GMP for Pre-Filled Syringes (PFS)

Objectives

In this conference you will learn which requirements for pre-fillable syringes are defined by the regulations. You get to know all aspects of the manufacture of pre-fillable syringes 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

Currently there is a growing demand in the development of pre-fillable syringes (e.g. ready-to-fill, ready-to-use, sterile clean filling) for several enhanced Biotech applications (i.e. for the final product, the Pre-filled Syringe). However, new GMP requirements, also for the sterile packaging material (e.g. regarding validation of the sterilization procedure for the syringe), apply with the revised 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 sterilization activities), and the pharmaceutical industry.


GMP for Pre-Filled Syringes (PFS)

click on the image to download the programme as PDF.

Registration

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

Moderator

Dr Wenzel Novak, Gerresheimer Bünde

Detailed Programme

Tuesday, 19 March 2024

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

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

Contamination Control Strategy
Dr Helen Sauter, Vetter Pharma-Fertigung

  • Practical experiences
  • CCS – a new Annex 1 requirement
  • Case Study: CCS implementation
  • Risk based approach for control point identification

Medical Device Regulations - Understanding the Impacts and ensuring Compliance for Syringe-based Combination Products
Christa Jansen-Otten, West

  • Navigating the EU MDR Regulations requirements
  • Advantages of platforming on prefillable syringes
  • Case example of technology being applied by the market for platform applications
  • Needs of suppliers for supportive documentation

PFS made from Glass or Polymer
Katharina Golly, Novartis

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

PFS and Needle Safety Systems
Katharina Golly, Novartis
Jinesh Sadalge, Novartis

  • Regulatory Requirements
  • Active vs. Passive Systems
  • Design Considerations
  • Examples

Validation of a Steam Sterilization Process for a Pre- Filled Syringe
Maria Luisa Bernuzzi, MesaLabs

  • Challenges in steam sterilization of a PFS and its biological validation
  • How to manage a heat sensitive load
  • Bioburden/biological indicators approach, D value determination and the correct choice of biological indicators
  • Validating the specific cycle

Wednesday, 20 March 2024

Container Closure Integrity
Jean-François Decoster, UCB

  • Requirements for CCIT
  • Method development and validation

Process Simulation / Media Fill
Dr Helen Sauter, Vetter Pharma-Fertigung

  • Media Fill Design
  • Worst-case parameters & requirements
  • Validation of processes with Media Fills
  • Trends with regards to Media Fills

Visual Inspection
Jean-François Decoster, UCB

  • Requirements
  • Method development and validation
  • AQL testing
  • Automated vs. semi-automated vs. manual inspection

Automated Visual Inspection: Process and Transfer
Dr Max Scheible, Vetter Pharma-Fertigung

  • Automated Visual Inspection (AVI) as an alternative to MVI
  • State-of-the-art technologies for a robust and reproducible process
  • Qualification & Transfer

Endotoxin Detection in Pre-Filled Syringes: Challenges during Method Development and Validation
Dr Bernhard Illes, Microcoat Biotechnologie

  • Introduction to Endotoxin testing and endotoxin masking (Low Endotoxin Recovery (LER))
  • General approach for development and validation of endotoxin detection methods
  • Considerations and challenges for method development and validation for PFS
  • Case studies for method development and validation for GMP release testing
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