, HK Packaging
Katharina Golly, Novartis

Tuesday, 24 March 2026

Safety Qualification Considerations for Prefilled Syringes
Dr Piet Christiaens, Nelson Labs Europe
Dr Carolien Buvé, Nelson Labs Europe

• Regulatory Challenges for qualifying a Prefilled Syringe as a Combination Product
• How to Design Testing Strategy that combines the requirements from both the Pharma- and Medical Device world
• The Specific Concerns related to the choice of materials for a Prefilled Syringe
• The Flow of an Extractable & Leachable Program: Defining the Different Steps in the Qualification of a Prefilled Syringe
  
  

Key Considerations for VH₂O₂ Sterilization of Prefilled Syringe Applications  
Juha Mattila, Steris

• Main characteristics of VH₂O₂ sterilization process and technology
• Key considerations for process and equipment implementation (sterilization efficacy, material compatibility, project, space, load transfer, utilities, maintenance)
• Process and equipment validation – the regulatory pathway and current developments
• Implementation and qualification to a pharmaceutical production application
• Case study example of implemented application
  
  

Process Robustness and Handling Concepts for RTU Systems
Hasan Catovic, Optima Pharma Germany

• Key aspects when handling COP and COC prefilled syringes
• Ensuring process robustness and compliance alignment across different primary packaging suppliers
• Comparison of nested versus denested filling processes for prefilled syringes (PFS)
• Container integrity of RTU systems and possible infeed handling concepts for tubs and nests
  
  

Importance of Silicone Oil Control in Pharmaceutical Containers
Dr Julian Plaickner, GIANT labs
Dr Georg Rössling, Senior Consultant

• Functional Importance: Silicone oil is essential to ensure smooth syringe operation and product integrity
• Challenges with Inhomogeneous distribution
• A novel method enables precise determination of silicone oil layer thickness and distribution in glass and polymer containers
• Case studies with pre-filled syringes demonstrate the method’s value for development, quality assurance, and manufacturing
  
  

Needle Safety Devices and Autoinjectors
Eva Conraths, Haselmeier
Katharina Golly, Novartis

• Introduction to Combination Products
• Needle Safety Devices and Autoinjectors
• Case Study – PiccoJect Autoinjector
  
  

Incoming Inspection of PFS Components
Horst Koller, HK Packaging

• What are the regulatory requirements?
• What are typical incoming inspections?
• Where and by Whom performed?
• Can we do better?
  
  

Wednesday, 25 March 2026

Regulatory Overview, Annex 1 Impact and Inspection Experience  
Dr Daniel Müller, Local GMP Authority of Baden-Württemberg

• Regulatory framework (EU), impact for pre-filled syringes
• Impact of new Annex 1
• Inspection experience
  
  

CCIT for Prefilled Syringes – Is there only one Way?  
Jens Höllein, be integral

• Regulatory context – Annex 1, USP <1207>, elastomer chapters
• PFS with two “ways” – plunger and needle side
• Gas permeability – material defines feasible technologies
• Development & defects – MALL, inherent integrity, special states
• Routine CCIT – technologies, pros/cons, challenges with coatings & clogging
• Lifecycle – stability and sterility over shelf life; special formats optional
  
  

More Than a Box – Why Secondary Packaging Is the Hidden Key to Pharma Success
Cihan Celik, Vetter Pharma-Fertigung

• From Bazaar to Pharma – Why Packaging Matters  
• The Hidden Hero: Secondary Packaging  
• Opportunities & Value Creation
• Risks & Complexity in a Global Market  
• Complexity in Action: Autoinjector Assembly  
• Conclusion: Packaging as the Patient’s Lifeline
  
  

Prefilled Syringe Industry in a Nutshell  
Horst Koller, HK Packaging

• Designs for manual use and use in delivery devices
• Manufacturing of PFS for glass and polymer
• Fill-Finish an ISO approach
• Regulatory classification of final PFS
  
  

Innovative Perspectives in PFS Development: Pharma’s View
Katharina Golly, Novartis

• Market Presentation: The Benefits of Prefilled Syringes
• Drug Development Needs Driving PFS Innovation
• Case Studies of Recent Developments in PFS
  
  

Development of Prefilled Syringes for Intravitreal Drug Delivery  
Jari Acocella, ten23 health

• Navigating the Challenges of Prefilled Syringes for Intravitreal Therapies
• Meeting the Standards: Regulatory and Pharmacopeial Expectations for IVT PFS
• Protection, Compatibility and Performance: Lessons from Development and Stability Studies
• Looking Ahead: Best Practices in IVT PFS Development