Tag: pharmaceutical cleaning validation

Validating Cleaning Protocols for High-Speed Compression Lines

May 28, 2025 Admin

Validating Cleaning Protocols for High-Speed Compression Lines Validating Cleaning Protocols for High-Speed Compression Lines Introduction: In the pharmaceutical industry, ensuring the cleanliness of equipment used in tablet production is crucial for maintaining product quality and safety. High-speed compression lines are integral to the efficient production of tablets, but they also pose significant challenges when it…

Solid Dosage form, Tablets

Poor reproducibility in rinse sampling data for lipid-based formulations.

April 17, 2025 Admin

Poor reproducibility in rinse sampling data for lipid-based formulations. Poor reproducibility in rinse sampling data for lipid-based formulations. Introduction: Lipid-based formulations have gained significant attention in the pharmaceutical industry due to their ability to enhance the bioavailability of poorly water-soluble drugs. However, ensuring the cleanliness of manufacturing equipment used for these formulations poses unique challenges,…

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

Poor reproducibility in recovery rates for rinse sampling validation.

March 15, 2025 Admin

Poor reproducibility in recovery rates for rinse sampling validation. Poor reproducibility in recovery rates for rinse sampling validation. Introduction: In the pharmaceutical industry, maintaining rigorous standards for cleanliness and contamination control is paramount. Rinse sampling validation is a critical component of this process, ensuring that manufacturing equipment is adequately cleaned between batches. However, achieving consistent…

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

Inadequate methods for detecting protein residues in gelatin tanks.

March 11, 2025 Admin

Inadequate methods for detecting protein residues in gelatin tanks. Inadequate methods for detecting protein residues in gelatin tanks. Introduction: The pharmaceutical industry relies heavily on the meticulous production of solid oral dosage forms, particularly capsules. Gelatin, both hard and soft, serves as a primary material for encapsulation. However, one critical issue that persists is the…

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

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