Berkshire Sterile Manufacturing (BSM) has announced its plan to add a third isolator line to expand capacity for future commercial clients. BSM is a fill/finish contract manufacturer providing formulation and sterile filling services to companies producing injectable medications for pre-clinical through commercialisation.
BSM produces injectable medications using state-of-the-art technology. These medications are filled inside isolators [top right] to create a barrier between the manufacturer and the drug product [bottom left]. This ensures all products are sterile and safe to inject. Robotic flexible fillers [top left and bottom right] are used to fill and seal each medication.
The injectable medications are produced inside isolators with robotic flexible fillers that can be modified to fill three container types: vials, syringes, and cartridges. The company currently has two isolators in operation with a fill rate of up to 1200 units/hour. The third line will contain a flex filler with the ability to fill at a rate of 3000 units/hour depending on container and fill volume. The isolator and filling line will be linked to a depyrogenation oven (sterilisation by heat), allowing for bulk vial use, with a vial washer located on the loading side of the oven.
The new line will contain a flex filler with the ability to fill at a rate of 3000 units/hour depending on container and fill volume
A rapid decontamination chamber will be included in the isolator for the introduction of pre-sterilised containers, and a high capacity lyophiliser (capable of producing 20,000 freeze-dried vials) will be also be connected to the isolator.
The company will also add a second ventilator autoclave (sterilisation by pressurised steam) and a new water for injection system (WFI; sterile water system) to the manufacturing area to provide redundancy in BSM's systems. This will ensure all necessary equipment is available if one of the systems were to be placed out of order.
Inspection will be updated with a semi-automated inspection system to handle the greater volume of product. This system will roll vials, cartridges, and syringes past inspectors and robotically spin the containers. This system will prevent loss of time due to manual inspectors having to pick up, swirl, and put down containers, and it will improve consistency in the inspection process.
The additions will be completed in 2020 to early 2021 and will offer expanded capabilities and better services to existing and future clients. "This is a win-win-win for our clients, the company and the community,” said CEO, Shawn Kinney.
The expansion will create 60 high-salary positions in Berkshire County, Massachusetts, expand services to our current and future clients, and produce high-quality medications to further clinical research.