Overview of Trends in Environmental Data

Environmental monitoring data is part of a continuum. Periodic analyses of environmental data should be formally prepared, reviewed by microbiological QA, then presented for informational purposes and consideration by the production, engineering, nonmicrobiological QA, and general management personnel responsible for particular areas, operations and products.

This preparation of overview reports is in practice often done rather halfheartedly.

Excessively frequent overviews (e.g., as part of a monthly report) are as ineffective as excessively infrequent overviews (e.g., as part of annual product review where the data is collated by product rather than by manufacturing area). For heavily used facilities quarterly overviews are recommended. When facilities are used on a campaign basis the environmental monitoring data from each campaign should be overviewed separately.

The presentation of the data is extremely important. All too often this is done either as a list of action limit infringements or as pages and pages of data tabulated or plotted as counts (usually zero) against time. Neither approach is very helpful.

Good presentation is graphical. Graphical presentation offers the opportunity to personnel not closely involved in data collection to chance upon a trend, to compare one filling room with another, or to ask an informed question. There are a variety of approaches, but whatever is adopted should incorporate the following considerations.

• Report each test separately. Multiline graphs with separate scaling are difficult to read and should be avoided. If possible, plot all data from each test on one graph dedicated to that test.

• Focus on facilities. If there are several sterile manufacturing facilities, each should be reported separately. It is often informative to be able to compare different filling rooms. It may be possible to include all the graphs from the several separate tests applying to one sterile manufacturing facility on one or two pages.

• Include all the available data on the graphs. Most environmental microbiological data from aseptic manufacturing facilities tend towards a value of 0 cfu with occasional much higher counts that result in action limit infringements. The data presentation should allow the identification of any other intermediate condition if it should arise.

• Include the limits on the graphs. It is essential to know if the general pattern of data is well within its limits or if it is close to the limits.

• Identify the locations, dates, identities and other pertinent details of action limit infringements. This may help a "second pair of eyes" to identify a repeating problem that requires attention.

The frequency histogram is a good method of achieving these purposes. The data values (say 0, 1, 2 , 3 ... n cfu per m3) should be plotted on the x-axis, with the number of datum points for each value plotted on the y-axis. Alternatively the percentage of the total data collected may be plotted on the y-axis. Data values may be plotted as group (say, 0 cfu, 1 to 5 cfu, 6 to 10 cfu, etc.) to improve the clarity of presentation, and the x-axis may be split for the same purpose. Examples from settle plates in an aseptic filling room and its supporting change room are given in Figure 2.4.

Aseptic Filling Room (Grade B) "White" Change Room

Aseptic Filling Room (Grade B) "White" Change Room

cfu per 2-hour settle plate Figure 2.4. Frequency histograms of microbiological environmental monitoring data.

cfu per 2-hour settle plate Figure 2.4. Frequency histograms of microbiological environmental monitoring data.

Data from personnel monitoring ought best to be overviewed for each individual separately because data are more likely to relate to individual practices than to general problems within the facility. In the interests of sensitivity and privacy these data should be published in overview reports with wide distribution. Any anomalous conditions or differences among operators (irrespective of whether these are within limits) should be discussed personally with area supervision, and the overviews kept on file subject to any national or local legislation relating to the individual rights of privacy.

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