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Excipient bioburden

Justifications for the use of nonstandard (i.e., nonpreferred or nonpharmacopeial) methods of sterilization may include the heat instability of the active ingredient or an essential excipient. The choice of a method based on filtration through a microbial retentive filter and/or aseptic assembly should be justified, and the appropriate in process controls (including bioburden controls on active ingredients, excipients, bulk solutions, process time constraints etc) discussed in detail in the application. Commercial considerations should not form part of the argument for the application of a nonstandard sterilization process. The highest possible sterility assurance level should be achieved. [Pg.660]

Excipients Council (IPEC) [10] (excipients), and the USP [11] have also published GMP guidelines. These guidelines require manufacture of pharmaceutical products with acceptable microbial bioburden and free of objectionable microorganisms. [Pg.545]

Another important consideration for excipients to be used in parenteral products is their quality, particularly in microbiological terms. Commonly used parenteral excipients can often be obtained in an injectable grade which will meet strict bioburden and endotoxin limits. Pharmacopoeial grades of other excipients may be acceptable, but it is prudent to apply in-house microbiological specification limits, where none are present in the pharmacopoeias. For non-pharmacopoeial excipients, the best approach is always to purchase the highest grade available and apply internal microbiological specification limits. [Pg.335]

Components of parenteral solutions (active substances, excipients, intermediates and packaging material) should be routinely tested for bioburden and bacterial endotoxin level to ensure they are not adding an excessive microbial load. Bioburden is usually determined on the unfiltered bulk solution. Testing of filtered bulk parenteral solution either before or after filling into the final container may be done by comparison to the previously tested unfiltered bulk solution. Initial bioburden and endotoxin monitoring should be conducted to establish appropriately designed and sized terminal sterilisation methods such as filtration/aseptic filling or terminal heat treatment (see Sects. 30.5 and 30.6). Bioburden is also used as a parameter to evaluate process control. [Pg.281]


See other pages where Excipient bioburden is mentioned: [Pg.545]    [Pg.548]    [Pg.23]    [Pg.104]    [Pg.1641]    [Pg.1657]    [Pg.84]    [Pg.297]   
See also in sourсe #XX -- [ Pg.1657 ]




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