Berkshire Sterile Manufacturing (BSM), a fill finish CDMO located in Lee, MA, recently purchased a high precision load cell to perform non-destructive weight checks as part of their low loss fill process. The load cell is a Mettler Toledo WMF Series balance featuring unique capabilities to auto adjust for the environment and take highly accurate measurements in turbulent or highly unstable settings. The balance is also constructed with materials and added features to withstand sanitizing vapor hydrogen peroxide (VHP) cycles.
BSM validated a new fill process aimed to reduce line losses and filter holdup to less than 30 mL in December 2022. In February, the company began looking for a solution to offer non-destructive weight checks for the fill process to further reduce drug product loss.
“Some products we work with cost six figures to produce less than a liter of drug product,” said BSM CEO, Dr. Shawn Kinney. “These are very expensive and precious medicines where saving every drop is a priority. It was evident that adding non-destructive weight checks to our low loss fill process was the next step to reduce product loss even further.”
Laminar flow, mechanical vibrations, and sanitizing VHP cycles created real challenges to adding an analytical balance into an isolator where drug product filling occurs. BSM worked with Mettler Toledo to select a highly accurate and durable scale, featuring internal gyroscopes, advanced software, and an internal 100g weight for internal weight checks that all work to calculate out vibrations, air currents, and other external factors that could affect accurate readings. BSM also designed and manufactured supporting structures to hold the scale, dampen critical mechanical vibrations in the isolator, and to increase ease of use for operators.
The filling team at BSM performs non-destructive weight checks by tarring an empty vial on the scale then weighing the vial again after filling. BSM can perform 100% non-destructive weight checks to ensure all vials having passing fill volumes.
“Every unit we can save will allow more product for patients, stability and release testing,” commented Process Engineering Manager, Dr. Jake Krans. “This investment is critical to getting more product out to patients and can be the difference between having enough product to run the clinical study or not.”
About Berkshire Sterile Manufacturing:
Berkshire Sterile is a state-of-the-art fill finish CDMO that is specialized in small-scale sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, and lyophilization of vials all within isolators. Analytical support, stability studies, lyophilization development, formulation development, and method development are also offered. For more information, please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact them at email@example.com.
Read the full article: Berkshire Sterile adds non-destructive weight checks to their low-loss fill line