Jeanne
Moldenhauer has written an informative article on cleanroom classifications for
Controlled Environments Magazine.
Here
is an extract:
“Many
global companies choose to use this classification system. All of these systems
are acceptable for use. However, we have also tended to link the systems
together, e.g., ISO 5/Class 100/Grade A. This type of linkage is seen in the
FDA’s Guidance for Aseptic Processing (2004). If you are manufacturing an
aseptic product and use this linked classification system it is not likely to
be an issue. However, if you are not manufacturing an aseptically processed
product, choosing to link the classification systems together may lead to other
consequences.”
Posted by Tim Sandle
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