ISO-7 Cleanroom

Cleanrooms are classified according to the number and size of particles permitted per volume of air. ke "ISO-7" refers to the ISO 14644-1 Cleanroom Standards and denote the number of particles of size 0.5 µm or larger permitted per cubic meter of air. ISO-7 cleanroom classification would have <352,000 particles >05.micron/cubic meter and minimum of 60 air changes per hour.

Common Class ISO-7 cleanroom applications:

Pharmacy compounding cleanrooms – USP797/800
Semiconductor non photolithography (bonding, metal deposition, testing) cleanrooms
Pharmaceutical manufacturing cleanrooms (non-critical areas)
Aerospace manufacturing cleanrooms
Printed circuit board manufacturing cleanrooms
Medical device manufacturing cleanrooms
Nutraceutical cleanrooms
Precision manufacturing cleanrooms

Figure 1. Recirculating Air flow diagram for ISO-7 modular cleanroom

Typical ISO-7 Cleanrooms Utilize:

Cleanroom Gowning room /air locks
Cleanroom Product pass thru’s
Cleanroom Heat welded vinyl or epoxy floors
Cleanroom Air conditioning for temperature control
Unidades de filtro de ventilador HEPA
Sealed cleanroom lighting
Magnehelic gauge for room air pressure monitoring
Workers typically garb up in non particulating cleanroom bunny suits, booties and hoods.
Some applications use air showers to enter.
Sticky mats at entrance and exit
Banco de acero inoxidable común para cuartos limpios
Gown racks
Stainless steel - hand free sinks

Interior ISO-7 modular cleanroom, medical device cleanroom

Figure 2. ISO-7 modular cleanroom – medical device

ISO-7 Cleanroom Design Features (typical) hard-wall/modular design:

Negative pressure cleanroom plenum
Cleanroom Ceiling mounted HEPA fan filter units
Cleanroom low wall air returns for laminar air flow
Cleanable modular walls

softwall cleanroom, cleanroom clear vinyl

Figure 3. Softwall cleanroom

Softwall Class ISO-7 cleanroom option:

Clear cleanroom flexible vinyl curtains
Cleanroom clear vinyl strip curtain for entrance
Painted steel anodized aluminum cleanroom frame
Cleanroom ceiling mounted HEPA FFU’s
Cleanroom ceiling mounted lighting
Casters for small size cleanrooms

Softwall cleanroom ISO-7 Limitations:

No temperature control
No measurable positive pressure
Cannot clean walls

ISO-7 Softwall Cleanroom Typical Applications:

Inside ISO-8 hard-wall cleanroom
Inside warehouse
Weighing product during packaging
Inspection stations
Temporary cleanroom

ISO 14644-1 Estándares de salas limpias | Clasificaciones de salas limpias
Clase	Máximo de Partículas/ft³						ISO Equivalente
Clase	>0.1 um	>0.2 um	>0.3 um	>0.5 um	>1 um	>5 um	ISO Equivalente
ISO 1	10	2
ISO 2	100	24	10	4
ISO 3	1,000	237	102	35	8		Class 1
ISO 4	10,000	2,370	1,020	352	83		Class 10
ISO 5	100,000	23,700	10,200	3,520	832	29	Class 100
ISO 6	1,000,000	237,000	102,000	35,200	8,320	293	Class 1,000
ISO 7				352,000	83,200	2,930	Class 10,000
ISO 8				3,520,000	832,000	29,300	Class 100,000
ISO 9				35,200,000	8,320,000	293,000	Room Air

Figure 4. ISO cleanroom classification table

FAQs About ISO-7 Cleanrooms

Q: What is the Difference Between an ISO-7 and an ISO-6 Cleanroom?

