Validation reports are critical for confirming the consistent performance of temperature-controlled equipment such as cold storage (refrigerators and freezers) and ovens. These detailed data driven reports provide insights into temperature distribution, trends, and system reliability, ensuring that your equipment meets compliance and quality standards.

Comprehensive validation reports are designed to support regulatory compliance, operational efficiency, and product quality through in-depth analysis and clear presentation of temperature data.

Our cGxP-qualified staff will provide complete validation documentation with essential insights for maintaining high standards in temperature control, supporting compliance, and optimizing equipment performance.

• Compliance and quality assurance: Meet regulatory standards such as FDA, GMP, and GDP while ensuring that all products stored or processed maintain safety and efficacy.
• Efficiency and Consistency: Understand and optimize your equipment's temperature performance, reducing risk of product spoilage or quality loss.
• Proactive risk mitigation: Early identification of temperature issues enables proactive solutions, helping you prevent potential product losses or process failures.
• Logged data analysis: Analysis of recorded temperature data over time for validation and compliance documentation.
• Customizable reporting: Generating customizable reports detailing temperature data, trends, and compliance status for internal records or regulatory submissions.

We gather extensive temperature data by placing calibrated sensors at multiple points within your storage or heating unit. This data is collected over a designated period to capture fluctuations and spot trends.

Continuous monitoring ensures that temperature readings reflect realistic operating conditions, accounting for potential variables such as door openings, damper adjustments, process variables and ambient temperature shifts.

Accurately mapping the cold storage unit, oven, autoclave or ambient storage area requires a large number of measurement sensors placed strategically to create a matrix. These temperature sensors can be purchased, rented, or provided by Paragon Robotics.

• Visual heat maps are created to represent temperature distribution within the unit. Heat maps help to clearly identify cold or hot spots, ensuring even temperature control across the space.
• Heat maps offer immediate visual insights into temperature consistency , with color-coding that distinguishes areas of concern.

Once the measurement data has been collected, our cGxP-qualified staff will review charts and heat maps for mapping process. Duration and sample frequency will follow specific regulations or recommended temperature mapping guidelines to meet data requirements and capture thermal dynamics accurately.

• Our analysis highlights temperature patterns and trends over time, identifying periods of potential variability or risk.
• Trending charts are provided to show the unit’s performance over time, illustrating any gradual drifts or significant deviations that may require corrective action.

After the data is collected, the mapping sensors may be removed. If the analysis of the data can be performed immediately, it may be best to delay removal of the sensors in case additional testing is needed later.

• Executive Summary: An overview of the testing parameters, goals, and key findings.
• Data Visualizations: Includes heat maps, trend charts, and graphical data for at-a-glance interpretation.
• Detailed Findings: Insight into temperature consistency, spatial variability, and any anomalies detected during the mapping period.
• Compliance Verification: Documentation of adherence to industry standards and regulatory guidelines (e.g., FDA, WHO) based on test results.
• Recommendations: Based on data findings, we offer actionable recommendations for maintaining or improving temperature stability.

Our experts interpret the findings, assessing compliance and providing targeted recommendations to improve temperature consistency.

Recommendations may include adjustments to shelving, airflow, or settings to address any identified hot or cold spots and ensure a stable environment .

For cGMP regulated processes, temperature mapping is commonly part of the Operational Qualification (OQ) step when commissioning new equipment. Regular remapping should also occur after repairs, adjustments, or process changes. With careful temperature mapping, you can improve equipment uniformity, product quality, and regulatory compliance .

Paragon can support customers throughout the temperature mapping process, ranging from providing plug-and-play monitoring equipment for the activity, to turnkey on-site mapping services for product commissioning or re-commissioning. As a cGMP regulated manufacturer ourselves, we have significant experience within our quality department to help assist customers with qualification activities such as temperature mapping.