Press Releases

11.07.2017, SCHOTT AG, Jambusar, India

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

SCHOTT Sets Unprecedented Quality Control Standards for Pharmaceutical Tubing. Photo: SCHOTT AG

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."

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 EUR 1.99 billion were generated in fiscal year 2015/2016. The parent company, SCHOTT AG, has its headquarters in Mainz (Germany) and is solely owned by the Carl Zeiss Foundation. As a foundation company, SCHOTT assumes special responsibility for its employees, society and the environment. www.schott.com

SCHOTT Sets Unprecedented Quality Control Standards for Pharmaceutical Tubing. Photo: SCHOTT AG

PerfeXion™ enables 100 % inspection of each individual FIOLAX® tube. Photo: SCHOTT AG

Press contact

SCHOTT AG

Christina Rettig
Public Relations Manager

Hattenbergstraße 10
55122 Mainz
Germany

Phone: +49 6131/66-4094

E-mail
http://www.schott.com

Further information

SCHOTT AG

Salvatore Ruggiero
Vice President Marketing and Communication

Hattenbergstraße 10
55122 Mainz
Germany