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Pharmaceutical Medical Devices

Pre-Filled Syringes

21 Mar 2018

GBP EUR USD
Standard 699 979 1090
Early 599 839 934
Excluding VAT @ 20.00%

Book by 22 Dec to get the early booking price shown above.

Venue: Cavendish Hotel, London

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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 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 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 our annual Injectable Drug Delivery on the 21-22 March 2017 and should you wish to attend both the Pre-Filled Syringes and the Injectable Drug Delivery events please enter code PFSIDD when booking on-line to receive £200/€200 discount.

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.

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 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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