Tag: Cleaning Procedures

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

Managing Cleaning Validation for Spray Coating Machines with Complex Designs

March 8, 2025 Admin

Managing Cleaning Validation for Spray Coating Machines with Complex Designs Managing Cleaning Validation for Spray Coating Machines with Complex Designs Introduction: In the pharmaceutical industry, maintaining the highest standards of cleanliness and hygiene is imperative to ensure product safety and efficacy. Cleaning validation is a critical aspect of pharmaceutical manufacturing, particularly for spray coating machines…

Solid Dosage form, Tablets

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation

March 4, 2025 Admin

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Introduction: In the pharmaceutical industry, maintaining high standards of cleanliness and sanitation is paramount. One critical component of this process is the use of purified water for cleaning validation. The flow rate of purified water…

Solid Dosage form, Tablets

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs

March 4, 2025 Admin

Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Ensuring Robustness in Cleaning Validation for Granulators Used with Low-Dose APIs Introduction: In the pharmaceutical industry, ensuring the cleanliness and safety of manufacturing equipment is crucial, especially when dealing with low-dose Active Pharmaceutical Ingredients (APIs). Granulators, essential in the tablet production process, must undergo…

Solid Dosage form, Tablets

Difficulty in validating cleaning procedures for encapsulation molds exposed to dyes

March 3, 2025 Admin

Difficulty in validating cleaning procedures for encapsulation molds exposed to dyes Difficulty in validating cleaning procedures for encapsulation molds exposed to dyes Introduction: In the pharmaceutical industry, the production of capsules—both hard and soft gelatin—often involves the use of various dyes to achieve the desired aesthetic and functional properties. These dyes can pose significant challenges…

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

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production

March 3, 2025 Admin

Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Validating Cleaning Procedures for High-Shear Mixers in Multi-API Tablet Production Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is paramount to maintaining the safety and efficacy of drug products. High-shear mixers are integral in the production of tablets, especially those containing multiple…

Solid Dosage form, Tablets