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Risk Levels In Sterile Compounding Essay

1393 words - 6 pages

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 ...view middle of the document...

This is also considered when assigning the expiry date of the CSP.
The conditions for low risk levels are that procedures, like measuring or transferring, are carried out using closed or sealed systems and that they are carried out quickly and effectively; all CSPs must be compounded within an ISO class 5 or better air quality using only sterile equipment; procedures are restricted to transferring sterile solutions in sterile syringes to sterile administration devices; aseptically opening ampoules and inserting sterile needles into vials by penetrating the sterile stoppers. Glass ampoules require additional sterile filtration to make sure that there are no glass particles present in the sample; before administration, CSPs are not exposed for longer than 48 hours at a controlled room temperature, for no more than 14 days at a cold temperature and no more than 45 days in freezing conditions (-200C or lower). A low risk level compounding would be a single transfer of sterile drug solution from a vial (or other sterile container) using a sterile needle and sterile syringe to another sterile device e.g. a sterile infusion bag.
The quality of the process needs to be assured (i.e. Quality Assurance) and some of the procedures to do so include: examining the air quality to ensure it is within ISO class 5 or better and regularly disinfecting the compounding environment to decrease the chances of microbial contamination of the aseptic facility; checking that personnel are wearing the correct protective garments and goggles and that they are garbing up correctly; to ensure that the correct amounts of the right excipients are being used to prepare the product; to visually analyse the CSP to determine the presence or absence of any particulate matter; to assess the quality of the labelling; to ensure the quality of the packaging and to ensure the absence of leakages. A media fill test is also undertaken annually by all personnel involved in the compounding process to evaluate their aseptic processing abilities, to ensure that it is maintained. The conditions of the test simulate the most strenuous conditions that could arise during the processing of a low risk CSP.
CSPs can be classified as medium level risk when a low risk level CSP has one or more of the following additional compounding conditions: the compounding process requires more complicated aseptic manipulations instead of single volume transfers; the compounding process requires a longer period of time for completion e.g. to get a drug into solution or to obtain a homogeneous emulsion; when multiple doses are pooled together to compound a CSP which will be administered to one patient multiple times or to multiple patients; if a CSP does not contain an antimicrobial preservative and is to be administered over a number of days. Before administration to patients, the CSPs must be stored for not more than 30 hours at a controlled room temperature, not longer than 7 days at a cold temperature and no...

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