Clean Room Gowning Area

For sterile processing additional precaution is needed to assure that no sterile surfaces contact non sterile surfaces during gowning processing or cleaning.

Clean room gowning area.

An organized gowning area that supports clean protocol. This design starts with a room with pressure greater than that of the outside air but lower than the. 6 7 enter the gowning room. And the sterile clean side where final steps are taken.

Clean glove liners may be worn beneath gloves if desired. The cleanroom classification standards fs 209e and iso 14644 1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. 6 8 obtain coveralls boots a second pair of gloves and armsleeves if necessary from supply rack. The sterile dirty side where personnel perform necessary activities to prepare for gowning.

6 9 while on the dirty side of the dirty clean line step into coverall one foot at a. When exiting the cleanroom leave via the entrance area and go through the gowning area to exit. We will be covering the procedures personnel should follow to get cleanroom ready and some of the cleatech gowning equipment that supports the gowning protocol. Sterile garments and gloves are recommended during aseptic workflows.

The rule of thumb is that you should not skip over more than one class when you move towards a cleaner room for example from iso 7 to iso 6 not from iso 8 to iso 6 as illustrated. 6 6 put on powder free bulk packaged gloves. The non sterile pre gowning area directly outside of the room where personal items are kept and shoe cleaning occurs. Using the stepover bench remove footwear one at a time placing leg over to dirty side once removed.

View usp 797 gowning and donning requirements and garbing order. D cleanroom buffer area buffer or core room buffer or clean room areas buffer room area buffer or clean area or buffer zone an iso class 7 area where the primary engineering control area is physically located. A well designed gowning room and strict gowning procedure must be followed in order to maintain a cleanliness classification. The simplest and most economical approach to this dilemma is a correctly designed gowning area complete with well designed cleanroom furniture that keeps personnel on a clean track.

Activities that occur in this area include the preparation and staging of components and supplies used when compounding sterile. All gowning rooms should consist of three designated sections. In the uk british standard 5295 is used to classify cleanrooms.