Critical Process Filtration Blog

Extractables and Leachables, these terms are a part of the manufacturing process of new medicines and other areas of such. These terms are very commonly misunderstood by one another and they both gave their distinct characteristics, which can be traced through the whole supply chain.  The definitions of these are not balanced. They overlap and have different utilization, and situations in the manufacturing process must be categorized to highlight the weight and necessity of both extractables and leachables.

How to evaluate a replacement filter equivalent to the one you're using now. For any number of reasons, you’re looking for a new filter supplier. If your current filtration performance is satisfactory, replacing the filters with the correct equivalent will do. But if you need to improve filter performance, a different configuration of your current filter or a different type of filter will be the solution. Either way, a quality supplier should take the time to determine exactly what equivalent means to you and help you identify the appropriate filter(s).

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.