HVAX: Serve the purpose of Clean Rooms

HVAX ranges from full turn-key design/build to plan & spec construction. Its a potential manufacturer of pre-engineered, pre-fabricated modular partitions/panels and doors for building infrastructure. Recently we have also shifted our focus into manufacturing of economical internal panels for non-pharma companies. Company also designs, fabricates, integrates, installs and services highly technical custom built Isolation/Containment Systems for pharmaceutical and biotech industry. Design Engineering & detailing We are committed to provide total solutions in the areas of Clean room equipments. We are also involved in refrigeration facility design, execution and qualify to serve quality conscious clients who desire to have correctly optimized facilities. These activities are carried out and coordinated by a team of professionals assisted by a group of associates, who have a wide-range of exposure in various aspects of Pharmaceutical Operations, Facility Design and Project Execution. Parameters for designing clean room: Air leaks through the walls around windows, piping etc. Air filters leaks in gasket and in the filters itself. Filtration efficiency of different filters. Fire proofing of material construction. Wearing resistances of surfaces. Air movement in the clean room. Regulatory Consent effectiveness and actual audit Concept development, feasibility study and front-end engineering. Process engineering and material flow control. Clean room facility as Per USFDA/WHO/UKMHRA Non-Clean Utilities like Potable Water, Plant Steam, Water Pre-Treatment Systems, Non-lubricated CA systems etc. INSTALLATION VALIDATION AND QUALIFICATION Validation and Qualification is the process of proving and documenting that the system performs as per the design specification and the Clients User Requirement Specification (URS).

ECS contractor entailed the following aspects: Air balancing Room air change rate calculations Room pressurization measurements Filter integrity (DOP) testing of HEPA filters Room particle count testing Control system software functionality tests Instrument calibrations Room temperature monitoring Room relative humidity monitoring Maintenance procedures The Operational Qualification process verified and documented that the systems operated within the required limits and tolerances and that the systems complied with the design requirements.

PERFORMANCE AUDIT: General specification and compliance check. HEPA filter leak test Factory ducting post welding leak test Room differential pressure test verification Particle test for cleanliness Air pattern smoke test Light intensity test Noise test Air velocity test Air temperature and RH tests Room pressure gradient including the system capability to avoid decay of negative pressure. All the conditions, class of cleanliness, air pressure gradients, temperature and RH and other parameter shall be ensured during the operation of the laboratory.