Product Information

DescriptionMakrolon Rx1805 thermoplastic resin is a transparentpolycarbonate formulated to provide increased resistanceto chemical attack from IV (intravenous) fluid products,such as lipid emulsions. It also takes advantage ofproprietary technology to significantly reduce thediscoloration associated with gamma radiation sterilization.The resin is available in clear tint (451118) and selectedcolors.

ApplicationsMakrolon Rx1805 polycarbonate offers an outstandingbalance of high strength, toughness, clarity, processibility,and bondability for medical device components. In addition,it offers improved resistance to chemicals typically encoun-tered in a hospital or clinical environment, particularlyintravenous lipid emulsions (see table below). Typical IVapplications include luer fittings, stopcocks, Y-sitemedication ports, tubing connectors, spikes, and othercritical components that may be subjected to high stresseswhile in contact with these chemicals.

Chemical Compatibility with Lipids*

BiocompatibilityMakrolon Rx1805 resin is designated as medical-gradeand has met the requirements of the FDA-Modified ISO10993, Part 1 Biological Evaluation of Medical Devicestests with human tissue contact time of 30 days or less.Only medical-grade products may be consideredcandidates for applications requiring biocompatibility.

Regrind resins must not be used in medical applicationsrequiring biocompatibility.

MAKROLON Rx1805Polycarbonate ResinLipid-Resistant, Radiation-Stabilized Medical Grade

Manufacturers ResponsibilityIt is the responsibility of the medical device, biologicalproduct or pharmaceutical manufacturer (Manufacturer)to determine the suitability of all component parts and rawmaterials, including Makrolon Rx1805 polycarbonate,used in its final product in order to ensure safety andcompliance with FDA requirements. This determinationmust include, as applicable, testing for suitability as animplant device and suitability as to contact with and/orstorage of human tissue and liquids including, withoutlimitation, medication, blood, or other bodily fluids. Underno circumstances may Makrolon Rx1805 resin be used inany cosmetic, reconstructive, or reproductive implantapplications. Nor may Makrolon Rx1805 be used in anyother bodily implant applications, or any applicationsinvolving contact with or storage of human tissue, blood,or other bodily fluids, for greater than 30 days, based onFDA-Modified ISO 10993, Part 1 Biological Evaluationof Medical Devices tests.

The suitability of a Bayer resin in a given end-use envi-ronment is dependent upon various conditions including,without limitation, chemical compatibility, temperature,part design, sterilization method, residual stresses, orexternal loads. It is the responsibility of the Manufacturerto evaluate its final product under actual end-use require-ments and to adequately advise and warn purchasers andusers thereof.

Single-use medical devices made from a Bayer resin arenot suitable for multiple uses. If the medical device isdesigned for multiple uses, it is the responsibility of theManufacturer to determine the appropriate number ofpermissible uses by evaluating the device under actualsterilization and end-use conditions and to adequatelyadvise and warn purchasers and users thereof.

* Test bars were soaked with gauze saturated with a 20% IV fat emulsion for 48 hours at 73F. Some test bars broke before they couldbe measured (indicated by a dash in the table).

Maximum % Elongation Retention

Strain Level Rx1805 Standard Polycarbonate

0% 119 1171% 119 1071.4% 115 922.5% 104 5% 64

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SterilizationParts molded from Makrolon Rx1805 resin are sterilizableusing radiation, ethylene oxide, or steam autoclaving.When sterilizing with steam, germicides and detergentsmust be rinsed thoroughly from polycarbonate parts priorto autoclaving. Failure to thoroughly remove germicidesand detergents from the part prior to autoclaving maycause accelerated degradation of the polycarbonate.

Steam sterilization temperatures for parts made ofMakrolon polycarbonate must not exceed 250F (121C)to avoid part deformation. Please note that permanentimmersion of polycarbonate parts in water above 140F(60C) or in steam causes loss of material properties andmust be avoided. Furthermore, condensed steam shouldnot be allowed to accumulate, as this may cause damageto the parts. Polycarbonate parts should also be protectedfrom damage by substances such as alkaline corrosioninhibitors, which are frequently added to boiler feedwater.

