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All Journal Indonesian Journal of Electrical Engineering and Informatics (IJEEI)
Pujari Prasantha
Antibody-Drug Conjugates Division, Manufacturing Site
Computer Science & IT Electrical & Electronics Engineering

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Comprehensive Temperature Mapping and Stratification Study of an Ambient Pharmaceutical Warehouse Influenced by Local CTU Heat Sources Pujari Prasantha
Indonesian Journal of Electrical Engineering and Informatics (IJEEI) Vol. 14 No. 3: September 2026
Publisher : IAES Indonesian Section

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.52549/ijeei.v14i3.7998

Abstract

This paper reports a temperature mapping study of a GMP-regulated ambient pharmaceutical warehouse of about 10,000 square feet (930 m²) whose storage space borders an interface zone with 44 controlled temperature units (CTUs). The study followed a risk-based IQ/OQ/PQ sequence with 63 calibrated wireless loggers sampling at 5-minute intervals in three 72-hour sessions: the empty warehouse (OQ, October 2023), the warehouse loaded to about 80 % (PQ, October 2023) and a winter session (February 2024). In the empty warehouse the mean over all channels was 21.87 °C; the global minimum (18.65 °C) was recorded on a wire-rack shelf and the global maximum (27.58 °C) at a logger mounted on top of a refrigeration unit, at 04:20, outside working hours. In the loaded session the sharp equipment-cycle peaks of the empty session were absent and a slow diurnal wave dominated, with isolated peaks of about 30 °C on working days. In winter, regular peaks of 30–35 °C coincided with heating cycles, and one channel started above 40 °C and ran at 28–32 °C for the rest of the session. The paper states the mean kinetic temperature (MKT) equation and its activation-energy convention and explains why MKT cannot replace a duration-based evaluation of excursions. The underlying time series and per-channel statistics could not be released, so the results are presented as a documented case with explicit limitations. The practical outcomes are recommendations on destratification, a buffer zone around heat-rejecting units and the placement of permanent monitoring points.
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