OUR PRODUCTION
FOOTPRINT
OUR PRODUCTION
FOOTPRINT
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MTD operates a state-of-the-art production platform that encompasses four cutting-edge production facilities located in Europe, one in Italy (Grandate) and 3 in Poland (Bydgoszcz, Łęczyca, Ozorków) – which together cover a total area of 135,500 Sq.m. One of the key strengths of MTD’s production platform is its scale, which provides an undeniable advantage in terms of the company’s ability to meet the demands of global markets.
With a strong commitment to quality assurance and adherence to regulatory requirements, MTD’s European facilities ensure that the products manufactured meet the most stringent quality and safety standards.
In essence, MTD’s production platform is a testament to its dedication to excellence, global reach, and unwavering commitment to delivering top-quality medical devices that meet the needs of customers around the world.
OUR PRODUCTION IN POLAND
MTD’s production operations in Poland are run by HTL Strefa and encompass 3 facilities, each contributing uniquely to the company’s manufacturing capabilities.
One of these facilities focuses on the assembly of pen needles and safety pen needles. It also performs overmoulding process for personal lancets and safety lancets needles. The production is carried out in ISO 8 clean rooms.
Another, the largest among them, is involved in various phases of production, including plastic component molding, springs winding, raw needle grinding, safety lancets assembly and the packaging of a range of medical products. Additionally, MTD operates a specialized tool-making facility, ensuring complete control over mold production and maintenance — a critical component of the manufacturing process. These facilities collectively support MTD’s production capabilities in Poland, ensuring the production of high-quality medical devices while maintaining rigorous quality control standards and efficient mold maintenance.
The peculiarity of this plant is the integration of all the production processes of the pen needles. All begins with a steel strip welding for the cannula production and with the injection molding of the plastic components up to the ethylene oxide sterilization passing through the assembly and packaging. Key operations encompass also tampo-printing, assembly and packaging for all kinds of syringes. Additionally, the plant manufactures medical supplies like plasters, gauzes and bandages, along with employing advanced technology for Blow Fill Seal (BFS) saline solution vial production.
Dedicated microbiology and mechanical laboratories ensure rigorous quality control. Overall, the Italian MTD plant is a vital hub, contributing to MTD’s mission of delivering high-quality healthcare products through innovation and automation.
OUR PRODUCTION IN ITALY
The Italian MTD plant, managed by Pikdare Spa, is a versatile and highly automated facility specialized in the production of medical devices, including pen needles and syringes.
CERTIFICATIONS
MTD Group’s plant certifications demonstrate a commitment to excellence in both quality management and environmental responsibility.
HTL and Pikdare plants have achieved ISO 13485:2016 certification, signifying adherence to rigorous quality management system standards, ensuring that their medical devices meet the highest industry standards.
They also have obtained FDA 510(k) clearance for their Class II medical devices. In addition, Pikdare has obtained FDA clearance also for its pen needles and syringes.
Furthermore, Pikdare is ISO 14001:2015 compliant, demostrating its dedication to environmental sustainability. This certification reflects the effort to implement an effective environmental management system, showcasing the commitment to reducing the ecological footprint and enhancing the environmental performance.