059-17 Wyo. Code R. § 17-5

Current through April 27, 2019

Section 17-5 - Personnel Training and Evaluation in Aseptic Manipulation Skills

(a) Personnel who prepare compounded sterile preparations shall be trained in the theoretical principals and practical skills of Aseptic Processing and in achieving and maintaining ISO Class 5 environmental conditions before they begin to prepare compounded sterile preparations.

• (i) This can be through any combination of written, audio, or video sources.

• (ii) Personnel shall also pass written and Media-Fill Testing of aseptic technique before they begin to prepare compounded sterile preparations.

• (iii) Results of all testing shall be recorded.

(b) Personnel shall also perform a didactic review and pass written and Media-Fill Testing of aseptic technique:

• (i) annually for Low- and Medium-Risk Level compounding;

• (ii) semiannually for High-Risk Level compounding.

(c) There shall be a process to retest and evaluate for personnel who fail testing processes.

(d) Results of all testing shall be recorded.

059-17 Wyo. Code R. § 17-5