ISO 14644 Class 8 Cleanroom Air Filter Requirements

Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
Those are just the measured micron sizes. The number of particles at those sizes defines the clean room classification. There is a lot that goes into the clean room particle count, not just the filter.
Is this for a clean room or for compressed air? For compressed air, you may want to check out the ISO 8573 family of standards.
 

prephil

Involved In Discussions
#3
Hi, thanks for your reply. Im a bit ignorant of clean room requirements. So we willbe building a machine for a pharma company that will be installed in a class 8 cleanroom. There will be pneumatic grippers used in the machine and therefore these will require a compressed air supply. Im wondering will a 5micron filter regulator be sufficient or will it need to be finer or does it not matter at all?
 

indubioush

Quite Involved in Discussions
#4
Typically, compressed air would not be class 8, but would be a lower class. I can't answer your question because there are too many factors to consider. I would discuss your issue with the manufacturer of the air compressor if that is possible (and if you are having the air compressor installed). You should set up your system to introduce as few particles as possible. Maybe someone else has additional insight.
 

AgnieszkaSz

Involved In Discussions
#5
First, you should aim at oil-free compressor, because oil mist is not acceptable for pharma. Typical tests for clean compressed air system involve gas chromatography (they compare peaks with air standard), moisture content and particle count. I doubt whether gas chromatography would be actual requirement for class 8 rooms, but moisture and particle count can be, and at each supply point.
 
Thread starter Similar threads Forum Replies Date
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
J ISO 14644-5 section C3 - ISO Class 7 question Other Medical Device Related Standards 4
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
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
A Construction of an ISO 8 Clean Room - ISO 14644-1 Manufacturing and Related Processes 2
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
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
N ISO 14644-1 Clean Room Occupancy State Validation Requirements Manufacturing and Related Processes 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
V Updated Clean Room Classification Table of ISO 14644 Other ISO and International Standards and European Regulations 2
L ISO 14644 Result Sheets for Particle monitoring and related monitoring? Other ISO and International Standards and European Regulations 2
R Standard on Clean room - Where can I buy ISO 14644-1 and ISO 14644-4 US Food and Drug Administration (FDA) 3
L Can anyone help me with ISO 14644? Other Medical Device Related Standards 17
I Non-sterile device - Rapid Test Kits - ISO 14644 Clean Room required? ISO 13485:2016 - Medical Device Quality Management Systems 12
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
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 8
Ron Rompen ISO 9001 Sanctioned Interpretations and FAQs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
Brizilla ISO 13485 for a Distributor ISO 13485:2016 - Medical Device Quality Management Systems 7
E Organisational Chart-ISO 17025 Laboratory ISO 17025 related Discussions 3
S Do ISO certs require an Apostille? ISO 13485:2016 - Medical Device Quality Management Systems 13
Q Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU) ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
Fjalar ISO 20417:2021: Technical Data (6.6.4 c) Other Medical Device Related Standards 0
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 49
L PFMEA for test procedures (ISO 14971) ISO 14971 - Medical Device Risk Management 5
J ISO 13485- 8.3.1 Non-conforming material high volume ISO 13485:2016 - Medical Device Quality Management Systems 4
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 2
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 0
R What are the new changes in EN ISO 11137-1:2015+A2:2019? Other Medical Device Related Standards 2
Y ISO 10993-14:2001 - Gel implants stored in glass syringes Other Medical Device Related Standards 1
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Sidney Vianna ISO 14001 News ISO 14001 Continual Improvement Survey ISO 14001:2015 Specific Discussions 0
Casana ISO 17025 - Contractor certification? IATF 16949 - Automotive Quality Systems Standard 5
B Sanctioned interpretation #10 - ISO 17025 IATF 16949 - Automotive Quality Systems Standard 2
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom