Pre-Filled Syringes (PFS)

Objective

In this course 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.

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

Background

Currently there is a growing demand in the development of prefillable 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), will apply with the revised EU GMP Annex 1 entitled “Manufacture of Sterile Medicinal Products”.
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.

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 ƒ

  • PFS Design & Safety Systems ƒ
  • Alternatives to glass
  • GMP Requirements for personnel, cleanrooms, equipment & facilities
  • Processing of pre-filled syringes
  • Auto-injector Assembling
  • Sterile secondary packaging
  • Observations during GMP inspections

Moderator

Dr Andrea Kühn-Hebecker

Detailed Programme

Presentations - 28 March 2023

Regulatory Overview, Annex 1 Impact and Inspection Experience
Dr Daniel Müller, Local Government, German

  • regulatory framework (EU), impact for pre-filled syringes
  • impact of new Annex 1
  • inspection experience

PFS made from Glass or Polymer
Horst Koller, HK Packaging

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

PFS and Needle Safety Systems
Horst Koller, HK Packaging

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

Tubs and Nests
Iwan Tresch, FischerSöhne

  • Production process with its challenges from the raw material until a “RTU-Tub” ready to fill
  • Requirements according to ISO 11040 – 7
  • Further developments on Tubs and Nests

Fill-Finish Processes for prefilled Syringes
Markus Busch, Vetter Pharma-Fertigung

  • Technology Overview
  • Bulk syringes
  • Pre-sterilized syringes

Device Assembling and Control Processes for Auto Injectors
Susanne Hall, Vetter Pharma-Fertigung

  • What do you have to think about before selecting a device
  • Impact of the Primary packaging material
  • Assembling and Final Packaging
  • Scale up process
  • Inline Controls, Function and Release Tests
Presentations - 29 March 2023

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

Silicone-free Primary Packaging Materials in Filling & Stopper Process Development – Challenges & Opportunities
Manuel Grund, Roche Diagnostics

  • Glass vs. COP - what are the differences?
  • Viscous solution, high-speed filling and vacuum
  • Process-technical requirements for NC vacuum stoppering
  • Helium leakage testing

High speed Syringe Filling Line for Oncological Drugs – Challenges & Solutions
Radek Fialka, Oncomed
Klaus Ullherr, Syntegon

  • Project setup
  • Choice of filling line and isolator
  • Learnings from the mock-up study
  • Integration into the building
  • Strategy for filling toxic drugs
  • Special challenges when filling toxic drug into syringes
  • Use of NTT (No-Touch-Transfer) with fully automatic bag opening for inner and outer bag

Sterile Secondary Packaging: Case Study
Peter Huonker, FRÜH

  • Basic Process Overview
  • Components
  • Assembly
  • EO Sterilization
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