Preparing Water for Injection (WFI) from raw water involves several purification and filtration steps to ensure it meets pharmacopeial standards (such as USP, EP, or JP). Here’s a general step-by-step process: Pre-Treatment This stage removes large contaminants and prepares the water for further purification. Reverse Osmosis (RO) System Electrodeionization (EDI) or Ion Exchange Ultraviolet (UV)…
ETP is used to treat wastewater and industrial effluents before discharging them into the environment or reusing them. In the pharmaceutical industry, ETPs play a crucial role in ensuring compliance with environmental regulations and maintaining sustainability. Key Components 1. Preliminary Treatment: 2. Primary Treatment: 3. Secondary Treatment (Biological Treatment): 4. Tertiary Treatment: 5. Sludge Management:…
A Dirty Hold Time Study is conducted to determine the maximum allowable time that equipment can remain uncleaned after use without exceeding acceptable microbial contamination limits. This study ensures compliance with Good Manufacturing Practices (GMP) and helps establish cleaning validation parameters. Objective Equipment Selection Includes process equipment like: Focus on surfaces and areas prone to…
When I first started executing routine Environmental Monitoring, I often wondered: Why do we use saline solution in Grade A and DEB solution in other areas? One key factor influencing microbial recovery accuracy is the choice of swabbing solution. Two commonly used solutions—Dey-Engley Broth (DEB) and saline solution—serve distinct purposes in microbial monitoring. Here’s a…
Sterile cleanrooms demand precision, discipline, and adherence to protocols, but human factors can sometimes jeopardize the entire operation. Let’s shine a light on the bad behaviors that compromise sterility assurance and discuss how to prevent them. Common Bad Behaviors Observed in Cleanrooms: Improper Gowning Techniques Excessive Movements Touch Contamination Non-Compliance with SOPs Lack of Awareness…
The CIP (Cleaning-In-Place) process is crucial in pharmaceutical, food, and chemical industries for cleaning equipment without disassembly. Using cleaning agents and water, it reduces time and ensures product safety. Key Stages of the CIP Process: Common Challenges: Key Considerations: Performance Monitoring: Read also:
CIP is the process of cleaning equipment, tanks and production lines without dismantling them, by pumping detergents and water while they are in place, to save time and ensure the stability of cleanliness. Basic steps of CIP Common challenges in CIP Monitor performance and ensure efficiency Periodic maintenance and best practices Guidelines In order to…
Imagine this: You’re in the middle of a bustling production line, and everything seems to be running smoothly. Suddenly, an alert goes off, notifying you that the particle count inside your vial filling machine has spiked. Panic ensues. But why is this such a significant issue, and how can you tackle it effectively? Let’s dive…
