O-Rings for Medical and Pharmaceutical Applications

In the dynamic realm of medical procedures and pharmaceutical processes, reliable, top-tier o-rings play a pivotal role. These crucial components support a range of applications, from routine procedures to life-saving innovations, ensuring safety and performance even under diverse chemical and temperature conditions.

The medical and pharmaceutical sectors face unique challenges when it comes to sealing solutions. This includes maintaining sterility, ensuring resistance to aggressive chemical and biological environments, sustaining high-temperature stability, and conforming to rigorous cleanliness requirements.

Commitment to Standards and Certifications

Adherence to specific standards and manufacturing conditions is a key consideration in overcoming these challenges. USP Class VI certification, for example, indicates that a material has passed stringent tests for biocompatibility, meaning it can be safely used in various pharmaceutical, biotech, and medical applications. USP Class VI o-rings, therefore, offer an added layer of assurance of a material’s safety and suitability for use in these demanding environments.

We also provide o-rings that are manufactured in cleanroom environments, ensuring their sterility and compatibility with the high sanitation standards of the medical and pharmaceutical sectors. We offer o-rings compliant with ISO Class 8, ISO Class 6, and ISO Class 5.

In addition to these, we offer FDA-compliant and metal-detectable o-rings. FDA-compliant o-rings are suitable for applications where the o-rings may come into direct contact with drugs. Metal-detectable o-rings are useful in applications where it’s critical to prevent the o-ring from becoming a contaminant, as they can be detected and removed using standard metal detection equipment.

These four categories – USP Class VI, cleanroom environment production, FDA compliant, and metal detectable – are tailored to meet the challenges of the medical and pharmaceutical sector, providing reliable sealing solutions that support equipment effectiveness and patient safety.

 

USP Class VI, FDA Grade, and Metal Detectable O-Rings

Different o-ring materials cater to specific industry needs. The table below highlights the most commonly used o-rings in the Medical and Pharmaceutical sectors and the standards we offer for each material.

Материал
Предлагаемые стандарты
Ключевые отраслевые свойства
Конкретные приложения
Silicone USP Class VI, FDA Compliant, Metal Detectable Maintains integrity in wide temperature ranges; remains flexible at low temperatures. Heating and cooling devices, respiratory equipment, implanted medical devices.
Fluorosilicone USP Class VI Good mechanical strength; resists diverse chemicals. Drug delivery systems, diagnostic devices, devices exposed to diverse chemicals.
EPDM USP Class VI, FDA Compliant, Metal Detectable Resists weathering, ozone, and steam; performs well in broad temperature ranges. Sterilization equipment, water purification systems, and broad temperature range applications.
Viton (FKM) USP Class VI, FDA Compliant, Metal Detectable Resilient against aggressive chemicals and high temperatures. Pharmaceutical processing equipment, chemical synthesis reactors, environments with harsh conditions.
FFKM USP Class VI Excellent resistance to a wide range of chemicals; retains performance in high temperatures. High-performance liquid chromatography (HPLC) systems, drug production equipment.
Teflon Encapsulated USP Class VI, FDA Compliant High chemical resistance, temperature range, and mechanical strength. Chemical handling equipment, bio-pharmaceutical applications.
Nitrile FDA Compliant, Metal Detectable High oil and fuel resistance; good abrasion resistance. Applications where oil and fuel resistance is paramount.

Trust Global O-Ring and Seal for your o-rings and related sealing solutions in medical and pharmaceutical applications. Ready to place an order or need more information? Please give us a call at 832-271-5218, shop on our online store, or fill out the Product Inquiry Form.

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