Enumeration And Presence Methods

It is the arena of rapid enumeration and detection methods that probably holds most appeal for pharmaceutical companies. Many companies are driven to achieve release from a microbiological perspective within the same timescale as for chemical analysis, i.e., 24 to 48 hours rather than the five to seven days of a traditional microbiological method. The four main areas for this drive are:

• Raw materials testing (natural origin)

*Further details of the technique may be found at www.aiha.org.

• Finished product testing

• Sterility testing

• Environmental monitoring swabs or air samples from clean rooms

Certainly we have personal experience of gaining widespread regulatory approval throughout the E.U. for finished product testing and are aware that approval has also been achieved in the U.S. Although theoretically rapid techniques could be applied to the sterility test, the sensitivity of most of the methods is proving a stumbling block, with the best systems still requiring the presence of 5 to 10 organisms per 100 ml sample. However, development of these systems is ongoing and it is surely only a matter of time before the 14-day sterility test could be supplanted by the one-day test!

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