Tag: manufacturing consistency

Addressing Non-Uniform Granule Size in Fluid Bed Granulators During Validation

May 20, 2025 Admin

Addressing Non-Uniform Granule Size in Fluid Bed Granulators During Validation Addressing Non-Uniform Granule Size in Fluid Bed Granulators During Validation Introduction: In the pharmaceutical industry, maintaining consistent granule size during the fluid bed granulation process is crucial for ensuring the quality and efficacy of solid dosage forms like tablets. Granule size uniformity affects the flow…

Solid Dosage form, Tablets

Poor reproducibility in monitoring shell thickness for soft gelatin capsules.

April 22, 2025 Admin

Poor reproducibility in monitoring shell thickness for soft gelatin capsules. Poor reproducibility in monitoring shell thickness for soft gelatin capsules. Introduction: In the pharmaceutical industry, soft gelatin capsules play a critical role as a popular dosage form due to their versatility and patient compliance. However, ensuring the quality and consistency of these capsules is crucial,…

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

Poor standardization of in-process quality control procedures.

April 20, 2025 Admin

Poor standardization of in-process quality control procedures. Poor standardization of in-process quality control procedures. Introduction: In the pharmaceutical industry, maintaining the highest quality standards is paramount. This is especially true for solid oral dosage forms, such as hard and soft gelatin capsules, where the absence of rigorous in-process quality control (IPQC) can lead to significant…

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

Inadequate control over changes in raw material suppliers.

April 19, 2025 Admin

Inadequate control over changes in raw material suppliers. Inadequate control over changes in raw material suppliers Introduction: In the pharmaceutical industry, maintaining consistent quality and efficacy of products is paramount. One critical aspect that can significantly impact these factors is the control over raw material suppliers. Changes in suppliers can lead to variations in product…

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

Poor reproducibility in nitrogen validation results for encapsulation processes.

April 11, 2025 Admin

Poor reproducibility in nitrogen validation results for encapsulation processes. Poor reproducibility in nitrogen validation results for encapsulation processes. Introduction: In the pharmaceutical sector, the encapsulation process is pivotal for manufacturing solid oral dosage forms like capsules. Ensuring the reproducibility and reliability of this process is crucial for maintaining product quality and compliance with regulatory standards….

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

Poor reproducibility in vacuum sealing of capsule containers.

April 1, 2025 Admin

Poor reproducibility in vacuum sealing of capsule containers. Poor Reproducibility in Vacuum Sealing of Capsule Containers Introduction: In the pharmaceutical industry, ensuring the integrity and stability of capsule packaging is crucial. Capsules, whether hard or soft gelatin, are sensitive to environmental factors such as moisture and oxygen, which can compromise their efficacy and shelf life….

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

Challenges in validating the performance of capsule filling equipment.

April 1, 2025 Admin

Challenges in validating the performance of capsule filling equipment. Challenges in validating the performance of capsule filling equipment. Introduction: In the pharmaceutical industry, capsule filling equipment plays a crucial role in the production of solid oral dosage forms. These machines are responsible for accurately filling hard and soft gelatin capsules with the appropriate dosage of…

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

Problems with ensuring consistent alignment of capsule cap and body parts during validation.

March 21, 2025 Admin

Problems with ensuring consistent alignment of capsule cap and body parts during validation. Problems with ensuring consistent alignment of capsule cap and body parts during validation. Introduction: In the pharmaceutical industry, the production of solid oral dosage forms such as capsules requires precision and adherence to stringent quality standards. Capsules, particularly hard and soft gelatin…

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

Difficulty in ensuring consistent performance of capsule sealing equipment.

March 14, 2025 Admin

Difficulty in ensuring consistent performance of capsule sealing equipment. Difficulty in ensuring consistent performance of capsule sealing equipment. Introduction: In the pharmaceutical industry, the use of capsules as a dosage form is widespread due to their ease of production, patient compliance, and ability to encapsulate a variety of drugs. The capsule sealing process is a…

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

Poor reproducibility in validation data for semi-automated encapsulation systems.

March 13, 2025 Admin

Poor reproducibility in validation data for semi-automated encapsulation systems. Poor reproducibility in validation data for semi-automated encapsulation systems. Introduction: In the pharmaceutical industry, the precision and consistency of encapsulation systems, particularly semi-automated ones, are paramount. Encapsulation plays a vital role in drug delivery, ensuring each dose contains the correct amount of active pharmaceutical ingredient (API)….

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

Managing Failures in Content Uniformity Tests for Immediate Release Tablets

March 13, 2025 Admin

Managing Failures in Content Uniformity Tests for Immediate Release Tablets Managing Failures in Content Uniformity Tests for Immediate Release Tablets Introduction: In the world of pharmaceutical manufacturing, ensuring that each tablet contains the precise amount of active ingredient is crucial for both efficacy and safety. This is particularly true for immediate-release tablets, where rapid onset…

Solid Dosage form, Tablets