Change Area

A change area is an area with defined particle and microbiological cleanliness standards usually containing a number of joined cleanrooms.

Source: EU GMP Annex 1

A cleanroom change room, or gowning area, is a room in which operatives can don their cleanroom garments prior to entering the main cleanroom zone. It is good practice for all cleanrooms to include a change area as it helps operatives adhere to gowning procedures. They should contain sufficient space for changing, storage for clothing and bins for the disposal of packaging.

Often a change area operates at a lower classification and pressure than the main area, so the pressure cascade is maintained. In GMP facilities, change rooms feature interlocked doors to create an airlock which maintains air pressure control between adjoining rooms to prevent the ingress of contamination from a lesser controlled area.