Maintenance, annual preventive

Most HPLC systems in pharmaceutical laboratories are calibrated every 6-12 months. Periods longer than 12 months are not recommended while periods shorter than 3 months are deemed unnecessary because each HPLC system is also subjected to a daily system suitability check to ensure sufficiency for the application. Ideally, the frequency of calibration should be dictated by the historical data of calibration failures and the manufacturer s recommendation. In practice, 6 months appears to be the norm adopted by most laboratories. Calibration is also required after annual preventive maintenance or major repairs though only the affected modules, and not the entire system, need to be recalibrated. 

Annual preventive maintenance, in which most wearable items such as pistons, seals, lamps, and filters are replaced, is to be scheduled before calibration. 

System calibration refers to the periodic operational qualification of the HPLC, typically every 6 to 12 months in most regulated laboratories. This calibration procedure is usually coordinated with an annual preventative maintenance (PM) program and is performed immediately after PM. A calibration sticker is placed on the instrument to indicate its calibration status and readiness for GMP work. The reader is referred to the principles and strategies behind HPLC calibration criteria published elsewhere.8 A summary of the calibration procedures and acceptance criteria, including additional procedures recommended for initial operational qualification, is listed in Table 9.3. 

Corrosion is both costly and dangerous. Billions of dollars are spent annually for the replacement of corroded structures, machinery, and components, including metal roofing, condenser tubes, pipelines, and many other items. In addition to replacement costs are those associated with maintenance to prevent corrosion, inspections, and the upkeep of cathodically protected structures and pipelines. Indirect costs of corrosion result from shutdown, loss of efficiency, and product contamination or loss. 

For further details of industrial operating costs see Annual Oil and Gas Kngine Fower Costs, published hy the American Society of Mechanical Engineers. Engine manufacturers will supply recommended schedules for preventive maintenance. 

Repetitive shutdown work This type of work is developed by experienced maintenance and operations supervision based on prior shutdown experience, job knowledge, and required shutdown preventive maintenance tasks. Each agreed-upon job is assigned an annual work order number frequency, established, work order plans written, and is entered in the work order log. The handling of repetitive work orders will be the same as non-repetitive work orders, except one copy of the work plan will be substituted for the first copy of the work order. 

Expenditure on corrosion prevention is an investment and appropriate accountancy techniques should be used to assess the true cost of any scheme. The main methods used to appraise investment projects are payback, annual rate of return and discounted cash flow (DCF). The last mentioned is the most appropriate technique since it is based on the principle that money has a time value. This means that a given sum of money available now is worth more than an equivalent sum at some future data, the difference in value depending on the rate of interest earned (discount rate) and the time interval. A full description of DCF is beyond the scope of this section, but this method of accounting can make a periodic maintenance scheme more attractive than if the time value of money were not considered. The concept is illustrated in general terms by considering a sum of money P invested at an... 

Maintain and calibrate the HPLC system periodically. Preventive maintenance performed by a service engineer annually and system calibrations performed every 6 months are recommended. ... 

The following is a listing of commonly recommended maintenance procedures. Some are included in the manufacturer s preventive maintenance (PM) program, which should be conducted annually. 

An annual target-setting process for operational improvements needs to be established. Very specific targets have to be set for each plant and production unit, that in sum will allow the overall company target to be achieved. The process should start with a top-down target for cost savings, followed by bottom-up action and milestone plans. The improvement opportunities could be reductions in annual plant downtime to below ten percent per year as a sum of numerous measures derived from observations on the shop floor, i.e., reduction of downtime for specific vacuum pumps via preventive maintenance or substitution of a repairintensive pump by one more suited to the process step. 

The first component of a successful clinical trial manufacturing program is the area or facility used for the production of clinical trial batches. This facility should have limited access and be segregated from other activities where the danger of cross contamination is removed and the control of materials, product, waste, and personnel flow can be achieved. Preparation of vector batches requires rooms where a controlled environment can be maintained. Here, under class 10,000 and class 100 environments, batches can be produced, purified, and vialed for use in trials. HVAC and other equipment used within the manufacturing facility requires annual calibration, initial installation, and operational qualification, and appropriate preventive maintenance programs. Written procedures for the use, cleaning, and maintenance of the facility, and the equipment must also be written and followed by appropriate personnel. 

Inspection and Preventive Maintenance As with all water-based extinguishing systems, particularly those installed outside, inspection and preventive maintenance are critical to reliable operation. Detection devices are typically inspected, tested, and maintained quarterly or at a frequency deemed more appropriate for a particular location. The water-spray system itself is typically flow-tested at least annually (NFPA 25, 1995). Because of the nozzles small orifice size, scale and corrosion buildup can compromise flow and spray patterns. The use of strainers and the conduct of flow tests will help minimize this potential problem. As stated earlier, preventive maintenance of the overall water supply and distribution systems is an integral part of a reliable system. 

