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Analyzing HPHV Cycle in Steam Sterilizer - A Complete Pharma Solution
Analyzing HPHV Cycle in Steam Sterilizer - A Complete Pharma Solution
STEAM STERILIZER
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1- Stating of cycle
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Ts sterilization temperature
Note: During the plateau period the temperature measured above the test pack shall not
exceed the temperature measured at the reference measurement point of the sterilizer
chamber by more than 5 °C for the first 60 s and 2 °C for the remaining period.
t2 equilibration time
t3 initial 60 s
t4 holding time
Definition:
Equilibration time: Period which elapses between the attainment of the sterilization
temperature at the reference measurement point and the attainment of the sterilization
temperature at all points within the load
Holding time: Period for which the temperatures at the reference measurement point and
at all points within the load are continuously within the sterilization temperature band
Sterilization: Validated process used to render a product free from viable microorganisms
Steam Quality:
Pure steam is one of the essential utility required for steam sterilization. Therefore it is
important to ensure the quality of the steam is adequate. Dryness, superheat and non-
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condensable gases are the three important physical tests need to be conduct before
proceeding for qualification cycle. Condensate quality for trace metal analysis.
Dryness: A continuous supply of saturated steam is required for steam sterilization. Excess
moisture carried in suspension can cause damp loads, while too little cannot prevent the
steam from becoming superheated during expansion into the sterilizer chamber.
Superheat
<25°C of superheat
Note: Carry out an operating cycle with the sterilizer chamber empty. Place the full load,
textiles in the usable space and within 5 min carry out a further operating cycle. At the end
of the operating cycle check the temperature recordings to confirm that the temperature
measured in the steam pipe did not differ by more than 3 K from that measured in the
steam pipe during the steam quality, dryness test.
Non Condensable Gases (NCG): The steam quality test, non-condensable gases, is used to
demonstrate that the level of non-condensable gases contained in the steam will not
prevent the attainment of sterilization conditions in any part of the sterilizer load.
<3.5% NCG
Note: Test to be conducted with the empty chamber sterilization load. Carry out at least 3
tests. The maximum result shall comply with the requirements specified.
Condensate Quality
During the plateau period the temperature measured above the load does not exceed the
temperature measured in the active chamber discharge by more than 5°C for the first 60 s
and 2°C for the remaining period;
The equilibration time determined from the measured temperatures does not exceed 15
seconds for chambers up to 800 L and 30 seconds for larger chambers;
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The holding time determined from the measured temperatures is not less than that
specified for the sterilisation temperature;
During the holding time the temperatures measured in the active chamber discharge and in
the load:
the indicated and recorded chamber temperatures are within 1ºC of the temperature
measured in the active chamber discharge;
the indicated and recorded chamber pressures are within 0.05 bar of the measured
pressure
Steam sterilisation. The use of biological indicators intended for steam sterilisation is
recommended for the validation of sterilisation cycles. Spores of Bacillus
stearothermophilus (for example, ATCC 7953, NCTC 10007, NCIMB 8157 or CIP 52.81)
are recommended. The number of viable spores exceeds 5 × 105 per carrier. The D-value at
121 °C exceeds 1.5 min.
Reference:
#483 #F0 #GMP #MHRA #Palash chandra Das #Palash Das #PRES #
Qualification #Steam Quality #Steam sterilizer #USCGMP #USFDA #
warning letter
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