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PRECISION STENT WASHING
Washing after electro-polishing is a vital and challenging part of stent
production. The biocompatibility and clinical performance of the implant
can be adversely affected unless all production residues and particles
are removed from the surface of the implant. The DISA Med Tech precision
washing machine assures total particle and residue removal through
a rigorous process of spraying and washing with ultrasound.
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| The bench-top machine
- suitable for use in the cleanroom - is fully automated and allows
for routine analysis of rinse water after washing to meet the British
Pharmacopoeia requirements. |
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STENT CRIMPING
DISA Med Tech has an ISO 7 certified cleanroom and provides services
including stent crimping, post-crimp heat-setting, product assembly
and packaging. A specially developed process also makes possible the
crimping of drug-eluting stents without damage to the sensitive coatings. |
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POST CRIMPING HEAT SETTING
The DISA Med Tech heat setting machine is used for post-crimp processing
of coronary stents. The machine makes possible the formation of small
pillows on the outer surface of the stent and between the stent struts.
Heat-setting after crimping increases stent retention and also protects
the end struts from dislodgement and flaring by protecting these struts
from catching against obstructions, such as the guide catheter or
hard, calcified lesions.
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| The machine also provides
a highly reliable test for balloon damage caused by the crimping process.
This is a far more robust test than vacuum testing. |
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ETHYLENE OXIDE STERILISATION
DISA Med Tech has a 3M ETO Steriliser suitable for small batches.
The machine is suitable for low temperature (37°C) sterilisation
of sensitive devices, such as drug-eluting stents. The company offers
full sterilisation validation services.
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