Hemostatic Gelatin Sponges

Gelatin has been used for many centuries in food and medicine¹ and today is one of the best characterized natural proteins and biopolymers in science². This natural hydrocolloid is often used in the medical industry for its properties such as gel formation, stability and compatibility. It is therefore well-established in the manufacture of capsules, tablets, wound dressings and other medical products.

Gelatin is particularly suitable for the production of hemostatic products such as sponges and powders, which are used to stop bleeding, promote blood clotting and support wound healing. Its hydrocolloidal properties enable it to absorb water and form a gel. This gel can both absorb blood and support clotting. For these reasons, gelatin-based sponges are often used in surgery and dental applications to control bleeding during or after surgical procedures.

With medical devices, the process of selecting the appropriate raw materials is crucial. To develop a safe and effective medical device, detailed technical documentation is required. This should contain all relevant information about design, raw materials and manufacturing steps, including quality testing and performance in accordance with established rules and regulations – for example, as requested by the US Food and Drug Administration (FDA) or the European Medical Device Regulation (MDR).

This paper discusses the mode of action, production steps, characterization and choice of raw materials for hemostatic gelatin sponges, with a brief overview of GELITA’s high performance portfolio, MEDELLAPRO^®.