09-21-2016, Elmsford, NY
From believing to knowing: New quality approach perfeXionTM controls every mm of pharma glass tubing
SCHOTT pushes towards zero defect philosophy in pharmaceutical glass tubing production
In quality control, details matter. When it comes to pharmaceutical primary packaging such as vials, cartridges or syringes, fluctuations in tubing dimensions such as the inner diameter or wall thickness can have a significant impact on the container performance – for instance, the filling or dosing accuracy for high potential drugs. Up until now, manufacturers of glass tubing have usually been monitoring quality parameters on a random sample base. SCHOTT, however, has developed a new production quality process called perfeXionTM. It controls and monitors every mm of the glass tubing that is later converted into a primary packaging container used by pharma companies to store and administer perhaps lifesaving drugs. With this, SCHOTT aims to contributing to patients’ safety from the very beginning of the value chain.
SCHOTT pushes towards zero defect philosophy in pharmaceutical glass tubing production Photo: SCHOTT AG
SCHOTT will officially introduce the perfeXion™ process to the industry with a presentation during the world’s leading pharmaceutical platform CPhI Worldwide in Barcelona (October 4, 2016, 2.30 pm, 2A70 InnoPack Showcase by Dr. Folker Steden).
From believing to knowing
“We are taking a major step towards a holistic view of quality in pharma glass production,” says Patrick Markschläger, Executive Vice President at SCHOTT Tubing. “We could see from our existing control mechanisms, which were already extremely tight, that the quality of our glass tubes meets the highest requirements. Now with perfeXionTM, we can verify that every mm of the glass tube is accurate.”
This is a significant achievement, as Markschläger explains: “Pharma glass is mostly drawn in tubes when it comes from the melt. SCHOTT as well as other quality oriented converters use these tubes later on to produce vials, syringes, ampoules and cartridges. The challenge lies in monitoring and measuring the curved tubing surface with 100 % accuracy, in a high speed production process.” This is achieved by using a combination of line scan and area cameras, laser and IR inspection systems that literally investigate the entire glass tube on-line. The measurement data is then collected and evaluated by a holistic inter-connected IT solution. “This system recognizes even the smallest defective spots in the ‘endless’ glass tube that comes from the melt. It is then able to attribute these spots to a certain position at a single tube once the cooled down glass string is being cut,” Markschläger says. This sophisticated system enables us to customize the quality level to the specific needs of the industry.
By storing the collected quality information in a data base, measurements can be traced back even years later if necessary.
Markschläger confirms that SCHOTT has already started implementing perfeXionTM at its main site in Mitterteich, Germany. A company-wide roll-out at its other facilities in Europe, Asia and South America is underway.
By doing so, SCHOTT is not only passing another milestone of its future oriented quality roadmap. More importantly, the company’s pharma glass known under the brand name SCHOTT FIOLAX® will enable even more sophisticated primary packaging solutions for advanced medical treatment than it already does today.
Each year, the international SCHOTT Group manufactures around 140,000 tons of glass tubing and more than 10 billion pharmaceutical containers such as vials, syringes, ampoules and cartridges.
Further information: https://microsites.schott.com/us-perfexion/english
FIOLAX® and perfeXion™ are registered trademarks of SCHOTT AG.
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, pharmaceutical, electronics, optics, 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 35 countries. With its workforce of approximately 15,000 employees, sales of $2.24 billion were generated in fiscal year 2014/2015.
Gregory FCA on behalf of SCHOTT
SCHOTT North America, Inc.
Rina Della Vecchia
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