The 360 sqm facility is equipped with state-of-the-art technology to ensure the highest standards of cleanliness and quality in the production of medical devices and pharmaceutical products. This expansion aligns with Rosti Group’s commitment to meeting the evolving needs of the global medical sector.
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Class 8 Cleanroom meeting Medical Standards
The cleanroom is designed to adhere to the most stringent medical industry standards with ISO 13485 and ISO 14644 accreditation, allowing Rosti Poland to manufacture with precision and reliability.
Live monitoring of crucial parameters within the cleanroom, coupled with robust archiving processes, ensures that the facility consistently operates within optimal conditions including advanced air filtration and contamination control systems.
This purpose-built space emphasises hygiene and safety, essential elements in the production of medical-grade components. A sensor-based hand cleaning and disinfection area, along with an interlocked human lock, further enhances how we meet strict cleanliness protocols.
Quality assurance is paramount in the medical industry, and the Class 8 Cleanroom addresses this need with a quality pass box featuring an interlock system. This innovative addition allows for seamless transfer of materials to remove the risk of contamination
Effective communication is crucial in a controlled manufacturing environment, and Rosti Poland has implemented an intercom system to facilitate communication between operators working in the clean production area and quality control personnel.
Plastic Injection Moulding Capabilities
With a production area spanning 180 sqm, the cleanroom offers an ideal environment for precision manufacturing of medical devices and consumable products. The facility is equipped to install up to four 180-ton injection moulding machines, we currently have a 2 tonne Crane & Demag (160T) injection moulding machine installed.
A key feature of the new cleanroom is the material feeding system from outside the cleanroom area, ensuring a streamlined and contamination-free workflow. Additionally, a dedicated tool storage area with the capability to store up to nine cleaned and production-ready tools underscores Rosti Poland’s commitment to efficiency and productivity.
Effective communication is crucial in a controlled manufacturing environment, and Rosti Poland has implemented an intercom system to facilitate communication between operators working in the clean production area and quality control personnel.
Introducing Sustainability Measures
Energy efficient LED sensor-based lighting is installed in the cleanroom, providing 1000 lux of brightness while minimising environmental impact by only have lights on in areas when required.
We have the ability Eco Mould which enables us to manufacture at the lower temperatures, whilst maintain quality and precision, reducing energy consumption during production. A further energy reduction and reuse concentrates on heat recovery capabilities, by capturing external heat from the injection moulding machines which is used to heat the cleanroom.
Rosti Poland’s continuous efforts to become a sustainable contract manufacturing partner to customers is demonstrated through planting over 6,000 trees in recent years and complimented 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 moulding in Europe but also underscores the company’s dedication to investing in cutting-edge capabilities to support the needs of our customers.
“With over 25 years experience in delivering precision plastic injection moulding and contract manufacturing services from our 31,000m² state-of-the-art facility, this investment in medical cleanroom capabilities compliments the continued growth of the site.”
