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A tablet press in operation An old rotary tablet press. A tablet press is a mechanical device that compresses powder into tablets of uniform size and weight. A tablet press can be used to manufacture tablets of a wide variety of materials, including pharmaceuticals, nutraceuticals, cleaning products, industrial pellets and cosmetics.
For compression testing, the analyst generally aligns the tablet in a repeatable way, [2] and the tablet is squeezed between a fixed and a moving jaw. The first machines continually applied force with a spring and screw thread until the tablet started to break. [3] When the tablet fractured, the hardness was read with a sliding scale. [3]
The compression is done either by a single-punch machine (also called stamping press, achieves an output of approximately 200 tablets per minute, making it ideal for manufacturing small batches of tablets) or by a multi-station machine (rotary press). The tablet press is a high-speed mechanical device.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.
The compression can take place in one or two stages (main compression, and, sometimes, pre-compression or tamping) and for commercial production occurs very fast (500–50 mg per tablet). Finally, the upper punch is pulled up and out of the die (decompression), and the tablet is ejected from the die by lifting the lower punch until its upper ...
Process validation involves a series of activities taking place over the lifecycle of the product and process.". [4] A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient ...
Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report [ 1 ] outlining best practices regarding business process validation in the pharmaceutical ...