A Portable, Foldable Negative-Pressure Aerosol-Containment System (FNPACS) for Aerosol Control During Aerosol-Generating Procedures.

Aerosol-generating procedures (AGPs) expose healthcare personnel to airborne pathogens and require portable engineering controls that can be integrated into routine clinical workflows. We developed a portable, foldable negative-pressure aerosol-containment system (FNPACS) combining adaptive fan control, an H14 high-efficiency particulate air (HEPA) filter, and a disposable metal-oxide prefilter in a mobile filtration module. Bench performance was evaluated using pressure-flow testing in accordance with National Environmental Balancing Bureau (NEBB) procedures and International Organization for Standardization (ISO) 14644-3, polyalphaolefin aerosol challenge testing, and smoke visualization, while an exploratory clinical study assessed environmental contamination via real-time reverse-transcription PCR (rRT-PCR) in 11 patients (31 assay analyses). Bench testing demonstrated HEPA filtration efficiencies of 99.994-99.997%, stable negative-pressure generation across fan duty cycles, no detectable downstream breakthrough beyond the HEPA filter under the tested conditions, and effective inward airflow on smoke testing. A Lagrangian discrete phase model (DPM) particle-tracking simulation further characterized size-dependent aerosol-surrogate transport. Under HEPA-ON active-extraction conditions, 73.0-86.1% of simulated 0.3-10 µm water-equivalent particles were transported to the HEPA suction pathway, while 13.9-27.0% were deposited on internal wall surfaces. In the clinical evaluation, SARS-CoV-2 RNA detection on environmental swabs was limited and predominantly low level. The clearest reproducible signal occurred on the top interior surface under HEPA-OFF conditions, whereas HEPA-ON detections were isolated or presumptive high-Ct signals without reproducible confirmation. These findings provide preliminary engineering and usability support for FNPACS as a feasible near-source aerosol-control platform for AGPs. The patient swab component should be interpreted as an exploratory, proof-of-concept assessment rather than confirmatory evidence of clinical containment efficiency because several clinical cases had non-supportive patient-related controls and were therefore not used in the primary containment interpretation.