ETO निर्जंतुकीकरण कामगिरी & तपशील | मुख्य तांत्रिक मार्गदर्शक

Ethylene Oxide Sterilizer: Complete Performance Specifications & Compliance

Master the critical design, material, safety, and cycle requirements for ETO sterilizers. Based on industry standards, this guide covers everything from chamber construction to automatic control and leakage testing.

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Ethylene Oxide (EO/ETO) sterilization remains a cornerstone for heat-sensitive medical devices. To ensure safety, efficacy, and regulatory compliance, the sterilizer must meet rigorous performance indicators. Below we break down the key specifications – from materials and door interlocks to automatic cycle control and validation.

1. Construction, Materials & Dimensions

देखावा & Structure

The sterilizer exterior must be smooth, uniform in color, free from burrs, cracks, or visible scratches. All fasteners, switches, and knobs shall be secure and operate without obstruction.

Chamber Dimensions

Rectangular chambers are defined by length, width, height, and volume; cylindrical chambers by diameter, depth, and volume. The usable space must maintain a minimum distance of 15 mm from heated surfaces and 30 mm from unheated surfaces.

साहित्य सुसंगतता

All parts contacting EO, steam, water, or compressed air must resist corrosion, not react with EO, and not promote polymerization. Natural rubber and latex are forbidden. Common approved materials: stainless steel (?8% nickel), ABS, PTFE, silicone rubber.

2. Piping, Vaporizer & Supply

Piping & Connections

  • लिक्विड निर्जंतुक पाइपिंग अखंड आणि गळती मुक्त असणे आवश्यक आहे.
  • सांधे (ईओ सिलेंडर कनेक्शन वगळता) वेल्डेड केले जावेत.
  • गॅस निर्जंतुक किंवा स्टीम वाहून नेणाऱ्या पाईप्सना थर्मल इन्सुलेशनची आवश्यकता असते.
  • EO साठी लवचिक टयूबिंगमध्ये स्टेनलेस स्टील, PTFE-लाइन किंवा नायट्रिल रबर वापरणे आवश्यक आहे.
  • मध्यम आणि प्रवाहाची दिशा स्पष्ट ओळखणे अनिवार्य आहे.

वाफ आणणारा & ईओ पुरवठा

  • चेंबरमध्ये प्रवेश करण्यापूर्वी वाफेराइझर ईओ गरम करतो; गरम पृष्ठभाग स्वच्छ करणे आवश्यक आहे.
  • वाष्पीकरणानंतर EO वायूचे तापमान 70°C पेक्षा जास्त नसावे.
  • ईओ काडतुसे किंवा सिलिंडर थेट गरम करण्यास मनाई आहे.
  • व्हेपोरायझरला EO पुरवठा लाइनमध्ये फिल्टर (?50?m) स्थापित केले आहे.
  • वजन-आधारित डोस: EO शुल्काच्या ±5% च्या आत स्केल अचूकता.
3. दरवाजा प्रणाली & सुरक्षा इंटरलॉक

दरवाजा सील करणे & प्रवेश

Doors must have replaceable seals, cleanable without removing the door. Before cycle start, loading door can be opened. Once cycle begins, door remains locked until “cycle complete” – unlocking requires a dedicated key, code, or tool.

Automatic & Manual Doors

Automatic doors stay locked and sealed if power fails. Manual door operation force must not exceed 150 N. Radial locking arms need a removable guard for inspection.

Double-Door Sterilizers

Simultaneous opening of loading and unloading doors is prevented except for maintenance. Indicators on both sides (and remote control room) show which door can be opened.

4. Instrumentation & Automatic Control

Mandatory instruments include:

  • Chamber pressure indicator
  • Chamber temperature indicator
  • Sterilization phase indicator
  • Cycle complete indicator
  • Door status indicator
  • Jacket temperature indicator
  • EO inlet temperature (if injection >30s)
  • तापमान & pressure recorders
  • Leak rate pressure monitor

तापमान & Pressure Accuracy

तापमान: range 0–100°C, accuracy ±1%, resolution 1°C, indication error <±1°C.
Pressure: range 0 kPa to max working pressure, accuracy ±1.6%, sterilization pressure error <±5 kPa. Leak test monitor: 20 kPa span, ±1% accuracy, 0.1 kPa resolution.

Recording & Data Integrity

Permanent records required (no thermal paper that fades). Sampling interval ?2 seconds. Digital records must be tamper-proof. Analog charts: speed ?1 mm/min, width ?100 mm. Digital records print cycle start/end values with out-of-tolerance alerts.

Automatic Controller

Class A sterilizers allow user programming with key/code; Class B are factory-programmed only. Over-temperature protection independent of control system. Software must be validated. Faults trigger visual/audible alarm and safe state.

5. Sterilization Cycle Stages (9 Phases)
  1. Chamber pre-heating
  2. Vacuum phase
  3. Automatic leak test
  4. Conditioning (heat & humidify)
  5. EO injection
  6. Sterilization exposure
  7. EO exhaust
  8. Aeration / washing
  9. Air admission & cycle end

Key requirements: Leak test must pass (pressure change ?0.3 kPa/min). Conditioning for Class B must maintain relative humidity >40%. Sterilization timing starts only when temperature, pressure, and concentration reach setpoints. After cycle, if door isn’t opened immediately, additional aeration or continuous flushing must ensure safe EO levels.

6. Performance, Electrical Safety & EMC
  • Chamber surface temperature ? setpoint +5°C.
  • Empty chamber temperature uniformity: ±3°C of setpoint.
  • Vacuum system must achieve -75 kPa or lower.
  • Leak rate: ?0.1 kPa/min for volumes ?1 m³.
  • Noise level ?65 dB(A).
  • Asbestos-free insulation; surfaces >55°C must be insulated.
  • Biological indicator inactivation required for Class B sterilizers.
  • Electrical safety per GB4793.1 / IEC 61010-2-040.
  • Electromagnetic compatibility per GB/T18268.1.
  • Sterilant verification independent of injection control (pressure, weight, or volume).
  • Fault diagnosis measures for maintenance.

Looking for a compliant ETO sterilizer?

Our ethylene oxide sterilizers meet the strictest performance specifications. Contact us today for a technical consultation or quote.

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