White Paper. Population C, The Standard Distribution of Resistances: Analysis and Commentary 5/30/17

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1 White Paper Population C, The Standard Distribution of Resistances: Analysis and Commentary 5/30/17 John B. Kowalski, Ph.D. Independent Consultant of Sterigenics/SteriPro President & Principal Consultant microgamma, LLC

2 Introduction Population C, the Standard Distribution of Resistances (SDR), is the model population that underlies Method 1 and Method VD max of ISO Population C is described in the publication by K. W. Davis et al. (1) as follows: "Population C represents the resistances of the same microbial population as population B where resistance was determined by drying a dense suspension of microbes on glass". Population B "represents microbial resistances likely to be found on medical devices of a cellulosic nature and is derived from Whitby" (2). The SDR has the following characteristics: D 10 (kgy) Frequency Plots of the radiation response of the individual components of the SDR (solid lines) and the composite population (dashed line) are shown in Figures 1 and 2, for average bioburdens of 1000 and 1, respectively. D 10 Components of the SDR and Their Effect on the Verification and Sterilization Doses Inspection of the SDR plots in Figures 1 and 2 shows that the D 10 components of the SDR more likely to affect the outcome of the verification dose experiment (VDE) are not the same as those that are more likely to affect the attainment of a sterility assurance level (SAL) of To quantify and visualize this observation, bar plots were made of the potential to affect the outcome of a Method 1 VDE (10-2 SAL) and attainment of an SAL of 10-6 by the 10 components of the SDR. This analysis was performed at bioburden levels of 1, 10, 100, 1000, and 1,000,000. A relative impact factor (RIF), which can range from 0 to 1.0 on the Y axis, was calculated in the following manner: The attained SAL for the SDR component at the 10-2 dose for the indicated bioburden level was divided by the lowest SAL attained by any of the 10 SDR components. Each of these values was then divided by the highest value in the group of 10 which yields a value of 1.0 for the D 10 component most likely to affect the outcome of the VDE. For example, at a bioburden of 1, verification dose of 3.0 kgy, SAL of 10-2 : D 10 Component (kgy) SAL 7.02E E E E E E E E E E-05 Impact Factor Relative Impact Factor

3 The 1.5-kGy D 10 component has the highest impact factor, , and therefore an RIF of Bar plots of RIFs versus SDR D 10 components are shown in Figures 3 to 7. Several observations can be made on inspection of the five bar plots. First, the SDR D 10 component most likely to affect the outcome of a VDE (change a "pass" outcome to "fail"), for a given bioburden, is not the same as the component most likely to affect the attainment of a 10-6 SAL at the SDR-prescribed sterilization dose. As the bioburden increases, the RIF pattern changes with an overall shift to the right to greater D 10 values. At a bioburden of 10 6, the 4.0 kgy D 10 component is equally likely to affect the outcome of the VDE and the attainment of an SAL of 10-6 ; this is not seen at lower bioburden levels. A comparison of the 4-kGy inactivation rate compared to that of the composite SDR, for bioburdens of 1 and 10 6 is shown in Figures 8 and 9. As can be seen, for a bioburden of 10 6, the two plots are essentially parallel indicating similar RIFs at 10-2 and 10-6 SAL values. At a bioburden of 1, the plots are not parallel over this SAL range giving a lower RIF for the 4-kGy D 10 component at an SAL of It is clear that there is a complex relationship between bioburden level and the D 10 components of the SDR that are most likely to affect the outcome of the VDE and the attainment of an SAL of 10-6 at the SDR-prescribed sterilization dose. Deconstruction of the SDR In an effort to further characterize the SDR, the SDR was broken down into three D 10 components: primary D 10 (PD 10 ), terminal D 10 (TD 10 ), and net D 10 (ND 10 ). PD 10 defines the inactivation rate over the interval from N 0 (starting count) to a 10-2 SAL. TD 10 defines the inactivation rate over the interval from 10-2 to 10-6 SAL. ND 10 defines the overall inactivation rate from N 0 to 10-6 SAL. See Figure 10 for an illustration and the table below. Bioburden Level SDR Response (D 10, kgy) PD 10 TD 10 ND ,000, PD 10, TD 10, and ND 10 increase progressively with increasing bioburden level because of the increase in concavity of the curve depicting the composite SDR response concomitant with its upward vertical displacement. 3