R: An ISO-7 cleanroom is allowed a maximum of 2,930 particles/m3 greater than 5 microns and less than 352,000 particles/m3 greater than 0.3 um. An ISO-7 cleanroom must have at least 60 air changes per hour. An ISO-6 cleanroom is allowed a maximum of 293 particles/m3 greater than 5 micron and less than 35,200 particles/m3 greater than 0.3 um. An ISO-6 cleanroom must have at least 180 air changes per hour. An ISO-7 cleanroom classification is closest to Class 10,000 Fed Std 209E . An ISO-6 cleanroom classification is closest to Class 1000 Fed Std 209E.

Q: What is an ISO-8 Cleanroom?

R: An ISO-8 cleanroom is allowed a maximum of 29,300 particles/m3 great than 5 microns and less than 3,520,000 particles/m3 great than 0.3 microns. An ISO-8 cleanroom must have at least 20 air changes per hour. An ISO-8 cleanroom classification is closest to Class 100,000 cleanroom classification.

Q: What Does the Term ISO-4 Cleanroom Mean?

R: An ISO-4 cleanroom is allowed no particles greater than 5 microns, less than 352 particles/m3 greater than 0.5 um and less than 1,020 particles/m3 great than 0.3 microns. ISO-4 cleanrooms have between 500 to 600 air changes per hour. An ISO-4 cleanroom classification is closest to class 10. ISO-4 cleanrooms typically use ULPA filters and have 100% ULPA filter ceiling coverage.

Q: ¿Cuáles son los requisitos de los cuartos limpios?

R: Cleanroom requirements typically refer to cleanroom classification, length, width, height, wall type, air flow of either recirculating or one pass, temperature, humidity, and room pressure. Other requirement can be related to exhaust, chemical resistance, biohazard, electrical discharge, or light frequency.

Q: What is an ISO-5 Cleanroom?

R: An ISO-5 cleanroom is allowed 29 particles/m3 greater than 5 microns, less than 3,520 particles/m3 greater than 0.5 um and less than 10,200 particles/m3 great than 0.3 microns. An ISO-5 cleanroom must have more than 300 air changes per hour and typically has at least 70% HEPA filter ceiling coverage. An ISO-5 cleanroom classification is closest to class 100.

Q: ¿Cuál de los cuartos limpios es el de mayor categoría?

R: Se considera que la ISO-9 es la más elevada de las clasificaciones de cuartos limpios ISO. El recuento de partículas corresponde a este cuarto y es aproximadamente 10 veces más sucio que el ISO-8. La clase 100k es la clasificación más alta de la FED Std 209E para cuartos limpios. La clase 100k es la más cercana a la ISO-8.

Q: ¿Cuáles son las clases de cuartos limpios?

R: The Fed Std. 209E cleanroom classifications are class 100,000 (class 100k) , class 10000 (class 10k), class 1000 and class 100. The ISO cleanroom classifications are ISO-5, ISO-6, ISO-7 and ISO-8.

Q: What is an ISO-7 Cleanroom?

R: An ISO-7 cleanroom is allowed a maximum of 2,930 particles/m3 greater than 5 microns and less than 352,000 particles/m3 greater than 0.5 um. An ISO-7 cleanroom must have at least 60 air changes per hour, have ceiling mounted HEPA fan filter units and low all air returns.

Q: ¿Qué clase de ISO es un cuarto limpio?

R: La clase ISO de cuarto limpio se define por el número de partículas por metro cúbico y el número de cambios de aire por hora con aire filtrado por el filtro hepa.

Q: ¿Cómo se clasifican los cuartos limpios?

R: Cleanrooms are classified by particle count and HEPA filtered air changes per hour. Particle counts range from 0 to 29,300 particles/m3 greater than 5 um, and air changes from 20 to 300 air changes per hour. For example, a ISO-8 cleanroom is allowed 29,300 particles/m3 greater than 5 microns, 3,520,000 particles/m3 greater than 0.3 microns and minimum 20 air changes per hour. Fed Std 209E cleanroom classifications are also by particle count and HEPA filtered air changes per hour. However, the particle counts are by feet3.