by Dr. Yashashwini Reddy | Aug 27, 2025
Media Fill Test — Sterile API Manufacturing (Aseptic Process Simulation) 1. Objective To demonstrate that the aseptic API manufacturing process (including personnel, equipment, materials, and environment) can reliably produce a sterile product by simulating routine...
by Dr. Yashashwini Reddy | Aug 27, 2025
🔹 Key Strategies to Strengthen Microbiological Control Raw Material Control Perform supplier qualification and audits. Conduct microbiological testing for bioburden and objectionable organisms. Establish strict acceptance criteria. Water System Management Validate and...
by Dr. Yashashwini Reddy | Aug 18, 2025
✅ Tips to Develop Equipment Cleaning Procedure Risk Assessment First Identify the potential for cross-contamination, product carryover, and microbial risks. Classify equipment as product-contact or non-product-contact. Define Cleaning Scope Clearly specify which...
by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation of Manufacturing Equipment Cleaning validation is a documented process that ensures manufacturing equipment in the pharmaceutical industry is consistently cleaned to predetermined limits, preventing contamination and cross-contamination between...
by Dr. Yashashwini Reddy | Aug 18, 2025
Types of Purified Water Systems in Pharmaceuticals Pharmaceutical industries require high-quality water for manufacturing, cleaning, and formulation. Different water systems are designed to meet specific pharmacopeial standards (USP, EP, IP, JP) depending on their...
