059-17 Wyo. Code R. §§ 17-8 - Introducing Items into the SEC and PEC

(a) Only furniture, equipment, and other materials necessary for compounding activities shall be permitted in a classified area or SCA. Items shall be placed in a manner that facilitates sterile compounding operations.

(b) Pharmacy staff shall not introduce shipping carton(s) or other corrugated or uncoated cardboard into a classified area or SCA.

(c) Pharmacy staff shall wipe down and item with a sporicidal agent, EPA-registered one-step disinfectant cleaner, or sterile 70% IPA using low-lint wipes prior to introducing the item into the clean side of the ante-room, pass-through, or inside the perimeter of the SCA. Pharmacy staff shall wear gloves when wiping down items.

(i) If a sporicidal agent or EPA-registered one-step disinfectant cleaner is used to wipe an item down, the item shall be allowed to dwell for the minimum contact time specified by the manufacturer before introducing the item into the classified area;

(ii) Pharmacy staff shall allow the item to dry if sterile 70% IPA is used to wipe it down; and

(iii) The wiping procedure shall not render the product label unreadable.

(d) Compounding pharmacy staff shall wipe down any item with sterile 70% IPA using low-lint wipes and allowed to dry prior to introducing the item into the PEC.

(i) Compounding pharmacy staff may remove items from sterile coverings as they are introduced into the PWC without the need to wipe them with sterile 70% IPA;

(ii) The wiping procedure shall not render the product label unreadable; and

(iii) Compounding pharmacy staff shall wipe all critical sires with sterile 70% IPA in the PEC and allowed to dry prior to entering or puncturing vial stoppers, IV bag septums, or ampule necks.

(e) Only equipment necessary for performing compounding activities shall be permitted in the PEC.

(i) Proper placement of equipment in the PEC shall be initially verified by a dynamic airflow smoke patter test during certification or recertification that demonstrates minimal disruption in airflow. The smoke pattern rest shall be repeated if equipment is moved to a different location in the PEC; and

(ii) Pharmacy staff shall not remove equipment used in the cleanroom suite or within the perimeter of the SCA except for calibration, servicing, cleaning, or other activities associated with maintenance.

Notes

059-17 Wyo. Code R. §§ 17-8

Amended, Eff. 5/13/2021.