Berkshire Sterile Manufacturing Expands Capacity

Berkshire Sterile Manufacturing (BSM), a fill/finish contract manufacturer providing formulation and sterile filling services for injectable medications, plans to add a third isolator line to expand capacity for future commercial clients. The expansion will be completed in 2020 to early 2021.

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 (sterilization by heat), allowing for bulk vial use, with a vial washer located on the loading side of the oven.  A rapid decontamination chamber will be included in the isolator for the introduction of pre-sterilized containers, and a high capacity lyophilizer (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 and a new water for injection system to the manufacturing area to provide redundancy in BSM's systems. This aims to 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, saving time from manual operation and improving consistency in the inspection process.

"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, MA, expand services to our current and future clients, and produce high quality medications to further clinical research."

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