Standard Cycle Operating Pressure -1 Bar to + 4 Bar:
(1) Heat up- ster hold (121°C) - exhaust
(2) Heat
up- ster hold (134°C)- exhaust
The technique uses the method of gravity air removal to ensure uniforms steam distribution and penetration.
Steam trap equipped with air vent ensure maximum air removal. Useful for sterilization of glass containers i.e. ampules, vials, glass bottles etc. It is also useful for Sterilization of glass wares, utensils, vessels, instruments, rubber articles linen etc |
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Dry Heat Sterilizer:
Salient Features
(1) Total GMP model
(2) Class 100 filter provided at air inlet in chamber.
(3) Pre Filter Provided at air inlet & outlet.
(4)
In Micro Processor for process operation with 10 programme.
(5) 8 Channel temperature scanning with processor
(6) Mimic display on control panel
(7) Cooling
attachment for rapid cooling
(8) Document like DQ, IQ, OQ, PQ provided.
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ETO Sterilizer:
J.b.Engineering ETO Sterilizer will be in sturdy construction using plates of appropriate thickness which prevents buckling under vacuum or bulging due to pressure. Made as per I.S. 3829 or ASTM Specifications.
(1) Standard Cycle Operating Pressure-1Bar to + 2 Bar
This technique uses near 100% air removal from sterilization chamber which results in better temperature uniformity in the chamber because of the absence of air pockets ie. Cold spots.
This technique increases the penetration of Eto gas in porous products from which removal of air is difficult.
(2) Vacuum
drying at the end of sterilizing
hold period ensures drying of the
material which has been sterilized
it is useful for ampoules in
cassettes, small items of processing
and packaging equipment entering the
class 1 area and processing drums,
garments, fabrics, drying, rubber
bungs vessels machine parts, liquids
in bottles and PVC pouches etc.
(3) Leak Test Cycle for periodic testing of door integrity and pipeline connections & detecting leakage ampoules.
(4) Another HP HV Cycle with post vacuum pulses can be provided, if required for special purpose. SS Construction with internal jacket plus Non contact part SS 304
The unit is mounted on sturdy tubular stand with level adjustment facility.
The jacket is made special technology (Dimple Jacket) which ensures better heat distribution in Chamber. And low cost operating fast sterilizing cycle.
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E.T.O. Sterilisation
Critical Process Paremeters and Safety
Presented by: Nishad Dhurandhar
Micretrol. |
How does ETO Kill ?
(1) Reacts
With critical molecules like dna
and enzymes inside the micro organism
(2)
Process is Called ALKYLATION
(3) E.T.O. irreversibly attaches itself to the
critical segments
(4) Since it is a chemical reaction,
appropriate atmospheric conditions are vital |
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ALKYLATION
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What Parametera Affect Kill?
(1) Several Parameters interact with each
other
(2) Most critical are:
-Temperature
- Ethylene Oxide Concentration
- Moisture (Humidity) leval
-
Exposure time
Tip: All paremetrrs must reach the most difficult
location in the load. |
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Temperature
(1) ETO Sterilisation most effective between 40-50c
(2) Air circulation inside the chamber
- Assures reducation in temperature variation
- Equilibrium in product and chamber temperature
(3) Location of temperature sensors for identifying
maximum temperature differential
- E.g. Unheated portions of the chamber. door. near
steam or gas entry points
(4) Periodic calibration of temperture gauges |
Humidity (waterVapour)
(1) Most critical parameter
(2)
The kill rate ofmicroorganismswithEto
depends on humidity
(3) Less
han30% may cause failure of theprocess
(4) Recommended: Relative Humidity of 50%
(Optimum range 40-70%)
(5)
Sensors to be placed at areas showing variable
humidity
- eg: pallet centre, Edges and Surfaces |
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How to achieve optimum humidity?
(1) Adequate pre conditioning
(2) Use steam pulses in your sterilisation
cycle
- steam helps achieve desired humidity leval
- it also reduces variation in temperature |
Sterilant concentretion and composition
(1) Quantity of Gas used depends on size of the steriliser
(2) Composition: 100% Ethylene Oxide
(3) Or a mixture of ETO and diluents
- 90% ETO & 10% co2
- 20% ETO & 80% CO2
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10% ETO & 90% CO2
(4) Dilution - relatively less flammable mixtures also
facilitating safe trensport of cylinders |
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Ensure a Non Flammable mixture inside the
steriliser at all times
HOW WOULD YOU KNOW? |
The Safety triangle
Figure 2.3 Flammable region of ethylene oxide/ caibon dixide/air mixtures
Air concentration (% vol)
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EXPOSURE PERIOD
(1) As determined during validation
(2) Half Cycle method of Validation: Commonly used technique
- Three Consecutive cycle to establish a minimum exposure time
- Population of not less than 106
- Specified Exposure time is at least double of minimum exposure time
- Includes a cycle of short duration from which survivors can be recovered (Eg: Aone sixth cycle)
(3) Typical exposure period of 6-8 hours for medical Devices . |
A Typical 100% ETO Cycle
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Other
Critical Parameters
(1) Pressure
- Pressure is directly proportional to gas
concentration
(2) Sterilant Temperature
- Ensure that gaseous ETO has been admitted into the chamber |
Safety Concerns
(1) Highty Reactive, Extremely Flammable
and Toxic
(2) Exothermic Reaction with many chemicals
- Contamination: a major source of hazards
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Precaution: Facility Design
(1) Strong Walls and Weak Roofs
(2) All electrical equipment shoud be
flameproof
(3) Insulation and sheathing advisable in the
interest of Energy conservation
- Refrain from using porous insulating
material
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Preventive Measures
(1) On siteEmergencyplanAstrategic Action plan to counter emergencies
(2) Training and awareness on ETO to all personnel
(3) Comply with stautory and regulatory authorities
- Pollution Control board
- Department of Explosives
- Health, safety & Environment
- Local drug control Authority
(4) Use of ETO Monitors in the facility
- 1 ppm in air as an 8 hr TWA
5 ppm 15 minute excursion limit
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