Medifab Polyester 21 Micron - Open Area %: 12 - Width: 40 in

SEFAR MEDIFAB Quality

• Passes USP plastics class VI tests
• Biocompatible according to ISO 10993
• Pyrogen-free
• Non-hemolytic, non-cytotoxic, low extractables
• Precision monofilament fabrics having defined surface characteristics
• 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

Packaging / Labeling

• Stamped pieces are packed into sealed PE bags
• Stamped pieces made of SEFAR MEDIFAB fabrics are double bagged
• The label contains the following standard information: manufacturer, material, outer dimensions, manufacturing date, order number, batch number
• If it is packed according to medical standards (double-layer packaging), the label is attached to the inner bag

Product forms

• Cold stamping is the most economical process and provides standard-tolerance pieces with edges that are not sealed. Cold stamping is possible for all fabrics. Piece dimensions range up to 1000 x 1000 mm
• Laser stamping provides a heat-sealed edge. Maximum dimensions are 480 x 480 mm
• Ultrasonic stamping is available for fabrics having mesh openings < 400 um. It ensures tight tolerances and provides high-quality sealed edges which do not fray
• Stamped discs with a diameter range of 6 to 95 mm are possible. Multilayer pieces are possible