Advances in glass for Pharmaceutical Packaging in India: Moving from sample-based quality control to 100% inspection
25 Jun, 2018
25 Jun, 2018
The growing demand in India:
The 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, and is expected to be the third largest pharmaceuticals market by 2020 in terms of incremental growth. The pharmaceutical packaging industry gets directly impacted by this mounting demand from the pharmaceutical market. This constantly creates the need for all pharmaceutical packaging companies not only to keep innovating in order to increase their production, but also to keep advancing towards further standardization of their manufacturing processes and reducing deviations.
SCHOTT Glass India – Tubing Division, a part of its German parent company, SCHOTT AG, is continuously committed to introduce path breaking technological advancements in its pharmaceutical glass tubing plant at Jambusar, Gujarat.
In 1988, SCHOTT’s German parent company, SCHOTT AG became the first manufacturer to publish exact specifications of important pharmaceutical glass tubing products, and has continued to build on that legacy of being the standard for quality in the industry. This was also proven in 2015, when SCHOTT received the ISO 15378 GMP (Good Manufacturing Practice) compliance certificate - an international standard in the pharmaceutical industry that brings together guidelines to ensure the quality of critical production processes through the global standards.
Most recently, SCHOTT has pioneered into using new technical specifications for its FIOLAX® clear and amber tubing in order to provide 100% inspected end-products to its customers – the manufacturers of pharmaceutical packaging.
SCHOTT brings unprecedented technology for 100% inspection of pharmaceutical packaging glass material to India :
The glass tubing for pharmaceutical packaging is converted into drug containers, such as vials, syringes, ampoules or cartridges. Making accurate glass tubes for this usage is a task involving utmost precision and complex specifications: at several meters per second, a virtually endless glass tube comes from the melt at over 1,600 degrees Celsius and is drawn over a rotating mandrel. By making adjustments to the drawing speed and the air supply, wall thickness and tube diameter can be precisely adjusted down to the hundredth of a millimeter. A few meters further down the line, the cooled glass section is then cut into roughly 1.50-meter-long pieces. The more precise the tubing, the better the container. The analysis of a curved tube surface at high drawing speeds, however, is one of the key challenges. Up until now, manufacturers have had to rely on only sample-based and therefore statistical testing to control the quality of the glass tubing used for pharmaceutical packaging for storing lifesaving drugs.
Thanks to a unique big data approach through the implementation of its perfeXion™ system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100% of every single glass tube in production. Therefore, perfeXionTM heralds a new era of quality processing: Instead of selecting a few glass tubes from each batch as samples, the new perfeXion™ system measures the entire glass tube many times over as it is drawn from the melt. So far, this was restricted to the outside diameter, but now also other dimensional features, namely the inside diameter, wall thickness and siding can be determined on-line over the entire tube length. Inspection systems developed in-house, such as lasers area cameras and IR inspection systems recognize deviations in diameter and wall thickness, for example, and can even detect the smallest inclusions in the glass. Around 100,000 data tags are generated every minute. An integrated IT system, evaluating the continuous glass tube with real-time data measurements, calculates incidents of imperfection with such precision that it can later differentiate corresponding individual tubes which can then be sorted out. Each single tube is then checked again at its completion regarding dimensional and visual features.
All measured single tube data is then used for certification of the final 100% inspected tubing. This data also enables for post-processing steps to be efficiently aligned with the tubing quality. With big data, the international technology group is creating a new industry standard and raising the quality of pharmaceutical glass production to a new level.
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 specification for FIOLAX® clear and amber tubing and thus made visible for customers.
Last year, an international trade portal, The Medicine Maker, regarded perfeXion™ as one of the Top 15 innovations of 2016, at the “The Medicine Maker Innovation Awards” which recognizes the most exciting drug development and manufacturing technologies across the globe. The judges explained, “the quality of syringes and other primary drug packaging is crucial – this process could help prevent some of the quality problems associated with glass, which are too often seen in industry.”
