The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP outlines the procedure for aligning the die and punch in tablet press machines to ensure the proper formation of tablets. Accurate alignment is critical to preventing tablet defects such as incomplete compression, uneven weight, or damage to tooling.
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The purpose of this SOP is to outline the procedure for the preventive maintenance of tablet manufacturing equipment. Preventive maintenance ensures that equipment operates efficiently, reduces the likelihood of breakdowns, and extends the lifespan of machinery used in tablet production.
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The purpose of this SOP is to define the procedure for the setup and validation of a semi-automatic tablet press. Proper setup and validation ensure that the tablet press is operating at optimal efficiency, producing tablets that meet the required specifications for weight, hardness, and other critical quality attributes.
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This SOP defines the procedure for optimizing the coating suspension viscosity during tablet coating processes. Optimizing the viscosity ensures uniform coating application, prevents coating defects, and improves tablet quality by controlling the flow characteristics of the coating suspension.
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This SOP describes the procedure for conducting the film adhesion test on enteric-coated tablets. The test ensures that the enteric coating adheres properly to the tablet core, maintaining the integrity and effectiveness of the coating throughout its shelf life and during gastrointestinal transit.
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This SOP outlines the procedure for testing the core hardness of sustained release tablets to ensure that they meet the necessary specifications for mechanical strength and integrity. Core hardness is an important quality attribute that affects tablet durability, release profile, and patient compliance.
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This SOP defines the procedure for applying heat during the sugar coating process for tablets. The application of controlled heat ensures the proper drying and uniform coating of tablets, which is crucial for the integrity, appearance, and performance of the final product.
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The purpose of this SOP is to describe the procedure for conducting lamination and stress testing during the film coating process of tablets. The test ensures that the film coating adheres properly to the tablet core and can withstand the physical stresses encountered during handling, storage, and transport.
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This SOP defines the procedure for the tablet dedusting process, which ensures that the tablets are free from loose powder or dust particles that may interfere with tablet appearance, quality, and subsequent packaging.
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This SOP outlines the procedure for using vacuum transfer systems in the handling of powders during tablet manufacturing. The use of vacuum systems ensures the efficient, hygienic, and safe transfer of powders between different stages of the manufacturing process while minimizing dust exposure and contamination.
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