ISO 14644-1 Clean Room Occupancy State Validation Requirements

N

Nyeli

#1
According to revised version of ISO 14644-1, there is a revised statement which is as follows:

Occupancy state(s)
The air cleanliness class by particle concentration of air in a cleanroom or clean zone shall be defined in one or more of three occupancy states, viz. “as-built,” “at-rest” or “operational”


Does this mean, even the newly built clean room does not need to be validated in three state? only validating in one occupancy state is enough? Any kind of help will be appreciated. Thanks.
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
Howdy Nyeli,

Do not confuse "defined" with "Validated". And certainly do not confuse either of this with "Acceptable" or "Fit for Use".

I set out to build a clean room...I must first define the level of cleanliness to achieve. Let us say Class 1000 (~ISO6)...that is not a complete definition of the goal...I also need to know how the room is used, and whether the room is currently in use during the measurement...or ever has been.

In most clean rooms, the dirtiest thing is the people in it.
If there are no people in it, it is easier to have a cleaner room.

Class 1000 'as built' means that it has never been used and had human traffic doing the intended work...it is just as brand new. This is the cleanest the room will likely ever be.

It is a good measure for paying the guy who built the room...it is the best that the room is likely capable of.

Class 1000 'at rest' means that people have done normal daily use in the room and done the intended work that the room was built for...but they are not doing it now during my test. There has been time for all of the human dirt, and process particulate to be purged from the room. It isn't as clean as brand new...but usually it is cleaner than when people are in it moving around doing their work.
This is often a measurement used to make sure ventilation systems and filters are working properly...it is what the room is capable of now that you've been using it.

Class 1000 'in operation' or 'operational' means that you are measuring the air quality during the normal course of the day while the room is occupied with people doing things and moving around...this is usually the dirtiest time since the people provide most of the airborne particulate, and stir up particulate from surfaces.

This is a measurement of what you and the parts you are making actually experience. This is the number most customers care about. Every 'validation' I have ever done for a customer has been mandated to be in 'operational' state.

For verifying that a room is 'clean enough' or 'meets the standards for the process'...most everyone I know will go only by the "operational" test data.
The parts that you need to keep clean are typically exposed to the air during operations, not when 'at rest'.

HTH
 
N

Nyeli

#3
Thank you so much Ninja for your time. I'm still wondering where in the guidelines or requirements say it clearly that we need to validate 'in operation' state? Should I say "No" if somebody wants to validate only on "At Rest" state. Thank you.
 

Ninja

Looking for Reality
Trusted Information Resource
#4
I don't have a direct answer to your question.

The standard is just that...a standard. There is guidance to know the difference between the three states, and tag your measurement to the state so that the measured number is not misleading...makes sense.

"Requirements" (presupposing that you are maintaining a cleanroom to achieve a purpose)...would come from the purpose. In most cases (in my experience)...that purpose is satisfying a customer whether by meeting a stated requirement or providing an in spec part with acceptable yield (profit).

What purpose are you trying to achieve?
What you should do next (the plan) will derive from that.
If your purpose is just to follow the standard, it looks like you're already done.
 
Thread starter Similar threads Forum Replies Date
A Construction of an ISO 8 Clean Room - ISO 14644-1 Manufacturing and Related Processes 2
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
V Not using gloves in Clean Room Class 8 (ISO 14644) Manufacturing and Related Processes 21
L ISO 14644 Class 7 Clean Room Requirements Training Presentation Training - Internal, External, Online and Distance Learning 2
V Updated Clean Room Classification Table of ISO 14644 Other ISO and International Standards and European Regulations 2
J ISO 14644 - Monitoring Clean Room Particulates (Class 8 Cleanroom) Other ISO and International Standards and European Regulations 4
S The requirements of an ISO 14644 Class 8 Clean Room Manufacturing and Related Processes 1
R Standard on Clean room - Where can I buy ISO 14644-1 and ISO 14644-4 US Food and Drug Administration (FDA) 3
I Non-sterile device - Rapid Test Kits - ISO 14644 Clean Room required? ISO 13485:2016 - Medical Device Quality Management Systems 12
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Ajit Basrur Why is ISO 14644-3:2019 not approved by US? Other Medical Device Related Standards 1
O Which part of ISO 14644 describe how can I classify cleanrooms between them? Other ISO and International Standards and European Regulations 0
M ISO 14644 Airborne Particle Count Testing Requirements Miscellaneous Environmental Standards and EMS Related Discussions 6
S Cleanrooms - Particle Measuring - ISO 14644 Other Medical Device and Orthopedic Related Topics 3
M ISO 14644 - Cleanrooms and associated controlled environments -Recovery Test Other ISO and International Standards and European Regulations 0
A Is ISO 14644 harmonized for US? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A ISO 14644 training in Austria, Germany and Switzerland ISO 13485:2016 - Medical Device Quality Management Systems 2
S Why is Microbiological (viable) monitoring not part of ISO 14644 ? Manufacturing and Related Processes 5
W ISO 14644 Cleanroom Validation - "Operational" Other Medical Device Related Standards 3
R ISO 14644-1 maximum particulate concentration limits concern Other ISO and International Standards and European Regulations 2
J ISO 14644-5 section C3 - ISO Class 7 question Other Medical Device Related Standards 4
L ISO 14644 Result Sheets for Particle monitoring and related monitoring? Other ISO and International Standards and European Regulations 2
L Can anyone help me with ISO 14644? Other Medical Device Related Standards 17
ISOsandy ISO 14644-3 - Testing Air for Particle Counts Other ISO and International Standards and European Regulations 10
I Building a new cleanroom - ISO 14644-3 or ISO 14644-4 ISO 13485:2016 - Medical Device Quality Management Systems 4
Marc Federal Standard 209E Replaced by ISO 14644 Various Other Specifications, Standards, and related Requirements 1
A ISO 14644 - Contamination Control Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
S Which ISO Standards to Purchase - EN ISO and/or ISO Other Medical Device Related Standards 1
A ISO Clause 4.1/4.2 & 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 27
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
D Management reviews ISO 17025 ISO 17025 related Discussions 3
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13

Similar threads

Top Bottom