New technical performance specifications underline aspiration towards ‘zero defect’ glass tubing
With perfeXion™, SCHOTT AG is able to include improvements to further increase the quality of the glass tubing e.g. for the following criteria:
• A zero defect tolerance is implemented for the following criteria: maximum airline length width of 0.08mm, aggregate airline length depending on application, cracks, closed or missing DENSOCAN® vent hole and its dimensions.
• Tighter tolerances for outside diameter, inside diameter and wall thickness up to ± 0.05 mm
• Tighter particle specification for DENSOCAN® glass tubing.
• More precise tubing end specifications, such as reduced tolerances for square cut and fissures
These standards are achievable due to 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.
Data usage opens new potential
A 100% online inspection of every individual tube will serve as the cornerstone for improved pharmaceutical packaging of the future. The system is tailored to production of glass tubing, but other areas of the company can certainly benefit from the findings in the medium-term. Companies that want to systematically control their production to make it more efficient in the long run can’t afford to miss a strategic use of production data. This ensures that the processing companies can optimally adjust their processes to the quality of the glass tube.
Making intelligently linked data available to others not only optimizes processes – it creates new creative potentials for product and process development in future.
Leveraging on the impetus of the current government’s flagship campaigns:
Under the illustrious “Make in India” campaign, the current government has given the right push to domestic as well as foreign companies to introduce and implement their R&D initiatives in India. This is further complemented by the government’s Skill India initiative that focusses on skill development for the abundant young workforce India. In a highly specialised industry such as the pharmaceutical packaging, it becomes even more imperative to invest in skill development of its workforce.
In 2010, SCHOTT AG’s Tubing Division started a global initiative called Fiolax Academy, which provides training and shares the latest information on the composition, properties and production of high quality pharmaceutical glass and advancements in glass manufacturing for pharmaceutical packaging. Participants come from specialist companies that are converting glass tubes to primary glass packaging, and from pharmaceutical businesses. The Fiolax Academy offers a complete training experience, covering topics such as drug-container interactions, regulatory requirements and glass quality. There have been more than 20 such events with over 700 participants in India.
Sharing knowledge on new technologies and innovations:
Through its Fiolax Academy here, SCHOTT Glass has provided opportunities to leading pharmaceutical companies to learn more about the benefits of using primary pharmaceutical packaging made of high quality glass. This knowledge helps the industry to manufacture and use even better vials, syringes, ampoules, and cartridges for the optimal storage of medicines – supporting pharmaceutical companies in their efforts to minimize risks and ensure patient safety.
The Academy takes its name from SCHOTT FIOLAX® glass tubing, which has grown to become the gold standard ‘raw material’ for glass containers in the pharmaceutical industry. These training events go a long way in improving quality and increasing efficiency for various industry stakeholders and in turn advance their position in both their domestic and international markets.
SCHOTT Participation at CPhI India 2017:
Present for over 26 years, CPhI Global events are the world's most important gatherings for various stakeholders from the pharmaceutical industry. Celebrating its 10th anniversary this year, the CPhI India event, in collaboration with P-MEC India, will be organised at two location in Mumbai from November 27 to 30, 2017. The event is focussed to pick up on the latest trends and innovations in the pharmaceutical market.
Dr. Claudia Heinl, PhD, Product Manager Pharmaceutical Tubing, SCHOTT AG, will be taking a lecture on the unprecedented perfeXion™ system during the event in Mumbai. Dr. Heinl has obtained her PhD in Inorganic/Organometallic Chemistry at the University of Regensburg, Germany. In December 2015, she joined the Scientific Services and Product Management team of SCHOTT AG Tubing for providing global scientific support. Dr. Heinl has wide experience in glass trainings for converters and pharmaceutical companies, fault analyses of defect samples and advice on specific regulations.
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.
About SCHOTT in India:
SCHOTT Glass India Pvt. Ltd is a 100% subsidiary of the German technology group SCHOTT AG. SCHOTT offers pharmaceutical glass tubing products & services as well as pharmaceutical containers to customers world-wide from its production sites all around the globe. SCHOTT’s India plant in Jambusar, present since 1986, now functions as a production hub for SCHOTT pharmaceutical tubing in Asia.
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