Volume 2025 | No. 2
SURVEYOR
PHARMACY
Compliance tips for:
DRX7-8O Frequency of the citation: 19%
■ The standard identifies requirements for a range of environmental conditions including air quality and pressure differentials based on ISO classification of spaces, primary and secondary engineering controls (PEC, SEC). ■ Include environmental monitoring items ( e.g., look for rust, cracks, crevices, dust, dirt) in the compounding observational audit mentioned above under standard DRX7-8N. ■ Implement timely corrective actions to address deficiencies with USP facility and environmental requirements. ■ Create an environmental monitoring checklist that addresses all the USP environmental monitoring requirements. ■ Develop a certification report summary checklist to ensure all the testing requirements are met (e.g., dynamic operating conditions, smoke testing), ■ Educate compounding personnel on the facility and environmental requirements. ■ Educate the designated person on the importance of addressing deficiencies immediately, implementing, and documenting appropriate corrective actions.
Nerd Newbies (understand the requirement)
Overview of the requirement: USP <797> categories are used as the standard for environmental conditions for compounding. Comment on deficiencies: Compliance is assessed by direct observation. Surveyors noted some issues with maintenance of the physical environment leading to unsanitary conditions. Most findings indicated noncompliance with currently effective USP <797> requirements for measuring and documenting air pressure differentials, and for certification studies that include dynamic testing with visual documentation of smoke studies. Examples of ACHC Surveyor findings: ■ USP <797> requires air pressure documentation to three decimal points. The organization is documenting pressure differential to two decimal points. ■ Temperature in the buffer room is not maintained at 20°C. At time of observation in the buffer room, approximately 10:30am, the temperature was 22°C. Staff reported that the temperature continues to rise throughout the day. ■ The most recent environmental report did not include a video of the smoke study, and the written report did not indicate any activity was being performed during the dynamic testing of the hoods. PIC stated that he was present in the room with the certifier and there was no video taken, nor any compounding activity performed during the testing. ■ Inside the anteroom, on the clean side, the window frame has a large crack in the casing and has separated from the wall, enabling debris to settle in the crack. There is a 1- to 2-inch gash/divot on the anteroom floor (dirty side), where debris can become imbedded. These items were also noted by the certifier performing environmental testing in August 2024. At time of survey, staff did not have an action plan or work order to correct these issues. ■ During the cleanroom suite survey, rust was observed on the hoods, exhaust vents, castors, table legs, TPN poles, and storage shelf legs. The suite needed a deep cleaning as dust was present and some debris in the corner of two areas. The diffusers on the BSC and both LAFW where the Exactamix is located have visible residue. Sporicidal agent (Peridox) is not being used in the PECs. ■ The entrance from the unclassified area to the ante room was a vinyl curtain type of barrier rather than a fixed door.
Nerd Apprentices (audit for excellence)
Nerd Trailblazers (prepare the path for others)
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