Comprehensive Temperature Mapping Strategies for Controlled Storage Environments

Author: Glenn VandeGrift

President CleanSpace

Date: September 28, 2023

Introduction:

Temperature Mapping, an essential process for assessing controlled storage environments, plays a pivotal role in ensuring that critical storage spaces, including fridges, freezers, rooms, warehouses, and incubators, maintain temperatures within specified limits. This article discusses the significance of Temperature Mapping in various regulatory contexts, emphasizing its importance in maintaining compliance and safe storage practices for life science assets. While we explore these concepts, it's worth noting that CleanSpace, in collaboration with its installation division Allied, offers expertise and solutions to support businesses in their Temperature Mapping endeavors.

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The Evolving Regulatory Landscape:

The regulatory landscape surrounding controlled temperature storage in the life science sector is continually evolving. Recent regulatory updates in Mexico, Canada, and the USA have expanded the scope of compliance requirements, necessitating a more thorough and widespread demonstration of compliance across the supply chain. Notably, more stakeholders are now accountable for compliance, highlighting the need for meticulous Temperature Mapping exercises.

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The Role of Temperature Mapping in GxP Environments:

In GxP (Good Practice) environments, Temperature Mapping stands as a critical strategy to validate the uniformity of temperatures within storage areas, a prerequisite for safe product storage. Any space designated for storing products with specified temperature requirements, such as freezer rooms, cold rooms, temperature-controlled storage areas, quarantine zones, receiving bays, and even laboratories, must undergo a Temperature Mapping assessment. The temperature ranges allowed in these areas can vary significantly, depending on the stored products.

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Temperature Mapping Beyond Controlled Environments:

Temperature Mapping isn't limited to spaces with active temperature control. It also extends to areas without such controls. This mapping process aims to understand temperature distribution, identify hot and cold spots, and provide essential data for ensuring the correct storage of time and temperature-sensitive pharmaceutical products (TTSPPs). Additionally, it helps pinpoint areas where corrective actions are needed, such as adjusting air distribution or retrofitting equipment to eliminate temperature stratification in high-bay warehouses.

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Regulatory Guidance on Temperature Mapping:

Regulatory guidelines, such as GDP (Good Distribution Practice) Chapter 3.2.1, emphasize the importance of initial temperature mapping exercises before storage areas are put into use. Monitoring equipment placement should align with mapping results, ensuring that devices are located where temperature fluctuations are most extreme. Furthermore, these mapping exercises should be periodically repeated, especially when significant modifications to the facility or temperature control equipment occur. Smaller premises also require attention, with risk assessments and temperature monitors tailored to their specific needs.

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The Need for Clarity:

In some cases, companies, particularly newcomers and those with limited storage areas, may face uncertainty regarding compliance with GDP guidelines related to Temperature Mapping. Clarifications and practical guidance are crucial to assist such entities in meeting their obligations.

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Collaboration with Third Parties:

Larger storage facilities often seek expertise from specialized third-party companies to carry out Temperature Mapping exercises. While guidelines mandate the need for mapping, they do not prescribe specific methodologies, allowing flexibility in approach. CleanSpace can assist in technical writing of all specific methodologies as required.

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Why Temperature Mapping Matters:

Temperature Mapping serves as documented evidence of a storage area's suitability for temperature-sensitive medicinal products. This extends to ambient products, underscoring its broad relevance. By conducting mapping exercises, companies gain insights into their storage areas, identifying potential issues and ideal locations for permanent thermometers.

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When to Conduct Temperature Mapping:

Ideally, Temperature Mapping should occur before actual stock storage. However, situations may arise, such as storage area reconfiguration, that make pre-storage mapping challenging. In such cases, dummy products can simulate normal operational storage without compromising actual products. Additionally, mapping exercises should be repeated once storage areas are fully stocked, taking into account seasonal variations.

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Conducting Temperature Mapping:

Temperature Mapping begins with a thorough assessment of the storage area, identifying the highest points for storage. Calibrated monitoring probes, in sufficient quantities based on storage area size, are essential. The mapping duration should demonstrate unit stability and account for routine changes, like defrost cycles. Existing Validation Master Plans (VMPs) or procedures may contain mapping duration recommendations.

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Data Risk Assessment:

After the initial mapping exercise, collected data should be recorded and subjected to a risk assessment. This assessment helps determine the most suitable locations for permanent monitoring probes, focusing on areas with significant temperature fluctuations or hot and cold spots. Regular reviews of the risk assessment are essential, potentially integrated into self-audit processes.

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Role of the Responsible Person (RP):

The RP plays a crucial role throughout the mapping process, staying informed about mapping exercise findings, risk assessment recommendations, and the review process. Beyond mapping, the RP oversees daily minimum/maximum temperature monitoring and recording, offering guidance during temperature excursions.

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Conclusion:

Temperature Mapping is an indispensable component of ensuring the safe storage of temperature-sensitive products. As regulatory requirements evolve, businesses must adapt and stay compliant. CleanSpace and its installation division Allied stand ready to provide expert support and solutions for your Temperature Mapping needs, helping you achieve the highest standards of temperature control and storage quality.