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Sterile manufacturing requires a
constant supply of saturated steam. When steam systems are shut
down, large amounts of air can become trapped in the distribution
system. It is therefore necessary to test the quality of clean /
pure steam
produced to ensure that certain conditions are met. The
Honeyman Group has been
performing clean / pure steam quality testing for the world's leading pharmaceutical
and medical device manufacturers and hospitals for many years. With our
vast experience and knowledge of steam systems we can:
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Install test
points in clean / pure steam systems
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Perform clean /
pure steam
quality testing
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Advise and
troubleshoot in the event of OOS results - our engineers can provide
advice on system design, validation and maintenance
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Develop and
prepare protocol documentation and data reports - either to your
site specific requirements or our own concise templates and
procedures
Our fully trained and equipped technicians carry
out the full range of HTM (Health
Technical Memorandum) testing to the following standards using fully
validated test and data logging equipment:
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Clean Steam Quality testing to HTM
2010 and EN285, carried out on your site
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Condensate Analysis to HTM 2031, EN 285 or WFI (Pure
Steam and Clean Steam) USP/EP specifications
The range of HTM 2010 tests required for compliance in
the UK and Ireland require specific knowledge and experience. Our
validation teams have many years of experience in satisfying the
requirements of the MHRA and the IMB for HTM 2010 as applied to porous
load autoclave cycles.
From 1st
October 2008 all member states of CEN (European Committee for
Standardisation) who use steam in any moist heat sterilization
application will be required to test the steam for non-condensable
gases, superheat and dryness value.
Documentary evidence
that the sterilizer complies with the requirements of the European
standard will need to be established, maintained and declared.
The steam supply
required for moist heat sterilization needs to be within the
specifications set out in EN285:2006. This is:
Non-Condensable Gases: Required Result ≤
3.5%
Air and other gases
such as Carbon Dioxide,
which do not condense under the conditions of steam sterilization.
Superheat: Required
Result ≤ 25șC
Superheat steam is a steam at a
temperature which is greater than its
boiling point for its pressure. It will not condense until its
temperature drops to its boiling point and until this occurs the
moisture required for sterilization cannot be produced.
Dryness Value:
Required Result ≥ 0.90: ≥ 0.95 for Metal Loads
Wet steam can cause wet loads
which in turn can be considered un-sterile. In today's world,
confidence of sterility is paramount. Modern packaging prevents
re-infection when dry but bacterial retentive properties will be
dramatically affected by the presence of moisture. A value of 1
represents steam that is completely dry and free of moisture.
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