SCHOTT Sets Unprecedented Quality Control Standards for Pharmaceutical Tubing Industry in India

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

· All SCHOTT FIOLAX® tubes will be inspected by the new perfeXion™ quality process starting July 1, 2017 in India

Jambusar, July 17, 2017: In an unprecedented development, 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 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 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 from July 1, 2017. 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 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.”

Indian pharmaceuticals market is in the midst of major developments and dynamic changes. According to industry reports, it is currently growing at double-digit rates per

year. Pharmaceutical packaging industry gets directly impacted by the growing needs

of the pharmaceutical industry. Mr. Sundeep Prabhu, Vice President Sales and Marketing, SCHOTT Glass India Pvt. states, “We constantly endeavor to innovate measures to further standardize the manufacturing process and reduce deviations that arise from ‘sample testing’ methods. We are excited to introduce the perfeXion™ standards at our plant in Jambusar, Gujarat, in our pursuit to provide 100% inspected end-products to our consumers.”

In addition to tightening the tolerances for outside diameter, inside diameter, and wall thickness, we have now 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.

“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.”

Corporate Comm India(CCI Newswire)