Gelatin is a naturally occurring protein extracted from animal collagen. There’s also a wider push to take patient safety to the next level. The world is currently seeing a bigger demand for products made with safe materials from natural origin. ![]() Gelatin melts at body temperature making it perfect for pharma-medical applications that require metabolization. BiocompatibilityĪs a natural protein, gelatin offer high biocompatibility and is well-tolerated by the human body. A hydrolyzed gelatin has no gel forming capability so it has a bloom value of 0. The bloom value of gelling grade gelatin determines the firmness of the gelled products. The exact transition temperature depends on the type and concentration of gelatin used, making it a versatile material that can be used in different applications that require different melting temperatures. Gelling grade gelatin is thermoreversible, meaning it has a reversible melting and setting ability at a temperature between 25☌ and 32☌ (gelatin solution at 10%). The Main Properties of Gelatin: Thermo-reversible Gelatin is a polydisperse polymer that has a unique set of functionalities and properties that make it suitable for a wide range of applications. Raw materials for medical devices and other specific applications (parenteral, regenerative medicine, cell culture, etc.) may have additional requirements depending on the final application, such as additional virus inactivation studies, free of endotoxins / pyrogens and free of mycoplasma. We’ll help you to keep in step with regulations and guidelines across the world. The process is audited by pharmaceutical companies. ![]() excipient, raw material for medical devices, tissue engineering etc). Gelatin needs to be produced in alignment with good manufacturing practices (GMP) suitable for its intended application (e.g. Gelatin has to meet the specifications described within the pharmacopeia: Testing, control and full traceability are important: careful selection of raw materials and suppliers, swift collection and transport, and strict testing and control of raw materials to ensure optimal quality and safety. To extract gelatin, the native collagen is rendered soluble via acid, alkaline or enzymatic treatment and then boiled in water.įor gelatin to be considered pharma-medical grade, it needs to meet certain standards: Quality Control and Traceability Gelatin is a soluble protein obtained by the partial hydrolysis of collagen derived from the bones, hides and skins of animals (mainly from cows, pigs and fishes).
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