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Validation of HVAC System
Choksi Laboratories Ltd. offers HVAC System validation services for any type of Storage Area/Production/Other Area in market. These validation services help our clients comply with pharmaceutical (USP/EP), healthcare & food regulatory requirements as well as International Standard for HVAC Validation.
Principle in HVAC
Heating Ventilation and Air Conditioning (HVAC) systems control the environmental conditions in different industries, including pharmaceutical. These systems provide necessary environmental conditions for drug manufacturing in a pharma facility. They also help to eliminate contamination and hazardous foreign particles in the surrounding air of the manufacturing area.
The room in which the concentration of airborne particles is controlled, and which is
Constructed and used in a manner to minimize the introduction, generation, and retention of
particles inside the room, and in which other relevant parameters, e.g. temperature,
humidity, and pressure, are controlled as necessary.(ISO 14644-03).
It controls 3 types of contamination transfer
- Air born contamination
- Direct contamination by personal equipment etc.
- Contamination From Fludis like cleaning fludis ,Solution etc.
Validation is the process of establishing documentary evidence demonstrating that a
procedure, process, or activity carried out in testing and then production maintains the
desired level of compliance at all stages.
- Pharmaceutical.
- Hospital Industry.
- Food Industry.
- Cosmetic Manufacturing Plants.
- Automobile Industry.
- HVAC Contractors.
Validation Standards/Guidelines ISO 14644-3
Type of Tests
- Air Flow Velocity Measurement & ACPH Calculation
- HEPA Filter Integrity Test OR HEPA Filter Leakage Test
- Non-Viable Particle Count Test
- Air Flow Visualization Test / Air Flow Pattern Test / Smoke Test
- Recovery Time Test
- Pressure Balancing (Optional Test)
- Air Balancing (Optional Test)