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Until HTM 2010 was published there had been no requirement for
routine physical steam quality testing within the NHS. While HTM 10
(4) provided details of dryness value and non-condensable gas tests,
these were to be employed as circumstances demanded. Prior to this,
testing had been restricted to the subjective assessment of load
dryness and the assessment of superheat as part of routine
thermometric testing In the mid 1970’s the British National Health
Service was incurring significant costs as the result of failed
porous load/equipment sterilization cycles. Failures were
principally due to wet loads, the failure of chemical indicators on
packaging and in the Bowie Dick test to properly change colour and
air detectors causing cycles to automatically fail. In addition to
the evident quality issues, this resulted in loads having to be
re-packaged and re-sterilized at considerable expense. Poor quality
of pure steam and pure steam distribution pipe line designing, steam
trap functioning of sterilizer results in failure of heat
distribution as Now, as a GMP, ISO, HTM 20 10, EN 265 has defined
the quality of steam used for sterilization purpose. It is necessary
to ensure and validate the quality of steam on regular basis
Steam quality to be
tested for following condition
- Dryness test
- Super heat test
- Non condensable gas test
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Pharmalab has developed a portable
test kit to perform above test, which is self contained to
perform the above test This kit is supplied with necessary parts
and fittings, a test procedure, draft of the documents to
prepare record of the test perform and calibration certificates
of the instruments and sensor used.
Contact us for further information....
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