What is referred to as the space between the HEPA filter and the sterile product in a cleanroom?

The space between the HEPA filter and the sterile product in a cleanroom is referred to as the critical area. This region is crucial because it is where products are exposed to the cleanroom environment and is subject to contamination risk. The HEPA filter plays a vital role by providing a high level of air cleanliness; however, maintaining the integrity of the environment immediately surrounding sterile products is essential to prevent microbial or particulate contamination.

In this context, the critical area must maintain specific cleanliness standards to ensure that any movement, transfer, or manipulation doesn't introduce contaminants. Establishing strict operational protocols within this area, such as wearing appropriate personal protective equipment and adhering to aseptic techniques, helps safeguard the sterility of the products being handled.

Other areas mentioned, such as the clean area, contaminated area, and controlled area, serve different purposes in the cleanroom environment but do not specifically address the immediate space where sterile product exposure to potential contamination occurs. The clean area refers to a broader zone where certain cleanliness levels are maintained, while the contaminated area indicates zones where contamination risks need to be managed. Controlled areas may regulate specific environmental conditions but do not emphasize the critical nature of maintaining sterility during product manipulation.