Pre-Filled Syringes

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.

20 Mar 2019

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Course overview

Quality, Quality, Quality: from manufacture, through fill/finish to final inspection

This seminar has been designed to provide a comprehensive, practical and usable overview of the production of Pre-Filled Syringes and will provide the latest information on manufacture, packaging for fill/finish through to final (post-fill) inspection. Quality will be a key focus for the day and 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.

Please note we are also running:

Book both

This meeting runs back-to-back with Injectable Drug Delivery on 22-23 March 2018 and there is a further £200/€280 discount when booked together with this programme.

To register on both events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Why should you attend?

  • Gain a comprehensive update of the manufacture of pre-filled syringes from experts in the field
  • Discuss key areas of quality in syringe manufacture
  • Know the requirements for inspections and how to implement them
  • Share an insider

Who should attend

Those working in the area of Pre-Filled Syringes with responsibility for device programmes, product development, product life cycle management, regulatory affairs, quality assurance, combination products, drug delivery specialists, business development managers, product development managers.

Programme

Welcome and introductions

Pre-filled syringes for biotech: improvement in the manufacturing process development

PFS systems

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

Discussion

Syringe manufacture from components to the final product – an overview

  • The initial choice – bulk or pre-sterilised components?
  • Siliconisation, not beloved, but required
  • Secondary packaging and more – assembly of PFS into auto-injectors

The next step: fill/finish for nested syringes, vials and cartridges

  • A unique machine for processing pre-sterilised syringes, vials and cartridges
  • Integrated capping
  • Maximum product yield by using special start up and end of production filling processes
  • State-of-the-art peristaltic pump technology together with a combi filling station
  • State-of-the-art single use filling technology including data from the performance qualification
  • Mock up study for optimised use of barrier system
  • Upstream processes for bringing the different containers to the point of fill

Discussion

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 of PFS

  • Materials
  • Dimensional requirements
  • Compatibility with existing filling lines

Discussion

Design verification testing of device function for PFS

  • Meeting the US FDA requirements for “Combination Products”
  • Meeting the essential requirements of the Medical Device Directive (MDD) in the EU
  • Identifying and verifying the critical functional and performance requirements for the components and finished pre-filled syringes

State-of-the-nation address for PFS and summary

Discussion

Close of seminar

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.

Dale Charlton

Dale has spent a life long career in Life Sciences & Biotechnology spanning over 28 years covering work in both the academic and industrial sectors. Following his first degree in Biological Sciences and spells at Porton Down & Pittman Moore vaccines (Formerly Glaxo Animal Health) developing vaccines/adjuvant systems, Dale settled back into the biotech industry proper developing therapeutic Monoclonal Antibodies at Celltech in Slough UK.

Dale successfully undertook a PhD at Pfizer Drug Discovery Sandwich, Kent UK & the University of Nottingham on peptide drug candidates before moving out of academia and into the supply industry in the field of robotics and automation for the biopharmaceutical industry. Dale progressed from Product Specialist to Managing Director of an independent Life Science company until moving to his role as Director of Business Development for the Optima Group pharma, Germany and more recently to ATS Sortimat.

He has a number of scientific publications to his name and has written a number of articles for journals and magazines and regularly gives presentations at numerous international conferences in the field of Fill/Finish.

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20 Mar 2019
20 Mar 2019 Venue not yet confirmed
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Previous customers include...

  • 3P Innovation Ltd
  • Abbott Laboratories
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Apotek Produktion & Laboratorier AB
  • Apoteket Produktion & Laboratorier AB
  • Astech Projects Limited
  • ASTECH PROJECTS LTD
  • Baxter Innovations GmbH
  • Bayer Pharma AG
  • BECTON DICKINSON AB
  • Bilthoven Biologicals BV
  • BIOCORP
  • Crospon Limited
  • Datwyler Pharma Packaging Belgium NV
  • Elcam Medical Ltd
  • Geistlich Pharma AG
  • Guerbet
  • Komax Systems LCF SA
  • Medac GmbH
  • Meridian Medical Technologies Inc
  • MSD/NV Organon
  • OnDrugDelivery Ltd
  • Owen Mumford Ltd
  • Q-Med AB
  • RPC Formatec GmbH
  • Sandoz GmbH
  • Schreiner Group GmbH & Co KG
  • Technology Partnership Plc
  • Teva Pharmaceuticals Europe B.V.
  • Tip-top.com Limited

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

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

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.