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The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems Biofilm is critical to water systems. Water systems professionals need to have thorough microbiology-focused education about all aspects of water systems, such as proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Better to be safe than to be sorry Why is this understanding necessary? Simple: lack of it can result in costly system downtime or even product recalls. This is why those in water systems need to have proper insights into what actually lies behind some common water system designs. They need to clear the air about several misconceptions on the topic. Removing ignorance is the key One factor common to almost all professionals in pharmaceutical biofilms, especially those in water systems, is the presence of fear and hype. This happens to those who fail to realize that there is no one, blanket one-size-fits-all set of rules for design and operation. For biofilm to be controlled; its complete grasp is the first prerequisite. The fact that each water system is unique explains why this is so. So, water systems professionals have to understand the uniqueness of each biofilm that grows into their system, since each is quite different from the other system. Developing a single source to tackle different issues Water systems professionals need to get hold of a set of learning that can be used as a single source that can is translatable to any system. Using this, they should be able to achieve an uneventful microbial control, meaning a microbial control that is free of errors. This is the foundation to effective operation and design. For this to come about, organizations need to realize that the costs of failure far outweigh the educational costs that could have prevented it. Get control of USP A good way to get understanding of this topic is to reference the US Pharmacopeia (USP), which has a lot of information on the topic of sampling and microbial enumeration. Organizations that work on water systems need to have a grasp of this. In addition, they need to be familiar with an understanding of water system validation and Change Control. This knowledge is necessary to help them come up with ways of improving outcomes and reducing the frequency of excursion investigations.
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Pharmaceutical Water Systems, microbiological education, Prior microbiological training, Validated System, FDA validation,
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