In this article, you will learn different methods to estimate the number of Temperature Data Loggers necessary to make thermal mappings, environmental monitoring, and other validation studies. Also, you can discover how to get a Thermal Mapping Validation Template and Validation Management Software Application to handle your qualification activities fast and easily.
The number of data loggers needed is based on the number of measurement points inside the area of monitoring in a particular equipment chamber, cleanroom, or product pallet.
Besides, the amount of measurement points depends on how big or small is the volume of area to be monitored covering all quadrants and spot location areas in which your product can be exposed.
Typically, before the start, thermal mapping monitoring is important to prepare a specific as-built drawing representing the dimensions of the area to be measured with space to add the location number of each data logger in a particular quadrant equidistant to each other to cover the entire area. See the following example sampling location diagram of a cleanroom.
Depending on the intended use and the type of thermal mapping, you can use a guideline to calculate the number of temperature data loggers recommended for a measured volume.
CALCULATE THE NUMBER OF TEMPERATURE DATA LOGGERS NECESSARY
You can use two 2 methods to calculate the number of sampling locations:
Method 1. Pre-defined Tables. Some guidelines contain a pre-established number of dataloggers required based on the square meters of the area. Examples of these guidelines are the ISO 14644-1-2015, Cleanrooms and Associated Controlled Environments — Part 1: Classification of Air Cleanliness, etc.
Method 2. Sampling Formula. The number of sampling locations or test sites to place and measure temperature during a thermal mapping can be established using the following formula:
1. Estimate the square root of the area in square meters and rounding the result up to a whole number. Make sure to define the units of the Area (A) in the formula to be evaluated in square meters.
2. Finally, use the formula for NL to calculate the minimum number of sampling locations or test sites.
For example, if you have room dimensions of 50 meters wide and 50 meters long, then the total area to be monitored shall of 50 meters x 50 meters = 2500 square meters (m2).
Then, the (NL) number of sampling locations or data loggers required to make the thermal mapping shall be: 27 x 2500 / 1000 = 68 data loggers.
Refer to Figure 2, to see an example diagram of a cleanroom with the number of data loggers. HOW TO ESTIMATE THE NUMBER OF TEMPERATURE DATA LOGGERS NECESSARY
TIP: In addition to the 68 data loggers estimated by the formula, we always recommend deploying and use 2 or 3 data loggers more in case any of them may have a malfunction or failure during the monitoring.
CIQA can bring you these services, as well as the rental of the data loggers to make the monitoring.
Thermal studies require the use of very expensive validation instrumentation and equipment, which represent a high cost in many cases if the utilization of that equipment is very low.
Since some companies do not have the internal personnel with the experience and knowledge to perform these studies, they contract third-party companies as CIQA Engineering to make that work. Thermal Mapping Outcomes
CIQA Engineering has the equipment and experienced professionals to perform the thermal mapping and qualifications. We can prepare the protocols, bring the measurement instruments for monitoring, make the analysis and reporting documents once the data is gathered.
Recommendations to Avoid Mistakes Using Temperature Data Loggers.
We suggest evaluating all your requirements and needs to use temperature data loggers, but, also consider the frequency of use monthly, and how fast you need them on-site for your validation study.
So, you can determine if is better to buy or rent them based on the expertise and time availability of your employees to configure and prepare the trending graphs and summary statistical reports on time.
Before buy, consider the cost of the data loggers, but, also the cost of the calibration and its lead time.
Evaluate and compare the total costs and lead times, against the costs to rent data loggers already calibrated.
If you are NOT using temperature data loggers frequently, consider a fast CIQA rental of the calibrated data loggers required for the thermal study. Thermal Mapping Outcomes
One of our data logger experts can set up, configure and bring to you the data loggers ready to use and be installed to collect information from your thermal mapping study. At the end of your monitoring, you can send the data loggers back to us for data extraction, evaluation, and perform the statistical analysis and plotting with averages, maximums, and minimums. For more information about services to make the initial setup, configuration, and statistical summary reports with trending graphs, click here.
THERMAL MAPPING PROTOCOL TEMPLATE
In case you need to create or update your thermal mapping protocol, you can use our template protocol to accelerate the process to perform the validation study and monitoring. To download a free sample of a thermal mapping protocol template in .pdf format, click here.
VALIDATION MANAGEMENT SOFTWARE APPLICATION
Moreover, soon you can get a Validation Management Software Application to handle all your qualification and validation documents from anywhere at any time.
TO RECEIVE NEWS AND USEFUL TOOLS ABOUT HOW TO DETERMINE THE NUMBER OF TEMPERATURE DATA LOGGERS, SUBSCRIBE, AND FOLLOW US.
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.
IF YOU HAVE ANY QUESTIONS ABOUT HOW TO USE THE TEMPERATURE DATA LOGGERS MEMORY, FEEL FREE TO CONTACT US EITHER BY EMAIL OR PHONE: 787-487-9235. (Hablamos Español)
REFERENCES: NUMBER OF TEMPERATURE DATA LOGGERS NECESSARY