THE APPLICATION OF STEAM QUALITY TEST （蒸汽质量检测中的应用）.pdf

Steam Q/1 THE APPLICATION OF STEAM QUALITY TEST LIMITS Keith Shuttleworth Senior Consultant Keith Shuttleworth Associates Ltd Keith Shuttleworth Associates Laburnum Cottage Eastbury Hungerford Berkshire RG 17 7JN United Kingdom Telephone Fax +44 (0)1488 71734 E-mail ksa@ Web Steam Q/2 THE APPLICATION OF STEAM QUALITY TEST LIMITS Steam quality testing, once the sole preserve of the British National Health Service is being adopted within the pharmaceutical industry on an increasing scale. The perceived need for such tests varies from company to company and country to country. The purpose of this paper is to relate the impact of poor quality steam to the pharmaceutical sterilization processes and consider the validity of the testfrequencies and limits generally applied. Background It is widely accepted that the original source for the test limits came from the British National Health Service with the first references appearing in HTM 10 1 (subsequently 2 superseded by HTM 2010 ). In addition to their adoption by European standards, the same limits may be found in ISO 111343. At the outset, the limits were established pragmatically and further information may be found in The Derivation of United 4 Kingdom Physical Steam Quality Test Limits . 5 While HTM 2010, ISO 11134 and EN 285 conta