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Aseptic filling, qualification

All documents of batch numbers 001, 002, and 003 (process simulation of 24-hour duration) of media-fill study 1, study 2, and study 3 for aseptically filled A-ml vials were reviewed and found to meet the media-fill qualification requirements per current USP monograph and ISO 13408-1 1998 (E), including process simulation, environmental and personnel monitoring results. [Pg.940]

For example, a company which experienced a customer complaint involving a large glass fragment in an aseptically filled powder vial introduced procedural preventive measures but concluded that the issue required automated vision inspection equipment. Once the corrective equipment was identified, a validation master plan detailed the key qualification elements for hardware, software, defect detection system, infeed/outfeed links, but also the specification requirements of the component and component quality, e.g ... [Pg.100]

A minimum of 4800 units will be filled and incubated. For multiple shift fills, at least 3000 vials/ampoules are to be filled per shift. Table 3 shows the acceptance criteria for initial performance qualification of an aseptic processing line. Table 4 shows the acceptance criteria for requalification of an aseptic processing line. Table 5 shows alert and action levels when a 0.1% contamination rate is attained for large numbers of media-filled units, i.e., when one elects to media-fill more than 3000 units. [Pg.881]

Broth fills should be a major part of the operational qualification of a new BFS machine to demonstrate aseptic processing capability prior to product manufacture (typically three successful consecutive broth fills are required) and should be carried out at defined intervals thereafter. [Pg.381]

While validation has a relatively short technical history, in practice it has largely been directed at aseptic processing (autoclaves and media fill vials, etc.). In recent years validation has been progressively expanded, firstly to cover all manufacturing, then computer systems, analytical methodology and more recently into packaging processes. Coincident with this, validation has itself evolved into qualification, with defined parts ... [Pg.100]


See other pages where Aseptic filling, qualification is mentioned: [Pg.6]    [Pg.6]    [Pg.180]    [Pg.381]    [Pg.381]    [Pg.179]    [Pg.180]    [Pg.93]    [Pg.121]    [Pg.148]    [Pg.230]    [Pg.302]    [Pg.635]    [Pg.638]   
See also in sourсe #XX -- [ Pg.6 , Pg.7 ]




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