ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Class 7

SGquality

Quite Involved in Discussions
#1
I have a question on the ISO Class 7 clean rooms.

When do perform particle counts of the clean rooms, it complies as per the requirements of ISO Class 7 (10,000) consistently as defined per ISO 14644 standard.

Is this requirement okay to label the clean room as per ISO Class 7 ? My question is specifically because when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area.

Is this acceptable ? Or is there anything that needs to be carried out seperately per ISO Class 7 ?

Thanks in advance

:thanx:
 
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Stijloor

Leader
Super Moderator
#2
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

I have a question on the ISO Class 7 clean rooms.

When do perform particle counts of the clean rooms, it complies as per the requirements of ISO Class 7 (10,000) consistently as defined per ISO 14644 standard.

Is this requirement okay to label the clean room as per ISO Class 7 ? My question is specifically because when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area.

Is this acceptable ? Or is there anything that needs to be carried out separately per ISO Class 7 ?

Thanks in advance

:thanx:
Can someone help?

Thank you very much!!

Stijloor.
 

harry

Trusted Information Resource
#3
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

...................when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area. .........................
Amazing! Unless somebody replaced the filters. Otherwise, my first suspicion will be on how the particles counts were measured. Did you get an independent lab to verify it?
 

somashekar

Leader
Admin
#4
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

I have a question on the ISO Class 7 clean rooms.

When do perform particle counts of the clean rooms, it complies as per the requirements of ISO Class 7 (10,000) consistently as defined per ISO 14644 standard.

Is this requirement okay to label the clean room as per ISO Class 7 ? My question is specifically because when we built the clean room, it was to comply per ISO Class 8 clean rooms (100,000) but since the particle counts are met per Class 7 areas, our Management label it as ISO Class 7 area.

Is this acceptable ? Or is there anything that needs to be carried out seperately per ISO Class 7 ?

Thanks in advance

:thanx:
The other way could happen, but from what you say, I would take an other validation run with workload situation to reassess if indeed it meets the class 7 consistently.
To maintain class 7 the man and material control could be a lot different, and you must consider this.
If I were you, I would apply caution and wait for repeated validation over time.
 
K

Kwesifaiola

#5
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Hello
Thanks for provide me information about ISO standards class because this will help me.
Thanks
Regards
Kwesifaiola
 

SGquality

Quite Involved in Discussions
#6
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Amazing! Unless somebody replaced the filters. Otherwise, my first suspicion will be on how the particles counts were measured. Did you get an independent lab to verify it?
Yes harry - all the particulates are measured by an external laboratory and there is no doubt on measurements. In fact the limits for particulate counts are so huge that most ISO Class 8 clean rooms areas would be acceptable at the higher classification too as the particle counts are low.

The other way could happen, but from what you say, I would take an other validation run with workload situation to reassess if indeed it meets the class 7 consistently.
To maintain class 7 the man and material control could be a lot different, and you must consider this.
If I were you, I would apply caution and wait for repeated validation over time.
Thanks somashekhar. That was my precise question. What would be different in these 2 areas ?
 

somashekar

Leader
Admin
#8
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Not knowing your product that you handle in the clean room, it is not too easy to suggest. However the selction of the clean room class and the processes performed thereafter as against requirement is a matter of risk assessment and supported by valid product testing.
Calling out your clean room as Class 7 and :applause: :applause: yourself is far less important than claiming meeting or exceeding class 8 and supporting the same with periodic validation and product test reports meeting to requirements.
 

SGquality

Quite Involved in Discussions
#9
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Not knowing your product that you handle in the clean room, it is not too easy to suggest. However the selction of the clean room class and the processes performed thereafter as against requirement is a matter of risk assessment and supported by valid product testing.
Calling out your clean room as Class 7 and :applause: :applause: yourself is far less important than claiming meeting or exceeding class 8 and supporting the same with periodic validation and product test reports meeting to requirements.
Thanks Somashekhar.

I would like all experts to comment on the engineering aspects of the Clean Room and not considering the product.

Conceptually, would a clean room be designated entirely based on particle counts ? If it was a Class 5 clean room, there are lots of things required like gowning / degowning area, wearing sterile garments etc. Like these, would there be any additional requirements between Class 7 and 8 ?

Sorry for taking this long :)
 
Last edited by a moderator:
#10
Re: ISO Class 7 Clean Rooms - built as Class 8 but complies with requirements of Clas

Thanks Somashekhar.

I would like all experts to comment on the engineering aspects of the Clean Room and not considering the product.

Conceptually, would a clean room be designated entirely based on particle counts ? If it was a Class 5 clean room, there are lots of things required like gowning / degowning area, wearing sterile garments etc. Like these, would there be any additional requirements between Class 7 and 8 ?

Sorry for taking this long :)
Yes.
A class 7 clean room is 10 fold better than class 8 as you can see from the ISO14644-1.
So the gowning, materials selection and cleanroom behaviour must be more better to always maintain a class 7 as compared to class 8.
Some details below for particle details.

Where do particles come from?
Clean Room Air
The task of the Clean Room filter is to ventilate the atmosphere with microbial and particulate free air. They create a positive pressure, so that any air-borne contaminants present are from within the room.
The source of micro-organisms is from people.
The source of particulates are from people and processes.

Microbes
Microbes are dispersed from skin cells, and a human body sheds the outermost layer of skin every 24 hours.

1 BILLION SKIN FLAKES EVERY 24 HOURS.

A skin flake is typically 33 microns - 44 microns. They break down to typically 20µ (micron) but 7-10% are less than 10µ (micron). The equivalent diameter of bacteria carrying particles is 12-14µ (micron). These settle by gravity at 0.37 meters per second.

12-14µ (micron) size particles will settle in wounds of hospital patients and aseptically filled containers in pharmaceutical applications by gravity.

Inert Particles

Particles from people are dispersed:

From their skin

From their normal outdoor clothing

From their Clean Room clothing (both through it and from the surface).

The mixture of skin flakes and fabric fibers fragment into smaller pieces, so that the total number of particles is:

10 BILLION EVERY 24 HOURS. This figure is dependent on activity rate, work activity, more particles.

Demonstrations have indicated that typically this means:

1 MILLION PARTICLES EQUAL TO OR GREATER THAN 0.5 MICRONS ARE DISPERSED EVERY MINUTE.
They disperse into the air from exposed skin, through the apparel fabric and also out through the neck, waist, trouser opening and wrists.

(Courtesy http://www.mvent.com.ph/references/cleanroom.htm)
 
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