Temperature mapping is a fundamental procedure for ensuring the stability and quality of temperature-sensitive pharmaceutical products (TTSPPs). It involves systematically documenting and controlling temperature variations within storage areas to ensure products remain within their required temperature ranges. This guide delves into the critical aspects of temperature mapping as detailed in the provided document, covering objectives, target audience, requirements, procedures, and more.
Requirements
All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process before the installation is commissioned and handed over by the installer. This must be done before it is safe to store TTSPPs in such areas.
The temperature mapping procedures should:
- Demonstrate the air temperature profile throughout the storage area, when empty and in a normal loaded condition;
- Define zones that should not be used for storage of TTSPPs (for example areas near cooling coils, cold air streams, or heat sources); and
- Demonstrate the time taken for temperatures to exceed the designated limits in the event of power failure.
Subsequent mapping exercises must also be carried out periodically – for example, every three years – to demonstrate continuing compliance. In addition, mapping should be carried out whenever significant modifications are made to the store.
Examples include changes in the pattern of use that may increase loading or affect air circulation, or changes to the refrigeration equipment, such as an alteration to the set point. Finally, a remapping exercise may be justified whenever an analysis of temperature and/or humidity monitoring records shows unexplained variability outside normal operating limits.
All mapping exercises should be fully documented to demonstrate compliance to management, clients, and regulatory authorities.
Objectives of Temperature Mapping
The main objectives of temperature mapping include:
- Ensuring temperature consistency within storage areas.
- Identifying and mitigating temperature variations.
- Documenting temperature profiles for compliance with regulatory standards.
- Defining unsuitable storage zones to prevent product degradation.
These objectives aim to guarantee that the storage conditions for temperature-sensitive pharmaceutical products are optimal, thereby maintaining their efficacy and safety.
This guide is tailored for:
- Wholesalers
- Warehouse operators
- Distributors
- Dispatchers
- Third-party logistics providers
Specifically, it targets Quality Assurance (QA) Managers and Operations Managers responsible for maintaining quality management systems within their organizations.
Requirements for Temperature Mapping
1. Initial Mapping:
- Conduct temperature mapping for all new temperature-controlled storage areas before they are commissioned.
- Ensure that mapping demonstrates the temperature profile when the area is both empty and normally loaded.
- Identify zones unsuitable for TTSPP storage, such as areas near cooling coils or heat sources.
- Assess the time for temperatures to exceed safe limits in case of power failure.
2. Periodic Mapping:
Perform temperature mapping every three years or whenever significant changes occur in the storage environment, such as:
- Changes in usage patterns
- Modifications to refrigeration equipment
- Observed temperature variability in monitoring records.
Steps in a Temperature Mapping Exercise
A comprehensive temperature mapping exercise involves several steps:
1. Prepare a Mapping Protocol:
- Define the objectives, scope, and methodology.
- Detail the equipment to be used, including the number and placement of Electronic Data Logging Monitors (EDLMs).
- Outline the procedures for data collection and analysis.
2. Carry Out the Mapping Exercise:
- Deploy EDLMs strategically across the storage area.
- Record temperature data over a defined period, capturing variations under different conditions (e.g., empty vs. loaded).
3. Analyze Data and Prepare a Mapping Report:
- Collect and analyze the recorded data.
- Document temperature variations and identify any out-of-range occurrences.
- Include detailed graphs and charts to visualize temperature distribution.
4. Implement Recommendations:
- Based on the analysis, make necessary adjustments to optimize temperature control.
- Relocate sensors or adjust air distribution mechanisms as needed.
ALSO READ: Temperature Mapping in Pharmaceuticals
Location of Data Loggers
Materials and Equipment Needed
Key materials and equipment for a temperature mapping exercise include:
1. Electronic Data Logging Monitors (EDLMs):
- Choose EDLMs with appropriate temperature ranges and reliable accuracy.
- Ensure they come with a NIST-traceable 3-point calibration certificate and an error margin of ±0.5°C.
2. Computer Equipment and Software:
Use appropriate software to store and analyze temperature data recorded by the EDLMs.
3. Interpreting Results and Making Recommendations
Upon data collection, interpretation involves:
a. Documenting Internal Temperature Variations:
- Consider the manufacturer’s specified errors for EDLMs.
- Identify temperature stability and variability within the storage area.
b. Assessing Temperature Factors:
- Evaluate the influence of heating and cooling components, and other structural elements like doors.
- Determine optimal storage locations based on observed temperature profiles.
c. Providing Recommendations:
- Suggest locations for routine temperature monitoring and control sensors.
- Propose corrective actions for identified temperature deviations.
Documentation and Compliance
To ensure compliance and provide proof of quality management:
Final Report Contents
- Include a site survey and detailed EDLM locations.
- Present raw data and temperature graphs.
- Document data analysis results and key observations.
- Attach calibration certificates for all EDLMs used.
Key Documents
Mapping protocol
Deviation reports
Corrective and Preventive Action (CAPA) forms if necessary.
Conclusion
Temperature mapping is vital for the effective storage of TTSPPs. By meticulously following a structured approach, organizations can ensure their storage areas maintain required temperature ranges, comply with regulatory standards, and ultimately protect the integrity of their temperature-sensitive products. This guide provides a comprehensive framework for executing thorough temperature mapping studies, ensuring all critical steps are addressed for accurate and reliable outcomes.
ALSO READ: SOP for Temperature Mapping of Warehouse
Test Data Sheet: Temperature Data Logger Locations
Data logger ID number | Data logger serial number | ID number on schema | Mounting height (meters) | Description / Comments |
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Test Data Sheet: Temperature Distribution
Thermostat Information | ||
Location | Setpoint | Comment |
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Test Data Sheet: Temperature Distribution
Data logger ID number | Min. temp. Recorded (°C) | Max temp. Recorded (°C) | Mean temp. (°C) | Within Range? | Inspected by | Date | |
Yes | No | ||||||
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The mapping period starts at (date/hour): |
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The mapping period ends at (date/hour): |
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Checked by: | Date: | ||||||
ALSO READ: Temperature Mapping Protocol
Tags
Warehouse
