EN285: 2006 Large Steam Steriliser Standard Update
EN285:2006 is the European standard for large steam sterilisers. This standard has superseded EN285:1997 and since 1st October 2008 all organisations using large steam sterilisers should adopt EN285:2006.
Are You Compliant?
- Does your Autoclave pass the new Bowie Dick Towel Pack test?
- Does your steam supply to the Autoclave pass the required standards?
- Does your Autoclave have an Air Detector?
- Is your Autoclave cycle capable of meeting the new standards?
Bowie Dick Towel Pack Test
The steam supply required for moist heat sterilization needs to be within the specifications set out in EN285:2006. These are:
Non-Condensable Gases: Required Result ≤ 3.5%
Air and other gases, which do not condense under the conditions of steam sterilization and prevent the attainment of sterilization conditions in any part of the load.
Superheat: Required Result ≤ 25ºC
Steam whose temperature, at any given pressure, is higher than that indicated by the equilibration curve for the vaporization of water.
Dryness Value: Required Result ≥ 0.90: ≥ 0.95 for Metal Loads
The dryness fraction is a measure of the amount of moisture carried by the steam being supplied and used for sterilization.
Honeyman Has The Solution....
The Honeyman Group offers a full package of services that will help to increase the compliance and efficiency of your sterilisation processes, including;
Autoclave Health Checks
Our specialists will review your autoclave and its associated practices, assessing the suitability and use to provide an overview of performance, compliance and management issues, benchmarked against current industry best practice and cGMP.
Honeyman manufacture, supply, install, set up and test Air Detectors for new or existing autoclave systems which are either connected to a control system or a standalone chart recorder. We also supply a large range of validation and test equipment including Bowie Dick towel packs...more info
Clean / Pure Steam Quality Testing
Non-condensable gases, superheat and the dryness value of the steam all need to be within specification to provide confidence in the Autoclave's performance - we can test the quality of the clean / pure steam supply to your autoclave...more info
Our MHRA approved analytical laboratory tests condensate samples to EN285, HTM 2031 and WFI specifications as defined in the EP & USP...more info
New Cycle Design - Ensuring your Autoclave Meets the New Standards
Correct autoclave cycle design is crucial in meeting the new standards - our validation experts can deliver new cycle designs giving increased compliance confidence.
Honeyman perform thermal/temperature mapping exercises across a wide temperature and humidity range from -80oC to 400oC, accurately validating extreme environments from autoclaves to cold product storage areas and stability suites...more info
Service, Maintenance and Re-qualification Support Packages
With current GMP requirements your process must be maintained to ensure continued performance and compliance, Honeyman offer a full range of support services to help you achieve this...more info
On or off site, our training courses are delivered by industry experts with up-to-the minute knowledge and experience derived from real-life project experiences...more info