A decontaminated unit supplied with grade A (ISO 5) or higher air quality that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel).
There are two major types of isolators:
Closed isolator systems exclude external contamination from the isolator’s interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations.
Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator.
Source: GMP Draft Annex 1
De accurate termen om deze eenheden te beschrijven zijn unidirectionele flow unit en neerwaartse luc...Lees verder
Een mini-omgeving is een gebied binnen een cleanroom dat een hoger zuiverheidsniveau heeft dan de re...Lees verder
DQ IQ OQ PQ
Validation protocols are a method of establishing documented evidence that shows a high degree of as...Lees verder