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Compelled by fear to do more than necessary, they may overdesign their filtration systems, adding wasteful and costly procedures.By embracing this fear, rather than studying the root causes of filter penetration and the specifics of each process, practitioners of sterile filtration impede the advancement of filtration science and its understanding within the industry and global regulatory agencies.For a process as critical and sensitive as sterile filtration, it’s not surprising that many filter end-users experience some “fear of failure.” As risk management consultant Peter Sandman has said, people become fearful when they feel they are not in control [1].

Since then, we have been leading the industry with efficient designs that provide the most throughput available, while enhancing patient safety.

The assay was adapted from a technique for staining the enzyme hexokinase to signal the presence of adenosine triphosphate in viable specimens by reducing a tetrazolium salt to formazan. These approaches have limitations because laboratory rearing is slow and sometimes complex, and morphological assessments require significant technical skill and time, and can be subjective.

Basic laboratory facilities and skills are required for production of the stain, but no specialist equipment, expertise, or facilities are needed for its use. There are few published assessments of the accuracy of morphological viability assessment methods, but it is likely that they sometimes either over- or underestimate mortality, depending on treatment and species. Some studies have investigated biochemical approaches to improve viability assessment methods.

With his vision and deep understanding of customer needs, O’Brien has guided Ultra Clean Systems to become an industry innovator and leader in Ultrasonic Cleaning systems.

Since its inception, Ultra Clean Systems is proud to have developed a number of industry firsts.This article will examine several unnecessary practices that are burdened upon the industry today, using process validation principles to explain why they are inadequate.