Verifying an Employee’s Aseptic Technique

Media-fill testing involving the manipulation of a suitable growth media (tryptic soy broth) represents one of the most objective methods of evaluating an employee’s knowledge and skill in asepsis. A media-fill or process-simulation test mimics an actual and entire compounding procedure, using a suitable growth medium, such as tryptic soy broth (TSB), in place of the typical ingredients to prepare a finished compounded preparation. According to USP Chapter <797>, media-fill testing also represents the most challenging or stressful conditions actually encountered by the personnel being evaluated when they prepare a compounded sterile preparation. In addition to verifying an individual’s ability, process-simulation testing can also be used to evaluate and identify the capabilities and weakness of aseptic compounding procedures that could contribute to the inaccuracy and/or contamination of the compounded sterile preparation. Using the Parenteral Drug Association’s Technical Report No. 22 (published in 1996) as a basis, a properly designed process-simulation test will be able to:

 

http://www.pppmag.com/article/137/April_2005/A_Practical_to_Aseptic_Technique_Verification_Policies_and_Procedures_that_Meet_USP_Chapter_797_Requirements/

 

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