During granulation, small particles are bonded to form larger clusters. The aim is to enhance the flow properties of the material for the downstream process stages. A basic distinction is made between dry and wet granulation, whereby the latter method is predominantly used.
Solutions for pharmaceutical production – and thus also granulating systems – are subject worldwide to the most stringent requirements in terms of safety, purity and reproducibility. The process must conform to the strict GMP regulations and FDA directives. The hygienic design of machines is an equally strict requirement in the pharma industry as in the food industry. Particularly in pharma production, containment requirements must also be satisfied, i.e. the environment must be protected from contamination by highly active substances. In addition, machines must comply with CFR21 Part 11 pharmaceutical controls validated according to current GAMP 5 directives.
Granulating in a vertical system
Different systems are available for granulating tasks in the pharmaceutical industry. Lödige’s high-shear mixers are a common solution for the mixing, granulating and sieving of pharmaceutical powders and granulates.