Tag: [Validation

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

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation

May 25, 2025 Admin

Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Addressing Residual Solvent Build-Up in Sugar-Coating Pans During Validation Introduction: The sugar-coating process in pharmaceutical manufacturing plays a crucial role in enhancing the aesthetic appeal, taste masking, and stability of tablets. However, managing residual solvent build-up during this process, particularly in the coating pans, is a…

Solid Dosage form, Tablets

Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation

May 24, 2025 Admin

Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation Addressing Powder Bridging Issues in Tablet Press Feed Systems During Validation Introduction: In the pharmaceutical industry, ensuring the consistent production of high-quality tablets is paramount. The tablet press feed system plays a crucial role in this process by delivering a uniform and precise amount…

Solid Dosage form, Tablets

Poor validation of capsule sealing temperature profiles.

April 23, 2025 Admin

Poor validation of capsule sealing temperature profiles. Poor validation of capsule sealing temperature profiles. Introduction: The pharmaceutical industry relies heavily on the precision and quality of its manufacturing processes. One critical aspect of ensuring the integrity and effectiveness of solid oral dosage forms, such as capsules, is the validation of capsule sealing temperature profiles. Proper…

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

Poor reproducibility in swab recovery rates for potent APIs.

April 15, 2025 Admin

Poor reproducibility in swab recovery rates for potent APIs. Poor reproducibility in swab recovery rates for potent APIs. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical, especially when dealing with potent active pharmaceutical ingredients (APIs). Swab recovery studies are essential for validating the cleaning processes that remove residues from surfaces….

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

Problems with validating cleaning procedures for encapsulation equipment.

April 2, 2025 Admin

Problems with validating cleaning procedures for encapsulation equipment. Problems with validating cleaning procedures for encapsulation equipment. Introduction: In the pharmaceutical industry, maintaining the cleanliness of manufacturing equipment is critical to ensuring product quality and patient safety. Encapsulation equipment, used extensively for producing both hard and soft gelatin capsules, poses unique challenges when it comes to…

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

Inadequate validation of capsule performance under variable storage conditions.

March 22, 2025 Admin

Inadequate validation of capsule performance under variable storage conditions. Inadequate validation of capsule performance under variable storage conditions Introduction: In the pharmaceutical industry, ensuring the stability and performance of dosage forms, such as capsules, under varying storage conditions is crucial. Capsules, whether hard or soft gelatin, are popular for their ease of administration and ability…

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

Poor reproducibility in validation results for air filtration systems.

March 3, 2025 Admin

Poor reproducibility in validation results for air filtration systems. Poor reproducibility in validation results for air filtration systems. Introduction: In the pharmaceutical industry, air filtration systems are crucial for maintaining cleanroom standards and ensuring the quality and safety of products, especially in the manufacturing of solid oral dosage forms like capsules. These systems are designed…

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