The following USP 797 Q&A helps answer your questions.USP 797 refers to chapter 797 "Pharmaceutical Compounding – Sterile Preparations," in the USP National Formulary.The standards in this chapter are intended to apply to all persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared (e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians' practice facilities, and other locations and facilities in which CSPs are prepared, stored, and transported).USP 797 requirements affect all disciplines involved in sterile compounding, including physicians, nurses, pharmacists, and pharmacy technicians.Glove fingertip sampling must occur outside of the ISO Class 5 environment.Do not disinfect gloves with Isopropyl alcohol immediately prior to sampling.Sampling for airborne viable particles must be conducted based on a risk assessment of your compounding activities.The sampling sites you select must include multiple locations within each ISO Class 5 environment, ISO Class 7 and 8 areas and in the segregated compounding areas at greatest risk of contamination (e.g., work areas near the ISO Class 5 environment, counters near doors, pass-through boxes).
Therefore, the greatest level of control over manufacturing must be proven.
For low, medium, and high-risk level compounding, perform air sampling at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning.
Locations must include zones of air backwash turbulence within laminar airflow workbenches (LAFW) and other areas where air backwash turbulence may enter the compounding area (doorways, in and around ISO Class 5 primary engineering control and environments).
Settling plates that were once suggested in earlier National Formulary guidelines are not permitted in the 2008 USP 797 revision since all sampling must now be volumetric.
Surface sampling is required in all ISO classified areas on a periodic basis.