A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner.
Source: GMP Draft Annex 1
Design Approach and Layout
In a URS, designers need to review the flow of people and products through the facility to assess th...Read more
Ongoing Performance Qualification requires a repeat of the initial testing on the cleanroom to ensur...Read more
Cleanroom Gowning and Entry Procedure
Contrary to safety PPE, clothing worn in cleanrooms acts to protect the environment from the wearer....Read more