Clean Room Validation
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HVAC Validaion
Thermal Mapping
Clean Room Validation
Calpoint performs HVAC validations as per ISO 14644, EU cGMP, US Federal Standard 209E, WHO, USFDA, TGA (Australia), European standards (EMEA), and MHRA (European Countries) guidelines for all room classifications.All test are performed with latest technology equipment with 21CFR compliance.
Cleanroom Validation/HVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards.
We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us.
Clean room validation typically involves a series of tests and measurements to assess the cleanliness of the environment, including air quality, particle counts, and microbial counts. These tests are conducted using specialized equipment, such as particle counters and microbiological samplers, and are carried out at various locations within the clean room.
Test Covered For Validation
- Air flow Test & ACPH Calculations
- Air Pressure Balancing
- Recovery Test
- NON -Viable Partical Count
- Filter Integrity Test
- Air Flow Patterne Test
