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Z-Value Calculation

Prepared by: SGM Biotech, Inc. 10 Evergreen Drive, Suite E Bozeman, MT 59714

......................................................... EN........... What is a Z-value? ................................. ............................. 7................................................................................................ ............................................. Equation 6....... SGM Biotech's internal standards... .............................. calculating a D-value from a Z-value and known D-values ................... Calculating a Z-value mathematically (log-linear regression analysis)....... USP ................5 6 8 2 2 2 3 4 5 7 8 8 8 2 ........................ ......................Table of Contents 1............... 2....... 3................................................ calculating a Z-value graphically ... ....................... Figure 2....................... ........ ISO... 3........ Determining a D-value from a Z-value and known D-values.... and AAMI standards......................... Determining a D-value from a Z-value and only one D-value.. 17.................. 8.............. Equations 16....................... 3 4.................... Calculating a Z-value graphically........... 4.............. 10.......... Equation 13............... 2............. ...... Notable Figures and Equations 1................................................. 4... 9... 5.......... 6. calculating a D-value from a Z-value and one known D-value ........... calculating a Z-value mathematically .... ................................... Regression Lines (line-of-best-fit)..................... More on Z-value calculations.............

Temperature 100 D-value 10 1 0. How do I determine a Z-value graphically? Calculating a Z-value graphically is relatively easy. 124. using your best judgement. In the practical sense. if the Z-value of a population is 10 degrees. as shown above in Figure 1. D-value vs. then increasing the sterilization temperature 10 degrees will result in a log reduction of the D-value. The Z-value can be found by plotting D-values against temperatures on a semi-logarithmic scale and adding a line that best fits the data. Why use a line-of-best-fit? In a perfect world.What is a Z-value? A Z-value is defined as the number of degrees (Celsius or Fahrenheit) required to change a D-value by one factor of ten.1 110 115 120 Temperature 125 130 Figure 1. it is a measure of how susceptible a spore population is to changes in temperature. In reality however. D-values at 121. The absolute value of the reciprocal of the slope of this line will be the Z-value. 3 . Plot at least 3 D-value/temperature pairs on a semilogarithmic graph and. the D-value of a particular spore will decrease exponentially as temperature is increased. determine the number of degrees required to change the D-value by one factor of 10 (see Figure 2 below). A line-of-best-fit is a statistically-correct method of representing our data points. draw a straight line through the points that most closely fits the data. For example. and 129C plotted against Temperature Since D-values are plotted logarithmically. the line of best fit will be of exponential form and will therefore appear linear on semi-logarithmic paper. D-values will not decrease perfectly due to natural variations and experimental error. From this line.

In the above case the Z-value appears to be approximately 8°C. log y pairs. To accomplish this we must know the equation for our line-of-best-fit. Estimating a Z-value graphically is far less perfect than calculating a Z-value mathematically. The following normal equations can be used to find the equation of a linear regression line: n i =1 n i =1 yi = b ⋅ n + m ⋅ n i =1 xi n i =1 (eq 1) n i =1 xiyi = b ⋅ xi + m ⋅ xi 2 (eq 2) where b is the y-intercept of the regression line m is the slope and n is the number of x. Calculating a Z-value graphically. y points.1 110 115 120 Temperature 125 130 Figure 2. however. Since. or more specifically the slope of our line. Can I determine a Z-value mathematically? Yes. which can be found using a log-linear regression analysis. the above equations must be modified to reflect our loglinear scale: 4 .Example Z-value Calculation 100 D-value 10 ∆ D-value = 1 log 1 ∆ Temperature = Z-value 0. we are dealing with x.

m= 1 ∆T (eq 8) In so doing. As you can see. Take another look at Figure 2. the slope ("rise over run") of our regression line is: m= ∆Dvalue ∆Temperature ∆D ∆T (eq 7) By the definition of a Z-value. this change in temperature now becomes our Z-value. we are only concerned with a 1 log reduction in the D-value. using the method of least squares. m= And solving for Z gives us: 1 Z 1 m (eq 9) Z= (eq 10) 5 .n i =1 log yi = b ⋅ n + m ⋅ n i =1 n i =1 xi n i =1 (eq 3) n i =1 xi ⋅ log yi = b ⋅ xi + m ⋅ xi 2 (eq 4) Now. we can find the following formula for the slope of our line: n⋅ m= n i =1 ( xi ⋅ log yi ) − n⋅ n i =1 n i =1 n i =1 xi ⋅ xi ) 2 n i =1 log yi (eq 5) xi − ( 2 where n is the number of D-value/temperature pairs (data points) x represents temperature and y represents D-value From this equation we can find the Z-value by taking the absolute value of the recipricol of this slope. Therefore we fix our change in D-value (∆D) at1. as such: Z= 1 m (eq 6) Why is the Z-value the recipricol of the slope? Explain further.

Inc.1097 3 ⋅ 43242 − 360 2 Now solve for Z (eq 6).9494 0. While all of this data may not be included on a certificate of performance. three D-value/temperature pairs. I understand Z-values.9 minutes 2. The unknown D-value should fit our regression line in such a way as not to affect its slope.181 38.0458 Σ log(y) = 1.1 € − 0.1 minutes 0.488 number of x. First we must define the problem. How do I determine a D-value from a Z-value and known D-values? While this task is self-explanatory when done graphically.1 0. we take the absolute value of our equation: Z= Example 1: Calculate a Z-value from the following D-values: Temperature 115C 121C 124C D-value 8. Therefore we are solving for an unknown D at a specified temperature. since the Z-value should always be a positive value (and slope of our regression line can be negative). say. it can in most cases be obtained by contacting SGM Biotech.4880 − 360 ⋅ 1.9 2.3222 -0. If we have.6792 Σx(log(y)) = 142.9862 -5. Performing this task will require that we know the entire data set that was used to generate the Z-value specified.1097 Ok.9 -----------------------Temperature (x) 115 121 124 Σx = 360 log(y) 0. 6 .824/126 = -0. then we are looking for a fourth D-value at a given temperature.9 minutes 1 m (eq 6) Construct a table to simplify the calculation: D-Values (y) 8. thereby not changing the Z-value. Z= 1 = 9.Finally.2258 x2 13225 14641 15376 Σx2 = 43242 x(log(y)) 109. y pairs = n = 3 Now plug these values into the equation for the slope of our regression line (eq 5).2258 = -13. it is rather difficult to perform mathematically. m= 3 ⋅ 142.

