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.

27 Mar 2019

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 15 Feb

Book now

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

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 Charlton, Senior Key Account Manager, Hameln Pharmaceuticals GmbH. 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.

Book now

27 Mar 2019
27 Mar 2019 Cavendish Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 15 Feb
Enrol now

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Previous customers include...

  • Advanced Electron Beams
  • Alfa Wassermann S.p.A
  • AMGEN INC
  • Apotek Produktion & Laboratorier AB
  • Apoteket Produktion & Laboratorier AB
  • Baxter Innovations GmbH
  • BIOCORP
  • Cabinet Michel Richebourg
  • Calea UK Ltd
  • Catalent Pharma Solutions
  • EMCM B.V.
  • Ferring Pharmaceuticals A/S
  • Guerbet
  • Harro Hoefliger Packaging Systems Ltd
  • Haselmeier GmbH
  • Komax Systems LCF SA
  • LEO Pharma
  • Medac GmbH
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MSD B.V.
  • MSD/NV Organon
  • Robert Bosch GmbH
  • Sandoz GmbH
  • Schreiner Group GmbH & Co KG
  • Synthon Biopharmaceuticals BV
  • Terry Weston
  • Teva Pharmaceuticals Industries Ltd
  • Toxikon Europe NV
  • West Pharmaceutical Services
  • West-Medimop

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.