Do you need to get into production quickly? Stock fill/finish machines are coming! The Versynta Isolated FLT is the compact fill/finish solution for clinical trials and small batch production. Easy to operate, with layered safeguards to maximize output and the shortest biodecontamination times on the market. Available for FAT in Minneapolis this fall, so get in touch to learn how to reserve your equipment today. Click here to view our brochure.
Whether you’re new to the field of aseptic fill/finish or a seasoned veteran, there is always more to learn when it comes to barrier technology. That’s why Syntegon is offering free, on-demand content as part of our online learning series, Syntegon presents….Isolators 101. You’ll find videos describing the differences between RABS and Isolators, how to develop a fast biodecontamination cycle, transferring materials into and out of Isolators, qualification and validation, and much more. Hosted by …more
Fill/finish lines surrounded by RABS and/or Isolators come with many benefits, but one of the initial challenges is determining how to transfer commodities, fluid paths, tools or drug product itself into the closed ISO 5 space. Have no fear, Syntegon’s experts are here! Join Matthias Angelmaier and Dr. Laura Moody on Wednesday, May 12th at 10am CDT for the final chapter in Syntegon’s Isolator webinar series, as they describe the various techniques used to quickly and safely move materials across barriers and into the final fill production space. Click here to register.
On Wednesday, April 28th, the next chapter in Syntegon’s Isolator webinar series launches. Our experts Stefan Schuh, Dr. Laura Moody and Matthias Angelmaier will lead our free event, “How to handle complex isolator lines: Insights into the project life cycle of a liquid lyo-line”. Join them to learn more …more
FLT #16 configured to fill gene therapy products in an isolator
The Minneapolis plant of Syntegon is proud to announce the delivery of its 16th and 17th model FLT small batch vial filler for ATMP applications. Configured to fill gene therapy products in an isolator and oncolytic immunotherapies and vaccines in a RABS, respectively, these latest deliveries of the proven FLT platform for RTU vials exemplify the trend towards smaller batches of higher value products and highlight Syntegon’s track record of providing solutions that meet the exacting requirements of the rapidly growing ATMP segment.
The Syntegon FLT vial filler is designed …more
Get your ATMP filler delivered in 6 months.
The model FLT in a standard RABS configuration from Syntegon is available in six months or less. The Syntegon FLT vial filler is designed as a platform for clinical trial production and small batch manufacturing of high value pharmaceuticals. Combining Syntegon’s know-how and design experience in both vial filler and barrier system technologies, the FLT …more
Since many of the machines and line solutions that Syntegon, formerly Bosch Packaging Technology, delivers to the North American market for the fill-finish of liquid pharmaceuticals are designed and manufactured in our center of competency in Crailsheim, Germany, Syntegon has established local, dedicated new machine and after-sales support teams to ensure the provision of timely and comprehensive support in the region. These teams are based out of …more
What is “Changeover Time”
ISPE Definition:
The time by which a processing area is cleared of supplies and components used in the manufacture of a previous product and then readied for production of a new product. This often includes parts change over and / or special cleaning to eliminate cross-contamination.
In other words:
Activities and the time needed between two batches …more
