SCHOTT charts long-term roadmap for Type I pharmaceutical glass with FIOLAX® Pro

1. Pharmaceutical primary packaging is undergoing significant transformation globally. What trends are shaping the future of primary packaging materials?

The pharmaceutical industry is experiencing a period of rapid change. Manufacturers today are expected to ensure the highest levels of patient safety while also improving manufacturing efficiency, meeting increasingly stringent regulatory requirements, and supporting sustainability goals.

As a result, pharmaceutical primary packaging materials are no longer viewed simply as components. They are becoming strategic enablers of product quality, operational excellence, regulatory compliance, and environmental responsibility. We see growing interest from pharmaceutical companies in solutions that can help them future-proof their operations while maintaining the highest quality standards.

 

2. In its recent communication, SCHOTT highlighted FIOLAX® Pro as the future standard for Type I pharmaceutical glass tubing within its portfolio. What led SCHOTT to take this direction?

At SCHOTT, continuous innovation has always been part of our commitment to the pharmaceutical industry. As market requirements evolve, we continuously review and strengthen our portfolio to meet future pharmaceutical glass packaging needs.

FIOLAX® Pro glass tubing is developed to address three fundamental industry requirements – drug safety, manufacturing efficiency, and product carbon footprint reduction with its optional product line FIOLAX® Pro OCF. 

The aim is to provide pharmaceutical companies with a future-ready glass solution that helps address both current and emerging expectations across the value chain.

 

3. What makes FIOLAX® Pro different from conventional FIOLAX® clear?

FIOLAX® Pro combines advancements in material composition, manufacturing technology, and quality transparency.

From a safety perspective, it offers a future-proof glass composition with the absence of any heavy metals and supports easy compliance with ICH Q3D requirements. It is designed to deliver minimal drug-container interactions through superior extractables and leachables performance, constant glass composition, and consistently high hydrolytic resistance.

From an operational standpoint, it supports smooth machinability during converting and fill-finish processes through high cosmetic quality and precise dimensional accuracy. Moreover, the transformation temperature of FIOLAX® pro is quite identical to FIOLAX® clear minimising disruption and simplifying adoption.

Every product delivery is supported by a digital quality data package enabled by SCHOTT’s perfeXion® process, providing an unprecedented level of quality transparency. 

 

4. Sustainability is becoming increasingly important for pharmaceutical manufacturers. How does FIOLAX® Pro address this?

Sustainability is now a strategic priority for many pharmaceutical companies, and this extends to primary packaging materials and supply chains. In fact, nearly top 20 pharma companies have set strategic SBTi climate targets to reduce their carbon footprint drastically in the upcoming years.

SCHOTT support these ambitions, with the optional FIOLAX® Pro OCF product line, which will be available first quarter of 2027 with an approx. 50 per cent lower product carbon footprint*. This is enabled by a new electric melting tank technology, powered by 100 per cent of electricity in the production process covered by renewable energy Guarantees of Origin; natural gas is now only used in the separate refining unit and working tank part for technical reasons any longer.

We believe innovations like these can help pharmaceutical companies advance their sustainability commitments without compromising quality or performance.

*Calculation of greenhouse gas emissions from cradle-to-gate per kilogram of saleable glass tubing compared to the market average for borosilicate glass tubing [average value according to ecoinvent 3.10; glass tube production, borosilicate // DE. The value currently calculated is based on empirical values and simulation data]. Relevant information about the FIOLAX® Pro OCF product line and the electrical tank can be found in the implementation plan.

 

5. Some pharmaceutical companies are asking how FIOLAX® Pro fits within SCHOTT’s broader FIOLAX® portfolio. Can you clarify?

Certainly. We understand that the right material makes all the difference in pharmaceutical packaging. As industry requirements rise, SCHOTT remains dedicated to advancing innovation and maintaining quality leadership, ensuring we are prepared to meet both current and future needs. Because patient safety starts with us. 

The journey of FIOLAX® Pro clearly demonstrates SCHOTT’s steadfast commitment. The introduction of FIOLAX® Pro does not alter SCHOTT’s commitment to supply reliably. Rather, it further develops our current portfolio and paves the way for the future of SCHOTT’s Type I glass portfolio.

 

6. There is considerable discussion around FIOLAX® Pro in the market. Should pharmaceutical companies view this as a signal that they need to immediately transition away from packaging made out of FIOLAX® clear?

Not at all. The introduction of FIOLAX® Pro should be viewed as the next evolution step of SCHOTT’s portfolio and our continued commitment to innovation in pharmaceutical primary packaging.

FIOLAX® Pro is developed to address emerging industry priorities around drug safety, operational efficiency, quality transparency, and sustainability. 

At the same time, FIOLAX® clear remains an established and trusted product used by pharmaceutical manufacturers around the world. 

FIOLAX® Pro will be established as the new standard Type I clear glass for all pharmaceutical applications, gradually succeeding FIOLAX® clear in the long term. But we understand that the pharmaceutical industry operates within long product lifecycles, extensive qualification requirements, and is a highly regulated. Therefore, this evolution will be managed with utmost care and in close partnership with converters and pharmaceutical companies, ensuring sufficient time for qualification, regulatory alignment, and adaptation. Please be assured that this transition is designed to unfold over an extended, decade-scale period, ensuring a seamless and well-supported process that prioritises pharma community requirements and the highest industry standards.

During this time pharmaceutical companies can continue to rely on FIOLAX® clear with confidence. FIOLAX® clear will be available for years to come, and any transition to FIOLAX® Pro would naturally follow global adoption patterns and will occur gradually over an extended period.

Our message to the market is simple – pharmaceutical companies should choose the solution that best fits their business, regulatory requirements, and sustainability objectives. For those interested in the benefits offered by FIOLAX® Pro, SCHOTT is ready to support them with comprehensive material in our Technical Dossier now. For companies continuing with FIOLAX® clear, SCHOTT remains fully committed to ensuring reliable supply and long-term partnership.

 

7. How should pharmaceutical companies approach FIOLAX® Pro today?

Like I already mentioned, FIOLAX® Pro should be viewed as an attractive option for companies that are looking to enhance safety, efficiency, or sustainability within their primary packaging strategy all given by a future-proof glass.

Every pharmaceutical company has unique technical, regulatory, and commercial requirements. Therefore, decisions regarding qualification and adoption should be driven by individual business needs and long-term plans.

Our role is to provide pharmaceutical companies with choices on the right basic glass material, technical support by knowledge sharing, and all information necessary to make the best decision for their product needs. We encourage pharmaceutical companies to use the coming years to evaluate FIOLAX® Pro and to define individual qualification and implementation roadmaps. SCHOTT tubing will be happy to extend its support to the pharmaceutical companies, at all times.

 

8. What assurance would you like to give pharmaceutical manufacturers in India or what would be the key take aways from this discussion?

India is one of the fastest growing pharmaceutical markets globally, and we see increasing interest from Indian pharmaceutical manufacturers in advanced patient care solution such as biosimilars like GLPs, ADCs, etc across pharmaceutical container formats.

As companies evaluate how to meet rising expectations around product quality, operational performance, regulatory compliance, and sustainability, FIOLAX® Pro pharmaceutical glass offers a compelling path forward. 

I would say that the market should see FIOLAX® Pro as an opportunity. It is a future-oriented solution for companies seeking additional benefits in areas such as safety, efficiency and product carbon footprint reduction. 

Our commitment is to provide all partners along the pharma value chain with reliable supply, clear communication and access to the best technologies available, today and in the future.