04-04-2017, Mainz, Germany
SCHOTT Sets Unprecedented Quality Control Standards for Pharmaceutical Tubing
New technical performance specifications underline aspiration to ‘zero defect’ glass tubingSCHOTT has presented new technical specifications for clear and amber FIOLAX® tubing that achieve unprecedented quality control standards. By harnessing big data through the implementation of the perfeXion™ system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100 percent 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.
The new 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 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,” says Dr. Patrick Markschlaeger, Executive Vice President Business Unit Tubing. “This update is proof of SCHOTT’s ongoing commitment to process improvement and excellence in the market.”
Case in point: 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. 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
- 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.
“The pharmaceutical companies put their patients first by ensuring high-quality products,” said Dr. Markschlaeger. “We owe them that same level of dedication to constant improvement right from the beginning of the value chain.”
SCHOTT is a leading international technology group in the areas of specialty glass and glass-ceramics. The company has more than 130 years of outstanding development, materials and technology expertise and offers a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance, pharma, electronics, optics, life sciences, automotive and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. The group maintains a global presence with production sites and sales offices in 34 countries. With its workforce of approximately 15,000 employees, sales of $2.21 billion were generated in fiscal year 2015/2016. www.us.schott.com
Gregory FCA on behalf of SCHOTT
SCHOTT North America, Inc.
Rina Della Vecchia
555 Taxter Road
Elmsford, NY 10523
Elmsford, NY 10523