Economic analysis of failure and maintenance of antibiotic fermentation equipment

Abstract: Based on the requirements of the fermentation industry for production equipment, the failure characteristics of the fermentation industry equipment were analyzed, and the failure rate curve of the fermentation industry equipment was proposed. According to the reliability requirements of the fermentation industry for equipment, the economic analysis of the maintenance of the fermentation industry equipment was carried out, and the basis for determining the maintenance cost of the fermentation industry equipment was proposed.

Key words: fermentation industry equipment; fault characteristics; fault curve; maintenance cost; reliability equipment is the material technology basis of production. Strengthening and improving the management of fermentation industry equipment is an important condition for improving product quality, reducing material consumption, safe production, increasing economic benefits and modernization of fermentation production. To do a good job in the management of fermentation industry equipment and ensure the reliable operation of the fermentation industry equipment, it is necessary to study the characteristics of the fermentation industry equipment and the law of equipment failure. In this paper, the fermentation industry equipment is taken as the research object, and the requirements of the fermentation industry for equipment and the failure law of fermentation industrial equipment are analyzed. Based on the reliability-centered equipment maintenance management idea, the economics of fermentation industry equipment maintenance are analyzed.

1 Fermentation equipment failure characteristics analysis Fermentation industry production is process-based production, and its production equipment generally consists of various reaction tanks, storage tanks, measuring tanks and pumps, valves and pipelines for conveying materials, and various separation equipment and exchanges. A combination of thermal equipment, all of which are combined in a production process line to form a type of fermentation production facility.

1.1 Fermentation process requirements for equipment operation 1.1.1 Sealability Requirements Fermentation production essentially obtains a metabolite of a cell by biotechnology. For example, the process of producing antibiotics is actually the process of reproduction and growth of certain bacteria. Therefore, in the fermentation industry production process to avoid contamination of other bacteria. Due to the sterility requirements of fermentation production, equipment used for fermentation production must have a certain degree of sealing. Moreover, since various solvents used for the extraction of the product are generally flammable, explosive, and toxic and harmful, they also have a sealing requirement for the device containing the solvent. It is an important task for equipment maintenance to ensure the reliability of all sealing points of the equipment and to prevent various leaks.

1.1.2 Continuity requires fermentation production is process-based production, the entire production is continuous, the main equipment is continuous operation 24 hours a day. Taking the erythromycin fermenter as an example, 7 days is a production cycle, and it is required to ensure stable operation of the fermenter in a time of about 160 hours, and serious functional failures such as stirring and inability to operate or leakage of the cooling pipe cannot occur. Otherwise, the entire tank of liquid or contaminated or the bacteria stop growing and forced to let go, will cause tens of thousands of economic losses, but also seriously pollute the surrounding environment of the plant. To this end, the erythromycin production workshop generally inspects and repairs each fermenter every 7 days. At the same time, when the fermenter is running, the maintenance personnel check the vibration of the fermenter, the sealing and the temperature rise of the rotating parts through ear hearing, eye seeing, hand touching, etc., according to which the potential failure of the fermenting tank is found, and the inspection and planning are arranged. repair.

1.1.3 Corrosion resistance requirements Most of the raw materials used in fermentation production have acidity and alkalinity, which is highly corrosive to production equipment. On the one hand, the equipment is designed and manufactured with corrosion-resistant materials or corrosion-resistant structural design. On the other hand, the corrosion-prone parts or components are regularly inspected during the use of the equipment, and the potential failure of the equipment is discovered in time. Patching techniques or replacements are used to prevent potential failures from developing into functional failures.

1.1.4 Pressure vessel specification Maintenance requirements The equipment used in the fermentation industry production is usually sterilized by superheated steam with a higher pressure. The vessel is subjected to a load of higher temperature and higher pressure during steam sterilization. From the perspective of safety, fermentation production equipment generally requires design, manufacture and maintenance of pressure vessel specifications, and requires regular inspection and reliability evaluation of production equipment.

1.2 Analysis of failure mode of fermentation equipment 1.2.1 Leakage In the fermentation industry, leakage of various containers is frequent. A production line with 30 tons of tetracycline raw materials per month has a static sealing point of about 30,000. There may be leakage at each sealing point, so it is likely that several leak points will appear randomly at some time on such a production line. In a production line where equipment management work is well done, the monthly average number of leaks per 30,000 static sealing points can be controlled to less than 10.

1.2.2 Wear and tear is also a common fault in the fermentation industry equipment, mainly in the constraint parts of the rotating shaft of the equipment, such as bearings, sleeves, shaft seals, etc. Wear begins with potential failures, but if it is not detected and disposed of in time, it will lead to functional failures, such as the fermenter mixing can not turn, the material delivery pump can not be pressed, or various shaft seals leak. For a certain constraint part of a single machine's rotating shaft, the wear is periodic, but for the entire production line, the occurrence of wear and tear is a random phenomenon.

1.2.3 Corrosion Due to the acidity and alkalinity of the materials used in the fermentation production, some parts or some parts or even the whole will be corroded by the materials after the production equipment has been used for a certain period of time. Corrosion failure will not occur in the early stage of the whole production line. Due to the different factors affecting each equipment, the corrosion time of the equipment will be different. However, if the corroded equipment can be replaced in time, the corrosion of the entire production line equipment will be broken. The rate is a trend of increasing infinitely close to a constant, and the magnitude of the constant depends on the acidity and alkalinity of the materials used in the production and the corrosion resistance of the materials used in the equipment.

1.2.4 Fatigue fatigue often occurs in the force-receiving part of the equipment, which is due to the deterioration of the material properties of the stressed part, and its appearance is sudden. The form of expression is broken, the consequences are more serious, or the production process is interrupted, or a safety accident is caused. The probability of this fault should be controlled to an acceptable range, but existing fault diagnosis techniques cannot predict fatigue failure. Therefore, the force-receiving parts of important equipment should be periodically replaced or repaired, and the time interval can be calculated based on historical data or test data provided by the equipment manufacturing unit.

1.2.5 Blockage blockage is caused by agglomeration of materials in the equipment passage, or other foreign matter mixed into the material, which often occurs in the fermentation industry. Although the consequences of the failure are not serious, it also affects the normal order of production. The appearance of the blockage has nothing to do with the equipment itself, which is caused by improper operation or incomplete cleaning in the middle of production. The occurrence of clogging is independent of the time of use of the device, and the probability that it tends to occur over a period of time is fixed. The probability size is related to the size of the operator's responsibility during that period of time.

1.2.6 Deformation In the fermentation industry production, although the deformation of the equipment rarely occurs, the consequences of the failure are very serious, often causing the entire equipment to be scrapped, or even a safety accident of personal injury and death, so it should be strictly guarded in production. Equipment deformation is often caused by overload operation, caused by human factors, and its occurrence is independent of the reliability of the equipment itself. It is an accidental and random phenomenon. For a given external environment factor of equipment, from a long-term perspective Look, the failure rate is a constant.

1.2.7 Quality of repair includes two aspects, one is due to the wrong maintenance method or the maintenance quality problem caused by the lack of responsibility of the repairman; the second is the quality problem due to the materials or spare parts used for repair.

About one-third of the faults in the fermentation industry production equipment are caused by the quality of the repairs.

1.3 Analysis of Failure Rate of Fermentation Equipment Reliability-centered equipment maintenance management thought The research on equipment failure is to grasp the regularity from the macroscopic level, and use the mathematical methods of probability and random process to conduct statistical analysis to find out the law of fault occurrence and development. To achieve macro control of the fault. The study of faults is to find the regularity from the probability of fault occurrence, which is based on the certain regularity of certain fault modes of equipment low-level components. This is due to the reliability-centered equipment maintenance management idea, which is mainly developed from the civil aviation industry. The failure mode of the aircraft components is relatively simple. The failure mode of the mechanical rotating components is mainly wear, and the bearing members are mainly broken. For the fermentation industry equipment, the occurrence of faults is diverse, and the regularity of fault occurrence is more diverse and uncertain.

Due to the particularity of the requirements of the fermentation industry and the diversity of factors affecting the production equipment of the fermentation industry, the law of the occurrence of failure of the fermentation production equipment from the whole to the component is special. Applying the reliability-centered equipment maintenance management idea to the maintenance management of fermentation production equipment, we should use the reliability-centered equipment maintenance management idea to find the special regularity of the failure of antibiotic production equipment. If a component fails, there may be multiple failure modes, such as failure of the material pipe, which may be caused by various modes such as fatigue, blockage, corrosion, and wear. And each failure mode has its regularity. Therefore, the failure rate curve of the fermentation production equipment component is superimposed by a plurality of failure mode curves. Compare the occurrence of the fault to an iceberg, as shown in Figure 1. The reliability-centered equipment maintenance management theory should grasp the law of the "fault" on the water surface from a macroscopic perspective, and it is necessary to study the law of various fault "modes" in the underwater part.

For a component of a fermentation production facility, one of its failures may be caused by one of six failure modes of fatigue, corrosion, wear, blockage, deformation, and leakage. The long-term failure rate curve is determined by the probability density function of the six failure modes. The six failure mode probability density function curves are shown in Figure 2.

From the failure mode function curve of the failure mode of the fermentation industry equipment, a special bathtub curve of the fermentation industry equipment failure can be obtained, as shown in Fig. 3.

It can be seen from the curve of the bathtub that the failure rate of a certain component of the fermentation industrial equipment is gradually increased during its life cycle. When the usage time exceeds a certain period of use, the failure rate is drastically increased, and it must be replaced at this time.

For the fermentation production equipment, there are more complex components and more simple components, and there are more components for the entire fermentation line equipment. The failure rate of each component arrives at different times, and the replacement time is different. If each component is replaced at the time, the failure rate of the entire production line equipment will tend to be constant. As shown in Figure 4.

The equipment component failure rate curve superposition constitutes the equipment failure rate curve, and the equipment failure rate curve superposition constitutes the production line equipment failure rate curve. The fermentation production line equipment is generally composed of equipment with more than one hundred units, which conforms to the conditions of Drenik's law complex equipment, and the whole fermentation Under normal maintenance of the production line equipment, the failure rate curve tends to be constant. The size of the constant depends on the technical level of maintenance and the level of maintenance management as well as the cost of maintenance. The higher the level, the lower the failure rate and the lower the maintenance cost. To achieve a lower failure rate (maintaining a higher level of reliability), it must be achieved by increasing maintenance costs.

2 Economic analysis of fermentation equipment maintenance Fermentation production line equipment is a complex equipment. Under certain maintenance levels, the failure rate of production line equipment tends to be constant, and its reliability is maintained at a certain level. The maintenance cost is low, the reliability of the production line equipment is low, the production loss cost is correspondingly large, the maintenance cost investment is increased, the reliability of the production line equipment is increased, and the production loss cost is correspondingly reduced. However, the reliability of the production line equipment has increased to a certain level. If it is to continue to increase, the difficulty will increase indefinitely, which means that the maintenance cost will increase greatly. Therefore, how to choose a reasonable maintenance cost level is the key to maintaining a certain level of reliability in the fermentation line equipment. The relationship between production line equipment reliability, maintenance cost curve, production loss cost curve and total cost curve is shown in Fig. 5.

Figure 5 Equipment reliability and operating cost relationship The reliability of the production line equipment is low, but the production cost is high, and the total cost level is not low. When the reliability of the production line equipment is met, the maintenance cost curve and the production loss cost curve intersect, and the production loss fee and the equipment maintenance fee are equal. However, due to the reliability of the production line equipment, preventive maintenance costs and inspection fees will lead to a significant increase in maintenance costs. At this time, the total cost is not low. The reliability of the zui economy corresponding to the low point of the total cost is the reliability of the zui economy corresponding to the fermentation line equipment.

As can be seen from Figure 5, the total cost of the Zui low should be between and between. And with the influence of external environmental factors such as rising prices of drugs and raw materials, it is approaching. Therefore, with the impact of price increases, the level of maintenance costs for production line equipment should be increased year by year.

When the reliability of the production line is time, the equipment maintenance should be excellent, and the corresponding production line failure rate should be reasonable. Under the conditions of a given technical level and market environment, if the failure rate of the production line is lower, it will cause excessive maintenance. If the failure rate of the production line is not reached, it may cause insufficient maintenance. The main task of equipment maintenance management is to make rational use of resources, so that the total cost of production line equipment operation is low. In a short period of time, it is relatively fixed, but in the long run, it changes with conditions such as technical level and market environment. Therefore, the maintenance management of fermentation line equipment is a dynamic management in the long run.

3 Conclusion The process of fermentation industry production determines that its production line contains hundreds of different devices with different functions and structures, each of which is connected by pipes of various specifications. To ensure the safe and economic operation of fermentation production, it is necessary to ensure that the operation of the production line equipment is maintained at a certain failure rate level. To this end, it is necessary to study the fault characteristics of the specific fermentation production line equipment and find out the failure rules of the production line equipment. For different production line equipment failure rate levels, reasonable maintenance costs are invested under the corresponding external environmental factors, so that the production line equipment operates at a certain level of reliability.

We applied the reliability-centered equipment maintenance modern management idea to the management of antibiotic fermentation equipment of a large pharmaceutical company in Xi'an, and achieved very good safety, economy and environmental effects. Practice and theory prove that in order to improve the maintenance management level of fermentation industry equipment, it is necessary to continuously study the fault characteristics of production line equipment, find out the regularity of equipment line equipment failure, and encourage enterprises to establish a dynamic maintenance system centered on reliability, thus benefiting enterprises. Economic benefits of development and social progress.

(Xi'an Lijun Pharmaceutical Co., Ltd., Xi'an 710077, China)

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