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What is Healthcare Technical Memorandum (HTM) Compliance?

The healthcare technical memorandum 2030 (HTM 2030) provides guidance on disinfection processes. Specifically it refers to the validation of all types of ultrasonic cleaner and washer disinfector used in the healthcare sector. HTM 2031 provides guidance on contamination within steam supply and also defines the specifications for ‘clean steam’ used within the healthcare sector

Why do we do it?

HTM 2030 defines microbiological specifications that washer disinfectors must meet to ensure patient safety. The final rinse water after the disinfection stage has occurred must meet quality standards to minimize microbial contamination of disinfected products. It is recommended that this monitoring be performed on a weekly basis. HTM 2031 outlines a specification that steam used for healthcare applications must meet. This ensures that the quality of the steam is appropriate for its intended use.

How?

At Honeyman we have a wide range of experience across the pharmaceutical and healthcare sectors. We are able to provide a fully comprehensive cGMP service ensuring your compliance with HTM 2030 for washer disinfector water and steam quality for HTM 2031.

For microbiological analysis of water to HTM 2030 we perform:

  • Total viable count (TVC) via membrane filtration (100cfu/100ml limit)

For steam quality testing to HTM 2031 we use specialist steam quality test kits to test steam dryness and non-condensable gases (NCGs).

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