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This research aims to identify and assess critical failure modes in HVAC systems essential for GMP compliance in radiopharmaceutical production.

May 29, 2026Open Access

A statistical analysis of failure mode and effects analysis validated by experts for heating ventilation and air conditioning systems in positron emission tomography radiopharmaceutical centers

Key Points

This research aims to identify and assess critical failure modes in HVAC systems essential for GMP compliance in radiopharmaceutical production.
Used Failure Mode and Effects Analysis (FMEA) with a Delphi expert panel of 10 experts from 8 Latin American countries.
Evaluated 15 HVAC failure modes using scales for occurrence, severity, and detection to calculate Risk Priority Numbers (RPN).
Applied statistical analyses including descriptive statistics, t-tests, and Pearson correlations to validate the risk model.
Low relative variability in expert assessments of HVAC failure modes.
Significant correlations between RPN and occurrence and severity ratings, p-value < 0.01.
Identified distinct differences in occurrence and severity ratings between critical (RPN ≥ 150) and non-critical failure modes.

Abstract

The reliability of heating, ventilation and air conditioning (HVAC) systems is critical for Good Manufacturing Practice (GMP) compliance and radiation protection in PET radiopharmaceutical production centers. This study applies a Failure Mode and Effects Analysis (FMEA) combined with a Delphi expert panel to identify and prioritize HVAC failure modes in a PET facility, and provides a statistical validation of the resulting risk model. A panel of 10 experts from 8 Latin American countries (Mexico, Uruguay, Argentina, Cuba, Dominican Republic, Costa Rica, Peru and Chile) evaluated 15 HVAC failure modes using 1–10 scales for occurrence (O), severity (S) and detection (D), and a risk priority number (RPN) was calculated as RPN = O S D. Descriptive statistics, coefficients of variation (CV), Shapiro–Wilk tests, Pearson correlations, independent t-tests and interquartile ranges were used to assess the stability, construct validity, discriminant validity and robustness of the method. Results show low relative variability of expert ratings, strong and significant correlations between RPN and O and S, significant differences in O and S between critical (RPN 150) and non-critical modes, and a balanced distribution of RPN across four risk categories. These findings support the Delphi-based FMEA as a statistically robust tool to prioritize HVAC-related risks in PET radiopharmaceutical centers.

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