Steriline Asia, the Indian subsidiary of Steriline (the well-known European manufacturer of aseptic processing solutions for injectable drugs), will proudly attend CPHI & PMEC India, which will be held in Delhi from 26 to 28 November 2024. Visitors will meet both the Indian team and colleagues from Steriline headquarters at booth 10.D23, where they will learn about the company’s latest technological and process advancements, developed with a strong focus on sustainability and with the mission to make medicines more accessible and effective.
Steriline is dedicated to developing equipment that not only meets the needs of today’s pharmaceutical industry but also contributes to a more sustainable future for the industry. Its strategy can be summed up in the concept of “Quality by Design” (QbD), a systematic approach to pharmaceutical development and manufacturing that emphasizes understanding and controlling processes from the outset. This ensures that the final product meets predefined criteria, building quality into the product rather than relying solely on end-product testing.
“The Quality by Design approach is essential for responding effectively and innovatively to the growing needs of the pharmaceutical market,” states Mr Federico Fumagalli, Chief Sales Officer of Steriline. “It allows us to understand and control every stage of the production process, ensuring that quality is built into the product from the outset and fully meets regulatory expectations. This approach enables us to offer our customers not only continuous quality improvement, but also greater efficiency, waste reduction, and the ability to quickly adapt to market challenges, making both us and our customers more competitive and reliable.”
To develop new technologies, collaboration at the engineering level between the company and regulatory bodies is crucial. Through periodic alignment meetings, Steriline’s technologies evolve in compliance with regulatory expectations and industry best practices. This close collaboration drives innovation, particularly in areas such as sterility and containment, ensuring that new solutions are efficient, compliant with the latest requirements, and economically competitive.
Currently, to meet the needs of today’s pharmaceutical industry, the Steriline portfolio is split into two areas: one featuring advanced robotic technology and the other with more traditional mechanical machines. The robotic solutions are ideal for high-value-added products requiring maximum flexibility and zero waste, while the mechanical machines are suited for large-scale and high-speed production.
That said, the market is always in flux and its needs are constantly changing. “The flexibility of production lines takes on significant strategic value for drug manufacturers,” states Filippo Parini, Sales Area Manager of Steriline. “Considering the observed trend in recent years – a notable increase in demand for self-injection devices – Steriline’s hybrid lines (composed of both robotic and mechanical elements) are designed to handle a variety of primary containers, such as cartridges for multi-dose injection pens, pre-filled syringes (PFS) for single-shot self-injection devices, and vials for multi-dose applications, typically used in hospitals.”
This flexibility offers significant advantages:
- Versatility and Adaptability: Lines that can process both Ready-to-Use (RTU) containers in nests and glassware in bulk allow manufacturers to choose the type most suitable for their production needs.
- Time and Cost Savings: By using a common platform for various container types, format changeover times are reduced and efficiency optimized, leading to lower production costs and increased overall capacity.
- Compliance and Safety: Advanced technologies ensure compliance with Good Manufacturing Practice (GMP) regulations, guaranteeing the safety of the filling and packaging process for sensitive medications, such as those used to manage blood glucose levels in people with Type 2 diabetes (GLP-1 agonists).
- Support for Product Customization: Steriline’s solutions cater to diverse market segments, enabling customers to tailor product presentations to end-consumer preferences, whether they are patients preferring pre-filled syringes for self-injection or vials for higher dosages.
“Steriline Asia will attend CPHI & PMEC, proud to be a company that combines the excellence and quality of Steriline's technologies with a deep understanding of the local Indian market,” declares Mr Chiranjeevi Kondapaka, Chief Executive Officer of Steriline Asia. “This combination allows us to develop innovative solutions that not only meet the highest international standards but are also perfectly aligned with the specific needs of our market. The mix of Italian technical expertise with great knowledge of the local context enables us to be more agile, competitive, and ready to face the challenges of a rapidly evolving market.”
