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.

24-25 Mar 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 24 Jan

Book now

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 day one

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

Programme day two

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

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 vs combined machines

Regulatory requirements for pre-filled syringes

  • ISO design compliance
  • Pharmacopoeia compliance
  • New MDR – what about it?
  • Responsibilities in contracted operations

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

Panel discussion

  • Terminal sterilisation vs aseptic filling
  • Secondary packaging
  • Case study

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

Andreas Rothmund

Dr. Andreas Rothmund is Qualified Person 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.

Horst Koller

Horst Koller started his professional career in 1994 to work for a large pharmaceutical company in Germany managing the Process Engineering Group. He holds a degree as Dipl. Ing (FH) in Biotechnology. In 2000 he joined Schott in the business segment Pharmaceutical Packaging. He has been a key player in building the manufacturing unit for the Schott TopPac® polymer syringe within Schott AG. He held different positions including Quality Manager, Head of R&D, Manager Scientific Advisory and Manager Global Regulatory Affairs and Quality R&D. He is now CEO of HK Packaging Consulting GmbH.

He is an active member as expert of ISO/TC 76/ working groups and a frequent speaker at extractables & leachables as well as Prefillable Syringe conferences.

Dale Charlton

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.

Patrik Thoma

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.

Book now

24-25 Mar 2020
24-25 Mar 2020 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 24 Jan*
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Abbott Products GmbH
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • ALK-Abello A/S
  • Apoteket Produktion & Laboratorier AB
  • Baxter Innovations GmbH
  • Baxter R&D Europe
  • Bayer Pharma AG
  • BD
  • Bespak Europe Ltd
  • Cabinet Michel Richebourg
  • Cambridge Design Partnership
  • Cardinal Health
  • Eli Lilly and Company
  • Geistlich Pharma AG
  • Glide Pharmaceutical Technologies Limited
  • Haselmeier GmbH
  • Interdos Pharma B.V.
  • Linac Technologies
  • Martindale Pharma
  • Merck
  • Mikron SA Boudry
  • Optima Group pharma
  • Portal Instruments
  • Robert Bosch GmbH
  • RPC Formatec GmbH
  • RUMPLER TECHNOLOGIES
  • Takeda Austria GmbH
  • Technology Partnership Plc
  • Teva Pharmaceuticals Industries Ltd
  • West Pharmaceutical Services Cornwall Ltd

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

Gabrielle Kelsey, Production Manager, Torbay Pharmaceuticals

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.

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

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