Tag: residue detection

Inadequate systems for verifying cleaning agent effectiveness for lipid residues.

April 22, 2025 Admin

Inadequate systems for verifying cleaning agent effectiveness for lipid residues. Inadequate systems for verifying cleaning agent effectiveness for lipid residues. Introduction: In the pharmaceutical industry, the effectiveness of cleaning agents in removing lipid residues is crucial, particularly in the production of solid oral dosage forms like capsules. Inadequate cleaning can lead to cross-contamination, affecting product…

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

Poor reproducibility in swab recovery studies during cleaning validation.

April 22, 2025 Admin

Poor reproducibility in swab recovery studies during cleaning validation. Poor reproducibility in swab recovery studies during cleaning validation. Introduction: Cleaning validation is a critical component of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It ensures that any equipment used in the production of drug products is adequately cleaned to prevent contamination of subsequent batches….

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

Inadequate systems for monitoring cleaning agent residues in rinse water.

March 11, 2025 Admin

Inadequate systems for monitoring cleaning agent residues in rinse water. Inadequate Systems for Monitoring Cleaning Agent Residues in Rinse Water Introduction: Ensuring the cleanliness of pharmaceutical manufacturing equipment is critical to maintaining product safety and efficacy. In the production of solid oral dosage forms, such as capsules, the presence of cleaning agent residues in rinse…

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

Difficulty in validating cleaning methods for enteric-coated formulations.

March 7, 2025 Admin

Difficulty in validating cleaning methods for enteric-coated formulations. Difficulty in Validating Cleaning Methods for Enteric-Coated Formulations Introduction: In the pharmaceutical industry, maintaining stringent cleanliness standards is crucial to ensure product safety and efficacy. One area that presents significant challenges is the cleaning validation for enteric-coated formulations. These formulations are designed to resist the acidic environment…

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