Risk-Based Qualification of Dual-Use Refrigerated Incubators Using Temperature Bracketing and Lifecycle Verification

( Vol-12,Issue-4,July - August 2026 )

Author(s): Pujari Prasantha

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Page No: 001-016
DOI: 10.22161/ijaems.124.1

Keywords:

Equipment Qualification, Temperature Mapping, GxP, Risk-based Approach, Refrigerated Incubators, Temperature Bracketing.

Abstract:

The article examines risk-based qualification of dual-use refrigerated incubators using temperature bracketing and verification embedded into equipment lifecycle management. The relevance of the work stems from the need to simultaneously satisfy increasingly stringent GxP regulatory expectations and the demand for operational leanness in laboratory infrastructure, where the traditional V-model of validation results in an excessive volume of mapping activities. The objective of the study is to develop a scientifically justified qualification scheme that, with a minimal number of tests, enables reliable extrapolation of results between boundary and intermediate setpoints. The novelty of the approach lies in integrating engineering data on the thermal behavior of the incubator with the ASTM E2500 methodology and quality risk management principles, as well as in introducing the concept of dynamic qualification, which treats recovery rate as a critical quality attribute. Based on mapping at +5.0 °C and +57.5 °C using 15 calibrated data loggers, a performance envelope is established within which intermediate modes can reasonably be regarded as qualified; acceptance criteria, sensor placement schemes, and the logic of risk-based monitoring within the lifecycle framework are substantiated. The article is intended for validation and quality specialists, equipment engineers, authors of GxP laboratory procedures, and regulatory inspectors.

Received: 27 May 2026; Received in revised form: 23 Jun 2026; Accepted: 27 Jun 2026; Available online: 01 Jul 2026

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