Guest Column

Why HVAC/Clean Room Validation is Critical


HVAC or clean room validation is critical for controlled environment or clean room applications due to its vital impact on internal process integrity, processes taking place in controlled environments and clean rooms are related to human health, research and development, delicate manufacturing processes and more!

A clean room is a room inside which the number grouping of airborne particles is controlled and ordered, and which is designed, constructed and certified in a way to control the presentation, age, and maintenance of particles inside the room, while different components may should be controlled, for example, temperature, pressure, electrostatic release, vibration, lighting and moistness.

A controlled situation, or a basic domain, alludes to a space with controlled temperature, weight, and mugginess without alluding to molecule sullying. Essentially, a clean room is a more tough adaptation of a controlled domain. Directing a progression of tests to qualify if a controlled domain is acting as per the procedure necessities and the pertinent administrative rules.

Validation Standards
• EU-GMP Annex-1
• Schedule M (India)
• ISO-14644-1, 2, 3.

HVAC/Cleanroom Validation Tests
• Filter leak test/filter integrity test (PAO Test)
• Airflow pattern
• Room air change per hour (ACH) / fresh air determination
• Temperature and humidity uniformity test
• Airflow velocity and air changes per hour
• Non-viable particle count / particles per volume
• Room air change per hour (ACH) / fresh air determination
• Room pressurisation test
• Recovery.

Validation of Units in Laboratories
• Bio-safety cabinet
• Laminar airflow unit
• Reverse laminar airflow unit
• Dynamic pass box.

Biosafety Cabinet Validation Tests
• Downflow velocity test
• Inflow velocity test
• Filter leak test/filter integrity test (PAO Test)
• Non-viable particle count
• Airflow pattern
• Light/Lux test.
• Noise level test.

Indoor Air Quality (IAQ) of a social insurance office includes an assortment of elements, for example, warm (temperature and relative moistness) conditions, nearness of substance parts and contaminants to the outside air quality. IAQ is indispensable comparable to the earth inside emergency clinics, nursing homes and other human services offices.

Helpless emergency clinic IAQ may cause flare-ups of building-related ailment, for example, migraines, weariness, eye, and skin disturbances, and different side effects. The pre-essential for any medical clinic office is to accommodate and guarantee a decent IAQ to protect patients, nursing staff and guests from the perils of word related ailments and nosocomial or emergency clinic obtained contaminations (HAI).

As per the World Health Organization, at some random time, over 1.4 million individuals over the globe experience the ill effects of a nosocomial or HAI. HAIs represent 2 million cases and around 80,000 passing per year. Understanding the prosperity of its patients and labourers and shielding their wellbeing involves most extreme significance to human services offices.

Nosocomial diseases are a significant danger to the patients’ security in any medicinal services office. Be that as it may, the predominance is higher in serious consideration units (ICUs) than in different zones of the medical clinic. This expanded pervasiveness of nosocomial contamination not just impacts the mortality and dreariness example of ICU yet in addition represents a noteworthy money related weight to the patient and society.

Further to this, a recent report by the International Society of the Built Environment of indoor and open air quality in emergency clinics in India uncovered the includes of microbes higher in ICUs and wards to be specific the orthopaedic ward, neonatal ward, dialysis ward and post-usable ward past the suggested levels.

The minor nearness of growths in emergency clinic air involved incredible worry the greatest number of spores can be delivered, prompting a frequency of HAIs and word related diseases. Important is the finding that the high checks were impacted by the action of ventilation gave.

The careful OT condition incorporates pre-operational rooms, recuperation rooms, tidy up extra spaces for careful instruments, confined temporary territories outside of the working rooms and the working rooms themselves. Other unique regions where obtrusive methods happen, for example, obstetrical suites, additionally are remembered for this condition.

Air flexibly to the careful condition is a fundamental piece of disease control. Wind current into the careful suite and evacuation of air through the fumes vents serve to weaken airborne microorganism focus. The expulsion of airborne microorganisms in medical procedure is significantly more exacting contrasted with the typical epidemiological safety measures since entry point has occurred on the patient, presenting open tissue to contaminants.

Significant in air volume to the careful suite is keeping up a positive weight in the working room. An anesthetising area ought to have a somewhat higher weight than abutting rooms and halls with the goal that invasion of tainted air will be disposed of. The positive pressurisation of the working room can be cultivated by providing more air to the area than depleting from it.

It is essential to take note of that airborne microscopic organisms in a working room may not be killed even by giving “microorganisms free” air from the air handlers top to down in a Laminar example which helps in wiping out the air borne microbes and encourages the specialist to work in contamination free careful site.

AHUs condition and circulate air inside a structure. They take new encompassing air from outside, clean it, heat it or cool it, possibly humidify it and afterward drive it through some ventilation work around to the planned territories inside a structure. Most units will have an extra conduit race to then draw the utilised, messy ventilate of the rooms, back to the AHU, where a fan will release it back to the environment. A portion of this arrival air may be recycled once more into the outside air flexibly to spare vitality.

Medical clinics are the foundation of human services conveyance framework in India; this again features keeping up a solid IAQ and requests the prompt consideration of emergency clinic specialists towards taking the important measures to keep up a sound and sound environment for the patients, social insurance labourers and others.

Air handling care of in an assembling processing plant where uncovered food items are available is altogether different from air taking care of in some other business or private condition. The air in these uncovered food creation situations must be controlled by boundaries decided through a hazard appraisal.

When the fundamental controls are resolved, the AHUs and related ventilation work can be planned, kept up, and cleaned in the most fitting approach to accomplish the ideal control. At last, check exercises will guarantee that the controls are kept up to the guidelines set by the manufacturing plant partners.

It will concentrate on key sterile assessment purposes of an air-taking care of unit (AHU) and the related ventilation work providing air to rooms where uncovered food items are prepared. These key focuses incorporate hazard evaluation and check, clean plan of AHUs and the related ventilation work, and a few significant sanitation and quality boundaries to consider for the air provided to these rooms. Not examined in this article are the designing parts of measuring, particulars, and limits of AHUs, roof mounted room refrigeration units, the preventive support of AHUs past cleaning and channel changes, AHUs utilised in non-exposed food item handling zones, air utilised for item movement, or compacted air age and conveyance frameworks.

Approval of HVAC or clean room is a fundamental liable to give recorded proof about the precision of results delivered by it. The different boundary to be assessed for HVAC approvals are light intensity test, air flow pattern test, sound level measurement, particle count test, recovery test, HEPA filter integrity test, air velocity test, clean room validation/HVAC validation is a vital segment in pharmaceutical, biotechnology, food preparing, hospitals, aerospace, automotive and semiconductor office functionality.

The next thing you want to do is to appoint an established, knowledgeable, and accredited calibration service provider to validate your HVAC and clean room validation requirements. Godrej Calibration Services is the business vertical of Godrej & Boyce Mfg. Co. Ltd, they have been providing the service from more than two decades with customer-centric approach and end-to-end customised solution.
The article explains why it is essential to conduct a series of tests to qualify if a controlled environment is performing in accordance with the process requirements and the applicable regulatory guidelines.

Authored by

Parameswari Kennedy, Head – Godrej Calibration Services

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