Technical Bulletin

SOLVAY SPECIALTY POLYMERS

More Products with More Performance

Ixef PARA in Single-Use Instruments

Ixef polyarylamide (PARA) is a semi-aromatic, semi-crystalline polymer that can be highly glass fiber reinforced and still have high flow and a very smooth surface. It is readily injection moldable into complex shapes with thin cross-sections and long flow lengths. Ixef 1022 is a 50% glass-fiber grade that offers high rigidity and strength, making it an excellent candidate for replacing metal in single-use medical instruments and devices. High-energy gamma radiation is a cost-effective method for the bulk sterilization of single-use medical instruments. This document presents data showing that sterilization with gamma radiation does not degrade the mechanical properties of Ixef PARA. The data also shows that a newly developed line of Ixef GS-1022 colors are quite stable to gamma radiation. Mechanical Properties To measure the effect of gamma sterilization on the mechanical properties of Ixef PARA, standard test specimens were irradiated at dose levels of 20 and 40 kGy. The irradiated specimens were then tested using the appropriate ASTM test method and the results compared to those of control samples that had not been irradiated. The high energy of gamma sterilization does not affect the mechanical properties of Ixef PARA. The data is shown in Table 1 and summarized in Figure 1.

Table 1: Effect of Gamma Radiation on Mechanical Properties ASTM Method Tensile Strength D638 No Exposure After 40 kGy % Retention Tensile Elongation D638 No Exposure After 40 kGy % Retention Tensile Modulus D638 No Exposure After 40 kGy % Retention Dynatup Max Load D3763 No Exposure After 40 kGy % Retention Ixef 1022/0006 294 MPa 294 MPa 100 2.5% 2.5% 100 18.4 GPa 18.6 GPa 101 181 kg 1812 kg 100 42,600 psi 42,600 psi 100 2.5% 2.5% 100 2,670 kpsi 2,700 kpsi 101 400 lb 402 lb 100 Ixef GS-1022/WH01 240 MPa 242 MPa 101 1.6% 1.6% 100 21.9 GPa 21.8 GPa 100 128 kg 125 kg 98 34,800 psi 35,100 psi 101 1.6% 1.6% 100 3,170 kpsi 3,160 kpsi 100 283 lb 277 lb 98

Figure 1: P  roperty Retention After 40 kGy Gamma Sterilization

100

One method for expressing the difference between two colors is the value E, which is calculated using this equation. E = (L2 + a2 + b2)1/2 High values of E indicate a substantial color difference. It is generally accepted that a E of 1 or less would be difficult for the human eye to perceive. The data in Table 2 shows that the Ixef 1022/0006, the natural colored grade, has a significant color change, but the color of the gammastabilized Ixef GS-1022/WH01 changes much less. Several other gamma-stabilized colors were created. These colors were measured before and after irradation and the E calculated. The data is summarized in Figure 2 and compared to the Ixef 1022/0006. In general, all of the GS colors have very low E implying that most observers would not perceive a significant color change. Figure 2: Color Change After 40 kGy Gamma Sterilization
40 35 30
35.7

80

Percent

60

40

20

Tensile Strength

Tensile Elongation

Tensile Modulus

Dynatup Max Load

Ixef 1022/0006

Ixef GS-1022/WH01

Color Stability Gamma radiation is a popular method for sterilizing singleuse medical instruments and devices because a large number can be sterilized at one time. To evaluate the effect of gamma sterilization on the color of various Ixef PARA grades, the color of samples was measured with a spectrophotometer before and after irradiation. The data in Table 2 is expressed using the CIE system where "L" denotes light vs. dark, "a" denotes red/green, and "b" denotes blue/yellow. Table 2: Color Change Due to 40 kGy Gamma Sterilization(1) CIE L a b E
(1)

Delta E

25 20 15 10 5 0
4.65 1.99 1.18 0.16 1.55 0.44 0.07 0.06

22

10

Ixef 1022/0006 0 kGy 80.97 -4.42 6.65 40 kGy 65.93 0.34 38.68 35.70

Ixef GS-1022/WH01 0 kGy 90.42 -1.88 3.36 40 kGy 91.34 -1.35 6.83 4.65

Ixef 1022/0006

Ixef GS-1022 Colors

CONCLUSION Ixef 1022 polyarylamide tolerates gamma-radiation sterilization very well, with virtually no loss of mechanical properties. Although the natural resin shows a tendency to discolor when irradiated with a shift toward green, special gamma-stabilized colors show minimal color change when exposed to gamma radiation.

There will be a shift in color when comparing pre-gamma sterilization and post-gamma sterilization colors. It is also expected that the colors will revert to some degree, back toward the as-molded color. Lighter colors may display the greatest variation.

Ixef PARA in Single-Use Instruments | 2

te Br ow n

01

02

51

ue

re e

00

ac Bl

k W

Bl

/0

ra

ra

ra

hi

Technical Bulletin

SOLVAY SPECIALTY POLYMERS

More Products with More Performance

www.SolvaySpecialtyPolymers.com
Contact Solvay Specialty Polymers Europe, Middle East and Africa SpecialtyPolymers.EMEA@solvay.com Americas SpecialtyPolymers.Americas@solvay.com Asia and Australia SpecialtyPolymers.Asia@solvay.com

Material Safety Data Sheets (MSDS) are available by emailing us or contacting your sales representative. Always consult the appropriate MSDS before using any of our products. Neither Solvay Specialty Polymers nor any of its affiliates makes any warranty, express or implied, including merchantability or fitness for use, or accepts any liability in connection with this product, related information or its use. Some applications of which Solvays products may be proposed to be used are regulated or restricted by applicable laws and regulations or by national or international standards and in some cases by Solvays recommendation, including applications of food/feed, water treatment, medical, pharmaceuticals, and personal care. Only products designated as part of the Solviva family of biomaterials may be considered as candidates for use in implantable medical devices. The user alone must finally determine suitability of any information or products for any contemplated use in compliance with applicable law, the manner of use and whether any patents are infringed. The information and the products are for use by technically skilled persons at their own discretion and risk and does not relate to the use of this product in combination with any other substance or any other process. This is not a license under any patent or other proprietary right. All trademarks and registered trademarks are property of the companies that comprise the Solvay Group or their respective owners. 2012 Solvay Specialty Polymers USA, LLC. All rights reserved. D 11/2010 | R 07/2012 | Version 2.1