Sterilization Steam Quality: New

Technologies in Cycle Monitoring

Eng. Paulo Roberto Laranjeira

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 Sterilization Steam Quality: New Technologies in Cycle
Monitoring
Eng. Paulo Roberto Laranjeira

• Current Monitoring
• Chemical indicators
• Physical indicators (printout)
• Steam
• Saturation and dryness
• Non condensable gas
• Daily monitoring
• B&D
• New technologies

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Current steam sterilization
monitoring

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 Identifying failures

134ºC

125ºC
121ºC

50ºC

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 Easily appointed villains

Equipment failure Steam saturation

Load assembly error CIs Lot problem Non condensable gas

Thermal Shock

Water Quality

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Steam sterilization variables

Temperature
X
Pressure

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Steam saturation

Transfered energy: 80% * 2725 = 2.180 KJ/Kg

T (°C) superheated
d

134 b P = 3,0 Bar c

(mixture) Gas

a Liquid
(Energy)

Transfered energy: 80% * 563 = 450 KJ/Kg

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• Is reaching temperature sufficient to guarantee
sterilization?

NO!!!

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 Non condensable gas (NCG)

• Air and / or other gas that will not undergo

liquefaction under the conditions of saturated
steam processes (ISO 17665-1)
• Sources of NCG:
• Water: underground source - carbon
dioxide
• Water treatment: RO - carbon dioxide
• O2, CO2, N2, etc.
• Leakage in steam pipes, fittings, etc.
• Regulatory limit: 3.5% in steam line feed.

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 Sterilizer control

134ºC
125ºC

3 minutes

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 Dalton Law
• Dalton's law states that the total pressure of a gas mixture is equal to
the sum of the pressures exerted by each constituent gas.
Absolute Pressure (mBar)
Volume (liters) Temperatur3 (ºC)
Dalton Law

Steam NCG Steam NCG Steam + NCG Theory Real

1000 0 2100 0,0000 2100 121,79 121,79

900 100 1890 210 2100 121,79 118,50

990 10 2079 21 2100 121,79 121,47

999 1 2098 2 2100 121,79 121,77

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• Is reaching pressure sufficient to guarantee
sterilization?

NO!!!

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Test Bowie & Dick

• Instructions for use (IFU)

• Residual air
• Steam penetration
• Non condensable gas
• Requirements
• ISO 17665-2 – Daily
• AAMI ST-79

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Parametric measurements – 250 liter
sterilizer

1050 ml of air

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 Current equipment performance
requirements

=
Cycle without air

Cycle with air

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Correct requirements

ISO 11140-4
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• An approved B&D is sufficient to assure that there is
no residual air in the chamber?

NO!!!

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What Now

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New technology

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New technologies

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 Water quality

ISO/TC 17665-2:2013

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Daily challenge: conductivity

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What Now

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Questions?

• Eng. Paulo Roberto Laranjeira

• e-mail: paulo@orionce.com
• Celular e Whatsapp: 11-98473-3020
• Facebook: prlaranjeira@gmail.com

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•¡Muchas
Gracias!

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