Clean rooms are designed to maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles. Clean room validation is intended for IVF Labs, Bio-safety Cabinets, Laminar Airflow Cabinets, Isolation Rooms, Operation Theatres, Pharmaceutical Industries, Semiconductor Industries, and Automobile Industries etc... All clean rooms must meet an international standard ISO 14644-1. As per this standard, every clean room must be validated once or twice in a year depending on the cleanliness requirement or ISO standard classifications.
Clean room validation is provided by conducting a series of tests to qualify, if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines, such as ISO 14644-1:2015 or GMP Annex 1.Clean room validation consists of series of tests such as Particle Count Test, Filter System Leakage Test, Air Velocity & Air Exchange Rate, Differential Pressure Test, Environmental Conditions (Temperature & Relative Humidity) etc… Other tests are also done as per the client request such as Air Flow Visualization and Recovery Test.
In addition to acquiring the necessary equipment when building a cleanroom, the environment must comply with clean air safety regulations in order to operate efficiently, both in process and cost. Cleanroom validation involves conducting a series of tests to determine whether these guidelines are being met, such as ISO 14644:2015 and guidelines from the Medicines and Healthcare Products Regulatory Agency (MHRA).
Cleanroom validation is important as it also aids in the detection of harmful contamination sources, ensuring peace of mind that your critical processes remain protected. Failure to comply with validation standards puts your business at risk of high maintenance costs and disrupted operations, the frequency of which should be defined by your business' individual risk assessment.
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Air Velocity and Air change rates are important factors in determining the design and performance criteria for a cleanroom HVAC system. The total rate, flow pattern, and exchange efficiency have far-reaching implications on cleanroom performance and cost. The performance and cost eventually determine the rate-of-return on investment for a cleanroom. Airflow engineering is the primary method of contamination control for both viable (living) and non-viable particles or microbes. However, it's also a primary requirement for the comfort and safety of a cleanroom's most prized producers: its operators.
Like Air Velocity and Air change rate, differential pressure has very much importance in maintaining cleanliness level, reducing contamination, cross contamination etc.,. Differential pressure is measured between 2 adjacent rooms/areas. The value might be negative or positive depending on the type of production/operation going on inside the main area. For example, an operation theatre should be in positive pressure compared to its corridor or adjacent room which will eliminate the chances of infection.
The dispersed oil particulate (DOP) scan testing, also known as filter integrity testing, or leak testing, is one of the most quoted methods by industry standards. The test is recommended to be repeated at regular time intervals to verify the continued efficiency of the filter. During the test, the filter is challenged by introducing particulates and measuring the output.
HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or through various points on the filter media. Thereafter, leak tests should be performed at suitable time intervals for HEPA filters. For example, such testing should be performed twice a year in the aseptic processing room
Environmental monitoring, especially particle counting, in cleanrooms is used to show that said cleanroom operates within its set parameters before and during manufacturing processes or its set of operations. The safety and quality of products can be affected if too many particles enter the manufacturing space or process. As per ISO 14644, there are 9 classes of cleanliness level. Each cleanroom comes under any of this depending on the operation going inside and cleanliness level required for the operation.
Temperature and relative humidity plays an important role in the cleanrooms. Each kind of operation going on inside a cleanroom requires different range of temperature and relative humidity levels. It depends on the kind of process going on inside a cleanroom, personnel comfort, machineries used for the process etc. A change in temperature and relative humidity will affect the process and its quality drastically. It might cause contamination also.
Air flow visualization studies are intended to demonstrate visual evidence of air flow direction. The test helps to identify stagnant areas within a clean room; these areas can further act as a channel or reservoir of contaminants. The test can also be used to demonstrate the effects on airflow caused by equipment. The predominant sources of contaminants within a clean room are people and machinery. Air flow patterns in the clean zones can be easily disturbed by the factors such as machine guarding, equipment design, inappropriate component specifications or necessary interventions. These factors can altogether contribute to a higher potential risk of air borne contamination.
This test is performed to determine the amount of time necessary for the cleanroom and its system to reach a steady state cleanliness level after a brief particle generation event within the clean space. An aerosol is introduced for recovery test. This test is important. If a particle generation is happened inside the cleanroom, recovery test will give us an idea about how much time it will take to return to the initial condition.
Noise level inside a cleanroom is very important. It directly affects personnel inside the cleanroom and their work. Continues exposure to high noise will lead to hearing loss. Also high noise will make disturbance in communication.
Illumination inside a cleanroom is vital in its operation. If the illumination is not good, it will lead affect the quality of production, discomfort to personnel, accidents during production etc.,. So the illumination level should be optimum inside the cleanroom or work space. It should not be too low or too high.
