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Management Forum

Pre-Filled Syringes: End-to-End Processing Training Course

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

★★★★★ "I enjoyed it. I came to the webinar knowing nothing about the process, and I got away with a lot of ... more"

20-21 March 2025
+ 21-22 July 2025, 5-6 November 2025 »
from £1099

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

This intensive two-day course has been designed to offer a comprehensive, practical, and usable review of the production of PFS and will provide the latest information on all aspects of the process from manufacture and packaging for fill/finish through to final (post-fill) inspection. Quality will be a key focus of the programme and there will be extensive coverage of improvements in the manufacturing process, including advances in cleanroom technology and sterilisation. Other sessions will address visual inspection and the latest regulatory requirements to ensure that you are fully up to date. The faculty of speakers will provide key guidance and advice from their practical experience in this field and there will be ample opportunity for discussion.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of attending

Explore recent improvements in the manufacturing process
Understand visual inspection
Know the latest regulatory requirements

Who should attend?

This event is ideal for pharma start-ups, small and medium-sized pharma companies, CROs, CMOs, machine suppliers, hospital dispensaries, and anyone new to PFS or wanting to learn more in a relaxed and open environment. It will be of value to those working in the area of PFS with responsibility for device programmes, product development, product life cycle management, regulatory affairs, quality assurance and combination products. Drug delivery specialists, business development managers and product development managers will also find this course beneficial.

Enrol or reserve

This course will cover:

Day 1
Day 2

Syringe manufacture from components to the final product – an overview

The initial choice – bulk or pre-sterilised components?
Siliconisation – not beloved, but required
Handling and process overview

Filling and closing: Introduction to PFS Filling & Closing Machines with Examples

The Basics
PFS Dosing Systems
PFS Closing Methods
Multi-Format Machinery (PFS, Cartridges, Vials)

Overview: Trends in PFS: Machine Technology

Pumps ‘fit for purpose’
In Process Control (IPC), filling & stoppering
Containment
Use of Robotics

Terminal sterilisation of pre-filled syringes – strange but feasible

Why
How it is done
Points to consider
Validation

Visual inspection of pre-filled syringes

Defects and their detection
Inspection Methods
Assessing Batch and Sorting Quality
Specific Aspects of pre-filled Syringes
Visual Inspection in the Quality Life-Cycle
Setting up a manual Visual Inspection

Secondary packaging machines for PFS: An Introduction

What is Secondary Packaging?
Walk through a typical facility 2° packaging line (example/video)
Trends in Secondary Packaging
PFS handling special: Glass-to-glass contact

Overview: Trends in PFS: Drug Delivery

Market Dynamics
Innovation in PFS
Drug Development Trends
Manufacturing

PFS from the early days to the latest developments

Evolution of systems
Evolution of components
Evolution of application and application systems

Device Assembling and Control Processes for Auto Injectors

Target Product Process
Impact Primary packaging material
Assembling steps
Inline Controls
Function / Release Tests
Final Packaging

A Primer on System Selection

Points to consider
Available options

Regulatory requirements for pre-filled syringes

ISO design compliance
New MDR – what about it?
US requirements for combination products

Case study/workshop

Based on the key user requirements provided, participants will come up with outputs for:

Design features of the PFS
Test methods
Manufacturing processes and manufacturing environment

PFS state-of-the-union address and event summary

Review of the Market for PFS
Review of PFS Processing
Future trends in PFS

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Dale Charlton
DCBio Automation SIA

Dale Charlton is a Freelance Consultant for automation and fill / finish. Dale has spent a lifelong career in Life Sciences and Biotechnology encompassing both the academic and industrial sectors. Dale worked in a technical capacity in basic R&D at a major University and EMBL Heidelberg before embarking on a more formal academic career in biotechnology and studying for a PhD within the Drug Discovery Group of Pfizer into growth factor research (rGH, GHRF, IgF) . With industrial spells at Porton Down and Pittman-Moore (formerly Glaxo Animal Vaccines) in API and API scale-up, Dale settled back into biotech manufacture and moved more into the supply chain of finished drug products for small molecules & biologics, first as the MD of a life sciences distribution company and later as Director of Business Development, Optima pharma in sterile production automation. Having worked in the pharmaceutical industry from R&D to finished drug product, Dale has a unique understanding of the entire drug development life cycle and offers insight from both the pharma and a suppliers perspective.

More details

Andreas Rothmund
Vetter-Pharma

Dr. Andreas Rothmund is Qualified Person (retd) at Vetter Pharma-Fertigung in Ravensburg, Germany, an independent contract manufacturer specialised in the aseptic production of pre-filled application systems. He started his industrial career in 1985 as a lab manager. After two years he took over production responsibility for a German company specialised in eye drops and eye ointments, a position he held for nearly eight years.

He joined Vetter in 1994, where he has held several positions, including Head of Production for one of Vetter’s aseptic production units. He holds a degree in organic chemistry from the University of Constance, Germany.

More details

Susanne Hall
Vetter Pharma

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

20-21 March 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
05:30-13:00 New York (UTC-04)
Timings may be different for each day
Course code 14610

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 13 Feb

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

21-22 July 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Timings may be different for each day
Course code 14876

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 16 Jun

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

5-6 November 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 15045

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 01 Oct

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Pre-Filled Syringes: End-to-End Processing training course

I enjoyed it. I came to the webinar knowing nothing about the process, and I got away with a lot of knowledge. I enjoyed the chat between Andreas and Dale during the presentation, sharing their experience and complementing each other, that was knowledge beyond videos and presentations.

Mar 30 2023

Serge Batubenge United States of America
Mgr. Engineering , Regeneron Pharmaceuticals, Inc.

Mar 30 2022

It was very good, I was impressed, I would have loved to do this course in person but this was a good alternative. The speakers were very good, very knowledgeable but also good at teaching/ relating information. The presentations were easy to follow, it was useful to have the documents there to follow along as the speakers talked. All the content was relevant to the topic and occasional humus. I enjoyed the course and would recommend Management Forum to my colleagues.

Zhané Healey United Kingdom
Senior Laboratory Technician, Medical Engineering Technologies