Sterilization service sterilizer

CSSDfor central sterilization supply unitsethylene oxide

Overview
The ETO sterilization autoclave is an automatic system designed for Ethylene Oxide (ETO) treatment of palletized groups and clinical-device lots. The chamber is a parallelepiped constructed in AISI 304 stainless steel with carbon-steel reinforcements. A dedicated electronic control system regulates and continuously monitors cycle time, temperature, relative humidity and sterilant pressure to ensure repeatable, validated treatments.

Plant layout and capacity
External dimensions: 2450 mm (height) x 1600 mm (base) x 5500 mm (length). Nominal internal volume: 12 m³. Maximum palletized grouping size: 80 x 120 x 180 cm (H). Gas supply is provided from stainless-steel cylinders stored externally; the autoclave room is adjacent to the storage area.

Conformity and certifications

• PED 97/23/EEC for pressure equipment, CE0035 issued by TUV (test report No P28105226)
• UNI EN 1422:2009 (Ethylene oxide sterilizers)
• UNI CEI EN ISO 11135:2014
• ISPESL registration No 02/300475PD

Sterilization process and traceability
Devices are identified and moved into the autoclave via an internal transport system. Each grouping receives an adhesive chemical indicator sensitive to Ethylene Oxide and a green lot identification tag; each load is assigned a unique lot number for traceability. Multi-parameter chemical integrators are placed on pallets at critical positions to record temperature, relative humidity, time and ETO concentration. Biological indicators are positioned in critical external locations for laboratory sterility checks. The cycle is fully automated from the control PC and starts automatically once set parameters are reached. De-gassing is performed to achieve residual ETO levels compliant with ISO 10993-7. After treatment, products are moved to dedicated storage and returned with the Treatment Declaration and cycle report graphics.

Operation, safety and personnel
Operation is allowed only for authorized and trained personnel certified for gas handling. The facility uses a 10% ETO + 90% CO2 gas mixture (by weight) to limit ETO exposure while maintaining sterilization efficacy. The installation complies with applicable safety legislation including storage and use rules for toxic gases.

Characteristics / technical specifications

• Autoclave type: automatic, parallelepiped chamber in AISI 304 stainless steel with carbon-steel reinforcements
• External dimensions: 2450 mm (H) x 1600 mm (base) x 5500 mm (L)
• Nominal internal volume: 12 m³
• Maximum palletized grouping size: 80 x 120 x 180 cm (H)
• Gas mixture: 10% Ethylene Oxide + 90% CO2 (by weight)
• Gas supply: stainless-steel cylinders (storage external to plant)
• Control: electronic regulation and continuous monitoring of time, temperature, relative humidity and pressure; preset cycles on control PC
• Indicators: adhesive chemical indicators per grouping; multi-parameter chemical integrators on edge pallets; biological indicators for sterility validation
• De-gassing: performed to meet ISO 10993-7 residual ETO levels
• Standards and conformity: PED 97/23/EEC, UNI EN 1422:2009, UNI CEI EN ISO 11135:2014, ISPESL No 02/300475PD
• Operation restricted to authorized, trained personnel