Tag: FDA cleaning requirements

Challenges in validating cleaning processes for aqueous-based capsule formulations.

March 26, 2025 Admin

Challenges in validating cleaning processes for aqueous-based capsule formulations. Challenges in validating cleaning processes for aqueous-based capsule formulations Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount, especially when dealing with aqueous-based capsule formulations. These formulations, found in both hard and soft gelatin capsules, pose unique challenges due to their propensity…

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

Problems with ensuring complete removal of oils and fats from soft gelatin equipment.

March 24, 2025 Admin

Problems with ensuring complete removal of oils and fats from soft gelatin equipment. Problems with ensuring complete removal of oils and fats from soft gelatin equipment. Introduction: In the pharmaceutical industry, soft gelatin capsules are a popular dosage form due to their patient-friendly administration and ability to encapsulate a wide range of substances. However, the…

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

Problems with establishing validated cleaning procedures for complex equipment assemblies.

March 18, 2025 Admin

Problems with establishing validated cleaning procedures for complex equipment assemblies. Problems with establishing validated cleaning procedures for complex equipment assemblies Introduction: In the pharmaceutical industry, maintaining a high standard of cleanliness is crucial, particularly when dealing with complex equipment assemblies used in the production of solid oral dosage forms such as capsules. Cleaning validation is…

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