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Cleanroom Performance Adequacy Test Instruction
In the cleanroom; These are rooms that are purified from particles, residual gases and dust particles and all kinds of microorganisms by appropriate filtering ways, air flow rate/amount, pressure, temperature and humidity can be measured and within certain dimensions and can be controlled as required. It is also important to ensure the continuity of these conditions along with the provision of the conditions in the construction of these rooms. This is possible with the selection of suitable equipment, a traceable system and trained personnel. Areas included in the cleanroom class; It is used in the pharmaceutical industry, medical industry, microchip production facilities, defense industry, some food production facilities, operating rooms, intensive care units, TPN units and any environment that requires effective provision and protection of other controlled conditions such as these.
Periodic tests carried out after the construction of cleanrooms are just as important. For the tests performed, the test methods described in the relevant standards are used. In the evaluation of the results obtained, the guidance of the standards can be taken as a basis, as well as the needs of the customer are questioned. This is clearly stated in the standards.
The following tests are the tests carried out within the scope of cleanroom Performance Competence, and the relevant document contains details for the realization of these tests.
· Measurement of Air Flow, Air Flow Rate, Air Change Number and Air Uniformity
· Measurement of Pressure Differences
· HEPA and ULPA Filter Equipment Leak Test
Particle Counting and Classification of cleanroom Air Cleanliness by Particle Concentration
· Decontamination/Recovery Test
· Temperature and Humidity Measurement
Flow Visuality Test
A complete cleanroom Performance Competency study includes the reporting of the process. For this reason, Raw Data record forms and Protocols and Reports of the study should be created to transfer the results obtained, so that all data should be documented.
The cleanroom Performance Adequacy Test Instruction specifically addresses manufacturers who want to self-test their cleanroom, or Inspection Bodies that offer the process accredited. While preparing the cleanroom Performance Adequacy Test Instruction, it is important to make references to the acceptance criteria of other reference documents (standard, guide, etc.) instead of the acceptance criteria not included in the ISO 14644 standard.
cleanroom performance adequacy is of great importance for businesses. Because it helps to increase the functionality and efficiency of the business. cleanroom performance competence helps the business maintain the health and safety of its employees and helps the business provide quality service to its customers. It also helps the business operate in an environmentally friendly way, which can increase the business's sense of social responsibility.
You can access the cleanroom Performance Adequacy Test Instruction document by clicking the link below:
Prepared by: Alper Sarı, Technical Specialist of TURKAK ISO 17021