Temperature Mapping in the Pharmaceutical Industry

One of the critical factors in ensuring and determining product quality and safety is temperature control in the area of operation or where a product is stored, because, chemical substances (from which pharma product is made), sensitivity to temperatures and efficacy, quality, and safety are directly linked to the temperature values. 

Due to these reasons and many more, a temperature control function is installed at various critical locations to ensure it does not drift from the acceptable limits. 

However, in some instances, temperatures drift out of range mainly due to a fault in the control system or human error, making temperature control ineffective and degrading the product in the relevant area.

Temperature mapping is implemented in critical areas to prevent damage to the product, especially in storage, and to detect deviations from acceptable temperature ranges. During accreditation, it also serves as a compliance requirement in the pharma industry (for storage areas).

Other than those mentioned above, some other reasons cause temperature defection in the area, which we will discuss later in this article.

Temperature mapping in the pharmaceutical industry is mainly required for storage areas, which is also the main subject of this article.

What is temperature mapping?

Temperature mapping involves placing several temperature sensors across an area to determine the exact values at specific points. Measuring temperature values in different regions and correlating them with each other creates a map of temperature distribution, which can be used to analyze the behavior of temperature in various sections of area of determine its impact, specifically hot or cold areas.

Temperature mapping is obtaining the temperature profile of an entire area and observing how it changes across different sections of an area. Its primary purpose is identifying and detecting anomalies and determining how temperature deviates. It also helps to decide what objects are causing deviation in a particular area.

Mapping is mainly performed for all critical points, which depends on the area's physical structure, product placement, and the effect of external temperature values. 

Temperature mapping in the pharmaceutical industry is mainly used to assess the temperature profile of storage areas, cold rooms, and refrigerators, where temperature-sensitive products are kept.

Why temperature mapping?

Let's discuss some whys of temperature mapping in pharmaceutical industry

Seasonal changes affect the overall temperature of an area

Between summer and cold seasons, temperature changes widely, as is commonly known. However, the external environmental temperature also affects their control and distribution mechanism. Hot and cold weather affects cooling equipment, energy consumption, heat distribution across different areas, and its ability to retain the required temperatures. Additionally, the sun's position on the wall of an area also impacts the temperature profile of the attached area. 

All the factors mentioned above and alike alter the temperature throughout a specific area, department, or equipment and change the temperature requirement and fulfillment. 

Temperature mapping help determine deviations in temperature during different seasons. It is also helpful in determining the equipment's behavior, and the equipment's operational parameters for an optimum temperature distribution.

Hindrance in airflow

It is common in pharma-critical areas that airflow faces resistance and hindrance during its flow in an area. This can be mainly due to the design of the facility, physical objects, and under or over-capacity of the blowing components. Certain spots within an area face temperature (and other environmental parameters) variations when this happens. 

These variations are intense in corners, while central space has accurate temperature values

Temperature mapping in this scenario helps detect the area affected by hindrance in airflow, commonly called Air Pockets. They can accurately locate these spots, no matter what the number is. The maintenance personnel can use this data to improve the airflow by adjusting the air blower, improving the area layout, and simply relocating critical items in an area.

Problems with the HVAC system

Heating Ventilation and Air Conditioned - HVAC system maintains a particular temperature and the desired airflow. However, in some instances, the HVAC system becomes outdated or starts malfunctioning, which can go undetected. It is also possible that a recent change in the area layout or item placement affects the HVAC performance.  

Temperature mapping, in this case, can be helpful to detect anomalies in HVAC operation by measuring temperature values at critical areas and comparing them with the standard values. It can be used to detect 

● What areas have been affected due to changes in the layout or placement of objects?

● The inability of the HVAC system to deliver the required environmental parameters due to any problem or simply due to the HVAC needing to be replaced.

Disturbance due to windows

Windows in any area transfer the effect of the outside environment to the inside of the area and can alter the area parameters.

