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General filling room 0. In this event, the risk factor increases to 1. Machine general 1. In this event, the risk factor increases to 2. Machine product 2. The second step is to assign a risk factor B based on ease of dispersion or transfer of micro-organisms. See Figure 10 for an example of the reasoning that would support Risk Factor B. Filtration room 0. General filling room or 1. Risk of transfer is low. Some risk of transfer exists, but protective measures should prevent this. Direct contact with product: highest risk.
The third step is to weight the risk factor C by assessing the effectiveness of the control measure. See Figure 11 for an example of this assessment. Barrier exists by way of filling or filtration room area machine doors and UDAF. Grade B. Machine product 1. Surface Sample Worked Example: Where a count of 2 is detected from a conveyor belt a filling machine non-product contact location. This scoring scheme is based on contamination of a product contact site being high risk by virtue of its direct proximity to the critical area or the product.
A count of 1 cfu on one of these product contact site locations would give a score of 9. In most filling zones and clean zones, sample results from product contact sites would be expected to record zero counts for samples out of every Whereas, a count of 3 from a non-product contact site would result in a medium risk category. Air Sample Assessment Approaches are available for the risk assessment of active air samples that use a numerical system.
However, the formulae associated with these are difficult to calculate in practice because often all information is not available and assessment of variables, such as impaction speed, are not readily calculable.
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Therefore, a qualitative assessment, such as the one included in the example of the numerical approach, may be more suitable. Alternatively, non-numerical risk assessment can be used based on the proximity and the operation. See Figure 12 for this example. General room Low Provided there are no Grade A interventions and there are environment during no counts recorded at Grade A, where counts are recorded filling or filtration, at Grade A and there is a micro-organism match, then the away from Grade A zone category is re-defined as medium risk. Grade A, near critical Medium Close, but not at the point-of-fill zone.
Grade A point-of-fill at High At point-of-fill critical zone.
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Note: Where growth is detected on the operator who placed the air sampler at Grade A, and this is shown to be the same micro-organism, the category of risk is increased by one i. Assigning a Risk Factor to Areas of the Filling Room The location where a high bio-burden is isolated within the filling area is arguably of greater consequence than the actual count.
The location can be given a risk rating in relation to its proximity to the critical zone, ease of dispersion or transfer, and effectiveness of control methods. The table shown in Figure 13 is proposed as a tool for risk assess- ment and to aid investigations. It supplements the risk assessment tools that have been previously examined.
Very low, e. Medium, e. High, e. The type of product and whether further processing occurs can also influence the risk factors.
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See Figure 14 for an example. Liquid product, heat treated 2 Undergoes pasteurisation - effective against most non spore-forming micro-organisms. Intravenous product, 4 Intravenous route; no further processing no further treatment. An Overall Assessment The approach taken for an overall assessment involves the historical examination of a number of operations and assigning a value above which the operation is considered to be atypical. This may be, for example, a batch fill.
The data from the session is examined and points are awarded for each result above a pre-set warning or action level. The total score is then summed and the results obtained are compared to a set level at which atypical sessions are indicated.
The pre-set level would be assessed from historical data over a reasonable time period such as one year. An example of such a scheme follows:. For Grade A The results from a filling operation are examined for individual viable counts and for the mean particle counts taken during the fill.https://casavomice.tk
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Each result, which equals or exceeds a warning or action level, is scored according to. Using the criteria presented in Figures 15 and 16 produces the Grade A score. For Grade B The results from a filling operation are examined for the individual viable counts and the mean particle counts taken during the fill. Each result that equals or exceeds a warning level is scored according to the criteria in Figure 17 and Figure Sample 1 cfu cfu cfu Warning Level Action Level Active Air Sample 1 point 2 points 3 points 3 points 5 points Settle Plate 1 point 2 points 3 points 3 points 5 points Contact Plate 1 point 2 points 3 points 3 points 5 points Swab 1 point 2 points 3 points 3 points 5 points Finger Plate 1 point 2 points 3 points 3 points 5 points.
If a warning level or action level is of the same count cfu as a value in the count cfu column, the warning or action level score should be select- ed. This produces the Grade B score. That figure would then be used as the cut-off value with which to assess the atypical filling operations. Figure 19 displays a simple representation of this assessment. For the data set, the criticality score was calculated at 25, which corresponded with the 95th percentile for a set of data from the filling of an example drug.
The graph in Figure 19 indicates that some fills exceeded the cut-off criticality value during a particular time period see fill numbers 12 through After some corrective action, the scores for the fills were reduced see fill numbers 16 through 29 and the situation returned to a state of control. The use of risk assessment approaches is an important current Good Manufacturing Practice cGMP topic in microbiological environmental monitoring.
This paper has outlined some possible tools for such a risk assessment approach; however, each suite of cleanrooms or isolator will be subtly different. The microbiologist must consider each aspect of the environment and decide what level of monitoring best suits his or her sys- tem, and then must justify the techniques used and the locations selected.
The approach adopted should be detailed in a written rationale and approved by senior management. After this, a rigorous and defensible sys- tem will be in place to satisfy regulatory expectations, and to aid the user in assessing the risk of problematic environmental monitoring situations or results. Jahnke, M. Ljungqvist, B. Sandle, T.
Whyte, W. De Abreu, C. Kaye, S. Meir, R.