Standards
What each standard governs, and what it asks of your room
Airvon designs, builds and tests to these. The accreditation itself is held by the facility, and the qualification package is what gets it there.
ISO 14644-1
Cleanroom classification by airborne particle count
What it requires
- Classification by maximum permitted airborne particle concentration at specified sizes
- A defined number of sampling locations, distributed across the room
- Classification stated for a defined occupancy state: as-built, at-rest or operational
- Periodic re-testing to demonstrate the room still meets its class
ISO 14644-1 classifies by particle count, not by air-change rate. Air changes are a means to the result rather than the requirement itself, which is why two rooms of the same class can carry different ACH figures and both be correct.
WHO-GMP
Good manufacturing practice for pharmaceutical premises
What it requires
- Premises laid out to prevent mix-ups and cross-contamination between products
- Air handling appropriate to the product and the process step
- Defined pressure differentials between areas of different cleanliness
- Qualification and documented evidence that facilities perform as intended
WHO-GMP governs the premises as part of the manufacturing quality system. The HVAC and cleanroom scope is one input to a much larger compliance picture, and the qualification documentation is the part that connects them.
What it requires
- Facilities of suitable size, construction and location for their operations
- Adequate ventilation, air filtration and control of pressure, microorganisms, dust, humidity and temperature
- Environmental monitoring appropriate to the operation
- Written procedures and records for facility qualification and maintenance
For a facility supplying the US market, the design and the record of how it was verified are both subject to inspection. What is being examined is not only the room but the evidence trail behind it.
NABH
Indian hospital accreditation standards
What it requires
- Air changes and filtration appropriate to operating theatres and critical care areas
- Defined pressure relationships between theatres, clean corridors and general areas
- Temperature and relative humidity maintained within stated bands
- Records demonstrating the above at commissioning and on an ongoing basis
NABH accreditation is held by the hospital. Our part is to design, build and document an air system that supports the assessment, and to provide the measured records the assessor asks for.
- Issued by
- Airvon
- Sheet
- Standards and compliance
- Entries
- 4 standards
Design practice
The other two names on our drawings
ASHRAE and ISHRAE are not compliance standards and nothing is certified against them. They are the design methodology the calculations follow, which is a different kind of claim and worth separating.
- ASHRAE
- Design practice for heating, ventilation, air conditioning and refrigeration, including load calculation methodology and ventilation rates.
- ISHRAE
- Indian design practice for HVAC, including conditions and load methodology appropriate to the Indian climate.