Kalrez Perfluoroelastomer Parts for Pharmaceutical and Food Handling Applications

Kalrez® parts made from compounds 6221 and 6230 provide superior chemical resistance and low contamination 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,

Unlike other elastomeric seals made with FDA compliant 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.

kalrez2In 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 perfluoroelastomer  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 perfluoroelastomer 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® 6221/6230 EPDM 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 Temperature 260°C (500°F) 135°C (275°F) 200°C (392°F) 200°C (392°F)
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
*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 the Gallagher Engineering Department or DuPont Down Elastomers for further information.
TABLE 2
Typical Physical Properties**
Compound Kalrez® 6221 Kalrez® 6230
Durometer Hardness, Shore A, point ±5 70 75
100% Modulus, psi (MPa) 1,050 1,020
Tensile Strength at Break1, psi (MPa) 2,200 2,400
Elongation at Break1, % 150 170
Compression Set2, 70hr at 160°C (320°F) 20 18
Color White Black
**Typical physical properties should not be the basis of design decisions.  Contact the Gallagher Engineering Department or DuPont Down Elastomers for further information.

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

2 ASTM D395 B, Size 214 O-rings

 
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.