What is Humidity Mapping?; Humidity Mapping is defined as temperature/humidity mapping. FDA and cGMP regulations require that the temperature and humidity values of areas and equipment such as all storage warehouses, oven-cold rooms, stability cabinets and cold chain transportation vehicles used during the storage and shipment of products that appeal to the pharmaceutical industry are recorded uninterruptedly and these data are kept. In this context, temperature/humidity mapping is required before the placement of the observation sensors in the relevant areas in order to determine the appropriate observation points in humidity and temperature controlled areas and equipment and to detect worst case points. These mapping processes should be repeated in revision applications that include changes such as repairs and repairs that may occur in the ventilation system or the area.
Devices to be used in temperature/humidity mapping must be in compliance with 21CFR Part 211 and have a measuring range and sensitivity that can meet customer requirements. The determination of the measurement points and the number of points is made by analyzing the physical conditions and customer criteria, if any, by our experienced field personnel with customer officials before the measurements. Mapping is a study that covers temperature and humidity mapping studies with datalogger devices, realizing worst case scenarios and documenting qualification studies in warehouses, cold rooms, stability rooms, ovens, stability cabinets, refrigerators, water baths and other controlled environments.
Mapping Areas:
Temperature and Humidity Mapping
All data obtained as a result of temperature and humidity mapping studies are analyzed with MKT and standard deviation values after deducting the time spent in various scenarios applied and reported within the scope of TURKAK accreditation. The Turkish Accreditation Agency (TÜRKAK) was established on 4 November 1999 under the Prime Ministry with the Law No. 4457. Today, it is a non-profit public institution with administrative and financial autonomy, which is related to the Ministry of Foreign Affairs of the Republic of Turkey and is subject to the provisions of private law. It fulfills the task of evaluating and approving the competencies of conformity assessment bodies on the basis of international standards. TÜRKAK Laboratory, which has complied with the ISO/IEC 17011 standard, accredits domestic and foreign institutions that will carry out certification and inspection services. It carries out the task of ensuring that these organizations operate in accordance with the determined international standards and thus the national and international validity of product/service, system, personnel and laboratory documents.
It has a documentary management system, which is structured in accordance with the ISO / IEC 17011 standard, which includes the rules that accreditation bodies must comply with in the international arena, and therefore, it has a documentary management system in accordance with the ISO 17011 standard and carries out its operations according to this standard. Test calibration, medical laboratories and proficiency test providers, inspection bodies, product certification bodies, system certification bodies and personnel certification bodies have the accreditation fields of activity. In addition to domestic accreditation services, TÜRKAK also provides accreditation services outside of Turkey in accordance with EU regulations.
Comprehensive temperature & humidity measurements should be made to determine the worst points and conditions and to verify performance adequacy in areas such as warehouses and cold rooms where temperature and humidity parameters are critical. Performance monitoring, determination of critical points, creation of graphics and distribution maps, and evaluation of results and situations are carried out under the conditions determined within the scope of mapping.
Applications within the scope of inspection-validation services of NOVATEST company:
As a result of the temperature-humidity mapping work to be carried out in the aforementioned air-conditioned warehouses and regions through datalogger-data collection systems, it is aimed to obtain the following, but not limited to, results at all points and volumes with a large number of sensors to be placed in the working area:
Our company was established in 2014. It has set out especially not to compromise on QUALITY and TRUST. Moreover, its own YOUNG, its team YOUNG, its equipment YOUNG, but it has set out with academic career people who have a say in the sector. In addition, it proceeds with the motto of continuous innovation. As can be understood from the meaning of its name, our company has set out to become a ‘shining star’ in the sector. In addition, NOVATEST provides HVAC Validation tests, Duct Leak Tests, Biosafety Cabinets Performance Tests and Air Flow Measurement services. In principle, we are in control of what we do. We work very meticulously. We also provide high quality services for our customers in all industries. However, NOVATEST undertakes to fulfill all the requirements of its quality policy.
The best way to present the measurement results of temperature and humidity values is to prepare a report rich with visual content. For this reason, in temperature mapping, not only the temperature graph but also the temperature isotherm map of the warehouse is presented to our customers. This way reporting happens for all kinds of variables.
Most of the air-conditioned areas are observed with one or at most several temperature-humidity sensors and it is seen that compliance with the permissible limits is mostly ensured. However, the real situation is often different. In a large area within the volume that should be under control, no measurement is actually performed. At the same time, many movements are constantly taking place in the environment, personnel traffic, movements of forklifts and similar vehicles, opening and closing of doors and windows, if any, also affect the environment. At the same time, the doors of the air-conditioned zone and some wall sections are adjacent to regions with different temperature-humidity conditions.
Moreover, it often causes the formation of conditions that will lead to undesirable heat transfer. Under all these conditions, how do you ensure that the temperature and humidity are evenly distributed throughout the volume and that the products are kept in the same conditions at every point in the environment? Are the sensors you place in the environment actually located at the most critical points? In the process of answering these and similar questions, we, as NOVATEST , are at your service with the Humidity Mapping data we will obtain periodically (at least every 10-15 minutes) from many points that we will determine in your climatic zone for a period of about a week, in real environmental conditions, and with the report we will prepare.