A microbiological view of sterile service production

The primary purpose of a Sterile Services Department is the prevention of infection. A specific guide to Good Manufacturing Practice (GMP) has been published by the Institute of Sterile Service Management to assist managers to ensure that the final products are of the nature and quality intended. The testing and monitoring of machinery, such as autoclaves, has an obvious microbiological relevance but other practices, such as expire dates and presterilization of used items, are of dubious microbiological advantage and can act against the main aim. GMP recommendations on environmental controls have received disproportionate attention to the remainder of the document, particularly relating to packing rooms. The standard should not be seen as a primarily microbiological measure but as a sensible control to limit the ingress of unwanted dust, flies and people and provide basic ventilation. Tests indicate that the standard for particle counts can be achieved without structural alteration in some departments. Microbiological counts are similar to those within operating theatres and additional protective clothing is of no apparent advantage. Process failure is the main cause of risks to the patient, and other practices, although both relevant and important, should not be given a false microbiological significance as these can detract and distract attention from the main issue.