All About Clean Rooms

Cleanroom is an isolated environment where products are manufactured. It is a room in which the concentration of airborne particles or micro-organisms is controlled to specific limits.

Contamination control is the biggest task to be taken care of in a clean room.  They are ubiquitous and they come from people, process, facilities and equipment. They must be continually removed from air. The level to which these particles need to be removed depends upon the standards required for that particular industry. Strict rules and protocols are followed to prevent contamination of the product.

Contamination is taken care of by controlling air flow rates and direction, pressure, temperature, humidity and specialized filtration.

Clean rooms are designed and manufactured using strict protocol and methods. They are frequently needed in industry of electronics, pharmaceutical, biopharmaceutical, medical device industries and other critical manufacturing environments.

Contamination could cost you an arm and a leg.  Product manufactured in that period of time (whole batch) just goes to waste.

For the same, different industry has a different quality of cleanliness. There are different grades of clean rooms. A Class 100 cleanroom is designed to never allow more than 100 particles (0.5 microns or larger) per cubic foot of air. Class 1000 and Class 10,000 clean rooms are designed to limit particles to 1000 and 10,000 respectively.

By the end of the day, after a clean room is done, the next big thing remains is to maintain a clean room with all the given standards and to get superior products.

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HVAX: Serve the purpose of Clean Rooms

HVAX ranges from full turn-key design/build to plan & spec construction. It’s 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 Client’s 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.

Profile

HVAX is a young and exuberant company comprising a group of people acting with a common purpose ofproviding users and industry with an across-the-board method of providing minimum requirements for services.These requirements can cover safety, performance, reliability, so that both the supplier and user understand what to expect from the product. Specializing in various industry segments like Pharma, Biotech, Hospitals,Engineering etc., across the country and overseas, HVAX can claim to have arrived.
With a holistic team of Managers, Engineers, Technicians – specially trained to conceptualize, design, constructand maintain clean rooms for different applications, HVAX aims to be the leading innovator in providing turnkeysolutions for clean rooms. Where innovation is the need of the hour, HVAX pursues excellence such that they canbe the trendsetter for the industry thereby setting a lineage for others to follow.
Our Promoter & Directors have years of ancillary experience which aid the organization to be more accurateand add value to the organization. They are highly experienced professionals familiar with all set standards for clean room. HVAX also offers validation/testing as per these standards, thus echoing the term of flawless execution. The systematic documents provided by the company for its services enables its clientele to obtain various international approvals like WHO, USFDA, UKMHRA etc.