Incepbio Group follows quality management system (QMS) which includes standard operating procedures (SOPs), processes and data management, customer feedback and man-material movement with training and traceability records to ensure that we are holding ourselves to the highest level of quality.
Incepbio Group follow regulatory guidelines such as ISO 14644, cGMP, cGLP, cGxP, cGDP, GAMP 5, 21 CFR Part 11, 21 CFR Part 210 as well as 21 CFR Part 211.
The revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
The ISO14644-1& 2 provides total validation approach related to Cleanrooms and associated controlled environments. ISO 14644-1 annexure B provides test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones.
ISO 14644-3 is consisting
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Particle Count Test
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Air Velocity Measurement
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Filter Integrity test using Photometer and smoke generator
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Air Flow Visualization test
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Light Intensity test
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Recovery Test
Advance Facility Testing Services
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Differential Pressure balancing
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Air Balancing Test
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AHU Hydro Test
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Duct Cleaning Test
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Duct Leakage Test
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Segregation Test
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Containment Test
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