Tag: USFDA compliance

Addressing Overheating Issues in Heat-Sealing Equipment

June 3, 2025 Admin

Addressing Overheating Issues in Heat-Sealing Equipment Addressing Overheating Issues in Heat-Sealing Equipment Introduction: Heat-sealing equipment is pivotal in the pharmaceutical sector, particularly in the packaging of solid dosage forms like tablets. These machines ensure the integrity and safety of pharmaceutical products by creating airtight seals that protect against environmental factors. However, overheating can pose significant…

Solid Dosage form, Tablets

Troubleshooting Failures in Compressed Air Quality Tests for Compression Machines

June 2, 2025 Admin

Troubleshooting Failures in Compressed Air Quality Tests for Compression Machines Troubleshooting Failures in Compressed Air Quality Tests for Compression Machines Introduction: In the pharmaceutical industry, the quality of compressed air used in tablet compression machines is paramount. Compressed air serves as a critical utility, influencing both product quality and operational efficiency. Ensuring that this air…

Solid Dosage form, Tablets

Validating Batch Records for Regulatory Compliance in Tablet Manufacturing

May 25, 2025 Admin

Validating Batch Records for Regulatory Compliance in Tablet Manufacturing Validating Batch Records for Regulatory Compliance in Tablet Manufacturing Introduction: In the pharmaceutical industry, ensuring the integrity and accuracy of batch records is paramount, particularly in the manufacturing of tablets. Batch records serve as a critical component in the documentation of each step of the manufacturing…

Solid Dosage form, Tablets

Managing Cross-Contamination Risks in Coating Machines Used for Extended Release Tablets

May 23, 2025 Admin

Managing Cross-Contamination Risks in Coating Machines Used for Extended Release Tablets Managing Cross-Contamination Risks in Coating Machines Used for Extended Release Tablets Introduction: In the pharmaceutical industry, ensuring product safety and efficacy is paramount, and one critical aspect of this is managing cross-contamination risks. This is especially crucial in the production of extended-release tablets, where…

Solid Dosage form, Tablets

Challenges in validating capsule drying equipment for formulations with volatile excipients.

April 15, 2025 Admin

Challenges in validating capsule drying equipment for formulations with volatile excipients. Challenges in validating capsule drying equipment for formulations with volatile excipients. Introduction: The pharmaceutical industry faces numerous challenges in ensuring the quality and efficacy of solid oral dosage forms, such as capsules. Among these challenges, validating capsule drying equipment is a critical step, especially…

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

Difficulty in detecting powder buildup in filling equipment.

April 2, 2025 Admin

Difficulty in detecting powder buildup in filling equipment. Difficulty in detecting powder buildup in filling equipment. Introduction: The pharmaceutical industry heavily relies on precision and efficiency, particularly in the production of solid oral dosage forms like capsules. Filling equipment plays a crucial role in ensuring that each capsule meets stringent quality standards. However, one persistent…

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

Troubleshooting Weight Variation in Tablets Across Batch Sizes

March 30, 2025 Admin

Troubleshooting Weight Variation in Tablets Across Batch Sizes Troubleshooting Weight Variation in Tablets Across Batch Sizes Introduction: In the pharmaceutical industry, maintaining consistency in tablet weight across different batch sizes is crucial for ensuring product efficacy and patient safety. Weight variation can lead to dose inconsistency, which is a significant quality issue that can affect…

Solid Dosage form, Tablets

Managing Failures in Moisture Content Tests for Coated Tablets

March 13, 2025 Admin

Managing Failures in Moisture Content Tests for Coated Tablets Managing Failures in Moisture Content Tests for Coated Tablets Introduction: Moisture content tests are an essential part of ensuring the quality, safety, and efficacy of coated tablets in pharmaceutical manufacturing. Accurate moisture levels are crucial as they impact the physical and chemical stability of the tablet,…

Solid Dosage form, Tablets

Addressing Overheating Issues in Heat-Sealing Equipment

March 11, 2025 Admin

Solid Dosage form, Tablets

Addressing Cross-Contamination Risks in Purified Water Systems for Multi-API Tablets

March 5, 2025 Admin

Addressing Cross-Contamination Risks in Purified Water Systems for Multi-API Tablets Addressing Cross-Contamination Risks in Purified Water Systems for Multi-API Tablets Introduction: In the pharmaceutical industry, the production of multi-Active Pharmaceutical Ingredient (API) tablets poses unique challenges, particularly concerning cross-contamination. Purified water systems play a pivotal role in tablet manufacturing, serving as a critical utility in…

Solid Dosage form, Tablets

Preventing Over-Drying of Hygroscopic Tablets in Fluid Bed Dryers

March 5, 2025 Admin

Preventing Over-Drying of Hygroscopic Tablets in Fluid Bed Dryers Preventing Over-Drying of Hygroscopic Tablets in Fluid Bed Dryers Introduction: In the pharmaceutical industry, maintaining the integrity and efficacy of tablet formulations is of paramount importance. Hygroscopic tablets, known for their moisture-attracting properties, present unique challenges during the drying process. Fluid bed dryers, a common tool…

Solid Dosage form, Tablets

Addressing High Friability in Sugar-Coated Tablets

March 4, 2025 Admin

Addressing High Friability in Sugar-Coated Tablets Addressing High Friability in Sugar-Coated Tablets Introduction: Sugar-coated tablets are a popular solid dosage form due to their appealing appearance, taste masking capabilities, and ability to protect the drug core from environmental factors. However, achieving the ideal balance between coating thickness and tablet robustness is crucial to maintain product…

Solid Dosage form, Tablets