Posts Tagged ‘Isolation Technology’

How do I get my materials into an Isolator?

by adminpharma

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.

Next chapter in Isolator webinar series

by adminpharma

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

Syntegon Delivers 16th and 17th Model FLT Small Batch Vial Filler for ATMPs

by adminpharma

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

ATMP small batch fillers done right, delivered fast

by adminpharma

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

Syntegon Expands Local Support for Import Projects in North America

by Bosch Pharma

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

Mini White Paper: Changeover on a Syntegon Isolator Line

by Bosch Pharma

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

Article in Pharmaceutical Processing by Bosch’s Jürgen Metzger: The Fine Art Of Transferring Products Into Barrier Systems

by Bosch Pharma

Pharmaceutical manufacturing processes are becoming more complex and guidelines stricter. Accordingly, the focus in aseptic operations is of course protecting the aseptic interior of a barrier system against the environment and vice versa also protecting operators from highly potent pharmaceuticals. This requires suitable barrier technologies. One of the first steps is the categorization of the actual pharmaceutical product, followed by …more

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