SCHOTT Incorporates Improved Technical Performance Standards

SCHOTT has taken new steps to help ensure its clear and amber FIOLAX® glass tubing has zero defects by implementing new technical performance specifications.

Now used to insect 100% of tubing, the new perfeXion™ system specifications achieve improved quality control standards in comparison to the previous statistical sample-based quality-control process. 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 are made visible for customers. The new technical standards are the culmination of years of in-house research into the development of tubing geometry measurement that is suitable for SCHOTT’s fast-paced production environment. Used for vials, syringes, cartridges, and ampoules, the tubing can now be produced at an even higher quality, including for parameters such as the inside diameter, which previously was difficult to measure.

By improving the measurement of visual quality characteristics, SCHOTT can offer individual specifications tailored even closer to customers’ requirements.

Executive vice-president of business unit Tubing Dr. Patrick Markschlaeger says: "In 1988, SCHOTT became the first manufacturer to publish exact specifications of important pharmaceutical glass tubing products, and we have continued to build on that legacy of being the standard for quality in the industry.

"This update is proof of SCHOTT’s ongoing commitment to process improvement and excellence in the market."

In the new specifications, the tolerances for outside diameter, inside diameter, and wall thickness have been expanded to now include precise measurements of circularity, siding, and straightness. In addition, 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 0.1mm to 0.08mm 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 0.08mm
  • 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 a minute and feeding them into a real-time production database. The process allows SCHOTT to automate inspection, while generating valuable data for potential improvements.

Dr. Markschlaeger added: "The pharmaceutical companies put their patients first by ensuring high-quality products.

"We owe them that same level of dedication to constant improvement right from the beginning of the value chain."

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