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.

Course overview

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

This course has been designed to provide a comprehensive, practical and useable 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, 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 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’s look at a PFS fill/finish facility

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 and combination products. Drug delivery specialists, business development managers and product development managers will also find this course beneficial. It will provide a good comprehensive overview for those new to the field and those who require a refresher.

Programme

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

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

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

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

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • 42 Technology Ltd
  • Abbott Laboratories
  • ALK-Abello A/S
  • Astech Projects Limited
  • ASTECH PROJECTS LTD
  • B Braun Melsungen AG
  • Baxter Innovations GmbH
  • Becton Dickinson
  • Becton Dickinson UK Ltd (Oxford)
  • Bilthoven Biologicals BV
  • Calea UK Ltd
  • Cambridge Design Partnership
  • Elcam Medical Ltd
  • EMCM B.V.
  • Genetech Inc
  • Haselmeier GmbH
  • Meridian Medical Technologies Inc
  • MSD B.V.
  • Novartis Pharma AG
  • OnDrugDelivery Ltd
  • Oval Medical Technologies Ltd
  • RPC Formatec GmbH
  • Salvus Technology Limited
  • Sanofi-Aventis
  • Schreiner Group GmbH & Co KG
  • Takeda Austria GmbH
  • Team Consulting Ltd
  • Terry Weston
  • Torbay Pharmaceuticals
  • West-Medimop

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

Gabrielle Kelsey, Production Manager, Torbay 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.