by Dr. Yashashwini Reddy | Jun 9, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems Purpose:To establish and document a systematic approach ensuring that the Clean-in-Place (CIP) system effectively cleans equipment and piping without manual disassembly, preventing cross-contamination and...
by Dr. Yashashwini Reddy | Jun 9, 2025
Sampling in Cleaning Validation in Pharmaceutical Industry Cleaning Validation is a crucial part of pharmaceutical manufacturing to ensure that equipment and production areas are properly cleaned to prevent cross-contamination, ensure product quality, and comply with...
by Dr. Yashashwini Reddy | Jun 9, 2025
Recovery Factor Determination in Cleaning Validation What is Recovery Factor?Recovery Factor (RF) is a measure of how effectively an analytical method can extract and detect a known quantity of residue from a surface or sampling medium (e.g., swabs, rinse solutions)...
by Dr. Yashashwini Reddy | May 19, 2025
The U.S. Food and Drug Administration (FDA) has issued multiple warning letters to pharmaceutical and medical device manufacturers for deficiencies in cleaning validation processes. These letters highlight the critical importance of robust cleaning procedures to...
by Dr. Yashashwini Reddy | May 19, 2025
Selecting the appropriate swab for cleaning validation is crucial to ensure accurate and reliable results, particularly in industries like pharmaceuticals, biotechnology, and food processing. An unsuitable swab can compromise the entire validation process by...