Temperature mapping can determine what, and up to what level, a window challenges the temperature inside an area. The results of temperature mapping can be used to 

● Change the window place, if possible

● Increase or reduce the heating or cooling capacity

● Change the location of critical objects, previously near windows, to nullify the temperature variations

Door opening and Closing 

Personnel working in an area frequently open and close doors, which impacts the temperature of the area and other environmental parameters. When a door opens, it exposes the inside air to the outside and abruptly changes the airflow. Temperature values in an area are also affected, and it can become severe if the frequency is high for an area.

Temperature mapping for this scenario is beneficial in measuring the impact on area temperature and what countermeasures can be taken to negate its effects. It can be used to perform measures such as

● Relocating critical items or processes to another location 

● Change the location of the door if it is impacting too much.

● Increase or decrease the HVAC parameters to offset the temperature affected.

● Apply protective measures on the door, such as an air cutter or PVC sheets, to protect the temperature inside from door opening and Closing. 

How do we carry out temperature mapping?

There can be any procedure for performing temperature mapping, but for the pharma industry, regulatory bodies provide guidelines. Regulatory bodies also inspect compliance procedures during their review.

Here is a brief procedure for carrying out temperature mapping, according to the World Health Organization - WHO

The WHO provides comprehensive guidelines on temperature mapping for pharmaceutical storage areas and includes procedure, documentation, scope, and other descriptions. 

Let's briefly discuss

● Choose an Electronic Data Logger with enough memory and a 3-point calibration completed. The report for calibration report must be included in the final mapping report. The logger's calibration point must cover the entire working temperature range. For example, if the range of logger is 0°C to 300°C, calibration must also be performed from 0°C to 300°C

● Prepare a mapping team to perform the activity. Record their initials to trace back their identity.

● Survey the entire site and determine the following.

● Dimensions

● Drawing of the area under being mapped, showing the position of every physical object, such as a pallet, that can impact the heating or cooling.

● Heating and cooling equipment 

● Existing temperature sensors 

● Determine the acceptance criteria depending on the product or item being stored.

● Determine the location of the electronic data logger by considering the following.

● Length and width depending on the layout of the area, physical items affecting airflow, product

● Position. 

● Height

● Label each electronic data logger with a unique ID, indicating the opposition of each logger.

● Place the data logger in its marked position w.r.to location of storage area.

● After performing the above activities, start mapping.

● There is no defined limit for the duration of the activity, but it is recommended that the activity may be continued for  

● Seven consecutive days for warehouse and ambient storage devices

● 24to 72 hours for temperature-controlled equipment not affected by seasonal variations ( freezer & cold rooms)

● If there are duplicate refrigeration units, map separate units for the abovementioned period, by following procedure mentioned above.

● After completing temperature mapping, download the electronic data logger for data analysis and compile a report.

After completing the study, prepare the report according to the approved format mentioned in the same WHO guideline.

What areas require temperature mapping

According to the World Health Organization, any space allocated for storage and product handling must undergo temperature mapping. These include

● Freezer: A specialized refrigeration unit used for storing pharmaceuticals, vaccines, and related products at low temperatures, mainly below 0⁰C, to protect their efficacy. 

● Cold Rooms: these keep items cold at specific temperatures while also controlling and maintaining humidity and moisture levels

● Temperature-controlled storage areas: They are also low-temperature devices used to store non-critical items such as samples. Its primary function is to prevent decay, and store them for a longer duration of time.

● Quarantine areas: These are areas where a drug is contained for a specified time to prevent contamination of other persons or medicines. It includes quarantine for destruction, returns, and primary quarantine.

● Laboratories: Temperature control is an integral requirement for pharma laboratories because some tests require specific temperatures. Additionally, laboratories store various chemicals and samples that require specific temperatures for a successful test.

About the Author:

Muhammad Asim Niazi

Muhammad   Asim Niazi has a vast experience of about 11 years in a Pharmaceutical   company. During his tenure he worked in their different departments and had   been part of many initiatives within the company. He now uses his experience   and skill to write interested content for audiences at PharmaSources.com.