2.1 Appearance and Structure Request For Eto Gas Sterilizer Manufacturer
2.1.1 The overall shape should be precise, with smooth, clean surfaces and uniform color. There should be no burrs, sharp edges, cracks, visible scratches, or unevenness.
2.1.2 All external text, graphics, and symbols must be printed clearly, with precise and durable markings.
2.1.3 Fasteners must be securely installed. All control switches and adjustment knobs (or buttons) should operate smoothly and reliably without obstructions.
2.2 Dimensions Request For Eto Gas Sterilizer Manufacturer
2.2.1 The sterilization chamber should adhere to the design dimensions in millimeters, with a tolerance of ±1%.
2.2.2 To mitigate adverse effects around sterilization loads, the chamber should maintain at least 15 mm of clearance from heated surfaces and 30 mm from unheated surfaces.
2.3 Materials and Construction Request For Eto Gas Sterilizer Manufacturer
2.3.1 General Requirements
2.3.1.1 The manufacturer must specify the maximum operating pressure available for user selection.
2.3.1.2 The chamber’s inner surface should be partially or fully heated, meeting the requirements in Section 2.13.1.
2.3.1.3 Materials exposed to ethylene oxide (EO) under operating conditions must:
a) Resist corrosion from EO gas and its mixtures.
b) Not react with EO or its known contaminants.
c) Avoid promoting EO polymerization or decomposition.
Stainless steel or corrosion-protected low-carbon steel is recommended for construction.
2.3.1.4 Untreated low-carbon steel must not be used for internal pressure components.
2.3.2 Testing Ports
2.3.2.1 Temperature Ports
Chambers ? 5 m³ must have at least 10 temperature ports. For chambers > 5 m³, add one port for each additional cubic meter. Chambers ? 10 m³ require a minimum of 20 ports.
Each port must maintain at least 100 mm of clearance from internal or external obstacles and conform to GB/T7307-2001 standards for external threads.
2.3.2.2 Vacuum Testing Ports
At least one vacuum testing port must be securely installed, directly connecting to the chamber. The port must meet specified dimensional and safety requirements.
2.3.2.3 Sampling Ports
Chambers must include at least one sampling port for measuring EO concentration or relative humidity, meeting the same standards as vacuum testing ports.
2.4 Components, Pipes, and Fittings of Eto Sterilizer Manufacturer
2.4.1 Components
All components connected to the chamber must comply with general material requirements and be easy to clean if they contact EO.
2.4.2 Piping and Fittings
Piping in contact with liquid sterilizers must be seamless and designed to prevent leaks. Joints should be welded, except where disassembly is necessary for maintenance.
2.5 Doors, Controllers, and Interlocks
2.5.1 Door Seals
Doors should use seals compliant with material requirements and allow for easy cleaning or replacement.
2.5.2 Automatic and Manual Door Operations
Automatic doors must remain sealed in case of power failure, ensuring safety. Manual doors must require no more than 150 N of force to operate.
2.6 Control Valves
Valves must allow maintenance without disconnecting pipes and should include pre-filters with specified efficiency.
2.7 Utilities
2.7.1 Water
Atomized water should not be injected directly.
2.7.2 Steam
Steam pressure for humidification should not exceed 50 kPa.
2.7.3 Air and Inert Gases
Air must be dry, oil-free, and filtered to prevent contamination.
IF YOU WANT TO KNOW MORE About Ethylene Oxide Sterilization
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