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Bottom line: expensive recalls from glass contamination can be avoided.

Glass particulates in vials poses a risk of contamination and costly recalls.

In a recent Fierce Pharma article, the inclusion of glass particulates in vials from failure in the manufacturing process has been tied to product recalls at several key phamaceutical companies. This particular type of recall poses a potential safety risk to patients such as a thromboembolism, a life-threatening pulmonary emboli or a host of other catastrophic health problems. Whether used as an audit of contract manufacturers or a regular line check, in-line monitoring is invaluable to recall prevention. An acrylic replica of the vials in-use is added to the line with embedded sensors transmitting a real-time report of the collision and acceleration rates, pressure and vertical load that the vials are subjected to. With accurate data, damage can be avoided to reduce the risk of contamination and expensive recalls.

 

 

Impact and improper set-points must be identified before critical failure.

In pharma, the responsibility a manufacturer has to the end consumer extends past container aesthetics. The industry's strict controls and regulations dictate material handling processes and precise monitoring of the production process. Vulnerabilities in the process and materials must be detected well before the point of critical failure. The use of precise in-line sensors such as ShockQC, PressureQC and VerticalQC can be used to identify areas of impact, pressure and vertical load to pinpoint weak points in the process and ensure precise calibration of set-points. Increased visibility of the process ensures data-driven decisions to isolate weak points and take immediate corrective action before critical failure. 

Glass breakage and downtime results in lost profit.

Though consumer safety is the utmost priority; the ultimate goal is to produce more than current levels, both safely and efficiently. One of the main obstacles in achieving this is production downtime due to breakage. Of course, loss is not only valuable product and materials but also lost production availability. ShockQC has been proven in numerous applications to significantly reduce breakage up to 80% to greatly improve operational efficiency. To do this, acrylic smart sensor replicas of the containers in-use are inserted on the line to transmit impact and IPS rates that the glass vials are experiencing. Damage can be averted when areas of possible damage are pinpointed and immediate action is taken.

Reduce recalls. Mitigate risk. Improve profit.
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