Tag: Manufacturing Best Practices

Troubleshooting Over-Lubrication in Powder Blends During Compression Validation

June 1, 2025 Admin

Troubleshooting Over-Lubrication in Powder Blends During Compression Validation Troubleshooting Over-Lubrication in Powder Blends During Compression Validation Introduction: In the pharmaceutical industry, the production of tablets is a complex process that demands precision and careful attention to detail. One critical aspect of tablet manufacturing is the lubrication of powder blends, which facilitates the tablet compression process….

Solid Dosage form, Tablets

Validating Spray Gun Settings for Even Coating Distribution

June 1, 2025 Admin

Validating Spray Gun Settings for Even Coating Distribution Validating Spray Gun Settings for Even Coating Distribution Introduction: In the pharmaceutical industry, ensuring that tablets have an even coating is crucial not only for aesthetic purposes but also for the functionality of the dosage form. The coating protects the active pharmaceutical ingredient (API), controls release profiles,…

Solid Dosage form, Tablets

Addressing Cracking in Film Coatings of Extended Release Tablets Under Stress

May 30, 2025 Admin

Addressing Cracking in Film Coatings of Extended Release Tablets Under Stress Addressing Cracking in Film Coatings of Extended Release Tablets Under Stress Introduction: Film coatings are a critical component in the development of extended-release tablets, playing an essential role in the control of drug release rates, protection of the drug from environmental factors, and improving…

Solid Dosage form, Tablets

Managing Failures in Process Validation for High-Speed Compression

May 27, 2025 Admin

Managing Failures in Process Validation for High-Speed Compression Managing Failures in Process Validation for High-Speed Compression Introduction: In the pharmaceutical industry, process validation is a critical component of quality assurance, particularly for high-speed compression in tablet manufacturing. This process ensures that tablets meet consistent standards for quality, safety, and efficacy. However, managing failures in process…

Solid Dosage form, Tablets

Addressing Brittleness in Sugar-Coated Tablets During Validation Studies

May 25, 2025 Admin

Addressing Brittleness in Sugar-Coated Tablets During Validation Studies Addressing Brittleness in Sugar-Coated Tablets During Validation Studies Introduction: Sugar-coated tablets have long been a popular choice in pharmaceutical manufacturing due to their aesthetic appeal, ease of swallowing, and ability to mask the taste of active ingredients. However, the process of sugar coating can introduce brittleness, posing…

Solid Dosage form, Tablets

Troubleshooting Failures in Equipment Calibration for Weight Variation Control

May 22, 2025 Admin

Troubleshooting Failures in Equipment Calibration for Weight Variation Control Troubleshooting Failures in Equipment Calibration for Weight Variation Control Introduction: In the pharmaceutical manufacturing industry, the production of tablets requires meticulous attention to detail to ensure consistent quality and efficacy. One critical aspect of tablet production is maintaining precise weight variation control, which directly impacts dosage…

Solid Dosage form, Tablets

Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation

May 19, 2025 Admin

Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation Addressing Cross-Contamination Risks in Blending Equipment During Cleaning Validation Introduction: The pharmaceutical industry is committed to ensuring the safety and efficacy of its products. One critical component of this commitment is the prevention of cross-contamination, particularly in the manufacturing of solid dosage forms like tablets. Blending…

Solid Dosage form, Tablets

Managing Failures in Cleaning Validation for High-Speed Coating Lines

May 14, 2025 Admin

Managing Failures in Cleaning Validation for High-Speed Coating Lines Managing Failures in Cleaning Validation for High-Speed Coating Lines Introduction: In the pharmaceutical industry, maintaining stringent hygiene and cleanliness standards is paramount, especially in the production of solid dosage forms like tablets. High-speed coating lines, which apply protective or functional coatings to tablets, play a critical…

Solid Dosage form, Tablets

Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations.

April 25, 2025 Admin

Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations. Inadequate systems for verifying cleaning effectiveness for gelatin-free formulations. Introduction: In the pharmaceutical industry, ensuring the cleaning effectiveness of manufacturing equipment is critical, especially when producing gelatin-free formulations. Such formulations represent a growing trend due to dietary preferences, allergies, and religious beliefs. However, the absence of…

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

Difficulty in validating capsule sealing for high-viscosity formulations.

April 23, 2025 Admin

Difficulty in validating capsule sealing for high-viscosity formulations. Difficulty in Validating Capsule Sealing for High-Viscosity Formulations Introduction: In the pharmaceutical industry, the development and manufacturing of solid oral dosage forms, specifically capsules, play a crucial role in delivering medications effectively to patients. Capsules, particularly those filled with high-viscosity formulations, present unique challenges in sealing validation….

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

Problems with ensuring consistent cleaning of capsule printing heads.

April 23, 2025 Admin

Problems with ensuring consistent cleaning of capsule printing heads. Problems with Ensuring Consistent Cleaning of Capsule Printing Heads Introduction: In the pharmaceutical industry, capsule printing is a critical process that involves imprinting information, such as dosage details or branding, onto the surface of capsules. Maintaining the cleanliness of capsule printing heads is crucial to ensure…

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