As a partner in the (bio)medical industry, we value the importance of quality and safety. From the sourcing of raw materials to the final products, we are committed to consistently delivering the highest possible quality and safety standards.
Committed to the highest quality and safety
- Gelatin and collagen are Generally Recognized As Safe (GRAS) by the US Food and Drug Administration (US FDA) and compliant with the US, European, and Japanese Pharmacopeia.
- Manufactured in our own state-of-the-art, HACCP- and ISO9001-certified plants, all Rousselot Biomedical solutions meet the highest international standards.
- The ingredients we use are 100% of natural origin, safe, fully traceable, and extensively tested and validated. We subject all suppliers to strict quality control programs and traceability standards
FDA-approved validation method for endotoxin levels
Our validated production process is performed under controlled clean room conditions and stringent quality control, with batch release conditions suitable for Current Good Manufacturing Practice (CGMP) in (bio)medical applications. We validate the endotoxin limit for each X-Pure® batch by means of the Limulus Amoebocyte Lysate (LAL) assay, the FDA-approved method for endotoxin level quantification in products used for (bio)medical applications.
FDA restrictions on the endoxin level in medical devices
For medical device applications, the US Food and Drug Administration (USFDA) has imposed restrictions on the endotoxin content. The FDA limit on the endotoxin levels of medical devices exposed to the central nervous system via cerebrospinal fluid is 2.15 endotoxin units per device (EU/device), or 0.06 EU/ml). For devices in peripheral applications reached by the cardiovascular and lymphatic systems, the limit is higher: 20 EU/device, or 0.5 EU/ml.
X-Pure: a compliant and totally safe biomaterial for the (bio)medical industry
- Furthermore, X-Pure is delivered virus-safe. This means any viruses are independently deactivated in multiple process steps
- Sterile X-Pure products are proposed on request and packaged and supplied under sterile conditions
- A non- immunogenic biomaterial, X-Pure is ideal for applications where low immunogenicity is desired.
Find out more about Safety and compliance at Rousselot Biomedical or learn about the process we use for manufacturing X-Pure