Delayed visual inspection due to lack of personnel is prevalent among fill finish CMOs, often leading to setbacks. Berkshire Sterile Manufacturing (BSM), a sterile filling CDMO located in Lee, MA, is attempting to solve this issue with its new semi-automated visual inspection system for vials. The system is manufactured by Optrel, and it eliminates manual handling of vials during inspection.
BSM performs a 100% visual inspection for all drug product lots it produces, followed by a smaller AQL inspection to confirm the reject rate. The current visual inspection process is manual and requires an operator to pick up each container, present it to a black and white background, swirl it, and quarantine or return vials.
“We consistently inspect drug product within a week of the drug product fill,” said Vice President of Manufacturing, Tyler Rush. “Though this is already fast, we wanted to continue to reduce backlog and get product inspected as soon as possible, so we looked for a system that would improve our efficiency and consistency in visual inspection.”
The Optrel visual inspection system handles the vials for the operator. The system presents the vials in front of a black and white background and automatically swirls the containers. The swirling speed can be adjusted up or down, and the system also optimizes the angle and lighting to allow inspectors to identify defects easily.
The new system increases inspection speed by up to four-fold by removing the time that the inspector spends handling the containers. The operating speed for this system can reach up to 1000 units per hour, and BSM also anticipates consistency between operators to improve.
If a reject is identified, the inspector will only need to point at the unit to have it automatically quarantined from the rest of the batch. Pausing the system is easy.
“We are constantly looking for ways to improve,” said Visual Inspection Manager, Aaron Gundlach, “Integrating this system into our inspection process will allow us to inspect more drug product with the same or greater quality and precision as our manual process.”
About Berkshire Sterile Manufacturing:
Berkshire Sterile is a state-of-the-art fill finish contract manufacturer that is specialized in sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization, 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.
Read the full article: Berkshire Sterile Installs Semi-Automated Visual Inspection System to Handle New Demand