In This Section
Specific Questions about USP <797> – Cleansing, Garbing and Disinfecting
Would a facility be in compliance with USP <797> if a "turbulent airflow" compounding aseptic isolator (CAI) is employed to compound or dispense sterile drug preparations (assuming that the placement of the above CAI and personnel cleansing meet the requirements as stated in USP <797> )?
Yes. USP <797> states: "The use of technologies, techniques, materials, and procedures other than those described in this chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein." In addition, however, a policy should be developed and enforced requiring conventional hand cleansing whenever the hands or arms are visibly soiled.
What are the requirements of USP <797> for disinfecting commonly used items such as syringe shields, vial shields, dose calibrators, and dose preparation or assay areas?
According to USP <797> , "Cleaning and disinfecting surfaces in the LAFWs [laminar airflow workbenches], BSCs [biological safety cabinets], CAIs [compounding aseptic isolators], and CACIs [compounding aseptic containment isolators] shall be cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding periods of individual CSPs, when there are spills, and when surface contamination is known or suspected from procedural breaches." If the ion chamber of a dose calibrator is located inside of any of the above-mentioned primary engineering controls (PEC), the inner wall of the ion chamber shall be cleaned and disinfected accordingly.
Any item (e.g., syringe shield or vial shield) brought into the PEC shall also be properly cleaned and disinfected.
If we wish to do low risk sterile compounding in a table top ISO Class 5 isolation unit, what garb does the person doing the compounding need to wear?
Compounding under Immediate Use provisions does not require special personnel cleansing and garb. However, compounding of any Risk-Level category products (including Low-Risk Level CSPs with 12-Hour or Less BUD) does require special personnel cleansing and garb.
We are currently creating our clean room to be USP <797> compliant. When reading the guidelines for the clean room and garbing before entry, the guidelines all state that the person must wear shoe covers, gowns, gloves, hair covers and masks, however, no reference has been able to identify what kind of gowns and masks are required. Would a simple infectious control type gown be sufficient or do we need something that completely covers you front and back like a surgical gown? Would a simple surgical mask be okay or do we need to make sure we use the more expensive air borne resistant N95 type masks? One reference mentioned sterile gloves while others mentioned using gloves then cleaning or wiping them down with 70% alcohol before use would be sufficient.
USP <797> contains the following statements relevant to gowning:
After completion of hand washing, a non-shedding gown with sleeves that fit snugly around the wrists and enclosed at the neck is donned. Gowns designated for buffer area use shall be worn, and preferably they should be disposable. If reusable gowns are worn, they should be laundered appropriately for buffer area use. When compounding personnel exit the compounding area during a work shift, the exterior gown may be removed and retained in the compounding area if not visibly soiled, to be re-donned during that same work shift only.
Hence, the non-shedding gown (either disposable or launderable) should cover the full front of the individual up to the neck. For example, a gown that ties in the back should be used rather than one that buttons in the front. USP <797> does not expressly require that the gown provide full coverage in the back.
There is nothing in in regard to the specific kind of facemask that should be used; USP <797> does not describe the specific type of face mask to be used. The intent of the facemask is, obviously, to reduce the bioburden in the air by trapping microbe-containing particulates (e.g., saliva droplets) expressed from the mouth or nose. Surgical-type masks are generally effective for this purpose.
USP <797> also contains the following statements relevant to sterile gloves:
In addition, the sterile gloves should be “powder-free” and “have been tested for compatibility with [sterile 70% isopropyl] alcohol disinfection by the manufacturer.” Sterile gloves shall be the last item donned before compounding begins. Gloves become contaminated when they contact non sterile surfaces during compounding activities. Disinfection of contaminated gloved hands may be accomplished by wiping or rubbing sterile 70% IPA to all contact surface areas of the gloves and letting the gloved hands dry thoroughly.
Hence, at the time of donning, the gloves should start off being sterile gloves. As these sterile gloves become potentially contaminated when handling non-sterile objects during compounding activities, they may be disinfected with sterile 70% IPA rather than being exchanged with new sterile gloves.