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Biological indicators role in CSSD equipment qualification and monitoring Paulo Roberto Laranjeira 1.

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Presentation on theme: "Biological indicators role in CSSD equipment qualification and monitoring Paulo Roberto Laranjeira 1."— Presentation transcript:

1 Biological indicators role in CSSD equipment qualification and monitoring Paulo Roberto Laranjeira 1

2 Brazil Population (2010) Brazil200.000.000 São Paulo State41.000.000 Greater São Paulo City22.000.000 Quantity Hospitals9.000 Pharmeutical Industries823 2

3 Orion C.E. - Brazil Founded 1998 32 employees 12 equipment qualification teams Certified Kaye System maintenance and calibration services 3

4 Regulations and Standards RegulationsStandards By country; Establishes minimum qualification requirements: o Frequency; o Load; o Responsibilities. Requirements for load monitoring International and local; Qualification and re- qualification steps; Critical normative criteria; Informative criteria; Load monitoring. 4

5 Manufacturer IFU´s Standards o ISO 17664 o ISO 11737 Standard 134ºC 4 minutes Cycle 5

6 First Step Protocols must be written and approved prior to equipment challenge o Qualification protocols o Indicators (biological, chemical and physical) protocols o CHANGE CONTROL 6

7 Thermal Destruction of Microorganisms 1.000.000Log 10 6 100.000Log 10 5 10.000Log 10 4 1.000Log 10 3 100Log 10 2 10Log 10 1 0Log 10 0 0,1Log 10 -1 0,01Log 10 -2 0,001Log 10 -3 0,0001Log 10 -4 0,00001Log 10 -5 0,000001Log 10 -6 Theory: Fo o Tref = 121ºC o D = 1 minute o Z = 10ºC OverKill = 12 logs 7

8 Thermal Destruction of Microorganisms 1.000.000Log 10 6 100.000Log 10 5 10.000Log 10 4 1.000Log 10 3 100Log 10 2 10Log 10 1 0Log 10 0 0,1Log 10 -1 0,01Log 10 -2 0,001Log 10 -3 0,0001Log 10 -4 0,00001Log 10 -5 0,000001Log 10 -6 8

9 Biological Indicator – Real evidence Fo = 1,8 * (Log 1,2 x 10 6 - Log 1,0 x 10 -6 ) Fo ≈ 21 minutes @ 121ºC 9

10 Cycle 121ºC/15 min (exposure only) Calculated Lethality during Exposure TempoTmín.Let. Inst.Let. Acum.No 16:03:30100,00,00 1,20E+06 16:04:30105,00,00 1,20E+06 16:05:30110,00,00 1,20E+06 16:06:30115,00,00 1,20E+06 16:07:30121,01,00 3,34E+05 16:08:30121,01,002,009,29E+04 16:09:30121,01,003,002,59E+04 16:10:30121,01,004,007,19E+03 16:11:30121,01,005,002,00E+03 16:11:30121,01,006,005,57E+02 16:12:30121,01,007,001,55E+02 16:13:30121,01,008,004,31E+01 16:14:30121,01,009,001,20E+01 16:15:30121,01,0010,003,34E+00 16:16:30121,01,0011,009,29E-01 16:17:30121,01,0012,002,59E-01 16:18:30121,01,0013,007,19E-02 16:19:30121,01,0014,002,00E-02 16:20:30121,01,0015,005,57E-03 16:29:30115,00,0015,005,57E-03 16:30:30110,00,0015,005,57E-03 16:31:30105,00,0015,005,57E-03 16:32:30100,00,0015,005,57E-03 Fo (required) = 21 minutes 10

11 Kill x Overkill 11

12 12 Cycle: 121ºC/15 minutes 121ºC 100ºC 50ºC Start Lethality Calculated for Tmin. > 100ºC TimeTmin.Let. Inst. Let. Acum.No END

13 BI´s in the Qualification 13

14 BI´s @ 134ºC/4 min Qualification Theory Based o D 121 = 1 minute o Z = 10ºC o Tref = 121ºC 14

15 BI´s @ 134ºC/4 min Qualification Based on BI information @ 121ºC o D 121 = 1,9 minutes o Z = 20ºC o Tref = 121ºC 15

16 BI´s @ 134ºC/4 min Qualification Based on calculated D 134 value o D 134 = 0,43 minutes o Z = 20ºC o Tref = 134ºC 16

17 Integrating F0 @ 134ºC/4 min cycles Theory Based o D 121 = 1 minute o Z = 10ºC o Tref = 121ºC Based on BI @ 121ºC o D 121 = 1,9 minutes o Z = 20ºC o Tref = 121ºC Based on calculated D 134 value o D 134 = 0,43 minutes o Z = 20ºC o Tref = 134ºC Lethality = 159 minutes Lethality = 25 minutes Lethality = 4,96 minutes 17

18 Monitoring 134ºC/4 min cycles 134ºC 125ºC 50ºC 121ºC Sal = 1 x 10 -7 18

19 Recent occurrence 19

20 20 134ºC/4 min 134ºC 125ºC 50ºC 121ºC Start Lethality Calculated for Tmin. > 100ºC TimeTmin.Let. Inst. Let. Acum.No End

21 Sterilization Cycle 1 21

22 Sterilization Cycle 2 22

23 Equipment Control 134ºC 125ºC 3 minutes 23

24 Equipment Control 155 135 120 115 100 85 70 55 40 568 joules 2727 joules Water Water + Steam Saturated Steam Super Heated Steam 2159 24

25 Sensor error Deviation Temp ºCLethality 1,026% 0,512% 0,37% 25

26 Monitoring best practices Biological Indicators o Monitor half cycles o Results depends on incubation period o Real evidence of sterilization o When placed inside a PCD will adequately monitor: NCG Superheated steam Chemical Indicators o Full cycle monitor o Immediate results o Requires: EN 285 ISO 17665 ISO 11607 o When placed inside a PCD will adequately monitor: NCG 26

27 Thank You! Eng. Paulo Roberto Laranjeira e-mail: prlaranjeira@usp.br Celular e Whatsapp: 11-98473-3020 Facebook: prlaranjeira@gmail.com Pictures and data: Google© e OrionCE 27

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