Cleanroom validation – A Cleanroom is the fundamental starting point for controlling contamination. A Cleanroom can be defined as “a room in which air filtration, air distribution, utilities, materials of construction, and equipments are maintained in a controlled manner”. The international standard, ISO 14644-1 is the current international standard of defining Cleanroom contamination levels. Typically Cleanrooms are assigned a class depending upon its ability to meet an appropriate standard of air cleanliness classification. The Cleanroom standards apply to all types of Cleanrooms, whether they are for industrial applications like pharmaceuticals/drugs, highly sensitive semi-conductor manufacture or for sterile (aseptic) productions. To maintain the cleanroom 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 your cleanrooms. We perform acceptance tests for installation of cleanrooms in production facilities as well as important routine monitoring of viable and non-viable contaminations of your production facilities.
Modi offers you a broad range of environmental monitoring services for cleanrooms and can also provide you with customized hygiene-monitoring programs that fulfill your needs.
☸ 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
☸ Fume Exhaust System –Testing & Validation Services
☸ Compressed Air Testing Services