Berkshire Sterile Manufacturing, a small-scale sterile fill finish operation in Lee, Massachusetts, has installed a new filler in its semi-automated isolator-based filling line.
The filler features a double headed filling and stoppering station, which is capable of filling multiple container types and sizes, including vials, cartridges and syringes. It also offers advanced nitrogen purging capabilities for vials, syringes and on-line weight checks.
This increases Berkshire Sterile Manufacturing’s capacity from 20,000-unit fills to 40,000-unit fills and provides improved accuracy, repeatability and quality of fill.
The machine was built by Colanar, specialist in advanced liquid filling systems and automated handling systems for Pharma and Biotech applications, with a high accuracy peristaltic and rotary piston pump hookup options for high viscosity fills. It can process up to 33 2R vials in a minute and has a significant range for the filling of vials (1ml to 100ml), syringes (0.5ml to 20ml) and cartridges (1ml to 20ml).
“We are continuously reinvesting in ourselves to ensure that our clients and their patients are receiving the highest quality filled drug products achievable,” Berkshire Sterile Manufacturing co-founder and CEO Shawn Kinney said.
“This is just another upgrade we have made to our facility to help meet and exceed their needs.”
Founded in 2014 by three industry experts totalling more than 50 years of experience in sterile drug manufacturing, Berkshire Sterile Manufacturing’s goal was to develop a process to provide the safest sterile drug products for clinical use and small-scale requirements.
Growing significantly since its inception, Berkshire Sterile Manufacturing provides the highest level of sterility assurance and quality via modern technologies for sterile manufacturing, stringent quality standards and highly trained employees. It also provides ancillary support to their clients’ drug productions such as analytical method development and validation, stability studies and formulation scale-up.