ISO 8 cleanroom
designed to house
medical device manufacturing processes.
Photography + Design
There is no one-size-fits-all answer for determin- ing the classification level of cleanrooms — they come in different shapes and sizes, they’re used for many different applications, and their cleanliness needs are quite varied. Therefore, it’s important
to know what classification level you’re dealing with,
and how best to tailor your practices, apparel, products, and equipment to meet these specific needs.
Controlled Environments spoke to Patrick McGee,
Cleanroom Division Manager at PortaFab Corp., for
details about how to properly accommodate different
levels of cleanroom classifications.
Controlled Environments (CE): How are cleanroom
Patrick McGee (PM): As of November 2001, ISO
14644-1 supersedes the previous Federal Standard
209E as the international standard for cleanroom
classifications. ISO cleanroom classifications are determined by how much particulate at a specific size (0.1
micron – 5 micron) are present per cubic meter in
the cleanroom space. Classifications range from ISO
1 (cleanest) to ISO 9 (dirtiest). As particulate levels
change dependent on the activity in the cleanroom,
these classification levels are tested at three different
stages: as-built, at-rest, and operational. Classification
is easiest to achieve at the “as-built” stage and becomes
more difficult during the “operational” stage as people
(the largest contaminate in a cleanroom) are added.
For clients to determine the classification of clean-
room they need, they must first define their process
and the particulate size and levels they are looking to
CE: What are common federal/global standards that
cleanroom companies must adhere to when manufacturing cleanroom products and components?
PM: Cleanroom products must be manufactured
to be non-shedding and have a cleanable surface.
Manufacturers should be ISO 9001 certified, resulting
in internal audits to ensure quality is being monitored.
ISO 9001 quality management systems (QMS) standards are designed to ensure that companies meet the
needs of their customers while meeting regulatory
requirements related to a product.
CE: How do you guide clients who need specific
accommodations for their cleanrooms?
PM: Despite the guidelines of ISO classifications, typically each customer’s cleanroom needs are dependent
on what process they are doing in the room and what
size particulate is causing problems for the client.
Therefore, you must first address both what you are
doing in the room and what you are trying to keep out
before you can design the room itself.
CE: Are there any components/products that will work
in all kinds of cleanrooms, or must the products be
specific to each classification level?
PM: As previously mentioned, ISO classifications are
measured by the number and size of particulates in
the room. One way these classifications are achieved