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Pre-Filled Syringes: End-to-End Processing

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.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

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.

Programme

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 filling overview

PFS over time

  • Evolution of components
  • Evolution of processes and equipment
  • Evolution of application and application systems

PFS for biotech: improvement in the manufacturing processes

  • Controlled tungsten
  • Optimised silicone oil
  • Tighter controlled dimensions • Fit-for-device function

Trends with PFS

  • New PFS formats
  • Safety devices
  • Self-injection devices
  • Leachable and extractable considerations

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

  • Dosing and filling systems in comparison
  • Closing methods and their applications
  • Format parts – easy to change
  • Containment

Secondary packaging of PFS/vials/cartridges

  • Materials/dimensional requirements
  • Compatibility with existing filling lines
  • Handling of ready-to-fill vials and cartridges

Advances in cleanroom technology

  • Isolator
  • RABS
  • V-CRT®

Panel discussion

  • PFS component choice
  • PFS filling and closing
  • Cleanroom technology

Terminal sterilisation of pre-filled syringes – strange but feasible

  • Points to consider
  • Aseptic filling vs terminally sterilised

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

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

Open floor: all topics and related topics

Including

  • Good distribution practice (GDP)
  • Drug delivery devices: auto-injectors, pen injectors, wearable devices

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

  • Review of market drivers and drug development
  • Future trends in PFS

Final discussion session and concluding remarks

Presenters

Dale Charlton (More...)

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.

Andreas Rothmund (More...)

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.

Patrik Thoma (More...)

Patrik Thoma,is Managing Director of Zellwag Pharmtech AG. Zellwag Pharmtech AG develops and builds filling and sealing systems for the pharmaceutical, health care and cosmetics industries in the medium-performance segment. Filling different types of containers on the same machine is their specialty. The machines and systems are modular and compact in design.

Patrik comes from the field of engineering and has 25 years of experience in the conception and production of customized systems in the areas of pharmaceuticals, cosmetics, health care, food and chemicals. He began his career as a project- and engineering director. Proximity to customers and products has shaped his development which has involved addressing customers, meeting product and market requirements in different areas and the development of new solutions.

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Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 30-31 Mar 2022
  • 21-22 Sep 2022

Book now

Previous customers include...

  • 3P Innovation Ltd
  • Abbott Laboratories
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Alexion Pharmaceuticals Inc
  • ALK-Abello A/S
  • Bayer Pharma AG
  • Bespak Europe Ltd
  • Catalent Pharma Solutions
  • Daicel Corporation
  • Eli Lilly and Company
  • F. Hoffmann-La Roche Ltd
  • Glaxo Smithkline Biologicals
  • Interdos Pharma B.V.
  • Linac Technologies
  • Medac GmbH
  • Meridian Medical Technologies Inc
  • Nipro Glass Germany AG
  • Nuova Ompi srl
  • OnDrugDelivery Ltd
  • Phillips-Medisize
  • Q-Med AB
  • Robert Bosch GmbH
  • RUMPLER TECHNOLOGIES
  • Salvus Technology Limited
  • Sinclair Pharma SRL
  • Tech Group Europe
  • Teva Pharmaceuticals Industries Ltd
  • Tip-top.com Limited
  • UCB Celltech
  • Ypsomed AG

Very knowledgeable and helped answer numerous questions. Very helpful and interested in individual challenges.

Gabrielle Kelsey, Production Manager, Torbay Pharmaceuticals, Mar 19

Very informative, good overview of PFS development. Speakers were knowledgeable.

William Turner, Associate Bioedical Engineer, Meridian Medical Technologies, a Pfizer Company, Mar 17

Friendly, knowledgeable people. I would have liked to go a bit deeper into the technical parts (syringes, tubs, machines)

Marc van Nispen, Project Engineer, EMCM B.V., Mar 17