Tag: Residue Limits

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs

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Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Introduction: In the pharmaceutical industry, ensuring the cleanliness and safety of manufacturing equipment is crucial, especially when dealing with low-dose Active Pharmaceutical Ingredients (APIs). Granulators, essential in the tablet production process, must undergo…

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Solid Dosage form, Tablets

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production

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Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining the safety and efficacy of drug products. High-shear mixers are integral in the production of tablets, especially those containing multiple…

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Solid Dosage form, Tablets

Managing Cleaning Validation Failures for Immediate Release Tablet Equipment

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Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Managing Cleaning Validation Failures for Immediate Release Tablet Equipment Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical to product quality and safety. Particularly for immediate release tablets, stringent cleaning protocols prevent cross-contamination and guarantee that residue levels remain within acceptable limits….

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Solid Dosage form, Tablets