Quali-Pure
What is Quali-Pure?
The Quali-Pure® range of clinical grade gelatins offers medical manufacturers endotoxin-controlled gelatins, providing guaranteed biocompatibility, biodegradability, and batch-to-batch consistency.
It is designed to meet high quality and safety standards. The whole range is GMP* ready and fully documented to support compliance with ISO standards and the new EU Medical Device Regulation (MDR).
The Quali-Pure range:
The range includes gelling and non-gelling gelatins. Gelling Quali-Pure has tunable properties that can be tailored for each biomedical application.
The new hydrolyzed (non-gelling) Quali-Pure HGP 2000 was launched in April 2022 and is the latest addition to the range.
| Gelling Quali-Pure | Type | Bloom (g)** | Properties | Applications |
|---|---|---|---|---|
| Quali-Pure 250P | Acid porcine skin gelatin | 250 | Tunable rheological properties Can be used in hydrogels, particles or films |
|
| Quali-Pure 300P | Acid porcine skin gelatin | 300 | ||
| Quali-Pure 300P HV*** | Acid porcine skin gelatin | 300 |
| Non-gelling Quali-Pure | Type | MW (Da) | Function | Applications |
|---|---|---|---|---|
| Quali-Pure HGP 2000 | Acid porcine skin hydrolyzed gelatin | ≤ 2000 | Surrounds particles and molecules to preserve and aid their function through storage, transportation and administration |
|
Visit our Product Finder to find the optimal gelatin for your biomedical application.
Applications of Quali-Pure
- Vaccines (supports vaccine development and acts as a gelatin vaccine stabilizer)
- Medical devices
- Embolization applications
- Wound healing applications
- Drug delivery
- Hemostatics
Advantages of the Quali-Pure range
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)
Quali-Pure gelatins come with the supporting documentation for compliance of medical devices with global market standards and regulations, including the new EU MDR that must be fully implemented by May 2024, as well as ISO 22442.
“We pro-actively support our customers towards regulatory compliance with full and documented traceability up to the farm (ISO 2242-2), validated viral inactivation (ISO 22442-3) and IPEC GMP compliance.”
Kathleen Jacobs - Regulatory Affairs Director at Rousselot Biomedical
Send us a question and we will respond within 72 hours.
For medical devices that require ultra-low endotoxin levels with LPS <10 EU/g, please find out more about Rousselot’s X-Pure® range.
* IPEC – Excipient Good Manufacturing Practices Guide, 2017 as of end 2021
** Measured at 6,67%, 10ºC, according to EP/USP
*** High Viscosity