Efficient Endotoxin Control in Purified Water Systems with FiberFlo® Hollow Fiber Filters and Minncare® Cold Sterilant

The most efficient control system involves both a program to monitor and control bacterial contamination of the water system and a system design that includes a barrier between the water system and the downstream processes that may be adversely affected by endotoxin contamination.

The Minntech Filtration Technologies Group has a unique combination of products that allows the efficient control of endotoxin contamination in medical and pharmaceutical water treatment systems. A program using Minncare Cold Sterilant for the periodic disinfection/sterilization of reverse osmosis systems and water distribution systems will control the bacterial source of endotoxins. FiberFlo Hollow Fiber filters are a proven barrier to endotoxins when included as either polishing filters in a water distribution loop or as point-of-use filters in a properly designed and maintained water distribution system. Bacterial Control with Minncare Cold Sterilant Minncare Cold Sterilant is a proprietary, high purity, peracetic acid/hydrogen peroxide solution that is a powerful oxidant.

It stops organism growth by oxidizing microbial cell proteins and enzyme systems. Minncare Cold Sterilant is fast acting, providing 6 log reduction of bacteria population at a 100X dilution (1%) within a 36 minute soak time and sterilization (12 log reduction of bacteria) within 11 hours. Minncare Cold Sterilant is biodegradable and will decompose into oxygen, water and acetic acid.

Testing of Minncare Cold Sterilant has shown how fast acting it is. The table below shows common water-borne bacteria that may be found in water treatment systems and the effectiveness of Minncare in killing those bacteria.

In Vitro Aqueous Test at 20O C Minncare Concentration .5%

The elimination of bacterial contamination using Minncare Cold Sterilant is an important part of the operating procedures for a water system that will help prevent endotoxin contamination from reaching a patient. However, system operating procedures can only go so far. Bacterial contamination of water treatment systems is virtually impossible to prevent completely. Using Minncare is not a preventive measure, but a simple, cost-effective method of limiting the level of contamination in a system.

As mentioned above, having a system design that includes a barrier to the contamination of downstream processes is just as important. Pyrogen Removal with FiberFlo Filters FiberFlo Hollow Fiber filters have the unique ability to remove endotoxin from water. When challenged with a concentration of endotoxin equal to 5 EU/ml, FiberFlo EN filters will retain 100% of the endotoxin challenge, as measured by a test with a detection limit of 0.06EU/ml. FiberFlo EN Cartridge Filters have a high surface area in a compact package.

This high surface area allows the filtration of water through each filter at a low pressure drop. The low pressure drop allows the efficient removal of endotoxins. FiberFlo EN Capsule Filters also have a high surface area for the device size, again allowing the efficient removal of endotoxins at critical low-flow, point-of-use locations.

The FiberFlo EN filters are “normal flow” filters that allow 100% recovery of water flow. The FiberFlo Hollow Fiber filters are the only normal flow filters validated to remove endotoxin in water. This is a tremendous advantage for system design and operation. All other proven methods of endotoxin removal require the use of tangential flow filtration systems that are expensive, difficult to operate and maintain and may require the loss of more than onequarter of the flow of the RO system as part of their standard operating procedures.

FiberFlo EN filters are made to the same quality standards as all products manufactured at Minntech Corporation, a medical device manufacturer. Pyrogen removal performance of each lot of membrane is validated as part of the procedure to accept that lot for conversion into finished products. Finished products are tested for integrity, and each is packaged in a controlled environment. Contact your Filtration Technologies Group representative for more information.