Sterility testing antimicrobial agents

Sterility testing Methods Antimicrobial agents 8 Further reading... 

Large-volume parenterals (LVPs) and small-volume parenterals (SVPs) containing no antimicrobial agent should be terminally sterilized. It is common practice to include an antimicrobial agent in SVPs that cannot be terminally sterilized or are intended for multiple-dose use. The general exceptions are products that pass the USP Antimicrobial Preservative Effectiveness Test [1] because of the antimicrobial activity of the active... 

Using a QC-approved antimicrobial agent, sanitize the exterior surfaces of the sample container by spraying with the agent until visibly wet or wiping the surfaces with a sterile, lint-free, agent-soaked towel. Put all the samples to be tested under the hood. Allow surfaces to dry before testing. 

One problem that may arise is when an antibiotic or preservative is the product, or part of the product under test. When this happens, the material must be inactivated or removed before sterility testing can take place. There are several methods of achieving this. Antibiotics, such as the penicillins, may be inactivated by the addition of the enzyme P-lactamase, whilst the action of sulphonamides can be blocked by the addition of />-aminobenzoic acid. Products containing preservatives or antimicrobial agents, such as benzoic acid, alcohols, or phenols, are diluted to the level at which the compound becomes ineffective. Products containing quaternary ammonium compounds can be inactivated by the addition of Tween, whilst many compounds containing heavy metals can be... 

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