Collagen for medical devices and wound care

Collagen earns its place in wound care because cells recognise it. Fibroblasts migrate across it, platelets bind and stabilise on it, and the scaffold breaks down over two to four weeks while new tissue takes over. What separates one device programme from another is whether the incoming material behaves the same way every time. A sponge that swells differently, a hemostat that sets slower than the last lot, a film whose degradation window shifts. Each one becomes a deviation report and a delayed release.

Alpstein supplies medical grade bovine type I collagen prepared for device manufacture, in the forms a production line already handles.

Atelocollagen fibrous raw material comes as paste, sheet or powder, sterile or non-sterile, for sponges, felts, pads and plugs where wet strength and structure carry the device. Soluble atelocollagen comes as solution or powder for casting films, coating substrates, forming gels and freeze drying into porous scaffolds of your own design. Powders and flakes suit hemostatic granules and compounding with alginate, chitosan, silver or an antibiotic. Electrospun mats suit layered dressings and barrier membranes where fibre orientation does the work.

The material ends up in absorbable hemostatic sponges and pads for surgery and trauma, dressings for diabetic ulcers, pressure sores, burns and donor sites, dental plugs for socket grafting and site preservation, vascular occlusion sheets deployed through a sheath to seal an arterial puncture, and composite dressings carrying an antimicrobial or a growth factor.

Consistency is a manufacturing decision, not a lucky batch.

The specification is tight where it matters to a device. Total protein above 98 percent, non-collagen protein under 1 percent, endotoxin below 0.5 EU per mL, pH 6.5 plus or minus 0.5, and an intact triple helix at roughly 300 kDa. Atelopeptide by design, so immunogenicity stays low and your biocompatibility package has less to defend.

Processing runs as a closed system from skin to vial, with fragment length defined across multiple centrifuge stations rather than left to the batch. A process you validate once keeps performing, and a scale up does not send you back to the start of your verification plan.

Characterisation and purity are confirmed by independent laboratories. Intertek covers identity and purity. Mechanical properties are tested at Cambridge and Oxford. The data arrives with the material, in a form your design history file and supplier qualification can absorb directly.

Bovine hides and tendons are sourced only from countries WOAH classifies as negligible risk for BSE, with unbroken cold chain in transit and full traceability to the herd. Manufacture follows ISO 13485:2016 and the ISO 22442 series, so the TSE and BSE file your notified body or FDA reviewer asks for already exists.

Quantities start at pilot scale for a feasibility build and move to production supply, from a Swiss company built around a handful of long term partners rather than a catalogue. Where a format does not exist yet, Alpstein’s development team can tune porosity, load an active, or shape a scaffold around one indication, so the material meets the device halfway.

Atelopeptide collagen, telopeptides removed.

Intact triple helix at approximately 300 kDa.

Endotoxin below 0.5 EU/mL as standard.

Closed system processing, skin to vial.

Fragment length defined across multiple centrifuge stations.

Sterile or non-sterile supply.

Four physical forms from one material stream.

Independent analysis from Intertek, Cambridge and Oxford.

Full ISO 22442 traceability and cold chain.

Pilot to production volumes.

Development support on top of supply.