Medical Rubber

Medical Rubber

Description:

The Medical and Life Science industries make wide use of elastomers and seals in the construction of medical devices, diagnostic and surgical instruments, laboratory equipment, tools, seals, gloves, masks, catheters, tubing, biopharmaceutical manufacturing equipment, drug delivery systems, and implantable devices.

Elastomer Usage in the Medical / Life Science Industry

All elastomers meant for use in the medical or life science industries must exhibit the following characteristics:

• Be bio-inert
• Bio compatibility
• Not promote microbial growth
• Be able to withstand aggressive sterilization procedures: including Gamma, UV, steam, etc.
• Exhibit stability and flexibility at extreme temperatures of heat or cold
• Resistance to extended exposure to specific potentially reactive chemicals and active pharmaceutical ingredients (APIs)
• Resistance to various solvents
• Resistance to irradiation

There are two very different sets of elastomer usage in the Medical Industry, each with different technical and legal requirements.

• Elastomer usage in non-invasive medical devices and equipment
• Elastomers used in invasive medical procedures and implantable devices

The use of elastomers in non-invasive equipment resembles in many ways elastomer usage in other industries. Many medical devices require a wide range of different types of O-rings, seals and sealing devices, extruded tubing, and molded parts.

Materials used in invasive procedures, however, must meet higher standards with respect to biocompatibility, chemical inertness, low extractable content and toxicity.

Techno Ad Solutions

Techno Ad has decades of experience in supplying many products for the Medical/Life Science industry. All Techno Ad products meant for the Medical/Life Science Industry are manufactured from FDA compliant and USP Class VI certified materials. We are GMP compliant, with a company-wide Quality Management System which monitors customer feedback, and ensures the company conforms to all ISO 13485:2016, ISO 9001:2015, and legislative requirements.

Techno Ad engineers are experienced in designing and producing a broad range of medical rubber components for use in pharmaceutical manufacturing, diagnostic and surgical instruments and other non-implantable medical devices.

Our stock includes a large selection of parts manufactured from FDA compliant and USP certified materials:

• A large selection of standard and non-standard O-rings
• Diaphragms and seals of various materials exhibiting:
  • Resistance to chemical solvents
  • Resistance to laboratory reagents and active pharmaceutical ingredients (APIs)
  • Resilience under aggressive sterilization conditions such as EtO, steam autoclaving, gamma or E-beam irradiation, and others.
  • Resistance to various types of diagnostic or clinical irradiation
  • Chemical inertness
  • Bio-inertness
  • Stability at extreme temperatures
  • Resilience to vacuum and suction pressures
  • Low friction and self-lubricating compounds
• Brass, stainless steel and aluminum customized parts
• Composite rubber-bonded parts

We can produce custom-shaped molded parts based on customer designs with FDA compliant and USP certified materials. We have extensive experience in engineering custom solutions for many different medical/life science technologies. Whether you are creating a new design or are re-engineering existing technologies, Techno Ad can work with you from idea to prototype to production with a very short lead time.

Medical – Life Science Industry Requirements

Medical grade silicone rubber is the material of choice for many medical and bioscience applications. It is biochemically inert, elastic and flexible, naturally resists bacterial growth, can be formulated to be anti-microbial, is heat stable and autoclavable. Silicone rubber parts can be easily sterilized, whether by Ethylene Oxide gas, gamma or E-beam irradiation, steam autoclaving, and other methods. Silicone parts can be manufactured through liquid injection molding (LIM), compression or transfer molding, or extrusion. Common medical applications include extruded tubing, drains and catheters, a wide range of different types of bellows, seals, gaskets, and sealing devices.

Other rubber materials available in grades compliant with FDA and USP Class VI standards include EPDM (Ethylene Propylene), Nitrile, and FKM (Flourocarbon). These materials are well suited for standard and non-standard sized O-rings, gaskets, butterfly valve seats, and inflatable seals for ball segment valves. Such rubber products are commonly used in medical/scientific equipment: diagnostic and surgical instruments, pharmaceutical manufacturing machinery, and many other non-implantable medical devices.

Resistance of elastomers to irradiation is an important factor in Medical – Life Science applications. Exposure to radiation can cause unwanted molecular cross-linking in the polymer which affects both performance and function. Typically radiation causes elastomers to harden or become brittle. Some polymers, such as Butyl Rubber, when irradiated, degrade and break down into low molecular weight tars and oils. The type of radiation is important. Gamma radiation is considered typical exposure for most elastomer testing. Polyethylenes and Perfluoroelastomers in particular have been found to be relatively stable when tested with various gamma radiation dosages. Important factors in developing elastomers with radiation tolerance include radiation type and dosage, the range of effects on the physical properties of the elastomer, and the possibility of using additives to provide additional molecular stabilization in exposure to radiation.

Read more about Medical Elastomer Standards