Steamsteriliser

VARIOUS GUIDELINE REQUIREMENTS ON VALIDATION OF STEAM STERILISER

Section No. Requirement Section No. Requirement Section No. Requirement Section No. Requirement4.3.4Insulation material

Temperature of the outer surface of the insulation material shall not exceed 55°C@environment temperature of 23+2°C

5.3Air filter Retain NLT 99.5%

particles of > 0.3micron

NRV Shall be provided between the filter & the steriliser chamberto prevent steam penetation from steriliser chamber to the filter.

11 5.4Vacuum requirement

< 70mbar Vacuum requirement

Pressure less than 70 mbar absolute

9 13.3Pure Steam Quality

Steam Quality

Non condenasble gas

NMT 3.5% Non condenasble gas

NMT 3.5%

Dryness NLT 0.9% Dryness NLT 0.9%Dryness for metal load

NLT 0.95%

Throuougout the dryness test operating cycle the steam temp. should be within

3 deg. to that measured during the super heat test.

Super heat NMT 25°C Super heat NMT 25°C

PDA TR1 May 200HTM 2010,Part 3-6, June 2001 EN 285:1997 PICS, Sep 2004

Compiled by:Rajesh Pai, 14.05.2007 Page 1 of 5


Section No. Requirement Section No. Requirement Section No. Requirement Section No. RequirementPDA TR1 May 200HTM 2010,Part 3-6, June 2001 EN 285:1997 PICS, Sep 2004

11.34 8.3.2.2Vacuum leak Test (Hold time 10 min. @ 70mbar) :

The rate of pressure rise shall not be greater than 1.3mbar/min

Air leak test (Hold time 10 min.):

The rate of pressure rise shall not be greater than 1.3mbar/min

11.35 NGT 0.13Kpa/Min.Pressure leak Test (Hold time 60 min.) :

the pressure leak should not exceed 1.0mbar/min

13.39 8.3.2.1Bowie&Dick Test dor steam penetration

Uniform change throughout the indicator

Bowie&Dick Test

Temp (deg.C) Hold time (min.)134 3.3 to 3.5126 10.8 to 11.0121 16.8 to 17.0

10.12Sound pressure test

NMT <70dBA at a distance of 150mm to 1M from the equipment

6.3.2.1Chart speed NLT 4mm/min.Holding time15 min 121°C10 min 126°C3 min 134°C




13.7 8.3.1.2Thermometric (load )

Thermometric (load )

Equilibrium time NMT 15 Sec for chamber up to 800 lit

Equilibrium time NMT 15 Sec for chamber up to 800 lit

NMT 30 Sec for chamber volume above 800 lit

NMT 30 Sec for chamber volume above 800 lit

Temp.Fluctuation + 1°C Temp.Fluctuation + 1.5°C Ditribution temp. range

+ 0.5°C across load steady state

Diff. From one another

+ 2°C Diff. From one another

+ 2°C

Diff. Between the indicator& recoreder w.r.t.chamber discharge temp.

+ 1°C Loaded chamber distribution

The diff. Between the coolest spot & the mean chamber temp. should not be greater than +2.5°C

Pressure + 0.05 bar Pressure supply +10% at all times8.3.1Stabilisation Temp load

+ 3°C

Thermal monitors > 10 locations Probes 5 Penetration : 10 Distribution10 to 20 probes

Temp.Sensor response time

< 5s when tested in water

Thermocouple accuracy

+ 0.5°C

Heat penetrtaion Detrmination of Fo @ cold spot

F0 >12 min.

Note: Heat distribution & Penetration studies

Empty chamber distribution

Identify the location of cool spot

1.Rubber load separate 2.The sesnor for Recorder, Controller/Indicator should be separate.




Change in load size, load config, container characteristic must be accompanied by repeat validation studies

Load pattern Min & Max. load

Parameters High & Low temp range

Avg.temp during dwell period

Min. & Max F0 Value

Dwell time including the time required for vening the steriliser air

The product come up time to the desired temp. & cooling time.

Calibration before & after validation experiment

@ 0 to 125 °C




6.2.3Timer accuracy + 2.5% for 5 min.

+ 1% for > 5 min.6.3Recorder & Controller

Recorder shall be independent from the controller

6.3.2.2Temp. RecorderScale 50 to 150°CAccuracy + 1°CGradation Devision NMT 2°C

Sampling rate at least 2.5 sec. Temp. Recorder printing capability

@ 0.1°C increments

6.3.2.2Pressure. RecorderScale -1 to 3 bar / 0 to

400kPaAccuracy + 1°CGradation Devision NGT 0.2bar/20KPa

Sampling rate at least 1sec.Microbial ficacy of the cycle

SAL > 6 log reduction


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Steamsteriliser