Clean Room Validation

Within highly regulated environments such as medical device and pharmaceutical industries, there is a requirement to provide an appropriate amount of assurance that critical processes can be performed within controlled conditions in order to produce a final product that is of eminent quality, reliable, and safe for the consumer.

Incepbio performs cleanroom HVAC validations as per ISO 14644-1:2,2,3(2015), EU GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) & NABH guidelines for all room classifications. We work with a range of clients from start-up labs to the world’s largest pharmaceutical and biotech companies.

We Serve

Pharmaceutical
Pharmaceutical
Hospital
Hospital
Semiconductor Industry
Semiconductor Industry

Clean room validation services we offer:

Air flow Test & ACPH Calculations
Air flow Test & ACPH Calculations
Filter Integrity test
Filter Integrity test
Non-Viable Particle Count Test
Non-Viable Particle Count Test
Recovery Test
Recovery Test
Air flow pattern simulation and visualizations test
Air flow pattern simulation and visualizations test
Air Pressure Balancing
Air Pressure Balancing
Temperature & RH Measurement
Temperature & RH Measurement
Light Intensity Measurement
Light Intensity Measurement
Sound Level Measurement
Sound Level Measurement
Microbiological/Viable particle count studies
Microbiological/Viable particle count studies
UV Light intensity test
UV Light intensity test

Clean Room Validation Workflow

01
Understanding User requirement
02
Surveying the site
03
Selection of appropriate instrument or equipment for validation
04
Determining the locations
05
Initiating validation activity
06
Downloading the accurate data
07
Summary & Report submission
08
Recommendations

Clientele