There can be no variation in the factors that present a possibility of microbial contamination, or the compounding process will encompass too many uncontrolled variables, and the results of testing will not be adequately representative of batch quality. Establishment of a Three-month Beyond-use Date A series of about nine time points with multiple tests establishing the initial interaction should be used for testing to establish a BUD of three months initial or time zero, weeks 1, 2, 4, 6, 8, and months 3, 4, and 6. Needles should be a twist-to-lock design and no thicker than 21 gauge to minimize disintegration of the septa. Content and other public information such as an author profile is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
Without passing a sterility test, medium-risk CSPs may be stored for 30 hours at room temperatures of 25 to 40 degrees Fahrenheit, 9 days at cold temperatures and 45 days if frozen solid and held at degrees or less. Omitting this component places the institution at risk of misrepresenting the sterility of preparations with extended BUD. As a result, hospitals that prepare Category 2 CSPs will find themselves subjected to a heightened standard that may require the facility build or renovate a compounding suite. High-risk compounding would include making a solution that will be terminally sterilized from non-sterile bulk drug or nutrient powders or measuring or mixing sterile ingredients in a non-sterile device prior to sterilization.