Comprehensive Temperature Mapping and Stratification Study of an Ambient Pharmaceutical Warehouse Influenced by Local CTU Heat Sources

Authors

Pujari Prasantha
Antibody-Drug Conjugates Division, Manufacturing Site
DOI: https://doi.org/10.52549/ijeei.v14i3.7998
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Published: 30-09-2026 • Issue: Vol. 14 No. 3: September 2026 • Section: Regular paper

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.
Keywords: Temperature mapping; Pharmaceutical warehouse; Controlled room temperature; Ambient warehouse; CTU farm

References

[1] D. Bhikadiya, “Pharmaceutical Quality Management Systems: A Comprehensive Review,” African Journal of Biomedical Research, vol. 27, no. 5S, pp. 644–653, Dec. 2024, doi: https://doi.org/10.53555/ajbr.v27i5s.6519.

[2] J. Weitzel et al., “Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group,” The AAPS Journal, vol. 23, no. 6, Oct. 2021, doi: https://doi.org/10.1208/s12248-021-00634-5.

[3] European Commission, “Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01),” Official Journal of the European Union, vol. 56, C 343, pp. 1–14, Nov. 2013.

[4] United States Pharmacopeia, “〈659〉 Packaging and Storage Requirements,” in USP–NF 2024. Rockville, MD, USA: United States Pharmacopeial Convention, 2024.

[5] S. Raj, G. Respicio, D. Zhang, D. Garcia, S. Malta, and H. Long, “Temperature Excursion Management: A Tier-Based Approach for Commercial Oral Solid Dosage Forms,” The AAPS Journal, vol. 26, p. 108, Oct. 2024, doi: https://doi.org/10.1208/s12248-024-00976-w.

[6] M. G. Şen and T. Başaran, “Experimental and numerical investigation of vertical temperature gradients in warehouses: Retrofit interventions to manage temperature-sensitive products,” Energy and Buildings, vol. 332, p. 115456, Feb. 2025, doi: https://doi.org/10.1016/j.enbuild.2025.115456.

[7] United States Pharmacopeia, “〈1079〉 Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products,” in USP–NF 2024. Rockville, MD, USA: United States Pharmacopeial Convention, 2024.

[8] United States Pharmacopeia, “〈1079.4〉 Temperature Mapping for the Qualification of Storage Areas,” in USP–NF 2024. Rockville, MD, USA: United States Pharmacopeial Convention, official May 2024, doi: https://doi.org/10.31003/USPNF_M16681_02_01.

[9] World Health Organization, “Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products,” in WHO Expert Committee on Specifications for Pharmaceutical Preparations: Forty-fifth Report, WHO Technical Report Series, no. 961, Annex 9. Geneva, Switzerland: WHO, 2011.

[10] World Health Organization, “Temperature mapping of storage areas: Technical supplement to WHO Technical Report Series, No. 961, 2011, Annex 9,” Geneva, Switzerland: WHO, May 2015.

[11] International Society for Pharmaceutical Engineering, ISPE Good Practice Guide: Cold Chain Management. Tampa, FL, USA: ISPE, 2011.

[12] Q. Chen, J. Qian, H. Yang, J. Li, X. Lin, and B. Wang, “Multiscale coupling analysis and modeling of airflow and heat transfer for warehouse-packaging-kiwifruit under forced-air cooling,” Biosystems Engineering, vol. 244, pp. 166–176, Aug. 2024, doi: https://doi.org/10.1016/j.biosystemseng.2024.06.007.

[13] D. Jenkins, A. Cancel, and T. Layloff, “Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs,” BMC Public Health, vol. 22, p. 300, Feb. 2022, doi: https://doi.org/10.1186/s12889-022-12660-9.

[14] E. Miura, “Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century,” Therapeutic Innovation & Regulatory Science, vol. 58, pp. 184–191, Oct. 2023, doi: https://doi.org/10.1007/s43441-023-00584-4.

[15] United States Pharmacopeia, “〈1150〉 Pharmaceutical Stability,” in USP–NF 2024. Rockville, MD, USA: United States Pharmacopeial Convention, 2024.

[16] International Council for Harmonisation, “Stability Testing of New Drug Substances and Products Q1A(R2),” ICH Harmonised Tripartite Guideline, Feb. 2003.

How to Cite

[1]
P. Prasantha, “Comprehensive Temperature Mapping and Stratification Study of an Ambient Pharmaceutical Warehouse Influenced by Local CTU Heat Sources”, IJEEI, vol. 14, no. 3, pp. 874–883, Sep. 2026, doi: 10.52549/ijeei.v14i3.7998.