4 SDR-Induced Conservatism in the Sterilization Dose Inspection of the table above shows that each TD 10 value is significantly greater than the corresponding PD 10 value thereby giving a higher sterilization dose than would be extrapolated from the N 0 to 10-2 interval. To investigate this observation further, plots were made of model VDEs at bioburden levels of 1, 1000, and 10 6 showing the SDR response in PD 10 /TD 10 format (solid lines) and also a linear extrapolation of PD 10 to a 10-6 SAL (dashed lines); see Figure 11. These plots assume a VDE result of 1+/100. As can be seen, rather unexpectedly, the difference between the 10-6 PD 10 -extrapolated and SDR-prescribed doses is similar across a large range of bioburden level and, in fact, the largest difference is observed at a bioburden of 1. The difference and ratio between these two "predictions" of the 10-6 dose was plotted for bioburden values from 1 to 10 6 ; see Figures 12 and 13. The relationship between the bioburden level and the difference and ratio of the 10-6 PD 10 - extrapolated and SDR-prescribed doses is clearly evident. The difference between these two 10-6 SAL doses peaks at approximately a bioburden level of four and declines as bioburden level increases. The ratio between the two 10-6 SAL doses is highest at a bioburden level of one and decreases thereafter. Discussion As the bioburden level increases, both the SDR-prescribed verification dose and the SDRprescribed 10-6 SAL sterilization dose also increase; this relationship is expected and not surprising. The composition of the SDR, 10 different D 10 components each with a different frequency in the overall population, results in other more complex relationships. It is clear that the D 10 components of the SDR that can most affect the outcome of the VDE are generally not the same as those that affect the attainment of a 10-6 SAL for a given bioburden. At a bioburden level of 10 (representing a "clean" medical product), the 2.5-kGy D 10 component is most likely to affect the outcome of the VDE but the 4.0-kGy D 10 component is most likely to affect the attainment of an SAL of At low bioburden levels, there could be a significant change in the frequency of 4.0-kGy microorganisms that would unlikely be detected in a VDE. Figure 14 shows the radiation response of the SDR at a bioburden level of 10 and the radiation response of the 4.0-kGy D 10 component at its normal frequency ( ) and at 10 times this frequency. As can be seen, this change would generally not affect the outcome of a VDE; at a bioburden of 10, the occurrence of this D 10 component would be ~3.6 x 10-3 for the 10x frequency. The 10-6 SAL dose for the 4.0-kGy D 10 component alone, at the 10x frequency, would increase to 19.4 kgy, a value higher than that of the composite SDR. An SAL of 10-6 would not be attained at the SDR-specified dose of ~17.6 kgy; it would be ~3.5 x This greater SAL would not generally be viewed as having clinical significance but rather illustrates a 4

5 consequence of using a fixed underlying model population when the actual bioburden of a product might have different characteristics. The SDR was derived from a study of naturally occurring bioburden on materials in hospital surgical packs. In these studies, isolates were cultured and inoculated onto glass tubes and D 10 values determined. Also, parallel testing was performed with inoculum placed on glass and Kaycel â material. When inoculated onto glass, isolates with D 10 values in the 4.0- and 4.2-kGy categories were identified. When testing was performed with the inoculum delivered onto Kaycel material, 4.0- and 4.2-kGy D 10 values were not observed. Below are the results of the study where 141 isolates were inoculated in parallel onto glass and Kaycel and D 10 values determined. Surface Number of Isolates at Indicated D 10 Value (Mrad) < 1.0 <1.5 <2.0 <2.5 <3.0 <3.5 <4.0 <4.5 Glass Kaycel The resistance to radiation is clearly greater when the inoculum was placed on glass rather than Kaycel material. The author commented that the lower resistance when inoculated onto Kaycel is most likely due to less occlusion and therefore irradiation under more aerobic conditions. Questions Raised The first question raised in this analysis of the SDR is its relevance to current medical products sterilized by ionizing radiation. The isolates were recovered from materials in hospital surgical packs and the D 10 determinations were made using inoculation of isolates onto a glass surface. The bioburden of hospital surgical packs is not clearly comparable to an injection molded polymeric device or a vialed vaccine, for example, and the conservatism introduced by inoculation onto glass is significant. A conservative underlying model population is clearly desirable but is the use of the SDR appropriate for a low-bioburden medical product with no recovery of spore formers or yeasts/molds? The D 10 value for Staphylococcus species, a common human-based clean room contaminant, is in the range of 0.6 kgy; the PD 10, TD 10 and ND 10 values shown above are very much higher than this value. For a bioburden of 10 of these microorganisms, seven log 10 reductions, a dose of 4.2 kgy, are required attain an SAL of 10-6 ; the SDR-prescribed sterilization dose for a bioburden of 10 is 17.6 kgy. The studies of Yan & Tallentire (3) and Takehisa et al. (4), were performed on isolates from a cotton-based medical product and "dry" devices (syringes/needles, infusion sets, dry dialyzers, cannulas and AV fistulas), respectively, termed hereafter YT and TD. The YT study found an 5

