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
Cleanroom Gowning and Entry Procedure
Contrary to safety PPE, clothing worn in cleanrooms acts to protect the environment from the wearer....Read more
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