Sterile Compounding Essay

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Sterile compounding is the preparation of products that should be free from all viable forms of life. There are more stringent requirements for sterile compounding than there are for non-sterile compounding. Staff must be trained and tested on their aseptic processing abilities, cleaner aseptic facilities are required, the quality of air entering the aseptic facility must be evaluated and maintained, sterilisation processes must be effective, knowledge of solution stability is needed and sterility testing of the products is required. The most common type of compounded sterile preparations (CSP) used clinically are aqueous injections. These CSPs require greater attention when being prepared as they pose the greatest risk to the patient if they …show more content…

There are several conditions which aid in defining a CSP as high risk level: when non-sterile ingredients are used in the preparation or when a non-sterile device is used before sterilisation; when the preparation is exposed to air which is not of sufficient quality (less than ISO class 5) e.g. when a manufactured sterile product that lacks a preservative is exposed to air in storage it would be classified as high risk; if a non-sterile product is exposed for at least six hours before being sterilised. Before administration to a patient, the CSP cannot be exposed for not more than 24 hours at a controlled room temperature, no more than 3 days at a cold temperature and no longer than 45 days in freezing conditions (-20°C or less). All non-sterile equipment being used in high risk level compounding must be is rinsed with pyrogen free sterile water and drained or dried directly right before compounding begins. CSPs which are subject to terminal moist heat sterilisation are to be filtered before or during transfer into their final container through a filter with a nominal pore size of no greater than 1.2µm. Sterilisation by filtration must be undertaken in an environment of ISO class 5 or greater. Some examples of high risk level compounding processes include dissolving non-sterile bulk ingredients to produce solutions which are to be terminally sterilised, or when sterile components of the CSP are mixed in non-sterile containers prior to sterilisation. Quality assurance tests must be undertaken to verify the quality of the compounding process. The procedures for such tasks are the same as for low risk level compounding assessment except that a media fill test which accurately simulates the most stressful conditions associated with high risk level compounding is done by personnel twice a

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