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Pre-Filled Syringes: End-to-End Processing Training Course
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.
21 Sep 2022
Details
Course overview
This intensive one-day course has been designed to offer a comprehensive, practical, and usable review of the production of PFS and will provide the latest information on all aspects of the process from PFS components, manufacture and packaging for fill/finish through to final (post-fill) inspection. Quality will be a key focus of the programme and there will be extensive coverage of improvements in the manufacturing process, including advances in cleanroom technology and sterilisation. Other sessions will address visual inspection and the latest regulatory requirements to ensure that you are fully up to date. The faculty of speakers will provide key guidance and advice from their practical experience in this field and there will be ample opportunity for discussion.
Who should attend?
This event is ideal for pharma start-ups, small and medium-sized pharma companies, CROs, CMOs, machine suppliers, hospital dispensaries, and anyone new to PFS or wanting to learn more in a relaxed and open environment. It will be of value to those working in the area of PFS 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.
Programme
Syringe manufacture from components to the final product – an overview
- Component selection – a primer
- Bulk or pre-sterilised components?
- Siliconisation – not beloved, but required
- Handling and filling overview
PFS over time
- Evolution of components
- Evolution of processes and equipment
- Evolution of application and application systems
- Safety devices
- Self-injection devices
Filling and closing: multi-format machine for nested syringes, vials and cartridges
- Dosing and filling systems in comparison
- Closing methods and their applications
- Format parts – easy to change
- Containment
Terminal sterilisation of pre-filled syringes – strange but feasible
- Points to consider
- Aseptic filling vs terminally sterilised
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 machines for PFS: hero or villain of the PFS world?
- Walk through a typical secondary packaging line
- Trends in secondary packaging: labelling, safety devices, glass-to-glass contact
- Single machines v’s combined machines
Regulatory requirements for pre-filled syringes
- ISO design compliance
- Pharmacopoeia compliance
- New MDR – what about it?
- Responsibilities in contracted operations
Open floor discussion
PFS state-of-the-union address and event summary
- Review of market drivers
- Future trends in PFS
Final discussion session and concluding remarks
Presenters
Dale Charlton (More...)
Dale Charlton is a Freelance Consultant for automation and fill / finish. Dale has spent a lifelong career in Life Sciences and Biotechnology encompassing both the academic and industrial sectors. Dale worked in a technical capacity in basic R&D at a major University and EMBL Heidelberg before embarking on a more formal academic career in biotechnology and studying for a PhD within the Drug Discovery Group of Pfizer into growth factor research (rGH, GHRF, IgF) . With industrial spells at Porton Down and Pittman-Moore (formerly Glaxo Animal Vaccines) in API and API scale-up, Dale settled back into biotech manufacture and moved more into the supply chain of finished drug products for small molecules & biologics, first as the MD of a life sciences distribution company and later as Director of Business Development, Optima pharma in sterile production automation. Having worked in the pharmaceutical industry from R&D to finished drug product, Dale has a unique understanding of the entire drug development life cycle and offers insight from both the pharma and a suppliers perspective.
Andreas Rothmund (More...)
Dr. Andreas Rothmund is Qualified Person (retd) 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.
Book now
Book now
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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21 Sep 2022 Live webinar 09:30-16:45 UK (London) |
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21 Sep 2022 Live webinar 09:30-16:45 UK (London) |
GBP 599 499 EUR 859 719 USD 970 814 Until 17 Aug* |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.