Tablets & Capsules

TC0718

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You can verify the volumetric flowrates using an ane- mometer and the principle of traverse flow measurements [1]. According to this principle, if the duct diameter is 4 inches or larger, you can obtain the average volumetric flowrate by taking a series of readings at points of equal area, also known as traverse readings. Figure 1 shows the five recommended traverse reading points for round ducts. To avoid turbulence in the airflow, identify four locations in the duct where there are no elbows, transi- tions, takeoffs, dampers, or other obstructions. Using a calibrated anemometer as a known test standard, measure the supply volumetric flowrate at the five traverse points for each of the four duct locations. Then average these 20 flowrate measurements to determine the supply air flow- rate. You can calculate the percent error of your supply air flowrate measurement using the equation: Use your averaged measured flowrate as the input value, and the system controller's actual displayed flow- rate as the output value. The recommended standard 32B July 2018 Tablets & Capsules T This article discusses important tablet film coating operating parameters and describes a simple procedure to verify the in-process controls to ensure coating uniformity, product quality, and regulatory compliance from batch to batch. he final rule of the FDA's Dietary Supplement GMP Regulation 21 CFR Part 111.30(c) requires dietary supple- ment manufacturers to "routinely calibrate, inspect, or check the equipment to ensure proper performance." Additionally, per 21 CFR Part 111.55, dietary supplement manufacturers must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of products to ensure the quality of the dietary supplement. This includes in-process tablet coater controls such as supply and exhaust air volu- metric flowrates, supply and exhaust air temperatures, pan rotation speed, coating solution spray rate, and atomizing air pressure. Verifying each of these controls using appro- priate methods will ensure GMP compliance and maintain consistent tablet quality from batch to batch. Verifying in-process controls Supply and exhaust air volumetric flowrates. Ensure that the supply and exhaust air volumetric flowrates are within the specified limits. Excessively high flowrates can prematurely evaporate the moisture from the coating solution before the solution contacts the tablet bed, caus- ing the dried solution particles to exhaust with the air- stream and resulting in undercoated tablets. On the other hand, supply and exhaust volumetric flowrates that are too low may overwet the tablet bed, which can lead to tablet sticking and picking problems. Verifying film coater operating parameters to ensure the quality of dietary supplement tablets Karthik Maniam Nature's Value coating input – output × 100 input Figure 1 Traverse reading points for a rounded duct Traverse points or centers of the equal concentric areas Equal concentric areas

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