Tag: drug manufacturing

Troubleshooting Failures in Rinse Sampling for Fluid Bed Dryers During Validation

May 28, 2025 Admin

Troubleshooting Failures in Rinse Sampling for Fluid Bed Dryers During Validation Troubleshooting Failures in Rinse Sampling for Fluid Bed Dryers During Validation Introduction: Rinse sampling is a critical step in the validation of fluid bed dryers within pharmaceutical manufacturing. Ensuring that no residues of active pharmaceutical ingredients (APIs) or cleaning agents remain is essential for…

Solid Dosage form, Tablets

Root Cause Analysis of Weight Variation in Tablets During Stability Storage

May 24, 2025 Admin

Root Cause Analysis of Weight Variation in Tablets During Stability Storage Root Cause Analysis of Weight Variation in Tablets During Stability Storage Introduction: In the pharmaceutical industry, tablets remain one of the most common solid dosage forms, prized for their convenience, stability, and precise dosing. However, a critical aspect of tablet production and storage is…

Solid Dosage form, Tablets

Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage

April 30, 2025 Admin

Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage Troubleshooting Surface Roughness in Sugar-Coated Tablets During Storage Introduction: Sugar-coated tablets are a prevalent form of oral pharmaceutical dosage due to their aesthetic appeal, taste masking abilities, and protective properties. However, during storage, these tablets can sometimes develop surface roughness, which can compromise their appearance, consumer acceptance,…

Solid Dosage form, Tablets

Addressing Over-Drying Issues in Granulation During Validation Runs

April 24, 2025 Admin

Addressing Over-Drying Issues in Granulation During Validation Runs Addressing Over-Drying Issues in Granulation During Validation Runs Introduction: In the pharmaceutical industry, granulation is a critical step in the production of solid dosage forms such as tablets. It involves the agglomeration of powder particles to form granules, which enhance the flowability and compressibility of the powder,…

Solid Dosage form, Tablets

Managing Non-Adherence to GMP Standards in QA Processes

April 18, 2025 Admin

Managing Non-Adherence to GMP Standards in QA Processes Managing Non-Adherence to GMP Standards in QA Processes Introduction: In the pharmaceutical industry, maintaining strict adherence to Good Manufacturing Practice (GMP) standards is critical to ensuring the safety, efficacy, and quality of drug products. GMP standards, established by regulatory bodies such as the US FDA, provide a…

Solid Dosage form, Tablets

Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time

April 13, 2025 Admin

Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time Troubleshooting Loss of API Potency in Sugar-Coated Tablets Over Time Introduction: Sugar-coated tablets are a popular solid dosage form in the pharmaceutical industry due to their ability to mask unpleasant tastes and improve patient compliance. However, maintaining the potency of the Active Pharmaceutical Ingredient (API)…

Solid Dosage form, Tablets

Problems with ensuring proper calibration of HVAC sensors during validation.

April 13, 2025 Admin

Problems with ensuring proper calibration of HVAC sensors during validation. Problems with Ensuring Proper Calibration of HVAC Sensors During Validation Introduction: In the pharmaceutical industry, maintaining optimal environmental conditions is critical for the production of safe and effective drugs. Heating, Ventilation, and Air Conditioning (HVAC) systems play a pivotal role in controlling these conditions. Accurate…

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

Challenges in validating capsule filling equipment for pediatric formulations.

April 12, 2025 Admin

Challenges in validating capsule filling equipment for pediatric formulations. Challenges in validating capsule filling equipment for pediatric formulations. Introduction: Pediatric formulations, especially in the form of capsules, present unique challenges in pharmaceutical manufacturing. The demand for precise dosing, patient compliance, and safety in pediatric populations necessitates rigorous validation of capsule filling equipment. Validation ensures that…

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

Identifying Problems in Potency Testing for Extended Release Tablets

March 31, 2025 Admin

Identifying Problems in Potency Testing for Extended Release Tablets Identifying Problems in Potency Testing for Extended Release Tablets Introduction: Extended release tablets are a cornerstone of modern pharmaceutical therapy, providing patients with the convenience of reduced dosing frequency while maintaining therapeutic efficacy over an extended period. Potency testing of these formulations is critical to ensure…

Solid Dosage form, Tablets

Managing Calibration Failures in Moisture Sensors for Fluid Bed Dryers

March 22, 2025 Admin

Managing Calibration Failures in Moisture Sensors for Fluid Bed Dryers Managing Calibration Failures in Moisture Sensors for Fluid Bed Dryers Introduction: In pharmaceutical manufacturing, fluid bed dryers play a crucial role in ensuring the precise moisture content of solid dosage forms, such as tablets. The accuracy of moisture sensors in these dryers is vital for…

Solid Dosage form, Tablets

Ensuring Consistency in Content Uniformity Tests Across Batches

March 19, 2025 Admin

Ensuring Consistency in Content Uniformity Tests Across Batches Ensuring Consistency in Content Uniformity Tests Across Batches Introduction: In the pharmaceutical industry, the consistency of content uniformity tests across batches is pivotal to ensuring the safety and efficacy of solid dosage forms, particularly tablets. Content uniformity is a critical quality attribute that determines whether each tablet…

Solid Dosage form, Tablets

Achieving Uniform Blend Distribution in Blending Machines

March 17, 2025 Admin

Achieving Uniform Blend Distribution in Blending Machines Achieving Uniform Blend Distribution in Blending Machines Introduction: In the pharmaceutical industry, ensuring the uniform distribution of active pharmaceutical ingredients (APIs) and excipients in solid dosage forms is critical for product efficacy, safety, and quality. Blending is a key process in tablet manufacturing, where achieving uniform blend distribution…

Solid Dosage form, Tablets