Medical & Life Sciences

The medical and life sciences industries make extensive use of elastomers and seals in the construction of medical equipment, diagnostic and surgical instruments, laboratory equipment, tools, seals, gloves, masks, catheters, tubing, biopharmaceutical manufacturing equipment, drug dosing systems, and implantable devices.

Use of Elastomers in the Medical / Life Sciences Industry
All elastomers intended for use in the medical or life sciences industries must exhibit the following characteristics:

  • Inertness to biological reactions

  • Biocompatibility

  • Prevention of bacterial growth

  • Ability to withstand aggressive sterilization processes, including gamma radiation, UV, steam, etc.

  • Stability and flexibility at extreme temperatures of heat or cold

  • Resistance to prolonged exposure to specific chemicals that may be reactive to active pharmaceutical ingredients (APIs)

  • Resistance to various solvents

  • Radiation resistance

In the medical industry, two very different sets of elastomers are used, each with different technical and regulatory requirements.

Use of Elastomers in Non-Invasive Medical Instruments and Equipment
The use of elastomers in non-invasive medical processes is very similar to their use in other industries. Many medical devices require a wide variety of O-rings, seals and sealing devices, tubing, and compression seals.

The materials used in invasive processes, however, must adhere to stricter standards regarding biocompatibility, chemical inertness, low leakage rates, and low toxicity.

Solutions
Tereefek Solutions can supply numerous products for the medical / life sciences industry. All products intended for the medical / life sciences industry are FDA-compliant (some materials are authorized according to USP Class VI if needed).

Tereefek Solutions has the capability to provide a team of experienced engineers in designing and manufacturing a wide range of medical rubber components for use in pharmaceutical manufacturing, diagnostic instruments, operating rooms, and additional non-implantable medical equipment.

Our inventory includes a large selection of seals made from FDA and USP-approved materials:

  • A wide range of standard and non-standard O-rings

  • Seals made from various materials that exhibit:

    • Resistance to chemical solvents

    • Resistance to laboratory reagents and active pharmaceutical ingredients (APIs)

    • Flexibility under aggressive sterilization conditions such as EtO, steam autoclaving, gamma or electron radiation, and others

    • Resistance to various types of radiation for diagnostic or clinical applications

    • Chemical inertness

    • Inertness to biological reactions

    • Stability at extreme temperatures

    • Flexibility under vacuum and suction pressures

    • Low friction and self-lubricating compounds

    • Custom-made brass, stainless steel, and aluminum parts

    • Composite material linked rubber seals

Requirements for the Medical / Life Sciences Industry
Medical-grade silicone rubber is the material of choice for most applications in the medical and biological sciences. It is biochemically inert, elastic and flexible, inherently resistant to bacterial growth, can be produced in antimicrobial compounds, stable at high temperatures, and resistant to autoclave processing. Silicone rubber components allow for easy sterilization using ethylene oxide gas, gamma radiation, electron beams, steam autoclaving, and other methods. Silicone parts can be manufactured using liquid injection molding (LIM), compression or transfer molding, or extrusion.

Common medical applications include tubing, drains, catheters, a wide range of bellows, seals, and sealing devices.

Other rubber materials available at FDA and USP Class VI cleanliness levels include EPDM (ethylene propylene diene), nitrile, and FKM (fluorocarbon). These materials are well suited for standard and non-standard sizes of O-rings, seals, butterfly valve seatings, and inflatable seals for ball valves. Such rubber products are commonly used in medical/diagnostic equipment: diagnostic instruments and operating rooms, pharmaceutical manufacturing machines, and many other non-implantable medical devices.

The radiation resistance of elastomers is an important factor in medical and life sciences applications. Exposure to radiation can lead to unwanted molecular crosslinking in the polymer, affecting both function and performance. Typically, radiation causes elastomers to harden or become brittle. Some polymers, like Butyl Rubber, may break down into tar and low molecular weight oils upon irradiation. The type of radiation is significant. Gamma radiation is considered a typical exposure in most tests of elastomers.

We can supply compression-molded components in custom shapes for clients from FDA and USP-approved materials. We can design custom solutions for various medical / life sciences technologies. Whether you are creating a new design or redesigning existing technologies, Tereefek Solutions can collaborate with you from the idea stage, through prototyping, to production with very short lead times.