Tag: validation troubleshooting

Problems with validating sterilization processes for gelatin solutions.

April 7, 2025 Admin

Problems with validating sterilization processes for gelatin solutions. Problems with validating sterilization processes for gelatin solutions. Introduction: Sterilization is a critical process in the pharmaceutical industry, especially for solid oral dosage forms like capsules. Gelatin solutions, used in both hard and soft gelatin capsules, require meticulous sterilization to ensure product safety and efficacy. However, validating…

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

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

Ensuring Compliance with Regulatory Standards for Utility Validation Reports

March 8, 2025 Admin

Ensuring Compliance with Regulatory Standards for Utility Validation Reports Ensuring Compliance with Regulatory Standards for Utility Validation Reports Introduction: In the pharmaceutical industry, utilities such as water systems, HVAC, and compressed gases are integral to manufacturing processes. Ensuring compliance with regulatory standards for utility validation reports is crucial for maintaining product safety, efficacy, and quality….

Solid Dosage form, Tablets

Addressing Non-Adherence to Cleanroom Temperature Standards During Validation

March 6, 2025 Admin

Addressing Non-Adherence to Cleanroom Temperature Standards During Validation Addressing Non-Adherence to Cleanroom Temperature Standards During Validation Introduction: The pharmaceutical industry hinges on stringent environmental controls to ensure product safety and efficacy. Among these controls, maintaining the correct temperature in cleanrooms during the validation phase is critical. Cleanrooms are designed to limit the presence of airborne…

Solid Dosage form, Tablets