Collagen and gelatin biomaterials are used to manufacture absorbable medical devices including haemostats, tissue scaffolds, ophthalmic shields, and dental membranes, with biocompatible and biodegradable properties.
Collagen & gelatin biomaterials for advanced medical devices
Collagen and gelatin are versatile biomaterials widely used in the manufacture of absorbable medical devices. Their biocompatibility, biodegradability and ability to promote tissue healing make them ideal for surgical haemostats, tissue scaffolds and regenerative medicine applications.
Absorbable gelatin sponges for surgical bleeding control
3D collagen matrices for tissue engineering
Collagen shields and corneal bandage lenses
Collagen membranes for guided tissue regeneration
Medical pharmacopoeia-grade gelatin and collagen raw materials for manufacturing absorbable medical devices
High purity low-endotoxin bovine bone gelatin compliant with medical standards. Suitable for absorbable gelatin sponges, hemostatic materials and implantable medical device substrates with controllable biodegradation.
Ideal for: Haemostatic sponge, absorbable medical biomaterials
View DetailsStable film-forming pharmaceutical gelatin used for microencapsulation of bioactive ingredients. Applied in sustained-release implant devices, antibacterial carrier systems and controlled-release medical consumables.
Ideal for: Sustained-release microcapsules, medical device active carriers
View DetailsBioactive collagen peptide raw material, promotes cell proliferation. Can be compounded into tissue engineering scaffolds, skin repair membranes and regenerative medical device formulations.
Ideal for: Tissue repair scaffolds, biomembrane medical devices
View Details| Parameter | Collagen Sponge | Gelatin Sponge | Type I Scaffold |
|---|---|---|---|
| Collagen / Gelatin Purity | ≥95% (Type I) | ≥90% (Gelatin) | ≥95% (Type I) |
| Residual Moisture | ≤10% | ≤10% | ≤8% |
| pH (0.1% Solution) | 6.0–7.5 | 5.5–7.0 | 6.5–7.5 |
| Heavy Metals | ≤10 ppm | ≤10 ppm | ≤10 ppm |
| Residual Solvents | ≤0.5% | ≤0.5% | ≤0.5% |
| Sterility | Compliant with USP <71> | Compliant with USP <71> | Compliant with USP <71> |
| Bacterial Endotoxin | ≤0.5 EU/mg | ≤0.5 EU/mg | ≤0.25 EU/mg |
Quality management system certified to ISO 13485 for medical device design and manufacturing processes
Collagen and gelatin biomaterials meet USP and EP monograph requirements for implantable and absorbable devices
Complete TSE/BSE risk assessment documentation with validated sourcing from Category A countries
Technical documentation and biocompatibility data packages supporting CE marking under MDR (EU) 2017/745
Type I collagen is extracted from bovine tendon or dermis using controlled enzymatic hydrolysis to preserve triple-helix structure and bioactivity
Multi-step purification removes non-collagenous proteins, lipids and immunogenic components to achieve ≥95% collagen purity with minimal endotoxin levels
Terminal sterilization by gamma irradiation (25 kGy) or ethylene oxide processing validated to achieve SAL 10⁻⁶ while maintaining collagen integrity
Double sterile barrier system with medical-grade Tyvek® pouches and foil overwraps, validated for shelf-life stability and sterility maintenance
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