Berkshire Sterile Manufacturing (BSM), a sterile filling contract manufacturing organization based in Massachusetts, has recently validated a new and innovative fill process designed to limit product loss to less than 30 mL per filled batch for small-scale sterile vial filling projects.
The new low loss fill process was designed for customers with limited drug product who need to conserve every drop. It’s also well suited for customers that have very small volume delivery needs and require excellent precision.
“A significant volume of drug product is lost in the tubing of the fill line,” said BSM CEO and cofounder, Dr. Shawn Kinney. “We wanted to reduce line losses as much as possible, so we removed the pump and fill line assembly entirely.”
“This technology is able to detect changes in charge profiles over time which makes it an excellent solution for evaluating drug product stability,” said Vice President of Quality Control, Devin Wigington.
Instead, the low loss fill process uses a pressure vessel and a time pressure filler to dispense the solution. Other than substantially reducing product loss, this change had several other unintended benefits. The new process is excellent for filling viscous solutions, and it is ideal for sheer-sensitive drug products.
“Another significant advantage of this new process is extremely low variability and high precision,” said Process Engineering Manager, Dr. Jake Krans.
The dispensed weight checks observed during the Installation/Operation Qualification (IOQ) of the low loss fill process were exceptionally precise and accurate, and the recorded variability was only 1.8%. This accuracy and low variability was demonstrated for very small dispensed volumes of around 150 mg.
“We designed this process to limit product loss. A typical batch filled on this process would lose less than 30 mL to line losses and filter hold up. That’s it,” said Krans.
The low loss fill process was validated in December. The process was demonstrated to maintain sterility for at least three calendar days and 36 working hours. Three fills of 1,000 units were performed for a volume of 1,200 mL of drug product. The process is validated to fill vial sizes of 2R to 6R at a rate of approximately 140 vials/hour.
“The results were better than expected,” said Kinney. “BSM now has a validated aseptic filling process for clients that significantly limits drug product loss without sacrificing quality.”
About Berkshire Sterile Manufacturing:
Berkshire Sterile is a state-of-the-art fill finish contract manufacturer 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 firstname.lastname@example.org.
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