Spectro is well versed in handling third party Clean Room Validation and Monitoring

May 4, 2012 - PRLog -- A Cleanroom is a contamination-controlled environment and is extremely crucial for optimum functioning of many industries like electronics, semi-conductors, optical products, pharmaceutical products. Taking the particular case of pharmaceutical manufacturing processes, a Cleanroom is designed and its environment controlled to attain a highest level of clean environment so as to prevent microbial (bacterial and viral) and particulate matter contamination of drug products being handled in the Cleanroom.  To maintain the clean room performance, it should be checked or validated at specified regular intervals. The cGMP (Current Good Manufacturing Practice), as enforced by certain regulatory bodies like USFDA, WHO etc. has set certain rules & regulations on different aspects of checking and ensuring the uncontaminated status of the clean rooms. Pharmaceutical companies must demonstrate compliance with the regulations at every stage before a drug could be released to market. We, at Spectro, perform acceptance tests for installation of clean rooms in production facilities as well as important routine monitoring of viable and non-viable contaminations of your production facilities.
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SPECTRO offers you a broad range of environmental monitoring services for clean rooms and can also provide you with customized hygiene-monitoring programs that fulfill your needs.
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Clean room Validation Services of ‘SPECTRO’ include:
•   Viable and non-viable particle counting of air samples in manufacturing, packaging and testing sites
•   HEPA filter Leak Testing
•         Velocity Measurement
•         Airborne Particle Counts Monitoring
•         Air Changes Calculations
•   Microbial sampling and enumeration of surfaces
•   Cleaning validation studies
•   Disinfectant efficacy studies
•   Microbiological tests on individual process media (air, water and technical gases)
•   Determination of bacterial count in the air under all operating conditions
•   Particle measurement
•   Determination of Total Organic Carbon (TOC)
•   Media control such as humidity, particles, oil and organic residues in gases
•   Testing surfaces, consumables and primary packaging
•   Qualification of production facilities after installation, reconstruction and standstill, etc.
•   Confirmation of personal hygiene, determination of microbiological exposure on clothing and hands or production personnel.