The Gericke continuous blenders for pharmaceutical formulation have been approved for use in explosive atmospheres. It fulfils the requirements for category one with a minimum ignition energy of >1mJ. Thus, the blenders are certified to be used in ATEX zone 20 without any need for inertisation or additional safety measures.
Most pharmaceutical granules and tablets are produced in batches, not just when preparing the raw components in accordance with the formula but also when mixing the excipients with the active ingredients.
After a long period during which the traditional batch process dominated the pharmaceutical manufacturing of OSD, the Food and Drug Administration and the European Medicines recognised the advantages of continuous manufacturing. This has removed regulatory barriers, which had historically held back the increased use of inline feeding and blending processes in the manufacture of drugs.
Gericke’s range of continuous mixers
Gericke’s continuous mixers offer a combination of radial and axial mixing (dispersion), ensuring high homogeneity with low RSD even for formulations containing less than 1% of API. The shape, layout and adjustment of the Gericke mixing tools have been developed based on upon 50 years of experience in continuous mixing and in collaboration with universities and industry partners. The residence time and the energy input can be adjusted to achieve the pharmaceutical process parameters.
The blenders are available as standalone machines for early phase development or integrated into the Gericke Formulation Skid GFS as part of a fully integrated continuous manufacturing line for Oral Solid Dosage forms. This includes the PAT for process automation and quality management.