Media Fills?: Make them Count!
Seven97 Training Solutions, PLLC - *Aseptic Technique Validation             *USP <797> Compliance
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Media Fills?: Make them Count!

Media Fill Challenge Valiteq RL-2The July 2018 proposed revision of USP<797> will require all compounding personnel to undergo semi-annual media-fills. The 2015 draft states, “use the most difficult and challenging compounding procedures and processing conditions…”. This assessment will be useful only if it includes core compounding competencies such as, multiple additive syringe transfers, vial reconstitution, ampule technique, gravity transfers via transfer set and the like. In a medium risk level (RL2) exercise, participants will usually add all components to a single bag. This will involve over 8 individual solution transfers and over 16 aseptic manipulations. You may expand the exercise by using the final media bag for filling an elastomeric reservoir (pain management simulation) or prepare a batch of 10 syringe doses (pediatric syringe simulation) or use an ACD to pump the final bag to an empty final container (ACD simulation). Using a test method that is not common to daily activities creates a “disconnect” and is not a good learning experience or accurate assessment. Incorporating common compounding activities gives personnel a “reality check” as to their own competency level and is a best practice to both fulfill required validation and improve staff performance as a sterile admixture compounder.

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