Temperature Mapping Report for Pharmaceutical Warehouse

Introduction

This temperature mapping report provides an overview of the temperature conditions within the pharmaceutical warehouse. The purpose of temperature mapping is to assess and validate the temperature distribution throughout the facility, ensuring compliance with regulatory guidelines and ensuring the integrity of stored pharmaceutical products. The mapping study was conducted using calibrated temperature monitoring equipment and followed industry best practices.

This report provides detailed information about the temperature mapping in which data was collected for the winter season between January 1st and January 15th, 2023. It includes these major sections:

1. Executive Summary: High-level overview of the mapping period.
2. Temperature Results: The temperature results are summarized and organized according to location and placement level in the facility.
3. Multi-Graph and Summary Statistics: Graphical and tabular data are used to analyze the results and prepare this report.

Objectives

The objectives of the temperature mapping study were as follows:

1. Determine the temperature distribution within the pharmaceutical warehouse.
2. Identify any temperature deviations or hot/cold spots.
3. Assess the effectiveness of the temperature control systems.
4. Evaluate the impact of external factors on temperature stability.
5. Ensure compliance with regulatory requirements.

The objectives of the study were to:

1. Create a 14-day facility thermal map for the PharmaGuide Ltd. Company in areas where products will be stored.
2. Characterize temperature variation from location to location within the mapped area.
3. Identify areas of the facility that are above or below the specified temperature range of 15°C to 25°C.
4. Provide data that enables us to determine if the current thermostat locations are appropriate and/or determine the ideal temporary placement of stationary temperature recorders.

Methodology

The temperature mapping study was conducted over a specified duration, typically a representative period of time. The warehouse was divided into zones or areas to assess temperature uniformity. Temperature data loggers or sensors were strategically placed throughout the facility, considering critical storage areas and potential temperature variations. The sensors were calibrated and recorded temperature readings at regular intervals.

There is a map of the area to use as a reference: Put in the location of the area mapped.

Area Layout

Insert diagram of the area mapped

1. Executive Summary

PharmaGuide Ltd. conducted a temperature mapping study from January 1st to January 15th, 2023. Temperature monitoring devices were placed throughout the designated area and recorded temperature levels for 14 days at 15-minute intervals. A total of 30 temperature monitors were placed in and around the area on Sunday, January 1st. All 10 temperature monitors were recovered and are included in this report. The data has been downloaded, analyzed, and used in this report to identify temperature levels outside of the specified limits of 20°C to 25°C.

Process

• A total of 100 temperature monitors were placed outside and inside the facility. All of the 10 monitors placed were recovered and are included in this report. The temperature monitors began recording data on Sunday, January 1st and continued recording temperatures at an interval of 15 minutes for 14 days.

Area	Low Level	Medium Level	High Level	Total

ALSO READ: Temperature Mapping Protocol

• Temperature monitors placed at low levels were located on the bottom level of product shelving.
• Temperature monitors placed at high levels were located on the top shelf. Monitors placed at “other” were located between the bottom and top shelf, depending on the shelving configuration. No loggers were placed at a location higher than that at which the product is stored.
• The temperature monitors were stopped on January 15th, 2023. They were then collected and downloaded into the Temperature Monitors Manager Desktop Software. All temperature data was then analyzed and presented in this report.

Results – Multi Graph

Example of graphs from temperature monitors Desktop Software.

Specific Location Details 

Populate Table with individual logger results

Temp. Monitor No.	Set Temp. (°C)	Observed Temp. (°C)	Temperature Range (°C)	Deviations

Findings

a. Temperature Distribution:

• The temperature mapping study revealed a generally uniform temperature distribution throughout the pharmaceutical warehouse. [Specify temperature range and any deviations observed].
• The majority of the storage areas maintained temperatures within the acceptable range specified by regulatory guidelines.

ALSO READ: Temperature Mapping in Pharmaceuticals

b. Hot and Cold Spots:

• No significant hot or cold spots were detected during the temperature mapping study.
• Any minor deviations observed were within an acceptable range and did not pose a risk to product integrity.

c. Temperature Control Systems:

• The temperature control systems in place within the warehouse demonstrated effectiveness in maintaining desired temperature ranges.
• Monitoring and alarm systems were found to be operational and responsive.

d. External Factors:

• External factors such as ambient temperature, weather conditions, and proximity to heat sources were evaluated.
• The impact of these factors on temperature stability was found to be minimal and well-managed.

Mean Kinetic Temperature

Mean Kinetic Temperature (MKT) is defined as: the single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures. Thus, MKT may be considered as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variation. 

It is not a simple arithmetic mean. MKT is calculated from temperatures in a storage facility. MKT is calculated by the following equation (derived from the Arrhenius equation): MKT is a measure of positive deviation from a mean value. Therefore it should hold less weight in a situation where the lower temperature limit is challenged.

Recommendations

Based on the temperature mapping study, the following recommendations are suggested to maintain optimal temperature control in the pharmaceutical warehouse:

1. Regularly monitor and calibrate temperature monitoring equipment to ensure accuracy.
2. Conduct periodic temperature mapping studies to verify ongoing compliance.
3. Maintain proper air circulation and avoid obstructions that could impede temperature distribution.
4. Train warehouse staff on temperature control procedures and the importance of maintaining appropriate storage conditions.
5. Implement a robust temperature alarm system to promptly detect and address any temperature deviations.

Insert recommendations resulting from the analysis of data.

Conclusion

The temperature mapping study conducted in the pharmaceutical warehouse confirms the overall effectiveness of the temperature control systems. The results demonstrate compliance with regulatory guidelines and the maintenance of suitable temperature conditions for pharmaceutical storage. By implementing the recommendations provided, the warehouse can continue to ensure product integrity and meet regulatory requirements.

ALSO READ: SOP for Temperature Mapping of Warehouse