Most Commonly Asked Filtration Question Series You’ve sanitized your system. You have sterilizing grade filters installed at key points in your process. Your bioburden measurements are low but you still have endotoxin issues. What’s going on?
If you’re using filtration to remove bacteria from your process, integrity testing will provide you with data to ensure product quality. Did you know you can perform integrity testing in-house without the huge expense of buying commercial equipment?
Most Commonly Asked Filtration Question Series The risks of not using vent filters on holding and mixing tanks are real. And costly. Unfortunately, we usually hear from a company after they've experienced serious issues because they did not install vent filters. So, this article is written for those not yet using vent filters on their tanks. It will address the most common issues/questions we're asked on this topic with the hope of sparing you a process headache you don't need. Many processes require the use of tanks for holding ingredients to be added into the process, mixing of ingredients, or to hold the final product pending final filtration and filling. During the course of normal operations these tanks will be filled and emptied many times.
The alcohol, low oxygen content, relatively low pH, hops extracts (alpha-acids) and dissolved carbon dioxide in beer inhibit the growth of pathogenic bacteria. That is why beer has been a safe drinking alternative for so many centuries. However, there are microorganisms that can survive and even thrive in beer and spoil the flavor and aroma of any good brew.
The goal of pharmaceutical water system operators is to produce bacteria-free water that meets or exceeds required purity standards. Water systems use several filters to protect system components and to assure that the water dispensed for use is free of bacteria and most other particle contaminants.
Keeping Contaminants Out of Water Tanks Most of the time, the old saying, “An ounce of prevention is worth a pound of cure” is true. Preventing an unwanted event is usually easier than doing remediation work to repair whatever damage is done if the event occurs. However, in virtually all water systems, including pharmaceutical water systems, it is safe to assume that BOTH prevention and remediation are needed to control bacteria and other contaminants.