Pre-Filled Syringes

In this In-house course be guided through 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.

In-house Training and Consultancy Services

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

This In-house 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 and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample 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

Recommended Trainer

Charlton Dale

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.

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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