Technology Elite Awards 2019

20 US BUSINESS NEWS / 2019 Technology Elite Awards , Berkshire Sterile Manufacturing Best Clinical Product Sterilization Manufacturers - USA Sep19045 Providing clinical to small commercial scale sterile manufacturing services, Berkshire Sterile Manufacturing continue to achieve the highest levels of sterility assurance and quality. With state-of-the-art technology and stringent standards, discover how this firmhave become America’s best clinical product sterilisationmanufacturers and won in US Business News’ Technology Elite Awards. Through using the most modern technologies for sterile manufacturing, rigorous quality standards and highly trained employees, Berkshire Sterile Manufacturing (BSM) fills syringes, cartridges and vials both bulk and ready-to-use for their clients’ programs. The company also provides ancillary support to their clients’ drug productions, such as analytical method development and validation, stability studies, and formulation scale up. Always seeking to exceed client expectations, BSM is unrivalled in responding to sterile drug or medical device manufacturing needs or supplying products to support clinical trials through to commercialization. Since the company was founded in 2014, they have set out to develop the most flexible formulation and filling processes with the highest level of quality achievable for small batch fills. The company ensures it stays ahead of emerging developments by continuing to incorporate the most modern technologies while developing its current capabilities. The company promises to serve their clients’ needs using the best-in-class technology and fully vetted quality systems. Using state-of-the-art flexible fillers and isolators, Berkshire Sterile can fill vials, cartridges, and syringes in an environment removed from the manufacturing staff, reducing human contamination drastically, and giving clients flexibility in their container choice and scale up. Most other contract manufacturing organisations do not have the aforementioned isolators that remove the manufacturer from the filling process, and they do not have the flexible fillers that are capable of filling several container types. BSM’s flexibility sets them apart from the competition, without compromising on quality. In addition to developing a better fill finish process, BSM’s founders wanted to revive industry in the Berkshires by bringing high salary jobs to the area. Since most activity is completed onsite and all other tasks can be shipped out, the company’s operation is not affected by its location. However, the area can prove difficult for hiring employees with an industry background. As a result, BSM provides extensive, on-the-job training to ensure its employees understand their roles and can follow procedures effectively. Looking to the future, BSM will be adding a third isolator line in 2020 to expand capacity for future commercial clients. 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 tied to the isolator. The company will also add a second ventilator autoclave (sterilization by pressurized steam) 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. With many companies working to simplify and incorporate their technology into isolated systems, Berkshire Sterile Manufacturing welcomes growth and innovation throughout the industry. With rapid expansion since the company’s founding in 2014, Berkshire Sterile has stayed ahead of emerging developments with best-in-class technology and their unyielding commitment to quality in order to produce a safe product. Company: Berkshire Sterile Manufacturing Contact: Andrea Wagner, Senior Vice President of Business Development Website: “The state-of-the-art flexible filler (pictured) allows BSM to fill multiple container types”. “BSM’s semi-automated isolator filling line (pictured) removes the manufacturer from the filling process”.