Clean Room Temperature and Humidity Measurement
The purpose of Clean Room Temperature and Humidity Measurement is to document and verify the success of air conditioning systems installed for clean rooms and clean spaces in maintaining the air temperature level for a given space for the required period of time. Temperature Measurement Test is carried out in accordance with ISO 14644-3:2005 and IEST-RP-CC006.3:2004, EU Guidelines to GMP:2015 standards and instructions. Temperature Measurement methods are applied at two levels. The first level is the general measurements made at the as-built stage after the connections of all devices are completed. The second level is the comprehensive tests carried out during the at-rest and in-operation phases after the completion of all equipment and goods. Second-stage tests are applied for setups that are expected to achieve more precise temperature success. In order to minimize the particle entry of the working personnel, the temperature value of their environment should be slightly lower, since they wear work clothes over their daily clothes. The ideal operating temperature for clean room temperature and humidity measurement is between 18-21 ºC.
Humidity Measurement
The relative humidity in clean rooms also has an impact on personnel. Relative humidity not only affects product quality in production, but also has a great impact on wound drying and blood coagulation in operating rooms. Relative humidity is important in health institutions to minimize the formation and reproduction of organisms and the interaction of chemicals used. Humidity-controlled production process, equipment and materials, reduction of electrostatic charges and personnel comfort should be considered. Humidity control in clean room installations is affected by the external environment rather than the equipment inside. The purpose of Humidity Measurement is to document and verify the success of air conditioning systems installed for Clean Rooms and clean spaces in maintaining the humidity level of the air (referred to as relative humidity or dew point) for the required period of time. Humidity Measurement Test is carried out in accordance with ISO 14644-3:2005 and IEST-RP-CC006.3:2004, EU Guidelines to GMP:2015 standards and instructions.
It is recommended to measure the Humidity Rate when the air conditioning system installed for clean rooms and clean areas is completely put into operation and when stable conditions are met. Due to the high air flow in the clean room, electrostatic charge (electricity) occurs. With the increase in ambient humidity, the particles adhering to the wall-ceiling surfaces are released in the air. It is recommended to keep the ambient humidity within the limits of 45 ± 5% in order to prevent the accumulation of particles as a result of loading.
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 Laboratory, which has complied with the ISO/IEC 17011 standard, is to accredit domestic and foreign organizations that will carry out certification and inspection services, to ensure that these organizations operate in accordance with the determined national and international standards, and thus, the product/service, system, personnel and laboratory certificates are obtained from national and international carries out the task of ensuring its international validity.
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.
13 Points to Consider in Clean Room Planning
Cleanroom setup and planning begins with the cleanroom design phase. At this stage, you should consider how the cleanroom will be used, the level of decontamination enamel allowed, its location, production process requirements, and cost. Cleanroom designers will need to conduct in-depth interviews with end users to ensure all needs are met at this stage. Once cleanrooms are established, you will need an experienced professional group to maintain the cleanliness and certification of these facilities.
There are many elements to consider when planning a cleanroom. As well as the practicalities of how much space you need for your equipment, you also need to consider:
1 – HEPA (High Efficiency Particulate Air) Filters: These filters support contamination control by filtering particles as small as 0.3 microns. Air must be circulated continuously through HEPA filters to remove pollutants from the air and provide clean air to people working in the clean room.
2 – Ventilation: Ventilation is necessary to maintain air quality and control process contamination. Since this will require a lot of energy, you need extra space for equipment such as air passage, noise canceling, backup generator for the cooling unit components.
3- Air Pressure: Clean rooms must have a static pressure higher than atmospheric pressure to prevent air leakage. Airlocks also help minimize or prevent pressure changes that could compromise the process.
4- Temperature and Humidity: Temperature control means stable and consistent conditions for material and equipment. Humidity control prevents corrosion and condensation of interior surfaces and eliminates static electricity. These two factors are integral to the function of a clean room as well as the comfort of the people working in it.
5- Architecture: To maintain a consistent flow of air throughout the cleanroom, air needs a path that is as unrestricted as possible. If the airflow is restricted, the resulting turbulence can cause the movement of particles, increasing the risk of airborne contaminants.
6- Measuring Equipment: A cleanroom must be constantly measured to ensure that factors such as particle count, airflow, humidity, temperature and cleanliness are at appropriate levels.
7- Electrostatic Discharge: Moving air and moving people create an electric charge. Electrostatic discharge shielding materials should be used to prevent potential damage.
8- Lighting: A clean room with sufficient lighting poses great risks. High performance, easy to clean, dust and water resistant special fixtures are needed in the facilities. In these applications where lighting is critical, downtime should be short and maintenance needs to be minimal.
9- Future-proof: Make sure your cleanroom is as flexible in design as possible to accommodate future expansion, new equipment or process changes.
10- Materials used for interior surfaces: In a clean room, you cannot use any surface material that can spill particles and pollute the air. They also need to be resistant to degradation when cleaned, so they need to be compatible with your cleaning products.
11- Showers and laundry facilities: This will depend on your needs and supplies, but you may need to provide shower and laundry facilities for decontamination purposes. This means you need to think about plumbing and hazardous waste treatment.
12- Hazardous materials: If your cleanroom handles hazardous materials, additional considerations should include a negative air pressure system and special handling of waste air and water, as well as personal protection and separate inlets and outlets.
13- From design to construction and maintenance, keeping controlled environments up to standards is a continuous process. Support for a maintenance program for any controlled environment ISO 14644 Class I to Class 8.