तापमान मानचित्रण - प्रभावशीलता के लिए तथ्य और महत्वपूर्ण बातें
Temperature mapping (also known as thermal mapping), is conducted to enable organizations monitor and maintain the overall condition of their environment with respect to its temperature level. It is a Good Manufacturing Practice (GMP) process which is intended to prevent fluctuations of temperature and humidity in controlled environments such as a warehouse, refrigerator, or vehicle.
Temperature mapping represents an integral part of the validation process, an important element of a successful compliance strategy; demonstrating that the environment in question is well suitable for sensitive products and complies with Good Manufacturing Practice (GMP). Hence, a stringent approach to temperature validation should be adopted to enable an auditor or a regulatory body immediately see that environmental control procedures are in place whenever they visit your facility for inspection.
Examples of industries where temperature mapping can be adopted include pharmaceutical, food production, chemical production and packaging industries etc.
Temperature Mapping Vs Temperature Monitoring
Temperature mapping is performed by placing data loggers throughout a specified area for at least 24 hours to study how temperature and humidity is distributed, unlike temperature monitoring which uses fewer data loggers to provide continuous monitoring where product is stored.
Temperature monitoring is a customary practice implemented after a temperature mapping study exercise. The data obtained from both enables organizations identify inconsistencies and implement changes within the environment. Inconsistencies are caused usually by opening and closing of doors, heat generation from electronics, or faulty HVAC systems.
How necessary is Temperature Mapping?
The practice of temperature mapping can assist in preventing product and monetary loss, as well as improve overall quality and public safety. Temperature mapping should be incorporated as part of a company’s GMP guidelines to enable easy and prompt detection of inconsistencies and correcting areas with such inconsistencies in order to ensure proper storage conditions and regulatory compliance.
Areas Requiring Temperature Mapping
It is a good practice to conduct temperature mapping in areas where the quality of a product can be affected by temperature or humidity. Temperature inconsistencies can cause products denaturing, altering their properties (physical, chemical or biological), and thereby deeming them unusable. This can be costly for manufacturers and dangerous to the public health.
How to Conduct Temperature Mapping
Before mapping, the following question should be asked and answered:
- Where is the highest point of storage?
- Where are items such as heaters, coolers, windows, doors and loading bays that could can result to temperature fluctuations located?
- Have additional areas such as packing and returns departments or mezzanine storage floors been included?
- Have areas such as racks, shelves and other storage areas where products are stored located?
- Have you identified areas that are unsuitable to store temperature sensitive materials?
The effectiveness of your answer to the questions above determine to a large extent, the effectiveness of your mapping exercise. After considering the questions above, the following steps can now be taken:
- Determine the total storage area for temperature mapping.
- Determine areas where product is most vulnerable when temperatures go out of limits.
- Establish the required number of calibrated devices such as data loggers. Usually, two layers of loggers, with one logger near each corner and another central logger are used, although the size of the temperature mapping area determines the number of loggers to be used.
- Evenly distribute data loggers across the area to be mapped in a grid formation.
Again, temperature mapping should be taken all seriousness to prevent product wastage to your company and harm to the general public health.
About the Author
Adebayo is a thought leader in continuous process improvement and manufacturing excellence. He is a Certified Six Sigma Master Black Belt (CSSMBB) Professional and Management Systems Lead Auditor (ISO 9001, 45001, ISO 22000/FSSC 22000 etc.) with strong experience leading various continuous improvement initiative in top manufacturing organizations.
You can reach him here.
