V6 2012.12.12

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Healthcare

SaatiCare ® fabrics are the main choice in

applications such as infusion and

transfusion filters, microaggregate filters,

arterial and venous filters in oxygenator

reservoirs and blood bags.

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Fabric’s Features

• Polyester or Polyamide filtration fabrics

• LAL tested / conforms to USP Class VI

• Uniform Pore Size (7-2000 μm)

• High open area

• Smooth monofilament fiber

• Consistent geometrical tolerances

• Excellent strength and dimensional stability

• Precise selective filtration

• Minimal Pressure Loss & High Flow Rates

• Non-shedding & reduced risk of Hemolytic

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SAATI medical fabrics can be tested and certified according to the following regulations:

Tests

USP CLASS VI TEST

USP 24/NF 19, 2000. Biocompatibility of plastics. Including

Systemic Toxicity, Intracutaneous Toxicity and Implantation Tests.

LAL TEST

USP 24/NF. 19, 2000 Limit: 0,125 EU/ml

Pyrogen Endotoxin Test. Detects endotoxins released after the

death of bacteria.

HEMOLYSYS TEST

DIN 58970 Test detecting compounds which may

damage red blood cells.

CYTOTOXICITY TEST

ISO 10993 Part 5 Investigates whether the leachables

from the material may cause cytotoxicity (death of cell) or not.

EXTRACTABLES

21CFR177.1630 21CFR177.1500 Amount of extractables from a filter

during its intended use.

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Certification

Certified to UNI EN ISO 9001

Vision 2000, SAATI is committed to

monitoring quality during weaving,

finishing and through at every

production phase

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All the geometrical and physical properties of the fabric are controlled daily.

These measures include:

Quality

All QCs are ruled by internal procedures

and international regulation (UNI EN for

textile), with dedicated instruments.

Mesh Opening, Open area

Thickness, Weight

Mechanical Properties

Mesh Count, Thread

Diameter

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Applications

MEDICAL DIAGNOSTIC

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Medical Applications

Blood bags

Infusion filter

Transfusion filter

Arterial filter

Cardiotomy

Oxygenators

TECHNICAL FEATURES :

• USP Class VI approved

• Precise aperture size

• High flow rates, low pressure loss

• Smooth and uniform surfaces

• Tight tolerances

• Good dimensional stability

• Lot-to-lot consistency

• Excellent strength

Medical Applications: Infusion & Transfusion filters

INFUSION FILTERS :

• Solution: medical grade woven mesh with 15-

18 mm opening

• Mesh polymer: PA

• Fabricated part: flat disc (15-20 mm diameter)

TRANSFUSION FILTERS :

• Solution: medical grade woven mesh with 100-

200 mm opening

• Mesh polymer: PET

• Fabricated part: seamed tubes (12-15 mm

diameter)

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Medical Applications: Blood Bags & Cardiotomy

BLOOD BAGS

•Solution: medical grade woven mesh

with 40-200 mm opening

•Mesh polymer: PET

•Fabricated part: shaped flat parts sealed

within the plastic bag

CARDIOTOMY RESERVOIR

•Solution: medical grade woven

mesh with 20-40 mm opening

•Mesh polymer: PET

•Fabricated part: pleated cartridge

Medical Applications

MICRO-AGGREGATES FILTERS :

• Solution: medical grade woven mesh with 7-30 mm opening

• Mesh Polymer: PET

• Fabricated Part: various shapes, flat or round pleated elements are very

common

ARTERIAL FILTERS :

• Solution: medical grade woven mesh with 20-40 mm opening

• Mesh Polymer: PET

• Fabricated part: pleated cartridges (30-60 pleats, 50 mm diameter, 60 mm

cartridge height)

OTHERS:

• Flow control devices

• Dialysis protection filters

• Syringe in-line filters

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Diagnostic Applications: Spyrometers & Biopsy bags

BIOPSY BAGS & IN-VITRO TESTING

•Solution: Woven mesh with 50-200

mm opening

•Mesh Polimer: PA/Terital

•Fabricated part: folded sealed bags (30-

70 mm size). Available with or without

flap

SPYROMETERS

•Solution: Woven mesh with 15 – 100 mm

•Mesh Polimer: PA/PET

•Fabricated part: disc

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Diagnostic Applications

APPLICATIONS :

• Diagnostic test strips

• Sample preparation

• Reagent delivery

• Substrate for membranes

• Meshes acting as pre-filter, spacers, sample collectors…

TECHNICAL FEATURES :

• Precise aperture size

• High wicking rate (lateral flow)

• Good hydrophilic properties

• Smooth and uniform surface

• Lot-to-lot consistency

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SAATICare Hyphyl

Hydrophilic treatment

It is a proprietary hydrophilic coating that gives a very low contact angle and increases the spreading

performance in a liquid diagnostic device or medical device.

test strip: the volume of the test liquid is transferred to the lower layers of the strip in a very efficient

way and big quantity

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Production Capabilities: “Warping & Weaving”

SAATI supplies hi-tech precision monofilament fabrics

in Polyester, Polyamide, and Polypropylene

Production Capabilities: “Finishing”

SAATI offers Medical Grade Finishing through the use of clean equipment:

PLASMA TREATMENT

(Optional)

TWO WASHING

CYCLES WITH SOLVENT

THERMOSETTING

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Manufacturing Capabilities

CLASS 10.000 CLEAN ROOM

(ISO 7)

•DIE CUTTING

•HEAT CUTTING

•ULTRASONICS

•LASER

Fabricated Parts: examples

Heat or Ultrasonic Slit Ribbon Pleated cartridges

Ribbon Multi-layered Ribbon and tubular ribbon Cold punched parts Biopsy bag

Tubes

Medical Packaging

Double or multilayer packaging for fabricated parts in order to guarantee a high protection