VARIOUS GUIDELINE REQUIREMENTS ON VALIDATION OF STEAM STERILISER HTM 2010,Part 3-6, June 2001 Section No. Requirement Section No. 4.3.

4 Insulation material EN 285:1997 Requirement Temperature of the outer surface of the insulation material shall not exceed 55°C@environment temperature of 23+2°C Retain NLT 99.5% particles of > 0.3micron Shall be provided between the filter & the steriliser chamberto prevent steam penetation from steriliser chamber to the filter. Pressure less than 70 mbar absolute Section No. PICS, Sep 2004 Requirement PDA TR1 May 200 Section No. Requirement

5.3 Air filter

NRV

11 < 70mbar Vacuum requirement 9 Pure Steam Quality Non condenasble NMT 3.5% gas Dryness Dryness for metal load Throuougout the dryness test operating cycle the steam temp. should be within Super heat NLT 0.9% NLT 0.95% 3 deg. to that measured during the super heat test. NMT 25°C

5.4 Vacuum requirement 13.3 Steam Quality Non condenasble gas Dryness

NMT 3.5%

NLT 0.9%

Super heat

NMT 25°C Page 1 of 5

Compiled by:Rajesh Pai, 14.05.2007

the pressure leak should not exceed 1.2. 121°C 126°C 134°C Compiled by:Rajesh Pai. Sep 2004 Section No.0 16. Requirement NGT 0. Requirement Section No.3.0mbar/min 8.VARIOUS GUIDELINE REQUIREMENTS ON VALIDATION OF STEAM STERILISER HTM 2010.5 10.2.3 to 3. Requirement 11.05.0 NMT <70dBA at a distance of 150mm to 1M from the equipment 6.) : 13. June 2001 Section No.): than 1.3. Requirement 8.C) 134 126 121 10.1 Bowie&Dick Test Uniform change throughout the indicator Hold time (min.35 Pressure leak Test (Hold time 60 min.1 Chart speed Holding time 15 min 10 min 3 min NLT 4mm/min.8 to 17.) 3.3.12 Sound pressure test EN 285:1997 PICS. 14.2007 Page 2 of 5 .34 The rate of Vacuum leak Test (Hold time pressure rise shall not be greater 10 min.39 Bowie&Dick Test dor steam penetration Temp (deg.8 to 11.3mbar/min 70mbar) : 11.2 Air leak test (Hold The rate of pressure rise shall not be greater time 10 min.3mbar/min PDA TR1 May 200 Section No.13Kpa/Min.Part 3-6.2. @ than 1.

From one another Ditribution temp.05 bar EN 285:1997 Section No.3.Fluctuation Diff. Sep 2004 Requirement PDA TR1 May 200 Section No.Rubber load separate 2. Pressure + 0.1 Stabilisation Temp + 3°C load Thermal monitors > 10 locations Probes 5 Penetration : 10 Distribution 10 to 20 probes Section No.5°C + 2°C Loaded chamber The diff. Requirement Temp. Requirement 13.1.Fluctuation + 1°C Diff. June 2001 Section No.2007 Empty chamber distribution Page 3 of 5 Identify the location of cool spot .Sensor response time < 5s when tested in water Thermocouple accuracy Heat penetrtaion Heat distribution & Penetration studies + 0.3.VARIOUS GUIDELINE REQUIREMENTS ON VALIDATION OF STEAM STERILISER HTM 2010. 14. Controller/Indicator should be separate.Part 3-6.r. Between the + 1°C indicator& recoreder w.7 Thermometric (load ) Equilibrium time NMT 15 Sec for chamber up to 800 lit NMT 30 Sec for chamber volume above 800 lit Temp.5°C across range load steady state Temp. Requirement 8. should not be greater than +2.chamber discharge temp.2 Thermometric (load ) Equilibrium time NMT 15 Sec for chamber up to 800 lit NMT 30 Sec for chamber volume above 800 lit + 1.5°C Detrmination of Fo @ cold spot F0 >12 min.t. PICS. Between the distribution coolest spot & the mean chamber temp.05. From one + 2°C another Diff. Note: 1.The sesnor for Recorder. + 0.5°C Pressure supply +10% at all times 8. Compiled by:Rajesh Pai.

Requirement Change in load size.05. 14.temp during dwell period Min. Calibration before @ 0 to 125 °C & after validation experiment Compiled by:Rajesh Pai. & cooling time.2007 Page 4 of 5 .VARIOUS GUIDELINE REQUIREMENTS ON VALIDATION OF STEAM STERILISER HTM 2010. load Section No. container characteristic must be accompanied by repeat validation studies Load pattern Min & Max.Part 3-6. June 2001 Section No. load config. & Max F0 Value Dwell time including the time required for vening the steriliser air The product come up time to the desired temp. Sep 2004 PDA TR1 May 200 Requirement Section No. EN 285:1997 Requirement PICS. Parameters High & Low temp range Avg. Requirement Section No.

6.1°C increments -1 to 3 bar / 0 to 400kPa Accuracy + 1°C Gradation Devision NGT 0.05.2 Temp. + 1% for > 5 min.2 Pressure.5% for 5 min.3 Timer accuracy + 2.2.3.3 Recorder & Recorder shall be Controller independent from the controller 6. Recorder Scale 50 to 150°C Accuracy + 1°C Gradation Devision NMT 2°C Sampling rate at least 2.Part 3-6. Requirement EN 285:1997 Section No. Section No. Requirement 6. 14. PICS. June 2001 Section No.2007 Page 5 of 5 . Microbial ficacy of SAL > 6 log reduction the cycle 6.VARIOUS GUIDELINE REQUIREMENTS ON VALIDATION OF STEAM STERILISER HTM 2010.2.2.2bar/20KPa Sampling rate at least 1sec. Recorder Scale Compiled by:Rajesh Pai. Recorder printing capability @ 0. Requirement Temp.5 sec. Sep 2004 Requirement PDA TR1 May 200 Section No.3.

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