spectro introducing clean room validation service



March 29, 2013

Clean Room Technology have broad scope of applications in various Industries, is now very common for Pharmaceuticals, Nano biotechnology, Microelectronics, Hospitals, Food processing industries, Software, PCB manufacturing Industry and in Various Aseptic, Sterile, and Precision-based industries. There are various National and International Recommendations, Standards and Regulation which are in form of ISO 14644, ISO 14698 ( for Microbiological Sampling ), US FDA, FS 209, ASHRAE, ISHRAE, GMP, GLP and many more either accept or recommend the concept of Clean Room Technology fully or Partially as Discussed In ISO 14644. Various Other Industry Specific Standards Like USP (Pharmaceutical), Schedule M (Pharmaceutical India), NABH ( Hospitals ) ISA Recommendation for Server Rooms, Electronics, and Data Canters etc. also supports and throw light on concept of controlled, Modular, Contamination and Submicron Particulate Free Indoor environment. What are these Micro particles after all? Why should these be considered and how should these be monitored and controlled? These basic questions acted as Oxygen for the experiment and development of Clean Room Technology. The micro particles with ‘Aerodynamic Sizes’ of 0.001 microns to 100 microns, present in air in various shapes and sizes are mainly considered as contaminants. These air particles are usually characterized by their aerodynamic size diameters. Particles with aerodynamic diameters less than about 0.01 microns act like gases, and thus are not treated as particulate matters with any ULPA filters; while particles greater than 100 microns, due to their size and mass, are typically not released as an air emission.

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