We are currently undergoing a $20 million expansion to increase our fill capacity and capabilities. This expansion has doubled our clean room and warehouse space, and will bring a first-of-its-kind isolator-based robotic flexible filling line, complete with pulsed light capabilities to decontaminate RTU (ready to use) outer packaging. With this equipment, we will be able to fill larger lots of vials (RTU and bulk), cartridges, syringes and custom containers while advancing our quality and providing the ultimate in sterility assurance of your aseptically filled products.
The new filling line will feature an RTU tub decontamination chamber in addition to using a traditional no-touch-transfer (NTT) system. In this fully isolator-based chamber, a Staubli robotic arm will pick up an RTU tub and present each surface to a high-power, broad spectrum UV light. In just a few flashes, the light will sanitize each surface of the tub to a six log reduction in bioburden.
This will be the first application of this technology in the United States (second in the world). Pulsed light is safe, effective, efficient, green, and has no impact the integrity of the material. It will enhance sterility assurance for drug productions as it is being performed in addition to NTT, not in place of. Currently, most small-scale CMOs rely on NTT alone.
Want to learn more about pulsed UV light? Watch our webinar about this technology!
This filling line is designed to be fully automated, isolator-based, and highly flexible. On this line, we can fill vials (RTU or bulk), syringes, cartridges, and custom containers. This line also has lyophilization capability up to 35,000 10R vials, with the ability to add additional lyo capacity down the road. This filling line also has both a piston and peristaltic pump option, allowing for high viscosity filling.
Learn more about this line’s flexibility by watching our webinar!
The filler on this line will feature a new technology: non-destructive, real-time, 100% in-process weight checks (IPC) for nested containers.
The new IPC method transmits radio waves through the container. A receiver on the other end of the container determines the signal strength, which is correlated to the number of water molecules in the solution. This is then translated to a highly accurate volume measurement.
This method can be used in addition to or in place of a traditional, destructive weight check to ensure consistent fill volume across a lot. Currently this technology only works for bulk vials and RTU syringes, but this may change in the future.
Learn more about this technology in our webinar:
Reducing reliance on operators is fundamental to enhancing sterility assurance in aseptic manufacturing. That is why we have designed this line to be 100% automated and isolator-based. The line will feature four robotic arms for manipulating containers and materials within the isolators, and automated transport systems will move drug product and containers from chamber to chamber.
The robots will be programmed to perform planned and unplanned interventions to further reduce reliance on operators.
The introduction of materials into an isolator poses a risk of contamination. While most small scale fill finish companies utilize no-touch-transfer (NTT) systems to prevent contamination, BSM, Steriline, and Claranor has discovered a method to provide active decontamination in addition to NTT.
Pulsed light technology provides significant added sterility assurance and is currently used in many other industries as a sterilant. Claranor, Steriline, and BSM has harnessed this technology to produce the first active decontamination chamber in the US for small scale fill finish.
Automation and isolators are rapidly becoming a part of sterile filling lines to reduce operator interactions and thereby increase sterility assurance. However, this typically comes with a huge expense, a lack of container choice, and a highly complex validation.
Not anymore! Berkshire Sterile Manufacturing’s new isolator filling line will introduce a fully automated, flexible filling line capable of filling the most popular containers types and sizes (syringes, cartridges, RTU vials, and bulk vials). In this one hour webinar, speakers from BSM, Colanar, and Steriline will introduce this new technology and their solutions to long-standing weaknesses with isolator based filling.
A newly developed, patent-pending technology now provides volume measures for 100% of filled drug product for bulk vials and syringes without slowing down production. This innovation provides real-time, non-destructive measurements that can replace the IPC step or compliment it.
In this one hour webinar, Colanar and BSM will discuss this new technology, how it works, and how it will be used at BSM. They will also discuss other advanced filling techniques, including a new recipe that will allow BSM to fill vials with a headspace of less than 1% oxygen levels.
Wednesday, October 19th | 1PM EST