Clean Room Temperature and Humidity criterion is a very important issue. As it is known, clean rooms are special rooms where airborne particles are kept under control, built and used in a way to minimize particle entry, particle proliferation and particle accommodation, and also kept under other parameters such as temperature, humidity and pressure. 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 room, stability cabinet and cold chain transportation vehicles used during product storage and shipment, which 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/or 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. Temperature and humidity values are also very important for clean rooms.
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. It is a study that covers temperature and humidity mapping studies with datalogger devices, realizing worst case scenarios and documenting qualification studies, especially in mapping warehouses, cold rooms, stability rooms, ovens, stability cabinets, refrigerators, water baths and other controlled environments.
Mapping Areas:
Comprehensive temperature & humidity measurements should be made to determine the worst points and conditions and to verify performance adequacy in areas such as warehouses, clean rooms, cold rooms where temperature and humidity parameters are critical. Performance monitoring, determination of critical points/conditions, creation of graphics and distribution maps, and evaluation of results and situations are carried out in the conditions determined within the scope of mapping.
The following areas are included in the inspection-validation services of NOVATEST:
Pharmaceuticals, food, raw materials, active substances, auxiliary substances, intermediates in factories, research-development and production facilities, related storage areas of industries such as food, pharmaceuticals, cosmetics, medical devices that carry out Good Manufacturing Practices (GMP-Good Manufacturing Practice). Measuring and reporting the volumetric and temporal temperature and humidity distributions that will be given by storage areas, cold rooms, stability test areas and air-conditioned zones, where various materials such as finished products, sensitive materials are stored, under various seasonal conditions, under both planned working conditions and scenarios that may occur Determining whether environments have been created. 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:
Clean Room Temperature and Humidity
All data obtained as a result of temperature and humidity mapping studies, if any, 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 based on international standards. TÜRKAK, which has complied with the ISO/IEC 17011 standard, accredits domestic and foreign institutions that will carry out laboratory, certification and inspection services. It carries out the task of ensuring that these institutions carry out activities in accordance with the determined national and international standards and thus the national and international validity of product / service, system, personnel and laboratory documents.
It has a documented 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. It has fields of activity in test calibration, accreditation of medical laboratories and proficiency test providers, accreditation of inspection bodies, accreditation of product certification bodies, accreditation of system certification bodies and accreditation of personnel certification bodies. In addition to domestic accreditation services, TÜRKAK also provides accreditation services outside of Turkey in accordance with EU regulations.
Novatest
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. It also 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 (Air Balance) 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. (As a result of the combination of the sketch of the warehouse and the device layout with the thermal image, it is easier to determine which location is the coldest and which location is the hottest in the warehouse.
Most air-conditioned areas are monitored with one or at most several temperature-humidity sensors and it is seen that compliance with the allowable limits is mostly achieved. 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 are at your service as NOVATEST with the Humidity Mapping data that we will obtain from a large number of points that we will determine in your climatized region for a period of about a week, in real environmental conditions, at certain intervals (every 10-15 minutes) and the Humidity Mapping study to be presented in the report we will prepare.