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.
