Iso 6 Cleanroom Requirements
Cleanroom Classifications and their Requirements
Sterility is key when creating items sensitive to contamination such as medical materials and electronic parts. The delicate nature of work that takes place in cleanrooms requires the utmost control of conditions. Cleanroom classifications allow for the discreet categorization of each level.
What are Cleanroom Classifications?
Cleanroom classifications are dictated by the number of particles per cubic meter. Each classification assigned by the ISO states the acceptable parameters for particles per cubic meter.
ISO cleanroom classifications range from ISO 1 to ISO 9. ISO 1 is the highest standard while ISO 9 is the lowest.
What are the Cleanroom Classification Requirements?
ISO cleanroom classification has strict requirements that ensure the cleanroom products such as injection molding for electronics and medical supplies.
ISO1-ISO3 changes air with UPLA filters 500-750 times per hour while others vary with HEPA filters.
ISO 1
Allows no more than 2 PTCL at 0.3 microns per m3.100% UPA ceiling coverage and raised floors prevent particles from landing on surfaces.
ISO 2
Requires less than 11 PTCL greater than 0.3 microns per m3. 100% ULPA ceiling coverage and raised floors are common to this classification as well.
ISO 3
Allows up to 102 PTCL greater than 0.3 microns, and only 8 PTCL of 1.0 microns per m3. This ISO cleanroom classification also has raised floors and 100% UPLA ceiling coverage.
ISO 4
Permits less than 1020 PTCL greater than 0.3 microns and a maximum of 2 PTCL weighing 5.0 microns per m3. UPLA filtration changes air 500-600 times per hour. 100% ULPA ceiling coverage and raised floors are often fixtures of this classification.
ISO 5
Allows 3,520 PTCL greater than 0.5 microns per m3and makes 250-300 HEPA filtered air changes per hour. Often used for pharmaceutical filling and semiconductor manufacturing.
ISO 6
ISO 6 cleanroom requirements allow greater than 35,200 PTCLgreater than 0.5 microns per m3180 HEPA filtered air changes are madeeach hour – common for assembly of electronic products according to cleanroom ISO 6 standard.
ISO 7
Requires less than 352,000 PTCLgreater than 0.5 microns per m3.HEPA filters change air 60 times per hour. This is also a common cleanroom classification for pharmaceutical and electronics production.
ISO 8
Allows less than 35, 200,000 PTCLgreater than 0.5 microns per m3. 20 HEPA filtered air changes are made per hour. Cleanroom products manufactured here are plastic extrusion for medical devices, e-liquids, and nutraceutical packaging.
ISO 9
Requires less than 293,000 microns greater than 5 microns and makes fewer than 20 HEPA filtered air changes per hour.
CleanPack Cleanroom Classification
Cleanpack’s facilities meet ISO 6 cleanroom requirements making them ideal for pharmaceutical packaging, injection molding, and cleanroom assembly of various products.
For 45 years CleanPack has been trusted with safely and reliably providing cleanroom thermoforming for clients. The quality control and in-house options allow clients to pursue turnkey cleanroom projects.