Follow these steps for proper aseptic cleanroom gowning: Don bouffant cap, be sure all hair is contained and ears are covered. Don disposable shoe covers making sure entire surface of street shoe is contained. Wash or sanitize hands. Make sure they dry completely.

ISO 8 is the least clean cleanroom classification. A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty.

A gowning room, often referred to as an ante-room, is a space outside of the cleanroom in which operators change in and out of street clothes when. The room is divided into a dirty and clean side and optimized for sequential procedures with fewer steps.

This article will help you understand the basic differences between an ISO 5, ISO 6, ISO 7 and ISO 8 clean room as per ISO 14644….

ISO 7 Cleanrooms. An ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufactured facility that utilizes HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot.

Surgical Gowning Steps

1. With one hand, pick up the entire folded gown from the wrapper by grasping the gown through all layers, being careful to touch only the inside top layer which is exposed.
2. Once your hands are securely pinching the gown in these slots, step back from the shelf and allow the gown to drop.

The “cleanest” cleanroom in FS209E is referred to as Class 1; the “dirtiest” cleanroom is a class 100,000. ISO cleanroom classifications are rated according to how much particulate of specific sizes exist per cubic meter (see second chart). The “cleanest” cleanroom is a class 1 and the “dirtiest” a class 9.

The gowning room is generally an ISO 7 or ISO 8, while the interior rooms range from ISO 5 to ISO 7. Both have HEPA filtered air which capture 99.99% of particles at a size of 0.3 micron or larger.

In ISO Class 7 or ISO Class 8 cleanrooms, frocks are often acceptable. A cleanroom classified as ISO Class 5 or ISO Class 6 (or cleaner) requires cleanroom coveralls, along with hoods, gloves, and booties (shoe covers).

ISO 5 Cleanroom (Class 100) In theory, for a classified room (not just below a LAFW hood) to reach ISO 5 air cleanliness, you need to enter the cleanroom via an ISO 8 (ante-room), then go through an ISO 7, followed by an ISO 6 to finally get into the ISO 5.

Cleanroom gowning room requirements differ based on cleanroom class and application. In ISO Class 7 or ISO Class 8 cleanrooms, frocks are often acceptable in place of a full coverall. A cleanroom classified as ISO Class 5 or ISO Class 6 (or cleaner) requires cleanroom coveralls, along with hoods, gloves, and booties (shoe covers).