USP Employee Validation
EOC1 can provide employee validation with on-site observation. As part of our AseptRx program, EOC1 provides Gloved Fingertip Sampling and Media-Fill Testing. If you wish to manage your program yourself EOC1 can provide supplies for media-fill testing and fingertip sampling. As with either program EOC1 will not only provide supplies but manage the process from start to finish to include testing supplies, lab incubation and reporting.
USP 797 text regarding: Personnel Training and Evaluation in Aseptic Manipulation Skills
“Personnel who prepare CSPs must be provided with appropriate training from expert personnel, audio-video 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-annually for high-risk level compounding.”
Media-Fill Challenge Testing
The skill of personnel to aseptically prepare CSPs may be evaluated using sterile fluid bacterial culture media-fill validation, (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.
Gloved Fingertip Sampling
Glove fingertip sampling is performed to evaluation personnel washing and garbing process. After observation of washing and garbing, employees must perform a gloved fingertip sampling no less than annually for low and medium risk level CSPs and semi-annually for High Risk CSPs. Initial competency for new employees require the process to be repeated three time prior to compounding with zero cfu after incubation.