EN 285:2015

5 Reasons to contact Honeyman for your EN 285:2015 queries

  1. Independent consultation and appraisal of steriliser / autoclave manufacturer’s equipment for compliance with EN 285:2015 and EN17665
  2. Assistance in producing a user requirement specification (URS) and traceability requirements throughout the validation life cycle
  3. Honeyman provides comprehensive and interactive training on EN285 principles and requirements
  4. Supply of steam quality test kits to support your test requirements
  5. Experienced in carrying out steam quality testing in compliance with EN 285:2015

EN 285:2015 is the European standard for large steam sterilisers which has superseded EN 285:2006. Since 1st January 2016 all organisations using large steam sterilisers should adopt EN 285:2015.

The Honeyman Group can offer steam quality testing services to ensure your organisation meets the requirements of EN 285:2015 and EN17665. The steam supply required for moist heat sterilisation needs to be within the specifications set out in EN 285:2015. These are:

  • Non-Condensable Gases: Required Result = 3.5%
  • Superheat: Required Result = 25ºC
  • Dryness Value: Required Result ≥0.95
  • Non-Condensable Gases: Required Result = 3.5%

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.

Air Detectors

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.

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.

Condensate Testing

Our MHRA approved analytical laboratory tests condensate samples to EN285, HTM 2031 and WFI specifications as defined in the EP & USP.

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.

Thermal Mapping

Honeyman perform thermal/temperature mapping exercises across a wide temperature and humidity range from -80°C to 400°C, accurately validating extreme environments from autoclaves to cold product storage areas and stability suites.

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.

Training

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.

Why Honeyman?

  • Established History in purity water and steam systems.
  • We can operate on a 'one stop shop' basis, or supply packages of work to suit.
  • From engineering design to installation management, we cover a wide range of skills.