ProSyries℠ Pre-filled Syringe Packaging and Labeling
It’s always a great experience to have clients visit our facility and personally show them our latest innovations (this time in pre-filled syringes) and services. Last week I had a wonderful opportunity to do exactly that with over 30 participants at our Behind the Scenes Facility Tour, part of our INSIGHTS Europe customer engagement event. On Tuesday we opened the doors of our Basel facility and welcomed our customers to see our fully automated ProSyries℠ pre-filled syringe line in the cold environment, as well as our brand new dedicated cold chain building. With me to showcase the new facility and all of its capabilities were experts Wolfgang Kramp, Senior Quality Manager and Stephan Rimpler, Director of Operations.
First up, our dedicated cold chain building – the first of its kind in the industry – which maintains cold temperatures all the way from truck to dock. During the tour, attendees were suited up in Good Manufacturing Practice (GMP) clothing and given a glimpse behind the scenes, able to watch two job steps running to gain a first-hand look at work in progress. Everyone was very impressed with the cold capabilities from the loading dock, syringe line, pick & pack, and out the door. Also during the tour, our own software system - GPM - was highlighted as a way to control materials as they are issued to the room. This same system is used globally at all Fisher Clinical Services locations, ensuring consistency no matter where your drug is being packaged and labeled. Lastly, when asked the million dollar question, “Have you had any Time Out of Environment (TOE) since the opening of the new building and to date?”, the answer was a firm “No!.” Our regular testing of the electricity backups, generator and systems further ensure that we do not have any TOE.
The second tour featured our fully automated ProSyries pre-filled syringe system, which includes plunger rod and backstop assembly as well as label printing with optical character recognition and verification (OCR/OCV) and application, all under temperatures ranging from 2°C to 25°C. Highlights of this tour included discussions surrounding the benefits of auditing only one line for both biologics and other ambient syringe assembly requirements. Questions arose during the tour that led to continued dialogue about maximizing flexibility to meet the unique needs of every trial as well as reducing risk through global processes and quality systems. Equally impressive is that our Fisher Clinical Services sites in Horsham and Allentown have identical or similar equipment which allows for manufacturing in both the US and EU in parallel, on the same/similar equipment, with the same processes, ensuring the same level of quality.
Speaking of quality, our roundtable session discussed the development and quality considerations surrounding syringe assembly and packaging. One point of interest was the impact of the Fisher Clinical Services quality team at the product specific validation stage. The team’s knowledge and expertise in running clinical trials is paramount to helping align client specific requirements for these syringe trials. There were also great discussions around the effects of temperature changes on material behavior when moving from ambient to cold conditions, as well as the impact of material selection when planning a clinical trial. The feedback from the attendees was overwhelmingly positive, with the biggest take-away, the time savings on valuable TOE allowing greater flexibility and helping clients to prevent excursions further down the supply chain.
Thank you to all of the attendees for your participation, questions, and feedback. It was a pleasure to have you and we look forward to serving you soon. If you would like to add a facility tour to your next site visit, we are more than happy to show you our state-of-the art capabilities.
Based in the US and interested in attending an Insights customer engagement event? Click here to register for our Insights West Coast this upcoming May; click here to register for our Insights East Coast this June.
If you're interested in learning more about pre-filled syringes, read our latest white paper - Cold-Chain Fully Automated Assembly and Labeling of Pre-Filled Syringes for Clinical Trials.