Tag: Residue Analysis

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

Poor reproducibility in rinse sampling results during cleaning validation.

March 22, 2025 Admin

Poor reproducibility in rinse sampling results during cleaning validation. Poor reproducibility in rinse sampling results during cleaning validation. Introduction: In the pharmaceutical industry, ensuring that manufacturing equipment is free from contaminants is crucial for maintaining product quality and safety. Cleaning validation is a critical process that verifies the effectiveness of cleaning procedures. One of the…

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

Troubleshooting Cleaning Validation Failures in Multi-Product Facilities

March 11, 2025 Admin

Troubleshooting Cleaning Validation Failures in Multi-Product Facilities Troubleshooting Cleaning Validation Failures in Multi-Product Facilities Introduction: In the pharmaceutical industry, maintaining cleanliness in manufacturing facilities is paramount, particularly in multi-product facilities. Cleaning validation ensures that the cleaning process effectively removes residues of active pharmaceutical ingredients, excipients, and cleaning agents. This process is critical to prevent cross-contamination…

Solid Dosage form, Tablets

Poor recovery of residues in rinse sampling during validation.

March 9, 2025 Admin

Poor recovery of residues in rinse sampling during validation. Poor recovery of residues in rinse sampling during validation. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount. One of the critical aspects of cleaning validation is rinse sampling, which helps ensure that no residue from previous manufacturing processes remains on the…

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

Difficulty in validating cleaning procedures for equipment exposed to hygroscopic powders.

March 8, 2025 Admin

Difficulty in validating cleaning procedures for equipment exposed to hygroscopic powders. Difficulty in validating cleaning procedures for equipment exposed to hygroscopic powders. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining product quality and safety. This task becomes particularly challenging when dealing with hygroscopic powders, which are prone to…

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

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities

March 5, 2025 Admin

Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Validating Rinse Sampling Protocols for Cleaning Validation in Multi-Product Facilities Introduction: In the dynamic field of pharmaceutical manufacturing, maintaining stringent hygiene and safety standards is paramount. Multi-product facilities, which handle the production of various drugs using shared equipment, face unique challenges in preventing cross-contamination. A…

Solid Dosage form, Tablets