ANSAmed
are the European leader of high quality, precision extrusion
with over 12 years experience in developing and producing
tubing for the interventional cardiology, radiology, urology,
gastrostomy and neuro-radiology fields.
Quality Control
ANSAmed operates state of the art extrusion equipment
with automatic feedback loop systems that allow them to
maintain constant melt pressure.
Ansamed’s quality system requires a Cpk of 1.33
for all production batches. However, for balloon tubing
and multilayer tubing where sample to sample consistency
in terms of dimensional & mechanical properties
is critical, Ansamed Cpk target is 1.50. Their state
of the art multilayer and balloon tube extrusion technology
allows them to hold tolerances down as low as +/-0.007mm
whilst maintain a Cpk level of 1.50
Cleanroom
All processing is carried out in Class 10,000 and 100,000
Cleanrooms complying with the industry`s highest standards
of GMP, ISO 13485 and FDA guidelines