6 overall resistance less than that of the SDR and no isolates with a D 10 value >3.6 kgy. They predicted that such microorganisms would occur at a probability of less than 1 in In the TD study, the distribution of D 10 values was different for the syringes/needles compared to the infusion sets. The syringe/needle results had a higher percentage of spore formers with D 10 value >3.1 kgy, 8.9% versus 1.7% for the infusion set. For the syringe/needle group, a large number of the Bacillus subtilis isolates were recovered from product manufactured at a single center. The overall resistance of the isolates from the "dry" products was found to be greater than the SDR. A plot of the radiation response of six of the described populations A, B, C, D, YT, and TD is shown in Figure 15. As can be seen, for a bioburden of 1000, the 10-6 SAL dose varies widely. Note the similarity of the radiation response of popb/yt and TD/popD from 10 3 to 1 and the divergence thereafter, due to the presence/proportion of high D 10 value isolates. The second question that comes to mind is the use of a model population to define both the verification dose and the sterilization dose. A methodology that specifies a target verification dose in another manner and uses a model population to define the extrapolation to a sterilization dose might have merit. Way Forward To facilitate studying the radiation response of product bioburden in comparison to the model populations discussed above, Method 1-like look-up tables are being developed for all six populations. These tables list verification doses for 10, 30, and 90 product samples and sterilization doses at SAL values of 10-3, , 10-4, , 10-5, , and Also, Method VD max and its associated calculation spreadsheet will be expanded to include the six populations. These look-up tables and calculation spreadsheets are intended for use in R&D studies only. A concept that specifies a target verification dose in another manner and uses a model population to define the extrapolation to a sterilization dose is under development. References 1. Davis, KW, Strawderman, WE, Whitby, JL The rationale and a computer evaluation of a gamma irradiation sterilization dose determination method for medical devices using a substerilization incremental dose sterility test protocol. J. Appl. Bacteriol. 57: Whitby, JL Radiation resistance of microorganisms comprising the bioburden of operating room packs. Radiat. Phys. Chem. 14: Yan, A and Tallentire, A Distribution of radiation resistance of microbiological contaminants of a cotton-based medical product. Radiat. Phys. Chem. 46:

7 4. Takehisa, M, Shintani, H, Sekiguchi, M, Koshikawa, T, Oonshi, T, Tsuge, M, Sou, K, Yamase, Y, Kinoshita, S, Tsukamoto, H, Endo, T, Yashima, K, Nagai, M, Ishigaki, K, Sato, Y, Whitby, JL The radiation resistance of the bioburden from medical devices. Radiat. Phys. Chem. 52:

8 Figure 1. Plot of the radiation response of the SDR and its components at a bioburden of

9 Figure 2. Plot of the radiation response of the SDR and its components at a bioburden of 1. 9

10 Figure 3. Bar plot of RIF values at an SAL of 10-2 and 10-6 for a bioburden of 1. 10

11 Figure 4. Bar plot of RIF values at an SAL of 10-2 and 10-6 for a bioburden of

12 Figure 5. Bar plot of RIF values at an SAL of 10-2 and 10-6 for a bioburden of

13 Figure 6. Bar plot of RIF values at an SAL of 10-2 and 10-6 for a bioburden of

14 Figure 7. Bar plot of RIF values at an SAL of 10-2 and 10-6 for a bioburden of

15 Figure 8. Plot of the radiation response of the SDR and the 4.0 kgy component at a bioburden of

16 Figure 9. Plot of the radiation response of the SDR and the 4.0 kgy component at a bioburden of 1. 16

17 Figure 10. Plot of the radiation response of the SDR at a bioburden of 1000 and illustration of PD 10, TD 10 and ND 10 calculations. 17

18 Figure 11. Plot of radiation response of the SDR at bioburden levels of 1, 1000, and 10 6 showing PD 10 and TD 10 and a linear extrapolation of PD 10 to an SAL of

19 Figure 12. Plot of the difference between SDR- and linear extrapolation-prescribed 10-6 SAL doses. 19

20 Figure 13. Plot of the ratio between SDR- and linear extrapolation-prescribed 10-6 SAL doses. 20

21 Figure 14. Illustration of the effect of a 10x increase in the 4.0 kgy D 10 component of the SDR. 21

22 Figure 15. Radiation response of six model populations. 22

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