Berkshire Sterile Manufacturing (BSM), a sterile filling contract development and manufacturing organization (CDMO), introduced a new semi-automated visual inspection system for vials. The system, manufactured by Optrel,is designed to eliminate manual handling of vials during inspection.

In a statement, the company said that the new system is intended to address delayed visual inspection due to lack of personnel which it said is prevalent among fill finish CMOs, which can lead to setbacks.

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.

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.

“We consistently inspect drug product within a week of the drug product fill, said Tyler Rush, vice president of manufacturing. “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.”

Aaron Gundlach, visual inspection manager said, “We are constantly looking for ways to improve. 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.”