Basic Clean Room Requirements

Clean Room Pressure Cascades

When considering pressures cascades, consider a design concept to have a “clean corridor” or a “dirty corridor” design ,typically, low moisture drugs such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential were positive to the corridor, the powder would escape out of the room and enter the corridor and will likely be transferred into the next-door cleanroom.

Which way should my cleanroom doors swing?

All doors should open into the room with higher pressure.

Annex 1, specifically states that sliding doors are not permitted in sterile plants as they typically create uncleanable recesses, projecting ledges and recesses. For these reasons, they should not be used in non-sterile facilities either.

What are the sources of contamination in a cleanroom?

Our concern is microbial contamination in most cases. Traditionally the technology did not exist to measure microbial contamination in real-time directly, so the “all airborne particulates” limits were used and extrapolated /assumed to represent possible airborne microbial contamination risk.

Personnel present in a cleanroom usually are the highest source of airborne particulates, and microbial contamination risk, so proper gowning and limiting the number of staff into a room must be carefully controlled to be within the cleanroom design.

So what makes a clean room a “clean room”?

There are three things that keep a cleanroom “clean”:

1. The internal surfaces of the clean room and the equipment.

2. The control and quality of air through the clean room.

3. The way the clean room is operated (i.e. the number of staff).

Let’s look at some of it in more detail:

1. The internal surfaces

For GMP compliance and to achieve the cleanliness specification, all surfaces in a cleanroom should be “smooth , easy to clean , not permeable”, and:

- not generate their contamination, i.e., don’t create dust, or peel, flake, corrode or provide a place for microorganisms to proliferate.

- are easy to clean, i.e., all surfaces are easily accessible, there should not be any ledges or recesses.

- are rigid and robust and won’t crease, crack, shatter or dent easily.

2. Clean room airflow

- Clean rooms need a lot of air and usually at a controlled temperature and humidity. This means that the cleanrooms Air Handling Units (AHU) typically consumes over 60% of all the site power in most facilities.

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Resource Person: Hassan Hussein

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