Real-time mapping solution

Why Use the SenseAnywhere temperature mapping equipment on your next qualification project.

The SenseAnywhere solution is revolutionary and has numerous benefits compared to other loggers, used in the pharmaceutical industry. Let us explain why.

Mapping: what is mapping?

Mapping is the process of documenting measurement of the temperature and/or relative humidity distribution within storage areas that are allocated for the storage and handling of products with specific storage temperature specifications. This measurement includes identification of hot and cold spots. The purpose of a temperature Mapping study is to document and control the temperature distribution within a storage area.

With these mappings you document the requirements from the regulatory authorities (GxP, HACCP…), your customers and your management.

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. Until this has been done, it is not safe to store time- and temperature-sensitive pharmaceutical products in such areas.

A Mapping Qualification results in the identification of hot and cold spots. Cold spot refers to the lowest temperature(s) recorded in the space over the study period. A hot spot refers to the highest temperature(s) recorded in the area studied over the study period. The purpose of determining hot and cold spots is to identify the locations where the monitoring system data loggers should preferentially be located. Average values can be useful to help confirm true hot and cold spots.

Mapping: why do we need one?

To know what the temperature and humidity distribution in a storage area is, where you can stock your critical medical samples and pharmaceutical substances, what effect seasoning (summer and winter) has on the storage area, what fluctuations are caused by opening doors, etc.… , mapping is required.

A Qualification mapping will identify the distribution of the temperature and humidity in the under-control unit, show hot and cold spots, give you the result of a 24-hours mapping in summer and winter time, …d
Indeed, a loss of quality or effectiveness, due to fluctuations in temperature and/or humidity are to be avoided.

Mapping is all about control and full documentation of your critical area. Through a fully documented verification process you demonstrate compliance with high standards. With these mappings you document the requirements from the regulatory authorities (GxP, HACCP…), your customers and your management.

Mapping: when do we need one?

When the equipment is new, has been serviced or relocated a temperature mapping is needed.
Periodic testing and seasonal conditions are to be performed as well to assure compliance over time.
Even with a change of load or different products, the characteristics and performance of the storage can change, and documentation is necessary to show compliance to the requirements.

Mapping: how to perform?

A complete detailed protocol is provided, in which all locations are identified.
A trained CMI – c/o Trescal expert will install all sensors on the locations. The loggers measure continuously (interval to be determined in the protocol). All loggers are assigned to a study and measurements are collected immediately.
This is a different approach than before.

Before :
Programming and collecting all loggers, reading data, running data in Excel, collecting findings, making graphs, processing the report and if things go wrong: everything has to be done all over again. Sound familiar? With the SenseAnywhere Real Time Mapping solution, this is a thing of the past.

Now:
You install the loggers in the warehouse and connect a Mobile AccessPoint, that’s all! With one click of a button you can see the correct temperatures in the SenseAnywhere Portal. It enables you to easily and quickly see if all data loggers are working and set correctly.

Advantage:
In the case of a study with SenseAnywhere sensors, the customer (QA, QC…) can follow the trends remotely at the same time. As soon as the criteria are met, the qualification can start. From that time the measurements are taken into consideration for the final report.

Due to this approach, no time is wasted. Where before, the data was available after the measuring campaign, now the data is available directly through the cloud-based approach.

Eliminate (human) errors

Working with SenseAnywhere eliminates human error in Mapping, storing, and processing data. The SAClient software does not allow the addition, modification, or deletion of logger data. Regulatory authorities and auditors can easily verify that the Digital Mapping report you provided is genuine. Guaranteed real data.

Mapping: what do we use?

SenseAnywhere developed a unique data logger with tailor mapping software. These wireless loggers measure continuously in real-time and is with that the most efficient way of executing GMP compliant Mappings.
The process is automatic and accurate. Easy to install, excellent documentation and economical through its process.

Mapping: benefits of SenseAnywhere?

The SenseAnywhere Temperature Mapping is an extremely efficient and economical Mapping process with a minimum of time and resources, which quickly and clearly discovers possible resist areas. Based on the generated Mapping Report in SAClient, users can make recommendations about the optimum storage locations for highly sensitive products, and those that are less sensitive.

The SenseAnywhere loggers are:

• Small and robust wireless data loggers with NIST-traceable or accredited calibration certificates and a 10-year battery life
• Easy to place and use, without any pre-installation or wiring and without pressing any buttons
• High accuracy: ± 0,10 °C (0 °C to 70 °C) and ± 0,15 °C (-40 °C to 0 °C) and long-term stability (drift in time <0,01 °C / year)
• User-friendly online application, no installation required, with detailed and customizable reports
• All data is available in real-time in the Cloud database
• Automatic reports, so no human intervention and real data guaranteed with the shortest possible validation time
• Tabular and graphical reports in accordance with 21 CFR Part 11
• The registrations are real-time stored in the Cloud securely for at least 5 years
• The data is immediately available to use, no download is necessary
• You as a customer can follow the qualification in real time and intervene immediately
• GxP and FED 21 CFR Part 11 compliant temperature monitoring solutions
• CMI – c/o Trescal expert mapping services available with over 500 sensors in one time

Looking for a Mapping expert?

Even with the intelligent real-time Mapping solution a Mapping expert remains indispensable. The Expert will supervise the Mapping, determine the frequency and location of the monitoring equipment, review the numerical data, draw conclusions, and prepare a recommendation. This is why CMI – c/o Trescal works with professional Mapping Experts.

If you would like to know more about working with one of our Mapping experts, please don’t hesitate to contact us.