Water sprays from monitor nozzles and hose lines can be used for vapor mitigation. Tests have been conducted in which monitor nozzles and hose lines have been used to create a chimney effect through which the gas is forced upward and dispersed at a high elevation (Beresford, 1981). Application techniques and flow rates are facility-, installation-, and material-specific. Careful planning, analyses, and testing should be conducted prior to deciding on the use of a mobile water spray as a proven means of mitigation. Preventive maintenance of this equipment is key to reliable operation. Hose lines, typically, are hydrostatically tested annually. Flow tests should also be conducted periodically. 

Thirteen other factors were also considered in evaluating each option (1) capital costs, (2) operating and maintenance costs, (3) liability cost rating, (4) timeliness, (5) transferability, (6) revenues, (7) equivalent annual costs, (8) pollution prevention mode, (9) net release reduction, (10) recovery costs, (11) cost effectiveness, (12) resource utilization, and (13) effects of secondary emissions. Finally, data Ifom public opinion polling in the community near the refinery were considered in evaluating potential public support or opposition to different pollution prevention strategies. 

The next element is Operating Procedures [29 CFR 1910.119 (f)]. This requires that the operation of a covered process be directed by written operating procedures that are accessible to and used by the employees who operate that process. They must be up-to-date and must cover normal operations, start up, emergency shutdown, temporary operations, and start up after a maintenance turnaround. They must cover safe operating limits for the critical process parameters as well as how to prevent the process from operating outside those limits (and what to do if the limits are exceeded). These procedures must be certified annually as accurate and up-to-date, have the input of the operators, and they must be trained in their use. ... 

Mining Corrosion in this sector is not as significant a problem as in other sectors. The primary life-limiting factors for mining equipment are wear and mechanical damage. Maintenance painting, however, is heavily relied on to prevent corrosion, with an estimated annual expenditure of 0.1 billion. 

Productivity improvements can often be achieved with minimal investment. For example, a pump in production-critical service may fail once every 3 months. If each pump failure leads to production losses of 15,000, then the annual cost of this problem is 60,000. Investigation into the pump failures shows that the breakdown rate could be greatly reduced where a preventive maintenance system was to be implemented, so that problems can be addressed before the pump actually fails. It is predicted that the new failure rate will be once per year, equivalent to a loss of 15,000 per year. Hence the annual savings that flow from the preventive maintenance program are 45,000. If the preventive maintenance system for that pump costs say 10,000 to implement and 5,000 per year to run, then the net savings over a period of 5 years is 190,000 (ignoring the discounted value of money), and the return on investment is very high indeed. 

TTie methodology of preventive maintenance has been developed for the purpose of operatir fertilizer plants. It may reduce unexpected downtimes of installations and increase overall annual operation time. ... 

All systems should receive a visual inspection each quarter. Test or inspect each antomatic system on an annual basis. Include all systems in the preventive maintenance plan. Test all snpervisory signal devices except valve tamper switches on a quarterly basis. Test valve tamper switches and water flow devices semiannually. Test duct detectors, electromechanical releasing devices, heat detectors, manual fire alarm boxes, and smoke detectors on a semiannual basis. Test occupant alarm notification devices to inclnde andible and visible devices at least annually. Maintain appropriate documentation on all tire-related system testing. 

Even in factories where planned maintenance is not officially applied the first method of breakdown maintenance is rarely followed completely. When a given item of equipment has failed several times in the same way or after similar intervals of time, someone is sure to suggest that some preventative action should be taken before the time that the next failure is due. This may be as simple as saying that a particular pump, gearbox, or motor is overhauled in the annual shutdown because it is known from past experience that it will not last for another year . 

The local fire department must be well acquainted with your facility, its location, and specific hazards. The fire alarm system mnst be certified, as required, and tested at least annually. Interior standpipes must be inspected regularly. Outside private fire hydrants must be flushed at least once a year and on a routine preventive maintenance schedule. All fire doors and shutters must be in good operating condition, unobstructed, and protected against obstructions, including their counterweights. 

Ongoing inspection during operations, preventive maintenance, and repair work Annual site inspections... 

A study by Hoar (1971) on behalf of the Department of Trade and Industry in the United Kingdom, found that the annual cost of corrosion in the UK was 1365 million pounds. A similar study in the USA in 1981 estimated the annual cost of corrosion to be 70billion US (Bennett and Kruger 1981). Even areas of new and advancing technology such as the aircraft industry cannot escape the ravages of corrosion. In 1990 the US Air Force calculated that maintenance costs associated with corrosion amounted to 718 million US per year (Cooke et al. 1990). These cost penalties include not only the costs of corrosion protection and prevention, but also the costs of replacement and loss of production time as a result of corrosion. Of course, some of these costs caimot be avoided... 

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