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...
by Dr. Yashashwini Reddy | May 12, 2025
Standard Operating Procedure (SOP) Here is a Standard Operating Procedure (SOP) for the Cleaning of Octagonal Blender, a commonly used equipment in pharmaceutical manufacturing for mixing dry powders and granules. 1. Objective To establish a...
by Dr. Yashashwini Reddy | May 12, 2025
Standard Operating Procedure (SOP) Here is a Standard Operating Procedure (SOP) for the Cleaning of Blister Packing Machine, typically used in pharmaceutical manufacturing to ensure hygiene, prevent cross-contamination, and comply with GMP. 1....
