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Study: Automatic Inspection for Lyophilized Drug Products in Valor Vials

Companies partnered to test whether the new vial material would present obstacles to proper inspection for pharmaceutical manufacturers.

Corning developed Valor Glass for vials designed to be more resistant to damage than conventional glass.
Corning developed Valor Glass for vials designed to be more resistant to damage than conventional glass.

While material developments can be exciting and full of possibility, the reality is that sticking with what works—and what’s validated—is a very tempting proposition for pharma manufacturers who question whether existing machinery will work with the new innovation.

With Corning’s new Valor Glass, the company set out to ensure that its new technology could exist as a “drop-in” solution, capable of being incorporated into production lines without replacing current machinery or necessitating significant augmentations.

First, what is Valor Glass? Glass tech has largely remained the same for the last century, but Corning has developed a glass for vials that is more resistant to damage than conventional glass and with a low coefficient of friction exterior coating. This is important because:

  • Pharmaceutical filling lines process hundreds of conventional borosilicate vials a minute, creating glass-to-glass contact that can lead to scratches and breakage.
  • In addition to causing waste, this frictive contact can generate small glass particles that necessitate cleaning, resulting in costly manufacturing downtime.
  • Conventional borosilicate glass vials have a high coefficient of friction surface, increasing their predisposition to jam. In this situation, operators may have to intervene, increasing the potential for contamination. 

With a “Quality by Design” approach, Corning’s Valor vial was specifically developed as a drop-in glass packaging solution that minimizes many of these challenges. For example, Corning identified and solved for the root cause of delamination by developing a new glass composition that still meets the USP hydrolytic requirements for Type I pharmaceutical glass. In addition, Corning applied chemical strengthening that the company reports improves breakage resistance and provides at least 30x protection against stable crack formation in laboratory testing.

Testing needed to be performed to confirm that Valor Glass’ patented exterior coating would not affect the lighting and performance of automatic inspection machines (AIM). AIMs are utilized by numerous pharmaceutical companies throughout the world and are a key component to consistent and efficient inspections that improve output and reduce false rejects. Automated inspection machines require substantial investment, so retrofitting or replacing them might cause manufacturers to pause and consider financial implications before incorporating any new vial, regardless of the container’s advantages.

Inspection testing

Corning approached Antares Vision, a global provider of inspection technology, and inquired whether the company could provide a machine capable of inspecting its new Valor vials, and determining what effects, if any, the containers would have on inspection performance. Antares worked with Corning to create filled Valor vials with defects similar to those found in pharmaceutical operations for lyophilized drug products. Then inspection was performed for both product and container defects utilizing the Antares Vision Lyo-check automated inspection machine.

Inspection was performed for both product and container defects utilizing the Antares Vision Lyo-check automated inspection machine.Inspection was performed for both product and container defects utilizing the Antares Vision Lyo-check automated inspection machine.The purpose of this study was to determine the effect of the Valor vial exterior coating on the challenging automated inspection of lyophilized drug defects–particularly regarding lighting and vision requirements. Lyophilized products are deemed difficult to inspect due to variations in the quality and consistency of the “lyo cake,” and the ability of particles to hide within the dried powder; a lack of contrast adds to imaging challenges. 

  • To minimize dimensional variability influence, Corning provided sized, matched, coated and uncoated small vials. The study was set up so that a sample set of “Good Vials” (coated and uncoated) was created with lyophilized product inside, with “no defects” present in the vial, stopper, crimp or lyophilized cake;
  • A second set of “Defect Vials” was also created with lyophilized product containing the various lists of defects found in Table 1. Inspections consisted of typical methods performed in a pharmaceutical automated environment, at speeds up to 24,000 pcs/hour. The study was designed to determine if automated inspections are affected by the glass composition or coating on the vials.  
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