Steam Quality Testing
Why test steam quality
From 1st October 2008 all member states of CEN (European Committee for Standardisation) who use steam in any moist heat sterilization application will be required to test the steam for non-condensable gases, superheat and dryness value.
Documentary evidence that the sterilizer complies with the requirements of the European standard will need to be established, maintained and declared.
The steam supply required for moist heat sterilization needs to be within the specifications set out in EN285:2006. This is:
Non-Condensable Gases: Required Result = 3.5%
Air and other gases such as Carbon Dioxide, which do not condense under the conditions of steam sterilization.
Superheat: Required Result = 25ºC
Superheat steam is a steam at a temperature which is greater than its boiling point for its pressure. It will not condense until its temperature drops to its boiling point and until this occurs the moisture required for sterilization cannot be produced.
Dryness Value: Required Result = 0.90: = 0.95 for Metal Loads
Wet steam can cause wet loads which in turn can be considered un-sterile. In today’s world, confidence of sterility is paramount. Modern packaging prevents re-infection when dry but bacterial retentive properties will be dramatically affected by the presence of moisture. A value of 1 represents steam that is completely dry and free of moisture.
Why use a contract service
Keith Shuttleworth & Associates undertake contract steam quality testing throughout the world for a wide range of pharmaceutical, biotech and healthcare companies and in this specialised field our experience is unparalleled. Because we are routinely undertaking these tests, we have absolute confidence in the results we achieve, without concerns about technique or methodology. For many businesses, the testing of steam quality is a new concept and the provision of independently obtained results allows them to proceed to test on their own, with confidence. Our work is routinely subject to audit by both regulatory authorities and internal/external auditors and we are able to provide them with a high level of confidence in the results we generate.
Skilled manpower is a valuable resource and the ability to call upon test professionals where extensive qualification work is being undertaken allows businesses to concentrate their efforts in areas where they have greater expertise.
All personnel used to carry out contract steam quality testing are formally trained Test Persons1 who have received formal and certified training on a UK National Health Service approved residential course. In addition to their formal training they have extensive experience of conducting steam quality tests on all types of systems around the world.
All Test Persons are equipped with an SQ1 Steam Quality Test Kit, a battery powered electronic balance, portable data logging equipment and laptop computers.
The work can be undertaken either to your own, or our protocols. Our reports provide a clear pass/fail statement for each test and recommendations where appropriate. The reports contain details of the test procedures used, any deviations and copies of calibration certification.
All of our engineers are qualified to provide advice on steam system design and qualification, in addition to undertaking demonstrations of the use of the SQ1 Steam Quality Test Kit.
Our fees are dependent on the number of tests and points of use. The rates will be based on a daywork rate for travelling time and work on site, plus travel and subsistence expenses at cost. Our experience in carrying out this type of work allows us to carry out a large number of tests in the minimum of time.