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Sterilization Equipment Technical Specifications
Sterilization equipment is essential for ensuring the safety of medical devices and surgical instruments used in patient care. This technical specification document covers steam sterilizers (autoclaves), ethylene oxide (EtO) sterilizers, hydrogen peroxide plasma systems, and related monitoring equipment used in healthcare sterile processing departments.
Steam Sterilization (Autoclave) Systems
Steam sterilization remains the most widely used and cost-effective method for sterilizing heat and moisture-resistant medical devices. Modern autoclaves incorporate advanced controls for consistent, validated sterilization cycles.
Steam Sterilizer Classifications
Type
Chamber Size
Primary Application
Tabletop Sterilizer
7-23 liters
Clinic, dental, point of care
Small Steam Sterilizer
24-85 liters
Ambulatory surgery, clinics
Medium Steam Sterilizer
150-280 liters
Hospital sterile processing
Large Steam Sterilizer
400-850 liters
High-volume SPD, central supply
Bulk/Cart Sterilizer
1000+ liters
Linen, bulk supply processing
Sterilization Cycle Parameters
Cycle Type
Temperature
Pressure
Exposure Time
Gravity (Wrapped)
121°C (250°F)
103 kPa (15 psi)
30 minutes
Gravity (Wrapped)
132°C (270°F)
186 kPa (27 psi)
15 minutes
Prevacuum (Wrapped)
132°C (270°F)
186 kPa (27 psi)
4 minutes
Prevacuum (Wrapped)
134°C (273°F)
207 kPa (30 psi)
3.5 minutes
Flash (Unwrapped)
132°C (270°F)
186 kPa (27 psi)
3 minutes
Immediate Use (IUSS)
132°C (270°F)
186 kPa (27 psi)
3-10 minutes
Chamber Specifications
Parameter
Specification
Construction
316L stainless steel, electropolished
Wall Thickness
3-6 mm depending on size
Maximum Operating Pressure
240 kPa (35 psi)
Temperature Range
105-138°C (221-280°F)
Vacuum Capability
-95 to -97 kPa (prevacuum cycles)
Door Type
Radial arm, sliding, or swing door
Door Seal
Inflatable silicone gasket
Utility Requirements
Utility
Small/Medium Sterilizer
Large Sterilizer
Steam Supply
Clean steam, 350-550 kPa
Clean steam, 450-700 kPa
Steam Consumption
30-70 kg/hour
100-250 kg/hour
Electrical
208-480V, 3-phase, 30-60A
480V, 3-phase, 60-200A
Water (cooling/steam)
Purified water, 20-40 L/min
Purified water, 40-100 L/min
Drain
Floor drain, 2-3 inch
Floor drain, 3-4 inch
Compressed Air
550-700 kPa, oil-free
550-700 kPa, oil-free
Low-Temperature Sterilization Systems
Low-temperature sterilization methods are used for heat and moisture-sensitive medical devices that cannot withstand steam sterilization.
Hydrogen Peroxide Gas Plasma
Parameter
Specification
Sterilant
58% hydrogen peroxide (H2O2)
Operating Temperature
45-55°C (113-131°F)
Cycle Time
24-75 minutes (depending on cycle type)
Chamber Pressure
0.3-0.5 Torr (vacuum phase)
H2O2 Concentration
1.8-6 mg/L
Chamber Volume
50-300 liters
Residual
H2O (water) and O2 (oxygen)
Vaporized Hydrogen Peroxide (VHP)
Parameter
Specification
Sterilant
35% hydrogen peroxide solution
Operating Temperature
25-50°C (77-122°F)
Cycle Time
30-55 minutes
H2O2 Concentration
1-4 mg/L
Relative Humidity
<10% during sterilization
Penetration
Limited lumen length capability
Residual
Water vapor and oxygen
Ethylene Oxide (EtO) Sterilization
Parameter
100% EtO
EtO Mixture
EtO Concentration
450-1200 mg/L
Varies by formulation
Operating Temperature
37-63°C (99-145°F)
37-55°C (99-131°F)
Relative Humidity
40-80%
40-80%
Exposure Time
1-6 hours
2-4 hours
Aeration Time
8-12 hours (at 50-60°C)
8-12 hours
Chamber Pressure
Vacuum or slight positive
Varies
Ozone Sterilization
Parameter
Specification
Sterilant
Ozone (O3) generated from oxygen
Ozone Concentration
85 mg/L (6.5%)
Operating Temperature
30-35°C (86-95°F)
Relative Humidity
85-95%
Cycle Time
4-4.5 hours
Chamber Pressure
Slightly above atmospheric
Residual
Oxygen (O2)
Sterilization Monitoring
Comprehensive monitoring using physical, chemical, and biological indicators is essential for validation and routine verification of sterilization processes. Understanding AAMI sterilization standards ensures proper monitoring protocols.
Biological Indicators
Sterilization Method
Test Organism
D-Value Requirement
Steam
Geobacillus stearothermophilus
D121 ≥ 1.5 minutes
H2O2 Plasma/VHP
Geobacillus stearothermophilus
D121 ≥ 1.0 minutes
Ethylene Oxide
Bacillus atrophaeus
D(54°C, 600mg/L) ≥ 2.5 minutes
Ozone
Geobacillus stearothermophilus
Per manufacturer validation
Dry Heat
Bacillus atrophaeus
D160 ≥ 0.5 minutes
Biological Indicator Performance
Parameter
Specification
Spore Population
≥10^5 to 10^6 CFU
Self-Contained BI
Integrated growth medium and indicator
Rapid Readout BI
1-3 hour fluorescence detection
Standard BI
48-hour incubation at 55-60°C (steam)
Control BI
Unprocessed positive control
Chemical Indicators
Class
Type
Purpose
Class 1
Process Indicator
Distinguishes processed from unprocessed
Class 2
Specific-Use Indicator
Bowie-Dick test for air removal
Class 3
Single-Parameter Indicator
Responds to one critical variable
Class 4
Multi-Parameter Indicator
Responds to two or more variables
Class 5
Integrating Indicator
Responds to all critical variables
Class 6
Emulating Indicator
Specific cycle performance
Physical Monitoring
Temperature Recording: Digital chart recorder, minimum resolution 0.1°C
Pressure Transducers: Accuracy ±1% of full scale
Time Documentation: Cycle phase timing with 1-second resolution
Printout/Digital Record: Permanent record of cycle parameters
Sensor Calibration: Traceable calibration per manufacturer requirements
Washer-Disinfector Specifications
Automated washer-disinfectors provide standardized cleaning and thermal disinfection prior to sterilization.
