Quality, safety and compliance
From the sourcing of raw materials to the final products, Rousselot Biomedical is committed to supporting our customers in compliance towards relevant quality and safety standards.
Supporting compliance with global market standards and regulations
All X-Pure® and Quali-Pure® gelatins and modified gelatins are carefully created for use in medical devices requiring compliance with global market standards and regulations.
From May 2024, all medical devices placed on the European market must conform with the new EU Medical Device Regulation (MDR). Regulation (EU) 2017/745 on Medical Devices (the MDR) has replaced the existing medical devices Directive (93/42/EEC) (MDD) and the active implantable medical devices Directive (90/385/EEC) (AIMDD). In addition, the ISO standard 22442 has been updated to bring it further in line with global requirements for medical devices.
Our X-Pure® and Quali-Pure® products come with:
- Supporting documentation for compliance of medical devices with the new MDR requirements ((EU) 2017/745)
- Documented traceability up to the farm (ISO 22442-2)
- Validated viral inactivation (ISO 22442-3)
- IPEC* GMP Compliance
High-quality gelatin for use in biomedical applications
- 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 state-of-the-art facilities, all Rousselot Biomedical collagens and gelatins meet the highest international standards
- The ingredients we use are of natural origin, safe, fully traceable, and extensively tested and validated. We subject all suppliers to strict quality control programs and traceability standards
Validated method for guaranteed low endotoxin levels
Our X-Pure® gelatin validated production process is performed under controlled clean room conditions and stringent quality control according to GMP*, making the product suitable for use in your biomedical applications. All X-Pure® and Quali-Pure® batches are also endotoxin tested by means of the validated Limulus Amoebocyte Lysate (LAL) assay to ensure compliance.
Restrictions on endotoxin levels in medical devices
Certain medical devices and pharmaceutical applications may be subject to endotoxin limits, depending on the route of administration, amount of product used and where the device is used in the body. For medical device applications, the US Food and Drug Administration (US-FDA) has set limits on endotoxin levels. 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.
*IPEC (International pharmaceutical Excipients Council) & PQG (Pharmaceutical Quality Group) Joint Good Manufacturing Practices Guide for pharmaceutical excipients (2017)