ISPE LIFE SCIENCES MAINTENANCE MICROBIALS MONITORING PHARMACEUTICALS PHARMACEUTICAL WATER OPERATIONS ROUGE SYSTEM DESIGN TRAINING USP

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Abstract

Proper high-purity water system design, as discussed in our previous article (“Keys to High-Purity Water System Design”) will often result in greater success as well as simplified operation and maintenance of the system. However, continuous successful operation will be difficult to achieve without proper initial training and periodic refresher training of all personnel involved with the system. At a minimum, training programs should include operators, maintenance staff, direct management, quality assurance, quality control, and anyone else who might benefit. This article discusses good practices for the maintenance and operation of a high-purity water system.

System owners and operators will be ill equipped to correctly operate, validate, service, or evaluate system performance without a clear understanding of the system’s proper and intended operation, features, capabilities, and limitations. While training is essential, it is prudent to hire employees who already have knowledge related to; sanitary design, sanitary materials and finishes, sanitary joining technology, unique sanitary equipment, microbiology basics, familiarity with the equipment and technology in use, system integration methods, subcomponent operation, service expectations, and controls and programming. Regardless of the knowledge personnel may have, training on each component of the system may still be necessary. This includes recommended maintenance for components and equipment, system operation, controls and automation of the system, instructions for disassembly and reassembly of components and equipment, and troubleshooting. The goal is to minimize failures and downtime. With personnel who have more experience and training, there is a higher likelihood of successful operation. In addition to direct system training, in-house procedural training will also likely be required.

Decisions regarding how to operate and maintain a high-purity water system may depend significantly on the criticality of the process water. For instance, how many hours of water system outage are tolerable? What will the cost of a water system outage be? How long will it take to recover from an outage? These are all the types of questions that need to be addressed when developing operating plans, maintenance philosophies, and associated schedules.

Based on the criticality of the system, standard operating procedures (SOPs) should be developed to assure the necessary performance levels and up-time is achieved. SOPs should provide adequate detail that can be easily followed by those operating the system and should address preventive maintenance as needed to minimize unplanned outages. The SOPs should include emergency plans for each of the possible scenarios that would lead to down time. The SOPs should also address system shutdown and restart, as well as, recovery from programming loss.

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