The production of medical devices like stents, dressings and
sutures is carried out in a cleanroom environment, where pollutants such as
dust, microbes and vapours are tightly controlled at low levels. Integral to
this environment is a humidification
system, but why exactly is it so important in medical equipment manufacturing?
Moisture sensitivity
The materials used to make medical equipment can be
sensitive to moisture and their integrity may be compromised if humidity falls
outside a certain range. A humidification system ensures air moisture can be
managed with the utmost accuracy.
Static elimination
To meet the requirements of IEC 60601-1-2 for
electromagnetic compatibility, medical devices must be resistant to ESD
(electrostatic discharge). To achieve this, relative humidity (RH) must be
maintained at 55%. This eliminates the effects of static electricity, which can
be discharged as a spark or cause materials to become attracted to each other.
Activating agent
Humidification also acts as an activating agent, which is
useful because some substances only become active at a certain RH. One such
substance is ethylene oxide, which acts as a sterilising agent but is only
active at 70% RH or over.
To enquire about humidification systems
and servicing for industrial, commercial, medical and many other applications,
call Steve Rix on 07966423165 or email steve.rix@gibbonsgroup.co.uk.
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