USP Class VI Approved Compounds

Parker currently offers gaskets with both the plastic and rubber portions certified to USP Class VI standards. Based on the environment, different elastomers can be recommended.

The USP Class VI approved elastomers are:

• Silicone (S0317-60) – A red colored material that offers the widest temperature range of all the material choices - going from -65°F to 400°F. This material is good in dry heat and has good ozone resistance. This material has been certified based on the USP Systemic Toxicity Study in the Mouse, USP Intracutaneous Toxicity Study in the Rabbit, and the USP Muscle Implantation Study in the Rabbit. This material does not contain any animal-derived ingredients.
• Fluorocarbon (V1274-80) – A black colored material that offers good high temperature resistance capabilities – having a temperature range of -15°F to 400°F. This material has excellent resistance to ozone, oxygen, aromatics, and many organic solvents and chemicals. This material has been certified based on the USP Systemic Toxicity Study in the Mouse, USP Intracutaneous Toxicity Study in the Rabbit, and the USP Muscle Implantation Study in the Rabbit. This material does not contain any animal-derived ingredients.
• EPDM (E3609-70) – A black material that offers good temperature resistance – having a range of -65°F to 300°F. This material is the recommended material for optimal steam and water resistance and also has excellent ozone resistance. This material has been certified based on the USP Systemic Toxicity Study in the Mouse, USP Intracutaneous Toxicity Study in the Rabbit, and the USP Muscle Implantation Study in the Rabbit. This material also meets ISO 10993-5 and ISO 10993-10.
• Platinum-Cured Silicone (S7387-70) – A translucent material that offers a wide temperature range of -65°F to 400°F. The platinum cure system used in this particular silicone further prevents the potential of crystalline powders migrating to the surface – and therefore provides improved cleanliness of the material. This material has been certified based on the USP Acute Systemic Toxicity test, USP Intracutaneous Toxicity test, and the USP Implantation test. This material does not contain any animal-derived ingredients.

Gasket Engineering
Parker's (compression limited) sanitary gasket increases long-term sealability, offers excellent wear performance and complete material traceability – while greatly facilitating installation and removal.
Compatible with all ASME-BPE hygienic clamp unions, Parker's design offers minimal intrusion (± .003"" compared to industry average of 0.050”) mitigating the entrapment of any media, the reduction of fluid flow or creation of turbulent flow (that may disrupt cell cultures) - all of which can lead to microbial growth and contamination.
In addition, there are alignment tabs to correctly and quickly ensure correct alignment. The controlled compression limiter minimizes the need to re-torque, promotes the integral long-term condition of the gasket and prevents erosion of the elastomer. Of equal value, these features have the added benefit of exponentially reducing general maintenance and servicing labor costs.
All Parker compounds are certified FDA, 3A and USP Class VI, unlike many of our competitors who are only compliant. Where applicable, Parker compounds are also ADI Free.
SAVE $10-$30 Per year/ Per Connection
Product Features/Benefits
• Integral plastic frame allows for controlled compression:
o Allows clamp to achieve bolt yield avoiding need to ever re-torque
• Industry leading intrusion levels:
o Average intrusion of -.003” (industry average 0.050”) eliminates opportunity for microbial growth
• Long term sealability/ Minimal wear:
o Independently tested over 500 SIP cycles with no sign of wear
• Full material traceability:
o Guaranteed consistent performance
• Alignment tabs facilitate installation/ removal and color-coded for instant visual confirmation:
o No re-torqueing
o No cheater-bars required
o No ferrule cleaning required

For further specifics on our materials or should you have any additional materials requirements, please feel free to contact Parker.

Hygienic Sanitary Gasket for Pharmaceutical/BioPharmaceutical