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
Medical Rubber: The Hidden Backbone of Safe and Reliable Devices
This article was written in collaboration with Anna Ochakovski, a Quality and Engineering Manager, from Techno Ad.
Introduction
Medical rubber is very different from ordinary industrial rubber. It is specifically engineered for medical environments, where failure is not an option. The compounds must meet strict standards such as ISO 10993 and USP Class VI. These approvals confirm that the material will not harm, irritate, or sensitize patients.
Beyond biocompatibility, medical rubber must survive tough sterilization cycles. Steam, gamma radiation, and ethylene oxide are common in hospitals worldwide. The material must also resist cleaning chemicals, pressure, and long-term contact with fluids. Such performance is possible only with carefully designed and fully documented compounds that can prove their safety.
Manufacturing also takes place under cleanroom conditions to avoid contamination. Every step is monitored, from mixing raw materials to molding final parts. Even a small trace of dust or bacteria can compromise the safety of a device. Cleanroom compliance and validated processes are therefore essential for ensuring product integrity.
Documentation ties everything together. Certificates, test results, and batch records prove compliance and guarantee traceability. Without them, regulators will not approve the device for market release. The message is simple: without approved rubber and strict documentation, no medical device can launch successfully. This makes medical rubber unique compared to standard industrial materials.
Why Medical Rubber Products Are Different – And Why Standards Matter
Medical rubber products cover a wide spectrum of components, each with a defined purpose. They include O-rings, diaphragms, cannulas, stoppers, and many custom designs. Although their shapes and functions differ, all must provide absolute reliability. Meeting this standard requires a structured process and close collaboration between supplier and customer.
The journey begins with specifications and performance goals. The supplier reviews chemical exposure, mechanical stress, and sterilization needs. Prototypes are produced and tested under realistic conditions, and feedback helps refine the compound and geometry. These early steps ensure the part meets both functional and regulatory expectations before moving forward.
Pilot series follow to confirm consistency and reproducibility. These runs simulate production at scale but allow fine adjustments if needed. Documentation accompanies every stage, including material certificates and performance reports. This provides regulators with a clear record of compliance and builds confidence for market approval.
It is important to remember that suppliers do not invent the medical device itself. Their role is to deliver safe, documented, and fully tested components. This means working closely with engineers, QA specialists, and regulatory teams to ensure alignment. The outcome is a product that matches both technical function and compliance demands.
The World of Medical Rubber Seals
Medical rubber seals deserve special attention because of their critical role in devices. They may look small, but they protect patients by ensuring sterility and safety. If a seal leaks or fails, the entire device can malfunction or become unsafe. For this reason, regulatory agencies classify seals as high-risk components requiring strict validation.
In earlier decades, requirements for seals were simpler and less strict. Today, the standards are far more demanding, and only certified medical-grade compounds are accepted. This shift reflects lessons learned from failures and the continuous rise in patient safety expectations. The history of seal regulation shows how much has changed.
Regulatory engineers also have the authority to stop a product if seals are not compliant. If a seal does not meet the required standards, approval will not be granted. This gives seals enormous influence over whether a device ever reaches the market. They may be small, but they hold great regulatory weight.
Even though seals seem insignificant, they determine whether a device succeeds or fails. They maintain fluid integrity, preserve sterility, and ensure reliable performance under pressure. For manufacturers, investing in compliant seals is essential. One seal can decide the future of a medical product, making seals one of the most important components.
Small Parts, Big Impact: The Critical Role of Medical Silicone Rubber
Medical silicone rubber stands out among elastomers for several unique advantages. Its chemical inertness makes it safe when in contact with drugs, tissues, or cleaning agents. It can withstand extreme heat, cold, and repeated sterilization without losing performance. This combination provides designers with confidence in long-term safety and reliability.
Silicone is also versatile during production. It can be molded in clean rooms into very precise and complex shapes. This makes it an excellent choice for implants, wearable devices, tubing, and drug delivery systems. Compared to other elastomers, it adds softness, comfort, and outstanding long-term stability.
Choosing silicone rubber means choosing reliability and proven performance. That is why it remains the preferred option for many critical medical applications.
Techno Ad’s Expertise and Value Proposition
Techno Ad stands at the forefront of high-performance medical-grade rubber solutions. With a proven track record in elastomer compounding and custom fabrication, Techno Ad:
- Offers tailor-made rubber components for medical devices.
- Collaborates in flexible methods to support custom device components.
- Manufactures and packages in a clean room when required by the customer.
Conclusion
Medical rubber compounds are more than passive materials; they’re evolving enablers of smarter and safer technologies. At Techno Ad, our commitment to excellence in material science, performance, and partnership places us among the leaders delivering the next wave of medical innovation.