The sterilization method and the number of sterilizationcycles a part made from Makrolon Rx1805 resin can with-stand will vary depending upon type/grade of resin, partdesign, processing parameters, sterilization temperature,and chemical environment. Therefore, the Manufacturermust evaluate each device to determine the sterilizationmethod and the number of permissible sterilization cyclesappropriate for actual end-use requirements and mustadequately advise and warn purchasers and users thereof.

DryingAll polycarbonate resins are hygroscopic and mustbe thoroughly dried prior to processing. A desiccantdehumidifying hopper dryer is recommended. To achievea moisture content of less than 0.02%, hopper inlet airtemperature should be 250F (121C) and inlet air dewpoint should be -20F (-29C) or lower. The hoppercapacity should be sufficient to provide a minimumresidence time of 4 hours. Additional information ondrying procedures is available in the Bayer brochureGeneral Drying Guide.

ProcessingMakrolon Rx1805 resin may be easily processed oncommercially available equipment suitable for polycar-bonate injection molding. Typical processing parametersare noted at right. Actual processing conditions willdepend on machine size, mold design, material residencetime, shot size, etc.

Additional information on processing may be obtainedby consulting the Bayer publication Makrolon Polycarbon-ate A Processing Guide for Injection Molding and bycontacting a Bayer technical service representative.

General Characteristics of PolycarbonateHydrolytic Stability. Parts molded from polycarbonateabsorb only 0.15 to 0.19% water at room temperatureand 50% relative humidity. Dimensional stability andmechanical properties remain virtually unaffected. Evenwith immersion in water, dimensional changes measureonly about 0.5%. Although frequent, intermittentcontact with hot water does not harm polycarbonate,continuous exposure to humidity or water at hightemperatures (>140F/60C) is not recommendeddue to hydrolytic degradation, which reduces impactstrength and tensile properties.

Gas Permeability. Steam permeability, measured on100-m thick film, is 15 g/m224 h (0.97 g/100 in224 h).Significant permeability also exists for other gases,such as hydrogen, carbon dioxide, sulfur dioxide,helium, ethylene oxide, and oxygen.

Chemical Resistance. Polycarbonate is resistant tomineral acids (even in high concentrations), a largenumber of organic acids, many oxidizing and reducingagents, neutral and acidic saline solutions, some greasesand oils, saturated aliphatic and cycloaliphatic hydro-carbons, and most alcohols. It is important to note thatpolycarbonate is degraded by alkaline solutions, ammoniagas and its solutions, and amines. Polycarbonatedissolves in a number of organic solvents, such ashalogenated hydrocarbons and some aromatic hydro-carbons. Other organic compounds cause polycarbonateto swell or stress-crack, e.g., acetone and methyl ethylketone. Since chemical resistance to various media isdependent on variables, such as concentration, time,temperature, part design, and residual stresses, theabove information should serve only as a guideline.It is imperative that production parts be evaluated underactual application conditions prior to commercial use.

Typical Injection Molding Conditions

Barrel Temperatures:Rear .............................................. 465510F (241266C)Middle ........................................... 515550F (268288C)Front .............................................. 535575F (279302C)Nozzle ........................................... 515585F (268307C)

Melt Temperature .............................. 540575F (282302C)Mold Temperature ............................... 150220F (65105C)Injection Pressure ......................................... 10,00020,000 psiHold Pressure .................................. 5070% Injection PressureBack Pressure ........................................................... 50100 psiScrew Speed ............................................................. 5075 rpmInjection Speed ................................................ Moderate to FastCushion ........................................................................ 1/81/4 inClamp ........................................................................ 35 ton/in2

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Makrolon Rx1805ASTM Resin

Typical Properties* Test Method U.S. SIfor Clear Tint Resin (Other) Conventional Metric

GeneralSpecific Gravity D 792 1.20Density D 792 0.043 lb/in3 1.20 g/cm3

Specific Volume D 792 23.1 in3/lb 0.83 cm3/gMold Shrinkage D 955 0.0060.008 in/in 0.0060.008 mm/mmWater Absorption, Immersion at 73F (23C): D 570

