Considerations when selecting pharmaceutical chamber probes
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Considerations when selecting pharmaceutical chamber probes - 1

1 Considerations When Selecting Temperature Sensors for Pharmaceutical Sterilisers > Modern pharmaceutical/biotechnology research and drug/medical product manufacturing organisations, face increasing costs in their endeavours to produce a market winner. Driven by the opposing needs of meeting the profit expectations of the shareholders and the seemingly continuing demands of the various regulatory bodies.Recent years have seen many of the smaller organisations swallowed up by their larger competitors followed by many of the major multinational organisations combining in an attempt to both reduce overhead costs and increase their ability to compete in the market place. Whether these efforts have improved their market positioning or led to increased cost benefits elsewhere appears to be open to question, judging from the various company reports of recent years. Where then, can costs be controlled or improved without further significant expenditure? Within the industry, the elimination of micro-organisms to the point at which they are no longer detectable in standard media culture, is the basic and essential process of sterilisation. This process plays a fundamentally essential part during research and manufacture, with the autoclaves employed, currently costing anything from 30,000 to ã500,000 depending on their duty. The items requiring sterilisation, particularly parenteral and other medical products in a large autoclave, can also be valued at many thousands of pounds, all amounting to a considerable investment by the pharmaceutical manufacturer. With such large investments made in the main process equipment and in production materials it is of the utmost importance that the autoclave system components offer a high reliability. There are various forms of sterilisation, but perhaps the most prominent of these is steam or moist heat sterilisation and for those products in liquid form and held in glass/plastic containers, the water cycle system. In both of these processes, time, pressure and temperature are the three main parameters that contribute to a successful sterilisation cycle. Of these three, reliable temperature measurement is the parameter most generally regarded as the one that causes most problems and frustrations to all those concerned with the efficient operation of an autoclave.So why should this be? In many cases it is down to the fact that many manufacturers of temperature sensors are not fully conversant with autoclave practise or the users requirements. It is also a fact that a large number of autoclave manufacturers are prepared to employ assemblies that fall below the minimum requirement. Consider the types of temperature sensors that are found in most modern autoclaves. In general they will fall into two major types, the thermocouple and the resistance thermometer. Both have been around in various forms since the early and late 1800s, but the advances made during the 20 th century have enabled them to be considered for almost all applications involving the measurement of temperature. size="-1">

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Considerations when selecting pharmaceutical chamber probes - 2

Fig. 1 Conventional wire wound Pt100 Fig. 2 Thin film Pt100 >

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Several tolerance grades are available with Pt100 detectors, the two most frequently used in industrial applications are Class Bђ and Aђ, followed by the fractional DINђ classes. Class Aђ should always be the minimum grade of tolerance for autoclave applications, the latter range of fractional DINђ classes only being available in the Pt100, conventional wound format. The term fractional DINҒ arose as detector manufacturing techniques improved, allowing detector manufacturers to offer commercially available detectors with higher tolerances. Since these could be of a tolerance several factors...

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Fig 4 Steriprobe chamber or load probe with a double linked, flexible conduit, offering improved flexibility and handling characteristics. >

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confidence level. The eventual cost of ownership in this kind of situation can then become very high.The cost of lost production through down time, caused by unreliable temperature measurement on a production autoclave, frequently contributes to overhead costs of no less than 1,000 per hour. In addition to this is the costly probability of having to reject a spoilt product load. Frustration is caused to the production department, often followed by a degree of animosity between them and the engineering department for providing unsuitable equipment. This general attitude regarding autoclave...

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