What gas abatement systems are connected?

The exhaust is piped to an in-line catalytic scrubber neutralizing 99.9% of ETO emissions into water and CO2.

What water quality does the machine require?

Final rinse requires Water for Injection or Purified Water depending on the dosage form, supplied at the specified pressure and temperature. Earlier rinse stages can run on potable or purified water, and the machine records the conductivity of the final rinse.

How is cleaning effectiveness demonstrated?

Effectiveness is demonstrated during performance qualification by riboflavin coverage testing, followed by swab and rinse sampling against the residue limit calculated for your worst-case product.

What drainage is required at the installation point?

A floor drain sized for the peak discharge rate is required adjacent to the machine, with an air break to prevent back-siphonage. The utility schedule supplied with the machine gives the exact flow and connection sizes.

What warranty applies to this machine?

Machines are supplied with a 12-month warranty from commissioning covering manufacturing defects, with wear parts and tooling excluded. Extended cover is available under an annual maintenance contract, which also fixes response times for breakdown attendance.

What documentation is supplied at handover?

Handover includes the operation and maintenance manual, electrical and pneumatic schematics, the spare parts list with part numbers, material test certificates for contact parts, sensor calibration certificates and the completed qualification dossier.

ET-100 Ethylene Oxide (ETO) Medical Device Gas Sterilizer

Name: ET-100 Ethylene Oxide (ETO) Medical Device Gas Sterilizer
Brand: GentlemanPharmed
Availability: InStock

Automated 10 m³ Ethylene Oxide (ETO) sterilizer chamber for heat-sensitive medical devices, syringes, catheters, and blistered surgical kits.

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Overview

About the ET-100 Ethylene Oxide (ETO) Medical Device Gas Sterilizer

The **ET-100 ETO Gas Sterilizer** provides low-temperature (37°C to 55°C) gas sterilization for heat-sensitive plastics, electronic medical sensors, and pre-packaged surgical devices. The system manages pre-conditioning humidification, ETO gas injection, dwell sterilization, and multi-cycle vacuum degassing aeration within a single ATEX-compliant pressure vessel.

Automated In-Chamber Aeration: Thermal aeration cycles remove residual gas below 0.1 ppm without transferring pallets to separate degassing rooms.

Recorded Final Rinse Conductivity: Final rinse water quality is measured and written to the batch record, giving objective evidence that the cleaning cycle completed to specification.

Validated Cycle Recipes: Wash, rinse and dry stages run to stored recipes, so the qualified cycle is reproduced exactly on every load.

Specifications

Technical Specifications

Technical specifications for the ET-100 Ethylene Oxide (ETO) Medical Device Gas Sterilizer
Chamber Volume	10,000 Liters (10 m³)
Gas Mixture	100% ETO or 90/10 CO2 Blend
Working Temp	37°C to 55°C

* Specifications may vary by model. Contact us for exact configuration.

Validation Support

Full IQ/OQ/PQ documentation packages available. Our validation team works with your QA department to ensure regulatory acceptance.

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)

Compliance Standards

Built and tested to international pharmaceutical manufacturing standards.

WHO-GMPISO 9001CE MarkedCDSCO

FAQ

Product FAQs

Common questions about our pharmaceutical machinery.

ET-100 Ethylene Oxide (ETO) Medical Device Gas Sterilizer — Product Brochure

Technical specs, dimensions & ordering guide · PDF

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About the ET-100 Ethylene Oxide (ETO) Medical Device Gas Sterilizer

Chamber Volume

10,000 Liters (10 m³)

Gas Mixture

100% ETO or 90/10 CO2 Blend

Working Temp

37°C to 55°C