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

Book now

20 Mar 2019
20 Mar 2019 Venue not yet confirmed
+ VAT @ 20.00%
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Previous customers include...

  • Admiral S.A.
  • ALK-Abello A/S
  • AMGEN INC
  • Baxter R&D Europe
  • Bayer Pharma AG
  • BD
  • BD Medical - Pharmaceutical Systems
  • Becton Dickinson
  • Bespak Europe Ltd
  • Eli Lilly and Company
  • Guerbet
  • MSD/NV Organon
  • Novo Nordisk A/S
  • Optima Group pharma
  • Oval Medical Technologies Ltd
  • Owen Mumford Ltd
  • Phillips-Medisize
  • Piramal Healthcare Limited
  • Q-Med AB
  • Rexam Pharma GmbH
  • RPC Formatec GmbH
  • RUMPLER TECHNOLOGIES
  • Salvus Technology Limited
  • Sanofi-Aventis Deutschland GmbH
  • Sinclair Pharma SRL
  • Team Consulting Ltd
  • Terry Weston
  • Teva Pharmaceuticals Europe B.V.
  • West-Medimop
  • Wyeth Pharmaceuticals

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.