材料,Kalrez 6230 6221

○○○○○○○○○○○○○○○○○○○○○○○○○○○○○Perfluoroelastomer Parts for Pharmaceutical and Food Handling Applications

Kalrez® parts made from compounds 6221 and 6230 provide superior chemical resistance and low contami-nation from extractables in pharmaceutical and food handling applications where FDA compliance is required. Compounds 6221 and 6230 are especially suited for Water For Injection (WFI) systems, Steam-in-Place (SIP) cleaning and other critical systems. Thermal Stability

Unlike other elastomeric seals made with FDA com-pliant elastomers, Kalrez® perfluoroelastomer parts are thermally stable up to 260°C (500°F), permitting use in applications such as Stage II Sterilization processes, where other elastomers lose their sealing capabilities.

Aggressive Water Resistance

In aggressive pharmaceutical and semiconductor processing environments, seal failure from excess swelling, embrittlement or decomposition can cause unscheduled downtime or product contamination. Elastomeric materials that come in contact with highly pure and aggressive water (e.g., WFI) must be chosen with care in order to prolong seal life. The perfluoroelastomer compounds used in Kalrez® parts have been shown to have extremely low to non-detectable extractable levels in aggressive water systems. Because the perfluoroelastomer polymer in Kalrez® parts is fully saturated, it is also well suited for Ozonated Deionized Water service. Kalrez® parts also exhibit very low swell and loss of mechanical properties after repeated steam cycling.

General Chemical Resistance

The overall chemical resistance of EPDMs, silicone elastomers and fluoroelastomers (FKM) is limited by their respective polymer structures. Kalrez® parts, on the other hand, offer the same universal chemical resistance as PTFE, but unlike PTFE, they have elastomeric properties, which help them maintain their sealing capabilities. Table 1 lists the chemical compatibility of Kalrez® perfluoroelastomer parts and other elastomers used as sealing materials in the pharmaceutical and food handling industries.

Table 1

Elastomer Chemical Compatibility*

Chemical Kalrez® 6221/6230EPDM SI FKM Acetic Acid A A A B Acetone A A C U

Citric Acid A A A A Hydrogen Peroxide A B B B Isopropyl Alcohol A A A A Methyl Ethyl Ketone A A U U Mineral Oil A U B A NaOH A A B B

Nitric Acid A B B A Sodium Hypochlorite A B B A Soybean Oil A C A A Steam (<150°C [302°F])A A C U Steam (>150°C [302°F])A C U U Toluene A U U A Xylene A U U A Maximum Service Temperature260°C (500°F)135°C (275°F)200°C (392°F)200°C (392°F) *Data has been drawn from DuPont Dow Elastomers tests and industry sources. Data is presented for use only as a general guide and should not be the basis of design decisions. Contact DuPont Dow Elastomers for further information.

A = little or no effect

B = slight swelling and/or loss of physical properties

C = moderate to severe swelling and/or loss of physical properties/limited functionality U = not suitable or recommended

Rev. 1, M arch 2001

(01/02)Printed in U.S.A.

Reorder No.: KZE-H82109-00-C0102

The information set forth herein is furnished free of charge and is based on technical data that DuPont Dow Elastomers believes to be reliable. It is intended for use by persons having technical skill, at their own discretion and risk. The handling precaution information contained herein is given with the understanding that those using it will satisfy themselves that their particular conditions of use present no health or safety hazards. Because conditions of product use and disposal are outside our control, we make no warranties, express or implied, and assume no liability in connection with any use of this information. As with any material, evaluation of any compound under end-use conditions prior to specification is essential. Nothing herein is to be taken as a license to operate under or a recommendation to infringe on any patents.

CAUTION: Do not use in medical applications involving permanent implantation in the human body. For other medical applications, discuss with your DuPont Dow Elastomers customer service representative and read Medical Caution Statement, H-69237.Kalrez ® is a registered trademark of DuPont Dow Elastomers.Copyright © 1999, 2001 DuPont Dow Elastomers.All Rights Reserved.

For more information on Kalrez ® or other elastomers, please contact one of the offices listed below, or visit www.dupont-dow.com

Global Headquarters

DuPont Dow Elastomers L.L.C.300 Bellevue Parkway, Suite 300Wilmington, DE 19809 USA Tel. (302) 792-4000 (800) 853-5515Fax. (302) 2-7390

European Regional Headquarters

DuPont Dow Elastomers S.A.2, chemin du Pavillon

CH-1218 Le Grand-Saconnex Geneva, Switzerland Tel. +41-22-717-4000Fax. +41-22-717-4001

Asia Pacific Regional Headquarters

DuPont Dow Elastomers Pte Ltd.1 Maritime Square #10-54World Trade Centre Singapore 099253Tel. +65-275-9383Fax. +65-275-9395

South & Central America Regional Headquarters

DuPont Dow Elastomers Ltda.Alameda Itapecuru, 506 - Sala 12

Alphaville - Barueri - SP CEP 054-080Brazil

Tel. +55-11-4166-78Fax. +55-11-4166-

Kalrez® Asia Parts Marketing

DuPont Dow Elastomers Limited Dempa Bldg., 11–15

Higashi Gotanda 1-chome Shinagawa-ku

Tokyo, Japan 141-0022Tel. +81-3-3444-5166Fax. +81-3-3444-6095

Kalrez® Parts Marketing

DuPont Dow Elastomers L.L.C.P.O. Box 6098Newark, DE 19714Tel. (800) 323-9806

Kalrez® European Parts Marketing

DuPont Dow Elastomers N.V.Battelsesteenweg 455d B-2800 Mechelen, Belgium Tel. +32 15 28 87 00Fax. +32 15 28 87 50

Table 2

Typical Physical Properties**

Compound

Kalrez ® 6221

Kalrez ® 6230

Durometer Hardness, Shore A, points ±57075100% Modulus, psi (MPa)

1,0501,020Tensile Strength at Break 1, psi (MPa)2,2002,400Elongation at Break 1, %

150170Compression Set 2, 70 hr at 160°C (320°F)2018Color

White

Black

**Typical physical properties should not be the basis of design decisions. Contact DuPont Dow Elastomers for further information.1

ASTM D412, 20 in/min (500 mm/min)2

ASTM D395 B, Size 214 O-rings