Tag: USFDA

Addressing Poor Adhesion in Enteric Coating Processes

March 18, 2025 Admin

Addressing Poor Adhesion in Enteric Coating Processes Addressing Poor Adhesion in Enteric Coating Processes Introduction: Enteric coating is a crucial process in the pharmaceutical industry, designed to ensure that tablets withstand the acidic environment of the stomach and release their active ingredients in the more neutral pH of the intestine. However, poor adhesion during the…

Solid Dosage form, Tablets

Ensuring Robustness in Weight Uniformity Tests Across Tablet Batches

March 9, 2025 Admin

Ensuring Robustness in Weight Uniformity Tests Across Tablet Batches Ensuring Robustness in Weight Uniformity Tests Across Tablet Batches Introduction: In the realm of pharmaceutical manufacturing, ensuring the consistency and quality of solid dosage forms, such as tablets, is paramount. One critical aspect of quality control is the weight uniformity test, which ensures that each tablet…

Solid Dosage form, Tablets

Detecting Layer Delamination in Multi-Layer Tablets During Production

March 8, 2025 Admin

Detecting Layer Delamination in Multi-Layer Tablets During Production Detecting Layer Delamination in Multi-Layer Tablets During Production Introduction: In the pharmaceutical industry, multi-layer tablets offer a sophisticated solution to delivering complex drug regimens. These tablets are designed to release active ingredients at different rates or to combine incompatible agents within a single dosage form. However, ensuring…

Solid Dosage form, Tablets

Ensuring Consistency in Clean Steam Quality for Fluid Bed Granulators

March 8, 2025 Admin

Ensuring Consistency in Clean Steam Quality for Fluid Bed Granulators Ensuring Consistency in Clean Steam Quality for Fluid Bed Granulators Introduction: In the pharmaceutical industry, the quality of clean steam used in fluid bed granulators is paramount. Clean steam is crucial for maintaining the integrity and efficacy of the final product, as it is directly…

Solid Dosage form, Tablets

Preventing Over-Drying in Coated Tablets During Curing Stages

March 6, 2025 Admin

Preventing Over-Drying in Coated Tablets During Curing Stages Preventing Over-Drying in Coated Tablets During Curing Stages Introduction: Coated tablets are a mainstay in the pharmaceutical industry, offering benefits such as controlled release, taste masking, and enhanced stability. However, one of the critical stages in the production of coated tablets is the curing process, which aims…

Solid Dosage form, Tablets

Validating Real-Time Process Monitoring Systems for Coating Applications

March 4, 2025 Admin

Validating Real-Time Process Monitoring Systems for Coating Applications Validating Real-Time Process Monitoring Systems for Coating Applications Introduction: The pharmaceutical industry is continually evolving, with advanced technologies enhancing precision, safety, and efficiency in drug manufacturing. One such advancement is the implementation of real-time process monitoring systems for coating applications in tablet production. These systems play a…

Solid Dosage form, Tablets

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets

March 4, 2025 Admin

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Introduction: In the pharmaceutical industry, the production of multi-layer tablets requires meticulous attention to detail to ensure product safety and efficacy. One critical aspect of tablet production is the use of fluid bed granulators, which…

Solid Dosage form, Tablets

Managing Non-Uniform API Distribution in Content Uniformity Tests

March 3, 2025 Admin

Managing Non-Uniform API Distribution in Content Uniformity Tests Managing Non-Uniform API Distribution in Content Uniformity Tests Introduction: The uniform distribution of the Active Pharmaceutical Ingredient (API) in solid dosage forms, such as tablets, is a critical quality attribute in pharmaceutical manufacturing. The reliability of therapeutic outcomes and patient safety hinges on the consistent delivery of…

Solid Dosage form, Tablets

Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies

March 3, 2025 Admin

Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies Introduction: In the pharmaceutical industry, ensuring the safety and efficacy of products is paramount. Residual solvent analysis plays a critical role in utility validation studies, which are essential to maintaining the integrity of solid dosage…

Solid Dosage form, Tablets

Managing Failures in Batch Sampling for Quality Assurance

March 2, 2025 Admin

Managing Failures in Batch Sampling for Quality Assurance Managing Failures in Batch Sampling for Quality Assurance Introduction: In the pharmaceutical industry, ensuring the quality of a product is paramount. Batch sampling plays a critical role in this process, providing a snapshot that represents the entire production batch. However, managing failures in batch sampling is crucial…

Solid Dosage form, Tablets

Validating Adequacy of Clean Steam Systems for Film-Coating Equipment

March 2, 2025 Admin

Validating Adequacy of Clean Steam Systems for Film-Coating Equipment Validating Adequacy of Clean Steam Systems for Film-Coating Equipment Introduction: In the pharmaceutical industry, ensuring the adequacy of clean steam systems is crucial for the successful operation of film-coating equipment used in tablet production. Clean steam, often used for sterilization and process control, must be free…

Solid Dosage form, Tablets

Managing Over-Lubrication in Blending Processes for Compression

March 2, 2025 Admin

Managing Over-Lubrication in Blending Processes for Compression Managing Over-Lubrication in Blending Processes for Compression Introduction: In the realm of pharmaceutical manufacturing, ensuring the quality and efficacy of solid dosage forms like tablets is paramount. The blending process, a critical step in tablet production, often involves the use of lubricants to improve the flow of powder…

Solid Dosage form, Tablets