059-17 Wyo. Code R. §§ 17-6 - Requirements for Certification and Recertification

(a) Before a classified area or SCA can be used to compound CSPs, it shall be certified using procedures in the current controlled Environmental Testing Association (CETA) certification guideline for sterile compounding facilities or an equivalent guideline. Certifications hall be performed by properly trained individuals.

(b) Certification shall be performed initially, and recertification shall be performed at least every six (6) months. Recertification shall be performed if there are changes to the area including, but not limited to redesign, construction, replacement or relocation if a PEC, or alteration in the configuration of the room that could affect airflow or air quality.

(c) Certification shall include the following:

(i) Airflow testing to determine acceptable pressure differentials in doorways between adjacent rooms and ACPH from the HVAC, ACPH from the PEC and total ACPH;

(ii) HEPA filter integrity testing to include leak testing. HEPA filters shall be tested after installation and as part of recertification;

(iii) Total particle count testing in all classified areas under dynamic conditions;

(iv) Dynamic airflow smoke patter tests for each PED during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the CSP;

(v) Viable air and surface sampling in each classified area during dynamic operating conditions.

(A) Viable air sampled shall be take using an impaction device that tests at least 1,000 liters of air from each location sampled;

(B) A general microbial growth media that supports the growth of bacteria and fungi shall be used for surface samples;

(C) Action levels for viable air sampling are > 1CFU for ISO Class 5, > 10 CFU for ISO Class 7, and > 100 CFU for ISO Class 8; and

(D) Action levels for surface sampling are > 3 CFU for ISO Class 5, > 5 CFU for ISO Class 7, and > 50 CFU for ISO Class 8.

(d) The certification report shall document the results of all required resting. The certification report shall be readily retrievable.

(e) A certification report shall document the results of the above required rests.

(i) The report shall indicate the locations of viable air and surface sampled, size of the sampled taken, incubation times and temperatures, and growth results; and

(ii) The number of pharmacy staff present in each PEC and SEC during testing shall be documented.

(f) All certification and recertification records shall be reviewed by the designated person(s) to ensure that the classified environments meet the above requirements of this chapter.

(g) In the event of failure, the designated person(s) shall identify the cause and implement a corrective action plan. Data collected in response to corrective actions shall be documented and reviewed by the designated person(s) to confirm the actions taken have been effective.

Notes

059-17 Wyo. Code R. §§ 17-6

Amended, Eff. 5/13/2021.