FFKM Sealing Solutions for Pharma & Biotech OEMs

Custom FFKM Engineered Molded Parts

Isolast® perfluoroelastomers (FFKMs) combine the resilience and sealing force of an elastomer with the chemical inertness and thermal stability of polytetrafluroethylene (PTFE). Verifiable cleanliness of parts throughout the supply chain, including Class 5 Cleanroom Quality, ISO 14644-1, make them ideal for use within ultra precise pharmaceutical and biotechnology equipment, such as mass spectrometers.

Isolast® FFKM compounds developed by Trelleborg Sealing Solutions offer exceptional chemical resistance over a wide range of temperatures from -25 °C/-13 °F up to +325 °C/+617 °F, and can be offered in a full range of bespoke sealing products including:

  • O-Rings
  • Custom Engineered Molded Parts
  • Rubber-to-Metal and Rubber-to-Plastic Bonded Parts
  • Rubber and Rubber-to-Metal Bonded Gaskets

Material Characteristics

The standard Isolast® grade, J9503 has been developed to ensure optimal performance and maximum meantime between failure through:

  • Very low outgassing at high temperatures and in vacuum applications
  • Exceptional hysteresis properties ensuring high elasticity and dynamic recovery
  • High quality surface finish further enhancing sealing performance
  • Excellent compression set characteristics giving the best possible leak-proof seals (see figure 1)

Figure 1: Long term compression set at +204 °C/+399 °F

In hazardous applications involving aggressive chemicals, high temperatures and long service life, Isolast® J9503 covers the widest range of chemicals from acids to alkalis and amines to esters.

Figure 2: Isolast® J9503 radar chart for chemical resistance

In tests, Isolast® J9503 has shown considerably better compatibility over comparable competitor products, as seen in figures 3 to 5. All tests were carried out on standard O-Rings size 214 (24.99 x 3.53 mm/.984 x .139 inches) and in accordance with test procedure DIN 53521.

Figure 3: Immersion in nitric acid at +98 °C/+208 °F

Figure 4: Immersion in acetic acid at +98 °C/+208 °F

"Verifiable cleanliness, including Class 5 Cleanroom Quality, ISO 14644-1, make Isolast® FFKMs ideal for use within mass spectrometers"

Figure 5: Immersion in pressurized steam at +200 °C/+392 °F

At lower temperatures, below -20 °C/-4 °F for example, retained flexibility to maintain sealing force is critical. The glass transition temperature (Tg) of Isolast® J9503 is -19 °C/-2°F, which is key to excellent low-temperature capability as the molecular backbone remains flexible.

Figure 6: Low-temperature properties measured using a Gehman torsional test (BS 903: Part A 13, DIN 53548 and ASTM D 1053)

Medical, pharmaceutical and biotechnology industries require a high level of cleanliness in manufacturing, usually utilizing cleanrooms in Classes 5 to 8, according to ISO 14644-1. In order to ensure the quality of the ambient air in the production environment, all brought in components must be prepared using adequate production technologies or cleaning processes.

Seals from Normal Production, Washed and Packed in Class 5 Cleanroom, ISO 14644 – 1

For basic cleanliness requirements, Trelleborg Sealing Solutions provides seals from normal production washed and packed in Class 5 cleanroom (ISO 14644-1).

Cleaning and drying of seals is performed, tailored to their condition in a Class 5 cleanroom and double packed according to cleanroom requirements. The bags are then heat-sealed and marked washed and packed in Class 5 cleanroom (ISO 14644-1).

Seals from Cleanroom Production, Washed and Packed in Class 5 Cleanroom, ISO 14644-1

Trelleborg Sealing Solutions can also offer seals manufactured in Class 8 cleanroom conditions. Following manufacture at this level of cleanliness, the seals are cleaned in a three-stage process with ultrapure deionized water, dried and double packed according to cleanroom requirements.

The seals produced and washed this way meet the highest cleanliness requirements that go beyond simple washing and packing in Class 5 cleanroom, as specified for seals from normal production. Special materials can also be offered from Class 8 cleanroom production.

In both cases, the packaging units are assigned by the recipient according to their needs. Seals can be individually packed if needed.

The information in this article is based on many decades of experience in the manufacture and application of sealing systems for pharmaceutical applications. However, unknown parameters and conditions may restrict general statements. For a complete design consultation on FFKM sealing solutions for pharmaceutical or biotechnology applications, contact your local Trelleborg Sealing Solutions Marketing Company.