Rosti Poland Expands Medical Solutions Operations with Class 8 Cleanroom Investment

As part of Rosti Group’s growth strategy and ongoing investment in our capabilities, we are excited to announce the opening of our new Class 8 Cleanroom facility at Rosti Poland.

The 360 sqm facility features state-of-the-art technology to ensure the highest standards of cleanliness and quality in manufacturing medical devices and pharmaceutical products. This expansion demonstrates Rosti Group’s commitment to meeting the evolving needs of the global medical sector.

Class 8 Cleanroom Meeting Medical Standards

The cleanroom is designed to meet the most rigorous medical industry standards with ISO 13485 and ISO 14644 certifications, enabling Rosti Poland to manufacture with precision and reliability.

Live monitoring of vital parameters within the cleanroom, along with robust archiving processes, ensures that the facility constantly operates under optimal conditions, including advanced air filtration and contamination control systems.

This purpose-built space emphasizes hygiene and safety—key elements in producing medical-grade components. A sensor-based hand cleaning and disinfection area, along with an interlocked personnel entrance, further enhances our ability to meet strict cleanliness protocols.

Quality assurance is paramount in the medical industry, and the Class 8 Cleanroom addresses this with a quality pass box featuring an interlock system. This innovative addition enables seamless material transfer to eliminate the risk of contamination.

Effective communication is vital in a controlled manufacturing environment, so Rosti Poland has implemented an intercom system to streamline communications between operators in the clean production area and quality control staff.

Plastic Injection Molding Capabilities

With a production area covering 180 sqm, the cleanroom provides an ideal environment for precision manufacturing of medical devices and disposable products. The facility can accommodate up to four 180-ton injection molding machines; currently, we have a 2-ton Crane & Demag (160T) injection molding machine installed.

A key feature of the new cleanroom is the material feeding system that operates from outside the cleanroom area, ensuring a streamlined and contamination-free workflow. Additionally, a dedicated tool storage area with room for up to nine cleaned and production-ready tools highlights Rosti Poland’s commitment to efficiency and productivity.

Effective communication is vital in a controlled manufacturing environment, so Rosti Poland has implemented an intercom system to facilitate communication between operators working in the clean production area and quality control staff.

Introducing Sustainability Measures

Energy-efficient LED sensor-based lighting is installed in the cleanroom, providing 1000 lux of brightness while minimizing environmental impact by activating lights only where needed.

We utilize Eco Mould capability, which allows us to manufacture at lower temperatures while maintaining quality and precision and reducing energy consumption during production. Further energy reduction and reuse are achieved through heat recovery capabilities, capturing external heat from the injection molding machines to help heat the cleanroom.

Rosti Poland’s ongoing efforts to be a sustainable contract manufacturing partner for our customers are demonstrated by planting over 6,000 trees in recent years, complemented by the introduction of ISO 50001 this year.

Michal Lubik, MD, Rosti Poland, commented, “Rosti Group’s investment in the Class 8 Cleanroom signifies a strategic and forward-thinking approach to meeting the evolving needs of the medical and pharmaceutical sectors.

“This state-of-the-art facility not only positions Rosti Poland as a key player in precision injection molding in Europe but also underscores the company’s dedication to investing in advanced capabilities to support our customers’ needs.

“With over 25 years’ experience providing precision plastic injection molding and contract manufacturing services from our 31,000m² state-of-the-art facility, this investment in medical cleanroom capabilities supports the site’s continued growth.”