If the D-value was to increase with temperature then we would use 1/Z. we know Z. This is due to the fact that our D-values are assumed to decrease as temperature increases. we know x1. and we know y1. yields: n 2 n 2 n−1 n n−1 [ − n⋅ xi +( xi ) ]÷Z −n⋅ ( xi log yi )+ xi⋅ log yi i=1 i=1 i=1 i=1 i=1 n n⋅xn− xi i=1 (eq 13) yn =10 While this equation is somewhat cumbersome.. what are we solving for? Well. our unknown D-value. x2 ... yn-1. thereby causing the slope of our regression line to be negative. Solving for yn. So. What we don't know is yn. xn as our temperatures.We must expand our original equation for the slope of a log-linear regression line to include the unknown D-value. its difficulty can be reduced using the methods of the following example. however it is highly unlikely that this would ever be the case. 7 .. y2 . which is of course the unknown D-value. we can substitute for m: n −1 i =1 n i =1 n i =1 n −1 i =1 −1 = Z n⋅( [ xi ⋅ log yi ] + xn ⋅ log yn) − n⋅ n i =1 xi ⋅ ( x) 2 [log yi ] + log yn) (eq 12) x2 − ( Note that we've substituted -1/Z for m instead of the absolute value of 1/Z. n −1 i =1 n i =1 n i =1 n −1 i =1 n⋅( m= [ xi ⋅ log yi ] + xn ⋅ log yn) − n⋅ n i =1 xi ⋅ ( x) 2 [log yi ] + log yn) (eq 11) x2 − ( Since the Z-value is known..

1 0.31 minutes We can check this value by including it in our data set and calculating a new Z-value.5C. Can I calculate a D-value using only the data on the certificate? In most cases a certificate of performance will at least include the D-value at 121C and the Z-value (where applicable).2258 x2 13225 14641 15376 16641 Sum of x12.9494 0.xn = 489 log(y) 0. Remember that in a perfect world all D-values would exist on our regression line. Since the Z-value only tells us about the slope of the original regression line and not its y-intercept... −4 ⋅59883+ 239121 − 4 ⋅142. we're simply going to make the assumption that it passes through the D-value at 121C. the D-values it reports will be skewed.181 38. 9.9862 -5.xn1(log(yn-1) = 142.log(yn-1) = 1..9 minutes Z-value = 9. we're going to use the most basic form for the slope of our line: m = Which in this case will be: y 2 − y1 (eq 14) .Example 2: Calculate a D-value for 129C from the following data: Temperature 115C 121C 124C D-value 8. Because we don't know where exactly to place our line. For our solution.3222 -0.9 2. it is not recommended. While it will always generate the same Z-value.1 minutes 0.2258 9.. While it is possible to estimate a Z-value from this data. x 2 − x1 8 .6792 -----------------------Sum of x1(log(y1)).9 minutes 2.0458 --------------------Sum of log(y).488 number of x values = n = 4 xn = x4 = 129 Now plug these values into the equation (eq 13).5C Construct a table to simplify the calculation: D-Values (y) 8. the line can exist anywhere along the y-axis.5 4 ⋅129 − 489 y 4 = 10 = 0. The new Zvalue should be the same as the one stated in the problem.9 yn -----------------------Temperature (x) 115 121 124 129 Sum of x1.. as they would decrease perfectly exponentially.488 + 489⋅1.xn2 = 59883 x(log(y)) 109.

2 Not stated. ISO. Z= T 2 −T1 log D1 − log D 2 What about the USP? The United States Pharmacopoeia does not discuss Z-values as a performance statistic. Regression analysis acknowledg ed. See equation 6. Solving for Dx results in: IFF Tx < 121 Dx = 10 1 (121− Tx ) + log D121 Z (eq 16) −1 IFF Tx > 121. the more accurate that estimation will be. Not stated. Graphically. We do not feel that using two D-values to determine a Z-value is proper.1C Log-linear regression. ISO. 9 . please contact SGM Biotech. Dx = 10 Z ( Tx −121) + log D121 (eq 17) What do the standards say about Z-values? AAMI. and EN all discuss Z-values. ISO 11138-3 110-130C 2 6C 0. If you have a product that is used to monitor a steam process and there is no Z-value on the certificate. Inc.1C AAMI ST34 Not stated. Not stated. SGM Biotech 110-130C 3 6C 0.m= log D121 − log Dx 121 − Tx (eq 15) where D121 is the D-value at 121C Dx is the unknown D-value and Tx is the temperature at which the unknown D-value exists. Valid Temperature Range Number of D-values Required Minimum Z-value Increment (accuracy) Formula EN 866-3 110-130C 2 6C Not stated. Three D-values is the minimum number of points required for practical yet accurate Z-value estimates. the more data used in an estimation. and AAMI? As every scientist and statistician knows. Why are SGM Biotech's standards more strict than EN. I can't find the Z-value on the certificate that came with the product!? Z-values are generally only reported for products used in steam processes. since the slope of a regression line through only two points will vary greatly from a line through three or more points.

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