Medical Silicone Manufacturing in ISO 8 Cleanroom
Manufacturing process of medical silicone components in controlled ISO 8 environment with ISO 13485 certification.
Manufacturing of pharmaceutical silicone components compliant with GMP and produced under an ISO 13485 management system. Formulations tested according to USP Class VI, ISO 10993, and European Pharmacopoeia in a certified ISO 8 Cleanroom environment.
Pharmaceutical and biotechnological processes require materials with guaranteed biocompatibility, chemical resistance, and integral traceability. At ProSilicones64, we manufacture technical silicones in ISO 13485 and ISO 9001 certified environments, complying with Good Manufacturing Practices (GMP). Formulations are tested under USP Class VI, ISO 10993, and European Pharmacopoeia, ensuring compatibility with CIP/SIP processes, autoclave, EtO, or gamma radiation sterilization.
Pharmaceutical components are produced under a framework of total quality and purity, compliant with the main international process and formulation testing standards.
| Normativa | Ámbito de aplicación |
|---|---|
| ISO 13485 | Quality management in health production environments (process certification) |
| GMP | Good Manufacturing Practices for pharmaceutical products (process system) |
| USP Clase VI | Biocompatibility and toxicology testing (formulation testing) |
| ISO 10993 | Biological evaluation of medical materials (formulation testing) |
| Farmacopea Europea | Compliance of raw materials and additives used in pharmaceutical processes |
| ISO 8 Cleanroom | Certified environment compliant with ISO 14644 for sterile production |
| REACH / RoHS | Chemical compatibility and control of restricted substances |
Technical knowledge and application cases in this sector.
Manufacturing process of medical silicone components in controlled ISO 8 environment with ISO 13485 certification.
Discover how silicone components are manufactured under ISO 13485 and ISO 9001 quality management systems.