Tag: cross-contamination prevention

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

Difficulty in validating cleaning procedures for encapsulation molds exposed to dyes

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Difficulty in validating cleaning procedures for encapsulation molds exposed to dyes Difficulty in validating cleaning procedures for encapsulation molds exposed to dyes Introduction: In the pharmaceutical industry, the production of capsules—both hard and soft gelatin—often involves the use of various dyes to achieve the desired aesthetic and functional properties. These dyes can pose significant challenges…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

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

Validating Steam Sterilization Systems for Coating Pans in Multi-Product Facilities

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Validating Steam Sterilization Systems for Coating Pans in Multi-Product Facilities Validating Steam Sterilization Systems for Coating Pans in Multi-Product Facilities Introduction: In the complex world of pharmaceutical manufacturing, ensuring the sterility of equipment is crucial for product safety and efficacy. This is particularly true in multi-product facilities, where cross-contamination risks are heightened. One critical piece…

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Solid Dosage form, Tablets