SCHOTT sets quality control standards for pharma tubing industry

New technical performance specifications underline aspiration towards ‘zero defect’ glass tubing

SCHOTT India has presented new technical specifications to achieve unparalleled quality control standards for its FIOLAX pharmaceutical glass tubing manufactured in India. By harnessing big data through the implementation of its perfeXion system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100 per cent of the tubing. As a result, SCHOTT now offers an improved product with superior auditability and traceability for the pharmaceutical industry. These improvements are anchored in the company’s new specifications and thus made visible for customers globally.

The new process has been introduced in all SCHOTT plants worldwide and will be applied to all FIOLAX tubes manufactured in its Jambusar plant. These technical standards are the culmination of years of in-house research into the development of tubing geometry measurement, suitable for SCHOTT’s fast-paced production environment. The tubing, used for vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning, even for parameters such as the inside diameter, which previously were difficult to measure. By improving the measurement of visual quality characteristics as well, SCHOTT can offer individual specifications tailored even closer to customers’ requirements.

In addition to tightening the tolerances for outside diameter, inside diameter, and wall thickness, SCHOTT India has added specifications for the precise measurement of circularity, siding, and straightness in these new standards. Furthermore, the minimum length restrictions for outside diameter and wall thickness tolerance deviations have been completely eliminated, the maximum permissible airline width has been reduced from 0.1 mm to 0.08 mm, and an extractables profile for the glass composition has been added for the first time.

SCHOTT has also implemented a zero-defect tolerance for the following criteria:

• Maximum airline width of 0.08 mm
• Aggregate airline length depending on application
• Cracks
• Closed or missing DENSOCAN vent hole and its dimensions

These standards are achievable with perfeXion, which uses state-of-the-art cameras and lasers to pinpoint potential defects along the production line, generating more than 100,000 data tags per minute and feeding them into a real-time production database. The process allows SCHOTT to automate inspection of 100 percent of tubes, while generating valuable data for potential improvements.