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HYGIENIC SEAL MATERIAL

Hygienic seal materials are elastomers or perfluorocarbons utilized in high purity sanitary hygienic seals where critical pure water, process fluids (both ambient and hot), and SIP environments exist. 

Download the Hygienic Seal Material brochure [PDF]

The following criteria is used in determining correct hygienic seal materials:

  • U.S. Pharmacopeia Class VI Certification
  • Cytotoxicity Criteria
  • CFR Title 21 Section 177.1550
  • CFR Title 21 Section 177.2600
  • Traceability: Lot and Batch
  • Certification: Lot and Batch
  • ASME-BPE Standards
  • USDA Standards
  • 3-A Sanitary Standards
  • Current Good Manufacturing Practices (CGMP)
  • Manufacturer data and specifications
  • Consultation with various pharmaceutical users
  • Animal Derived Ingredient Free

EXPOSURE LIMITS

It is important to define the operating parameters of a new or existing processing sanitary system. The user specifications for exposure limits and reactivity to process fluids are compared with process operating parameters. All materials are acceptable for steam excluding Buna. All materials should meet process fluid reactivity parameters. Even though all compound exposure limits fall within operating parameters, the service life of some compounds will be different under certain conditions. This must be considered when selecting a compound.

FDA & USP QUALIFICATIONS

CFR’s define the criteria for extractables and for compounds used in the manufacture of rubber and plastic articles. The two applicable categories are; rubber articles (Buna, EPDM, FKM Fluoroelastomer, Silicone) and perfluorocarbon resins (PTFE). USP defines the criteria for testing biological reactivity and the amount/type of extractables. The hygienic seals in service must meet USP Class VI specifications, and be manufactured using the proper compounds as stated in the CFR, Title 21, Sections 177.1550 and 177.2600 respectively. Certificates are available from Rubber Fab Technologies Group verifying compliance with regulatory requirements, traceability lot and batch and certification lot and batch. Note: Not all hygienic seals meet these requirements.

CURING METHODS

Curing agents have an affect on the amount and type of extractables a material will emit. Typically, the hygienic seal group in service uses three methods; sulfur cured*, peroxide cured and platinum cured. When dealing with elastomers, peroxide cured is the most favorable method. When dealing with silicone, platinum curedis the most favorable. All gaskets shall be post cured. Using these methods minimize potential reactions with the respective process fluid applications and can uphold pure water and process fluid standards.

HYGIENIC SEAL MATERIAL USAGE GUIDELINES

Material Code

1

2

3

4

5

6

Material Name

Excellent

Good

Acceptable

Marginal

Poor

Do Not Use