Technoloy & Innovation from SCHOTT AG

Dr. Patrick Markschlaeger Executive Vice President
The German technology group, SCH OTT Tubing, manufacturers of pharmaceutical glass and packaging is further growing its production capacity through the launch of a new glass tank in its Indian manufacturing plant at Jambusar, Gujarat. The expansion is in response to the increasing demand for high -quality pharmaceutical packaging material in the global market.
Dr. Patrick Markschlaeger, Executive Vice President, SCHOTT AG , Business Unit Tubing, in an exclusive interview with PBW shares how SCHOTT AG has been leading the pharma innovation.

With perfeXion® initiative, SCHOTT has set out to elevate pharmaceutical glass quality. Could you give us a briefly explain the concept of perfeXion?
Last year, SCHOTT implemented perfeXion® - the new era of quality processing - in all its global plants, to achieve unparalleled quality control standards for its FIOLAX® pharmaceutical glass tubing. By harnessing big data, we have moved from a statistical samplebased quality-control process to 100% inspection of each individual FIOLAX® tube. This also allows us to customize the specification of the glass tubing according to specific needs of the container format. perfeXion® uses state-of-the-art cameras and lasers to pinpoint potential defects along the production line. A process control and integrated data management system works as an integrated network for real-time collection and evaluation of the data. More than 100,000 data tags per minute are collected in this system. All this generates valuable data for controlling and stabilizing the tubing production process. As a result, we now offer an improved product with superior auditability and traceability for the pharmaceutical industry.

This leads to a unique approach to the market. How do you proceed ?
The pharmaceutical companies put their patients first by ensuring high -quality products. We owe them that same level of dedication towards constant improvement, right from the beginning of the manufacturing value chain. With perfeXion®, we implemented a zero-defect philosophy, so that the tubing, used as basic material for the production of vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning. This even applies for parameters such as the inside diameter, which were difficult to measure online previously. Moreover, by improving the measurement of visual quality characteristics, SCHOTT can offer individual specifications tailored even closer to customers' requirements .

What are the impact of glass tubing on the future packaging challenges?
One of the key challenges that the packaging industry foresees is that of supply. There has been recent surge in demand for pharmaceutical packaging, and is expected to grow at a rapid rate globally in the next years. This has resulted in emergence of lower quality alternatives, which pose an imminent threat to patient safety. This, in fact, is one of the key reasons why SCHOTT decided to invest in increasing the production capacity of its Jambusar plant in India. With further investment of over 20 million Euros, SCHOTT Tubing India has begun construction of a new tank facility that would increase the plant capacity by 50%. This will facilitate our supply to the Indian as well as export markets, especially in Asia.

Apart from quality and quality-related issues such as delamination, extractables and leachables, etc., which result in drug contamination, the industry is also coping with the issue of growing complexity of drugs, fostered by increasing lifestyle diseases, growing health awareness and aging population. This brings more focus towards need for highest standards of quality to be maintained in the glass tubing, as well as capabilities to customize our product according to the client needs.

What are your strengths to succeed in this market?
Our main product, FIOLAX® glass tubing, has grown since 1911 to become the gold standard 'raw material' for glass containers in the global pharma industry. Known for its unmatched quality, our packaging material is the first preference for most of India's leading pharmaceutical companies. Our continuous R & D initiatives help us to be abreast with the market trends and requirements, and hence, we are able to introduce unprecedented advancements in the industry. For instance, through perfeXion®, process- and product quality data of each individual glass tube is collected online and in real-time. We foresee that these precise data points will not only be instrumental in terms of technology advancements at our plants, but will also help provide intelligence that can be passed further down the supply chain in future.

Why should the pharmaceutical industry give special consideration to pharma glass?
The current environment especially calls for pharmaceutical players to focus on their packaging material. There is a strong trend of highly sensitive drug formulations, which require unique and stable packaging that minimizes drug and container interaction over the shelf life of the product. Also, there is an increasing number of higher dosage volumes, which leads to longer durations for which the packaging remains in use. Such expectations call for the containers to have very accurate dimensions, especially regarding the inside diameter. Thus, usage of precise tubing becomes critical.

Smart packaging emerges as the key to tackle the complexities and challenges facing the pharma packaging industry. Your comments.
With the ever-increasing customer expectations and product complexity, smart packaging is definitely the need of the hour. Smart packaging is already being seen as essential for optimising logistics operations and stock control throughout the product lifecycle, for providing information and validation around issues such as anti-counterfeiting, product tampering, etc .

SCHOTT is continuously working to introduce Germany's Industry 4.0 concept of bringing digitalization and automation in different processes at its manufacturing sites. Be it the fully controlled environment for stacking the end product, or 100% inspection of the tubes through the automated system, we have been pioneers in bringing the latest German technology to the country.

Conducting automated controls seems logic, why is this not yet a standard in the glass tubing industry given the rising quality demands ?
I am sure this will become a standard in the industry, and we are now seeing many players and clients taking a number of R & D and investment initiatives . However, we must appreciate that analysis of such a specialized product, that too at high drawing speeds is difficult to perform and requires heavy investments. Our technology group developed the inspection devices in-house based on many years of R & D and has taken a conscious decision to always keep its focus on innovation, and this is what reflects in our end product for our clients.

Looking at the challenges that lie ahead - what current trends in the pharmaceutical industry can you support on the part of glass tubing? What are the key trends shaping the pharma Packaging industry?
There are few trends that I feel SCHOTT has been actively supporting. Firstly, the push to capitalize on huge marketplaces in rapidly developing nations is a common aim for all global players. With this, adherence to complex standards becomes a basic expectation. SCHOTT has manufacturing plants for pharmaceutical tubing glass on three continents, and all plants manufacture glass of the same quality as per the same global standards, and thus, all serve as export hubs for various markets.

In addition, developing and implementing superior processes related to rapidly evolving client as well as new regulatory requirements has been a constant endeavor for SCHOTT. One of the greatest threats to patient safety is counterfeit drugs. Smart packaging is instrumental to combat this issue. SCHOTT has pioneered many advancements that have supported the industry with critical knowledge sharing on issues such as anti-counterfeit, qualitative concerns, etc.

Lastly, we run initiatives for the general development of the industry, such as the FIOLAX® Academy which informs industry partners, clients, and other stakeholders on the latest trends, best practices, etc. and topics, such as why not all glass is the same, breakage risks or drug-container interaction .

SCHOTT's pharma packaging experts also see a number of trends in the primary packaging industry itself. For example, an increase in formulations with sensitive and complex molecule structures, e.g. biotech drugs, which require innovative packaging solutions to ensure drug stability. Another trend shaping the industry is the move from hospital to homecare to enable patients to selfadminister the drugs in an environment they feel most comfortable in. Such trends require the containers and subsequently the tubing to have highly accurate dimensions, especially in regards to the inside diameter. We achieve this through our perfeXion® process.