Secure your production
Working for the health of users, the medical industry needs reliable partners who can meet standards and regulations and guarantee the origin of their products.
Even more critical than in other sectors, sealing must be achieved without any contamination affecting the manufacturing cycle in order to ensure the health and safety of patients.
Hutchinson’s expertise and quality ensure optimal sealing of the installations, preventing losses and waste and maximizing the performance and competitiveness of the production lines.
We offer a range of FDA and USP Class VI approved compounds for non-invasive Class 1 applications (excluding DM Class 2a, 2b and 3).
We can meet various levels of cleanliness requirements (e.g. ISO 15001:2010 standard) thanks to our washing equipment and clean rooms (ISO 7 level according to ISO 14644-1 standard): Clean or UV-resistant packaging, EC regulations N°1935/2004 and FDA21 CFR177-1520. We also offer traceability by micro-engraving or specific surface treatments.
Our production plants are certified ISO 9001, ISO 140001, ISO 50001 and OHSAS 18001.
Certifications
We offer a wide range of compounds with following approvals:
Official certificates are available on request.