SCHOTT invests in a global quality initiative for pharmaceutical tubing manufacturing: an international production network with uniform high standards helps to reduce risk right from the start
As part of its global quality initiative for the manufacture of pharmaceutical tubing, SCHOTT has announced that it is investing approximately 5 million euros in the modernization of its Rio de Janeiro plant. The site is home to FIOLAX® glass tubing production – a base product, which for over more than 100 years, has grown to become the gold standard for glass packaging in the global pharmaceutical industry.
The modernization of the Brazilian plant, which will include the latest measurement technology for process and quality control, highlights SCHOTT’s commitment to high and unified production standards across all of its facilities. This emphasis on quality ensures that FIOLAX® glass tubing can be used worldwide, including India, for the manufacture of high-quality vials, syringes, ampoules, and cartridges for the optimal storage of medicines – supporting the pharmaceutical industry in its efforts to minimize risks and ensure patients’ well-being and safety.
The technology transfer between SCHOTT’s tubing sites follows a strict process: manufacturing machines and processes as well as corresponding measurement technology are developed at the main plant in Mitterteich (Germany) and then implemented at all sites worldwide in accordance with clearly defined timeframes. Furthermore, all plants adhere to the same quality manuals which are stored in a central database. India’s SCHOTT tubing facility based in Jambusar, Gujarat stands to benefit from this development. Any changes are shared with every site within 24 hours and are executed immediately.
SCHOTT has voluntarily introduced far stricter quality standards for its technical terms of delivery than is required in the industry. As a result, customers receive FIOLAX® glass tubing – with highly accurate geometrical and visual attributes – regardless of where the tubing is manufactured. “The premium quality of the tubes is crucial for the production of premium packaging later-on,” said Reinhard Männl, Vice President Technology. “It determines the process capability of the tubes once they are formed into ampoules, vials, cartridges or syringes and later also their performance on the pharma company’s filling line.”
Furthermore, the company’s stringent process for change management provides enhanced safety. Before any changes, such as optimization measures, are implemented a full analysis and risk assessment is conducted. This process offers insight into any potential effects a change may have on the manufacturing process associated with the packaging. “Change management is only one of the tools we employ as part of our quality management system, which are based on GMP (Good Manufacturing Practice) standards. We are also committed to full traceability of our products, uniform standards and comprehensive risk management across the entire process chain – from purchasing and production through to delivery,” said Dr.-Ing. Karsten Hennig, Director Quality Management for SCHOTT Tubing.
Schott Glass India Pvt. Ltd., part of the speciality glass manufacturing major Schott AG of Germany, has been present in India since 2006. The plant is equipped with high technology melting tanks to produce FIOLAX® tubing for the manufacture of vials, ampoules and syringes. Last year, SCHOTT was appointed to the Bureau of Indian Standards (BIS) to advise CHD-10 – a subcommittee of the Chemicals Department. Schott provides CHD-10 specifications and guidelines for various kinds of glass manufacturing in India, including pharmaceutical tubing, fire-safe glass, household appliances and fiber optics.
“We understand the trends in the pharmaceutical industry and the needs of companies seeking to eliminate all potential risk facing the patient. This is why we make a professional contribution right from the start,” said Dr. Patrick Markschläger, Executive Vice President and responsible for SCHOTT’s Tubing Business Segment. In addition to South America, SCHOTT also manufactures glass tubing in Europe and Asia, with a production capacity of more than 140,000 tons. These plants not only use the same machines, quality manuals, production and management processes, they also employ the same procedures for the inspection of raw ingredients. “This allows us to deliver high glass quality, consistently, all over the globe,” Markschläger added.
The focus on quality is completed by investments into related services including the e-commerce order system and the technical-scientific consultation service which supports customers in the selection of materials and generates product feasibility studies as well as glass defect analyses. Furthermore, the FIOLAX® Academy is continually expanding to offer pharmaceutical companies a complete training program covering topics like glass quality, interactions between glass and medication and regulatory requirements.
All of these procedures enable SCHOTT to minimize risks for pharmaceutical companies significantly at the very beginning of the value chain.