Biological indicators role in CSSD equipment qualification and monitoring Paulo Roberto Laranjeira 1 Brazil Population (2010) Brazil So Paulo State Greater So Paulo City Quantity Hospitals9.000 Pharmeutical Industries823 2 Orion C.E. - Brazil Founded employees 12 equipment qualification teams Certified Kaye System maintenance and calibration services 3 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 Manufacturer IFUs Standards o ISO o ISO Standard 134C 4 minutes Cycle 5 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 Thermal Destruction of Microorganisms Log Log Log Log Log Log Log ,1Log ,01Log ,001Log ,0001Log ,00001Log ,000001Log Theory: Fo o Tref = 121C o D = 1 minute o Z = 10C OverKill = 12 logs 7 Thermal Destruction of Microorganisms Log Log Log Log Log Log Log ,1Log ,01Log ,001Log ,0001Log ,00001Log ,000001Log Biological Indicator Real evidence Fo = 1,8 * (Log 1,2 x Log 1,0 x ) Fo C 9 Cycle 121C/15 min (exposure only) Calculated Lethality during Exposure TempoTmn.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 Kill x Overkill 11 12 Cycle: 121C/15 minutes 121C 100C 50C Start Lethality Calculated for Tmin. > 100C TimeTmin.Let. Inst. Let. Acum.No END BIs in the Qualification 13 134C/4 min Qualification Theory Based o D 121 = 1 minute o Z = 10C o Tref = 121C 14 134C/4 min Qualification Based on BI 121C o D 121 = 1,9 minutes o Z = 20C o Tref = 121C 15 134C/4 min Qualification Based on calculated D 134 value o D 134 = 0,43 minutes o Z = 20C o Tref = 134C 16 Integrating 134C/4 min cycles Theory Based o D 121 = 1 minute o Z = 10C o Tref = 121C Based on 121C o D 121 = 1,9 minutes o Z = 20C o Tref = 121C Based on calculated D 134 value o D 134 = 0,43 minutes o Z = 20C o Tref = 134C Lethality = 159 minutes Lethality = 25 minutes Lethality = 4,96 minutes 17 Monitoring 134C/4 min cycles 134C 125C 50C 121C Sal = 1 x Recent occurrence 19 20 134C/4 min 134C 125C 50C 121C Start Lethality Calculated for Tmin. > 100C TimeTmin.Let. Inst. Let. Acum.No End Sterilization Cycle 1 21 Sterilization Cycle 2 22 Equipment Control 134C 125C 3 minutes 23 Equipment Control joules 2727 joules Water Water + Steam Saturated Steam Super Heated Steam Sensor error Deviation Temp CLethality 1,026% 0,512% 0,37% 25 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 ISO o When placed inside a PCD will adequately monitor: NCG 26 Thank You! Eng. Paulo Roberto Laranjeira Celular e Whatsapp: Facebook: Pictures and data: Google e OrionCE 27