24 Hours 0.12%Equilibrium 0.30%

Melt Flow Ratea at 300C/1.2-kg Load D 1238 6.5 g/10 min

OpticalTransmittance at 0.125-in (3.2-mm) Thickness D 1003 76%

MechanicalTensile Stress at Yield D 638 9,400 lb/in2 65 MPaTensile Stress at Break D 638 10,200 lb/in2 70 MPaTensile Elongation at Yield D 638 6%Tensile Elongation at Break D 638 120%Flexural Stress at 5% Strain D 790 13,000 lb/in2 86 MPaFlexural Modulus D 790 340,000 lb/in2 2.4 GPaImpact Strength, Notched Izod: D 256

73F (23C)0.125-in (3.2-mm) Thickness 18 ftlb/in 960 J/m

ThermalDeflection Temperature, Unannealed: D 648

0.250-in (6.4-mm) Thickness264-psi (1.82-MPa) Load 259F 126C66-psi (0.46-MPa) Load 273F 134C

Vicat Softening Temperature: 50N; 50K/h D 1525 291F 144C

* These items are provided as general information only. They are approximate values and are not part of the product specifications. Type andquantity of pigments or additives used to obtain certain colors and special effects can affect material properties.

a For information on using melt flow as a quality control procedure, see the Bayer publication Makrolon Polycarbonate A Processing Guidefor Injection Molding.

Regulatory Compliance InformationSome of the end uses of the products described in thisbulletin must comply with applicable regulations, suchas FDA, NSF, USDA, and CPSC. If you have anyquestions on the regulatory status of this product,contact your Bayer representative or Bayers RegulatoryAffairs Manager in Pittsburgh, Pa.

Health and Safety InformationAppropriate literature has been assembled whichprovides information concerning the health and safetyprecautions that must be observed when handlingMakrolon Rx1805 resin. Before working with thisproduct, you must read and become familiar with theavailable information on its hazards, proper use, andhandling. This cannot be overemphasized. Information isavailable in several forms, e.g., material safety data sheetsand product labels. Consult your Bayer MaterialSciencerepresentative or contact Bayers Product Safety andRegulatory Affairs Department in Pittsburgh, Pa.

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Bayer MaterialScience LLC100 Bayer Road Pittsburgh, PA 15205-9741 Phone: 1-800-662-2927 www.BayerMaterialScienceNAFTA.com

The manner in which you use and the purpose to which you put and utilize our products, technical assistance and information (whether verbal, written or by way ofproduction evaluations), including any suggested formulations and recommendations are beyond our control. Therefore, it is imperative that you test our products,technical assistance and information to determine to your own satisfaction whether they are suitable for your intended uses and applications. This application-specificanalysis must at least include testing to determine suitability from a technical as well as health, safety, and environmental standpoint. Such testing has not necessarilybeen done by us. Unless we otherwise agree in writing, all products are sold strictly pursuant to the terms of our standard conditions of sale. All information andtechnical assistance is given without warranty or guarantee and is subject to change without notice. It is expressly understood and agreed that you assume and herebyexpressly release us from all liability, in tort, contract or otherwise, incurred in connection with the use of our products, technical assistance, and information. Anystatement or recommendation not contained herein is unauthorized and shall not bind us. Nothing herein shall be construed as a recommendation to use any product inconflict with patents covering any material or its use. No license is implied or in fact granted under the claims of any patent.

Note: The information contained in this bulletin is current as of December 2002. Please contact Bayer MaterialScienceto determine whether this publication has been revised.

Sales Offices17320 Redhill Avenue, Suite 175, Irvine, CA 92614-5660 1-949-833-2351 Fax: 1-949-752-13061000 Route 9 North, Suite 103, Woodbridge, NJ 07095-1200 1-732-726-8988 2401 Walton Boulevard, Auburn Hills, MI 48326-1957 1-248-475-7700 Fax: 1-248-475-7701

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