Pleated elements, Tubes and Ribbons
High throughput rates, precise mesh openings and the proven biocompatibility of Sefar filters contribute to the excellent reliability and performance of cardio devices used in open-heart and other surgeries.
Tightly-controlled manufacturing processes and production in clean-room facilities guarantee the high quality demanded for medical device components.
Microporous depth filter and woven filters are built into the venous/cardio reservoir.
The filter fabrics serve as highly precise security filters to reliably block particles, blood clots etc.
The filter surface area is increased through pleating to obtain a high filtration performance.
The thermal properties of polymers, as well as the tuned heat settings, allow an exact fit of the pleat pack to customer requirements.
SEFAR MEDIFAB Quality
Passes USP plastics class VI tests
Biocompatible according to ISO 10993
Non-hemolytic, non-cytotoxic, low extractables
Precision monofilament fabrics having defined surface characteristics
Customer specific surface coatings available (including plasma)
Customer specific fabrication in a clean room class 7 (ISO 14644-1)
Raw materials comply with FDA 21 CFR 177
Raw materials used are polyester (PETP) and polyamide (PA)
Non-standard materials, e.g. polyetheretherketone (PEEK) or polypropylene (PP)
can be supplied in MEDIFAB quality upon request
ISO 13485 certified production processes
Validated washing and finishing process in accordance with GMP guidelines
ISO 9001 quality system and ISO 14001 environment management system
Additional information on our fabrication capabilities can be found by following the links below: