Product

Quali-Pure® range of pharmaceutical gelatins

February 9, 2022

Quali-Pure® is a range of pharmaceutical gelatins, that has been specifically designed to support biomedical application areas including embolization, wound healing, drug delivery, vaccines and hemostatics.

Quali-Pure® delivers biocompatibility, biodegradability, controlled endotoxin levels, and batch-to-batch consistency. It is GMP* ready and fully documented to support medical device compliance with ISO standards and the new EU Medical Device Regulation (MDR) 2017/745 on Medical Devices that replaces the existing medical devices Directive (93/42/EEC) (MDD) and the active implantable medical devices Directive (90/385/EEC) (AIMDD).

Full traceability, readily available documentation and validated viral safety

Quali-Pure provides the supporting documentation for full compliance of medical devices with the new MDR requirements 2017/745 and with ISO 22442. Importantly, Quali-Pure gelatins come with full traceability, readily available documentation and validated viral safety, helping to save time when reaching the clinic.

Key features of Quali-Pure:

• Full and documented traceability up to the farm (ISO 22442-2); Prolonged document retention
• Batch-to-batch consistency
• Good Manufacturing Practices (GMP)*
• Validated viral inactivation (ISO 22442-3)
• Controlled endotoxin levels (specification upon request)