Clean rooms require various physical tests to validate or certify the cleanroom to meet the accredited cleanliness standards that ensure that the cleanroom operation meets all of the following requirements:
Quality.
Clean rooms are closed environments used to manufacture items that require low levels of environmental pollutants such as aerosol particles, dust, airborne microorganisms, and chemical gases. Mainly used in biotechnology, high tech, healthcare, and manufacturing. Suspended particulate matter concentrations are minimized in a controlled environment. Regular testing is essential to prove that your cleanroom meets specified requirements and to ensure that your facility operates within operational limits while maintaining the reliability of your quality assurance program. Clean Room Certifications are necessary in the industry.
What is a cleanroom test?
Cleanroom Certification that meets cleanliness standards requires regular certification, monitoring, periodic verification, or recertification. Total Clean Air specializes in licensed facility clean room certification. Clean rooms are located in various facilities such as aerospace manufacturing, aseptic packaging equipment, aseptic manufacturing area of hospitals, pharmaceutical manufacturing, communication equipment, biotechnology research, microfabrication equipment, vaccine manufacturing plant, etc.
Clean rooms have specific requirements based on the standards of the industry and the country in which the cleanroom is installed. Clean rooms related to medical products sold market require a license from the Pharmaceutical and Healthcare Products Regulatory Authority. Cleanroom Testing and Certification are essential in biotechnology.
Preparation for clean room certification
From a structural perspective, most clean rooms are similar. There are airtight walls, return vents, windows, and doors. They all recalculate air and remove pollutants. Therefore, room airflow and air exchange rates are essential for clean room certification.
Production must be analyzed during the process development stage to create the optimum clean room environment for the product. Make sure you have the proper pollution controls necessary to produce a quality product.
It also needs to supply clean air through ULPA/HEPA filter for low pollution environment, controlled access environment, the correct number of air exchanges per hour, and proper amount of negative or positive air pressure. There is. Some products have other specific conditions such as relative humidity, temperature control, latex, or silicone free.
Prior to large-scale operation, a verification master plan should be completed. Must be included
Strategy: A design phase that defines the goals and results to be achieved.
Protocol: Specify how to achieve the objective and cover the implementation stage.
Assessment: Describes the test methods and tools used to analyze clean room performance.
Which ISO class is the cleanest?
According to the ISO 14644-1 classification system, the highest clean room standard is Class 1 or FS209E and the lowest is the same as normal ambient air, Class 1,000,000 or ISO 9. Clean room classifications are classified according to the number and size of particles allowed per cubic meter (cm). For example, if a clean room needs to meet ISO Class 6 requirements, the clean room space cannot contain particles with a cfm greater than 0.5 microns and a cfm greater than 35,200. A clean environment means a low ISO class rating.