6. Cleaning validation

In some applications, we are interested in evaluating the ability a process in which we only observe whether the product is inside or outside budget.

Example:

In a pharmaceutical industry, there is interest in evaluating the performance and stability of the amount of residues after cleaning the equipment. The equipment that measures the residues detects values ​​above LD = 0.02348 and can quantify values ​​above LQ = 0.07862. The upper specification limit for this case is USL = 0.18.

LCL	UCL
0.08002	0.08002
0.14927	0.14927
0.02348	0.07862
0.02348	0.07862
0.02348	0.07862
0.02348	0.07862
0.02348	0.07862
0.02348	0.07862
0.08777	0.08777
0.09848	0.09848
0.15716	0.15716
0.09648	0.09648
0.07	0.07
0.25	0.25
0.11	0.11
0.13	0.13
0.06	0.06
0.06	0.06
0	0.02348
0	0.02348
0	0.02348

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We will upload the data to the system.

Configure as shown in the figure below to perform the analysis.

Then click Calculate we obtain the results. You can also generate the analyses and download them in Word format.

The results are:

SPECIFICATIONS

	Value
Sample	21
Upper Specification Limit	0.18
Detection limit	0.02348
Limit of Quantification	0.07862

ESTIMATION METHOD

Method	Probability distribution
Maximum likelihood method	Weibull

ESTIMATION COEFFICIENT

Parameter	Estimate	Standard error	Lower limit	Upper limit
shape	1.487	0.2722	0.9534	2.0203
scale	0.089	0.0141	0.0615	0.1168

QUANTILES

Percentile	Quantile	Standard error	Lower limit	Upper limit
1	0.1	0.02	0.007	0.006
2	0.2	0.033	0.008	0.014
3	0.3	0.045	0.011	0.024
4	0.4	0.057	0.012	0.034
5	0.5	0.07	0.013	0.045
6	0.6	0.084	0.014	0.057
7	0.7	0.101	0.015	0.071
8	0.8	0.123	0.018	0.087
9	0.9	0.156	0.024	0.109
10	0.95	0.187	0.031	0.125
11	0.96	0.196	0.034	0.13
12	0.97	0.207	0.037	0.135
13	0.98	0.233	0.041	0.142
14	0.99	0.249	0.049	0.153
15	0.999	0.318	0.073	0.175
16	0.95	0.187	0.031	0.125

PERFORMANCE INDEX

Parameter	Value
PpK	0.444990381722115
PPM	58378.0132293608

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Control Limit

		Value
1	Alert Threshold	0.186544150929521
2	Upper Control Limit	0.317566810277244

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