The following is a select question submitted from a customer to one of our Industry Experts.
Customer: We are currently realigning our cleanroom specifications. Can you give us insight into current regulatory expectations for cleanrooms?
Jerry Chapman: Cleanroom specifications were put in place for the manufacture of sterile products, although other industries such as the semiconductor industry also use them. These specifications are based on the numbers of particles in the area, as particles are the source of both viable (living, think bacteria) and non-viable contamination.
The ISO classification methodology has been adopted by the U.S. FDA. The European Union, however, long ago put in place a different system using A, B, C, and D designations. This system has been adopted across Europe and by Canada, Russia, and other health authorities. In essence, they are just different ways of naming the pretty much same things, although there are some subtle differences in whether the classification refers to static (at rest) or dynamic (in motion) particle counts.
A company can certainly choose to standardize on one over the other for their own reasons. But it doesn’t effectively change regulator expectations for what environment which activities are conducted in. Depending on what activity is taking place, there are requirements for a certain class or grade to ensure product protection.
For example, for aseptic processing:
- Grade A is used for aseptic preparation and filling of sterile ointments, creams, suspensions and emulsions
- Grade B must be maintained as a background environment for grade A zone operations, when needed for transfers and other less-critical tasks
- Grade C is used for preparation of solutions that need to be sterile filtered
- Grade D is required for handling of components after washing
Here is how the two classification systems compare:
- Grade A is approximately equivalent to class 100 or ISO 5
- Grade B is also approximately equivalent to class 100 or ISO 5
- Grade C is approximately equivalent to class 10,000 or ISO 7
- Grade D is approximately equivalent to class 100,000 or ISO 8
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About the Expert
Jerry Chapman is a Senior GMP Quality Expert at Redica Systems. He writes the Redica Systems blog “Conference Spotlight” and is working on machine learning models for analysis of agency enforcement documents. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.
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