Principle: Coating Pan working principle is based on the rotation of the coating pan. The rotation creates a centrifugal force that moves the tablets inside the pan. The atomized coating solution is then applied to the product. Film Coating Solution Preparation Critical Process Parameters: Mesh Size of Nylon cloth/Integrity of Nylon Cloth/Appearance CPP Acceptance Criteria: 200# / Should be integral
Decoding Coating Pan
Critical Quality Attributes: Uniform Suspension CQA Acceptance Criteria: No lumps should be observed in suspension Film Coating Critical Process Parameters: Number of Guns Pre warming temperature TIme Pan RPM Peristaltic Pump Speed Spray Rate Inlet Temperature Tablet Bed Temperature Distance from tablet bed Atomising Air Pressure Nozzle Drying Temperature After Coating Drying Time After Coating Description Average Weight Uniformity of Weight Diameter Thickness Disintegration Time
CPP Acceptance Criteria: 03 Guns 35-45 degree centigrade 10 minutes 1-4 RPM 35-45 RPM 60-80- gm/min/gun 50-60 degree centigrade 35-45 degree centigrade 8-9 inches 2-4 kg/cm2 NMT 50 degree centigrade 15 minutes Physical appearance +- 5% +-4% Diameter Thickness NMT 30 minutes Critical Quality Attributes: Assay Related Substances Residual Solvent CQA Acceptance Criteria: 95-105% of the label claim Single maximum impurity NMT 5% Total Impurity NMT 3%