Background
The testing of steam quality for physical attributes
such as levels of non-condensable gases, dryness
value and superheat is a requirement of EN 285 and
HTM 2010. While these specifically apply to the
European medical devices industries and the UK
health service respectively, they are applied to the
sterilization of porous loads (also known as wrapped
goods, equipment loads, hard goods etc.) within the
pharmaceutical and biotechnology industries by the
UK Medicines Control Agency, both within the UK and
overseas. While the relevance may not be immediately
evident, it is argued that the standards of
sterilization of equipment loads, particularly those
used to sterilize materials that are used for the
manufacture of aseptically filled product should at
least match published standards applied within the
medical devices industries.
Who
needs to test steam quality?
Manufacturers and processors of sterile products and medical devices within Europe and those who supply Europe. The requirement is restricted to the porous loads/dry goods/equipment processes, which impact on the sterility of finished products. Links The SQ1 Portable Steam Quality Test Kit - Scope of supply, Ordering information and Distributors. SQ1 Portable Steam Quality Test Kit Download brochure pdf 150 kb)
Information on the installation of the test points
required to conduct steam quality testing.
Installation/Test Point Information
Information on the
following services we offer worldwide:
For Steam Quality
Testing Service -
Click here
For Steam & Steam
Quality Training -
Click here
And for Steam System
Audits and Consultantcy Services -
Click here
Background information
on each of the tests and hints and tips.
Steam Quality Testing -
Hints and Tips
A short paper explaining the derivation of the steam
quality test limits.
Paper - Derivation of
Steam Quality Test Limits
Download pdf version (105 kb)
Paper "The Application
of Steam Quality Test Limits"
Download pdf version (171 kb)
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