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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

& 30 Mar 2023 , 27-28 Jul 2023 , 8 Nov 2023

Book or reserve now

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 or reserve 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
21 Sep 2022
Live webinar
09:30-16:45
UK (London)
21 Sep 2022
Live webinar
09:30-16:45
UK (London)
GBP 599.00
EUR 859.00
USD 970.00
+ VAT @ 20.00%
Enrol now
to attend Live webinar
30 Mar 2023
Live webinar
09:30-16:45
UK (London)
30 Mar 2023
Live webinar
09:30-16:45
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 23 Feb 23*
Enrol now
to attend Live webinar
27-28 Jul 2023
Live webinar
13:30-16:45
UK (London)
27-28 Jul 2023
Live webinar
13:30-16:45
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 22 Jun 23*
Enrol now
to attend Live webinar
8 Nov 2023
Live webinar
09:30-16:45
UK (London)
8 Nov 2023
Live webinar
09:30-16:45
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 4 Oct 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* 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.

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • 42 Technology Ltd
  • Abbott Laboratories
  • Actelion Pharmaceutical Ltd
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Aptar Pharma
  • Archimedes Development Ltd
  • Astech Projects Limited
  • BIOCORP
  • Cabinet Michel Richebourg
  • DelSiTech Ltd
  • Eli Lilly and Company
  • F. Hoffmann-La Roche Ltd
  • Ferring Pharmaceuticals A/S
  • Forteq Healthcare
  • GlaxoSmithKline
  • Guerbet
  • IDEO
  • LEO Pharma
  • Mikron SA Boudry
  • NA
  • Nipro Glass Germany AG
  • Novartis Pharma AG
  • Optima Group pharma
  • Portal Instruments
  • RPC Formatec GmbH
  • Sandoz GmbH
  • Sindolor Medical Ltd
  • Teva Pharmaceuticals Industries Ltd
  • Vetter Pharma International GmbH
  • West Pharmaceutical Services Inc.

It was very good, I was impressed, I would have loved to do this course in person but this was a good alternative.
The speakers were very good, very knowledgeable but also good at teaching/ relating information. The presentations were easy to follow, it was useful to have the documents there to follow along as the speakers talked. All the content was relevant to the topic and occasional humus.

I enjoyed the course and would recommend Management Forum to my colleagues.

Zhané Healey, Senior Laboratory Technician, Medical Engineering Technologies, Mar 22

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

Gabrielle Kelsey, Production Manager, Torbay Pharmaceuticals, Mar 19

Very informative, good overview of PFS development. Speakers were knowledgeable.

William Turner, Associate Bioedical Engineer, Meridian Medical Technologies, a Pfizer Company, Mar 17

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., Mar 17