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.

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

The Pre-Filled Syringes: End-to-End Processing 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

PFS over time

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

Summing-up: Trends in PFS: Drug Delivery

New PFS formats
Safety devices
Self-injection devices

Advances in cleanroom technology

History
RABS
Isolator
V-CRT® - Vetter Clean-Room Technology

Filling and closing: multi-format machine for nested syringes, vials and cartridges

Dosing and filling systems in comparison
Closing methods and their applications
Containment

Terminal sterilisation of pre-filled syringes – strange but feasible

Points to consider
Aseptic filling vs terminally sterilised

Summing-up: Trends in PFS: Machine Technology

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

Visual inspection of pre-filled syringes

Why do we inspect? Regulatory requirements
Inspection basics
- Defects – classification and defect evaluation lists
- Pros and cons of different inspection methods
Automated visual inspection of syringes – scope and limitations
Current developments

Secondary packaging machines for PFS: hero or villain of the PFS world?

Walk through a typical facility
Trends in secondary packaging: labelling, safety devices
Single machines v’s combined machines

Autoinjectors

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

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

Shipping PFSs all over the world

Points to consider
Shipping validation
GDP - Good Distribution Practices

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

Review of market drivers & drug development
Future trends in PFS

Enrol or reserve

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

Book Pre-Filled Syringes: End-to-End Processing Live online training

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

8-9 November 2023

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)
Course code 12664

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

Until 04 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

21-22 March 2024

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)
Course code 13574

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

Until 15 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

25-26 July 2024

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)
Course code 13805

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

Until 20 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

6-7 November 2024

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)
Course code 14035

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

Until 02 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.

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