The most efficient way to conduct GMP-compliant mapping studies
How often a mapping needs to be conducted depends very individually on the respective circumstances. In the pharmaceutical industry, annual summer mapping and winter mapping are very common.
Are you combining temperature mapping with cumbersome, time-consuming work?
Then you should get to know our efficient mapping service that will bring back the joy in your mapping tasks.
Process of our Temperature Distribution Studies:
- We analyze the premises together with you
- You receive the required number of wireless data loggers
- The wireless data loggers are placed at the monitoring points
- The temperature or humidity recording is initiated
- We analyze the data in real-time over the desired period
- You receive a comprehensive GMP-compliant documentation of your mapping study
Thanks to real-time data collection, you receive your mapping report before you have collected the data loggers again. After completing the mapping study, you can return the wireless data loggers to us or use them for further studies.
Optionally, you can receive information about possible weaknesses (PRE-Mapping) even before the official mapping study
Unique advantages for your mapping study:
No Investment
You don't need your own measuring system, so you don't tie up capital.
Comprehensive Report
With an analysis of the measurement results.
"Simply Simple"
No elaborate data retrieval, no operation, no configuration, no wiring, no calibration of measuring instruments.
PRE Mapping
Conduct a study before the official mapping to identify weaknesses.
Global Mapping
We map your warehouses worldwide without you being on-site.
Self-contained System
We do not access your company's internal IT, nor your Wi-Fi.
What to consider in temperature mapping?
To guarantee the quality of products, storage at a defined temperature is essential. Temperature fluctuations must not exceed the specified limits.
This is a challenge in many warehouses, and temperatures can easily deviate by 10°C or more. The temperature depends on many factors inside and outside the warehouse:
- Storage Size - A warehouse with a volume of 125 m³ (5mx5mx5m) is easier to keep at a constant temperature than a warehouse with several thousand cubic meters.
- Load - A largely filled warehouse will have a different temperature profile due to changing airflows compared to a nearly empty warehouse.
- Layout - The arrangement of shelves, partitions, shelves, pallets, etc., also influences air circulation.
- Position - Generally, the center of a warehouse has more consistent temperatures than the more problematic outer zones.
- Season - Obviously, there are different temperature conditions and distributions in a warehouse in winter than in summer, and unexpected weather events can change warehouse conditions.
- Openings - Open loading doors at loading ramps, doors, and windows can quickly change the prevailing temperature.
- Light Entries - Window fronts and glass domes through which the sun shines can cause significant temperature fluctuations in the area behind them. Artificial light from light fixtures can also be an unwanted source of heat under certain circumstances.
- HVAC - Heating, ventilation, and air conditioning systems can significantly alter conditions, especially in close proximity to fans, air outlets, diffusers, air handlers, etc.
- Convection - The fact that warm air rises must be taken into account and investigated in a warehouse.
What is the mapping process with CiK Solutions and what benefits does it offer?
- For the mapping study, we send you small, robust, wireless data loggers that can be easily placed at any location without presetting or wiring and continuously record the collected data.
- Map your warehouses worldwide without being on-site yourself. We are happy to send the system to any company worldwide. You only need a competent and reliable person on-site to set up the measurement systems - you will receive the report.
- The wireless signals are strong enough to monitor refrigerators and freezers as well.
- The data loggers are rated IP67 (waterproof) and can be used outdoors if, for example, an outdoor storage area needs to be monitored or if the outside temperature needs to be recorded in parallel with the storage temperatures.
- A floor plan of the room to be monitored shows the distribution of measurement points and ensures clear allocation of temperature measurement points.
- All measurement modules are accredited calibrated according to DIN/ISO 17025. Corresponding calibration certificates are attached to the mapping report. With ± 0.10 °C (0 °C to +70 °C) and ± 0.15 °C (-40 °C to 0 °C) and a long-term stability of less than 0.01 °C/year, the accuracy of the measuring instruments is exceptionally good.
- Measurement data is transmitted in real-time via an access point directly to us and securely stored for at least 5 years. The transmission is done via a SIM card integrated into the access point over the GSM mobile network, so access to your company's internal IT is not necessary.
- Since this is an online application, this mapping study can be conducted without any installation effort.
- As a result, you will receive a comprehensive report with information on hot spots (maximum temperature) and cold spots (minimum temperature), average temperature (AVG), MKT (Mean Kinetic Temperature), informative tables and graphics, as well as ISO 17025-compliant certificates.
- Upon request, we can conduct a PRE-Mapping (description see above)
Simple - Fast - Cost-Effective
CiK Solutions' Temperature Mapping Service is an extremely efficient mapping process for you with minimal time and resource investment, quickly identifying potential risk areas.
Call us, and in an informal, non-binding conversation, we will discuss your requirements, costs, and everything you want to know.
Why not now?
0721 - 62 69 08 50
Background on Temperature Distribution Studies
To ensure the safety and health of patients, consumers, and users, producers in today's highly regulated environment must have a clear understanding of how processes and procedures affect the quality of their products.Guidelines such as GMP (Good Manufacturing Practice) or GDP (Good Distribution Practice) prescribe how quality assurance in the production, storage, or transport of active ingredients and pharmaceuticals, as well as cosmetics, foods, and animal feeds, must be guaranteed.
Regulatory authorities worldwide focus specifically on compliance with temperature requirements in warehouses, distribution centers, refrigerated storage areas, and other storage facilities.
Temperature mapping, which involves verifying temperature distribution and compliance within a storage area, is of great importance in this context. In critical industries/areas where temperature-sensitive products are processed, stored, and transported, there is typically a validation master plan/validation plan/test plan that regulates when and how temperature mapping should be performed.
Industries for Which We Offer Temperature Mapping
Quality assurance plays a central role in the pharmaceutical industry, as deviations from quality standards can directly impact consumer health.
Whether pharmaceuticals (medicines, vaccines, active ingredients, blood products) or biochemical substances in the life sciences industry, GMP-compliant quality management in the pharmaceutical industry ensures product quality and compliance with health authority requirements.
This includes monitoring pharmaceutical warehouses and production facilities as well as climate chambers/stability rooms used for stability tests.
However, risk management is also important in the food industry.
Meat products, dairy products, fruits & vegetables, and more must be processed, stored, and transported under defined temperature conditions.
The cosmetics industry, chemical industry, and many other sectors are also required to implement strict temperature control mechanisms to guarantee the quality of their products.
In all the mentioned areas, ensuring good cold chain management (CCM) is essential, which involves adhering to and monitoring the cold chain during manufacturing, storage, and transportation.
Frequency
How often a mapping needs to be conducted is highly individual and depends on the specific circumstances. In the pharmaceutical industry, annual summer mapping and winter mapping are very common.
What is Pre-Mapping?
Mapping studies are important and official investigations that must be documented and certified comprehensively.
In conventional mapping methods, it is often the case that data recording devices need to be collected or accessed after a mapping study is conducted in order to read the data and evaluate the results. If it is only then discovered that significant temperature fluctuations have occurred, this labor-intensive, time-consuming, and costly process must be completely repeated.
Not so with the CiK Mapping Service. Here, it is possible to conduct a pre-mapping, essentially a test mapping before the official mapping run. If weaknesses are identified in this pre-mapping, they can be addressed in advance, without the need to collect and read recording devices.