EO sterilisation capability in a medical devices manufacturing facility
Key Statistics
Confidential client
PM Group Office
2,550 sqm

PM Group was awarded the project for an EO (Ethylene Oxide) Sterilization facility by a major Medical Device manufacturer in Ireland. The scope involved providing a new Ethylene Oxide Sterilization capability on the client’s site, replicating existing sterilisation cycles used for its current products. Project approval to qualification commencement was achieved in less than 18 months.

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Dermot Donnelly
Dermot Donnelly

Medical Technologies Sector Director

Safety and occupational exposure

The safety philosophy of the project was to design all EO exposed areas as a ‘Closed System’. This led to several innovations that eliminate risk to personnel and the environment.

The closed loop system employs state of the art FTIR (Fourier Transform Infrared) technology to control occupational exposure and monitor adjacent areas. The FTIR spectrometer sampling equipment measures all the IR wavelengths simultaneously and produces a full spectrum review.

All components of the sample spectrum can be analyzed from a single measurement. Any background interferences are resolved to avoid false alarms. Thus making it capable of detecting the smallest amount of EO in production exposed areas, or EO breaches into occupied areas.

Innovative features

  • Product Challenge Device (PCD) operator removal post EO cycle in a closed system for occupational exposure (first of kind)
  • Pressurized manual forklift for pallet transportation within a hazardous environment.
  • PPM monitoring for occupational exposure
  • FTIR spectrometer analysis technology.
  • Measurement of other common gas spectra to eliminate false alarms.
  • Zoned production and support areas with local and remote status indicators.



PM Group services included BOD, detailed design, procurement, regulatory licensing (Planning, Fire, EPA), RE services, construction oversight, support during construction, project cost control and reporting.

Dermot Donnelly

Medical Technologies Sector Director