Labfacility Ltd. - PRODUCT NEWS

Temperature monitoring & sensor conformance in clinical & laboratory sterilizers

Autoclave sterilizers present temperature sensors with a very demanding operational environment in terms of high levels of pressure and moisture. Temperature sensors specified for autoclave applications, usually type T thermocouple or Pt100 thermometer, must be specially designed and constructed for such environments; reliability, accuracy and stability are essential for ensuring safe sterilization procedures.

Sterilizer Temperature Sensors
The Labfacility Autoclave Load thermocouple is specially designed to provide the best possible accuracy and stability in the rigorous environment of clinical and laboratory sterilizer chambers. The design has been subjected to successful, thorough evaluation by CMI Healthcare including leak testing in a vacuum chamber and processing through normal, porous load sterilization cycles. The sensor complies with test standard HTM 2010, Clause 6.19/6.21.

The special multiple seal construction of this Autoclave Thermocouple ensures that moisture ingress is prevented, even at elevated pressure. The combination of a close tolerance type T thermoelement and exceptional rugged construction ensure high accuracy, high stability and long term reliability. Alternatively, Pt100 resistance thermometer sensors using similar construction methods can be supplied.

The sensor is protected by a 316 grade stainless steel sheath and bulkhead tube; rugged, flexible stainless steel armour conduit protects the 2m lead with 2.5m of silicone rubber exiting the bulkhead tube. The assembly tolerance complies with IEC 584-2 class 1 and colour code with IEC 584-3. Single and duplex versions are available.

Validation of the Temperature Sensors
All temperature sensors used in the sterilization process must be routinely checked and/or calibrated in accordance with procedures described in HTM 2010 Part 3 or any other national standards. There are various ways of achieving such compliance which typically involve sending the sensors to an accredited laboratory for certification, an expensive and time consuming procedure.

A practical, highly cost effective alternative method is to use an in-house, portable temperature calibration system from Labfacility; this provides a rapid and simple method of sensor checking and traceable calibration "on the bench".
This comprises a thermal reference (dry block) calibrator, a UKAS certified reference thermometer (Pt100), a calibrated L200 8 channel indicator/logger and PC software: this, when used with any Windows PC represents a complete solution for on-site accreditation which allows direct comparison of the sterilizer probes (up to seven at a time) with the UKAS certified reference sensor. A simple calculation of difference temperature (if any) between the logged values indicated by the reference and each test probe at a given, stable temperature (chosen by the user) in the dry block calibrator gives the error value for each sensor at particular temperatures. The procedure can be repeated for alternative temperatures set on the dry block as required (e.g. 70, 100, 125, 150oC).

The system can even be used independently of a PC if desired; rather than working with logged data, readings for each probe can be taken manually by means of the L200 front panel key and differences calculated by the user. This is an equally valid procedure.

The design of the dry block ensures that all sensors located in its "well" will be at exactly the same temperature. The necessary calculations can be performed in a spreadsheet by applying formulae to the relevant cells and the logged values imported into the worksheet.

On this basis, the sterilizer probes are traceably calibrated (UKAS traceable) in-house for full compliance with specified testing and validation procedures.

System Accuracy
The accuracy of a type T, Class 1 thermocouple is similar to that of a Pt100 Class B; nominally ±0.5oC and ±0.3oC respectively at 0oC a Class A Pt100 will provide an order greater accuracy however.

Measurement uncertainty with such a system will be of the order of ±0.6oC for both types of sensor at a typical working temperature.

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For more information, please contact :-

Labfacility Ltd.
Bognor Regis, UK
Tel: +44(0)1243 871280 Sheffield Tel: +44(0)1909 569446

May 2015

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