PERSONNEL TRAINING AND EVALUATION IN ASEPTIC MANIPULATION SKILLS
Personnel who prepare CSPs must be provided with appropriate training from expert personnel, audiovideo instructional sources, and professional publications in the theoretical principles and practical skills of aseptic manipulations before they begin to prepare CSPs. Compounding personnel shall perform didactic review, and pass written and media-fill testing of aseptic manipulative skills initially; at least annually thereafter for low- and medium-risk level compounding; and semi-anually for high-risk level compounding. Compounding personnel who fail written tests, or whose media-fill test vials result in gross microbial colonization, must be immediately re-instructed and re-evaluated by expert compounding personnel to assure correction of all aseptic practice deficiencies.
Media-Fill Challenge Testing
The skill of personnel to aseptically prepare CSPs may be evaluated using sterile fluid bacterial culture media-fill validation,1
(i.e., sterile bacterial culture medium transfer via a sterile syringe and needle). Media-fill testing is used to assess the quality of the aseptic skill of compounding personnel. Media-fill tests represent the most challenging or stressful conditions actually encountered by the personnel being evaluated when they prepare particular risk level CSPs and when sterilizing high-risk level CSPs.
Commercially available sterile fluid culture media, such as SoybeanCasein Digest Medium (see Sterility Tests 71
), shall be able to promote exponential colonization of bacteria that are most likely to be transmitted to CSPs from the compounding personnel and environment. Media-filled vials are incubated at 25
for 14 days. Failure is indicated by visible turbidity in the medium on or before 14 days.
Example of a Media-Fill Test Procedure
Perform the test as directed in the section Quality Assurance of Low-Risk Level CSPs.