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20.11.2023 Continuous manufacturing: now available for ATEX Zone 20

The Gericke continuous blenders for pharmaceutical formulation have been approved for use in explosive atmospheres. It fulfills the requirements for category 1 with a minimum ignition energy of > 1 mJ. 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 recognized the advantages of continuous manufacturing. This removed the regulatory barriers, which historically had held back the increased use of inline feeding and blending processes in the manufacture of drugs.

Gericke Continuous Mixers offer a combination of radial and axial mixing (dispersion), ensuring highest homogeneity with low RSD even for formulations containing less than 1% of API. 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.

gerickegroup.com

 


 
ATEX approved continuous blender from Gericke

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