Few industries have stakes as high as the medical industry. That’s why it’s so important that the seals used in medical devices are of the highest quality. Unlike standard seals, medical-grade seals are specially designed to prevent air and fluid leaks and keep contaminants out. These essential functions keep patients safe and support long-term equipment operation.
Read on for more about the significance of high-quality seals in medical devices.
Key Functions of Seals in Medical Devices
Seals are critical in ensuring medical devices comply with all necessary regulations and operate safely. The primary functions of medical-grade seals include the following:
- Containment: Seals help contain fluids and gases within devices so that harmful substances do not leak into the surrounding environment.
- Isolation: Seals act as barriers to the external world. They protect components from all kinds of external elements, including dust, dirt, and other particulates that could interfere with device operation.
- Regulatory compliance: Seals must meet stringent standards and regulations to guarantee their safety for use in medical applications. For example, seals must withstand repeated sterilization processes and be made with fully traceable raw materials. In addition to protecting patients and healthcare providers, compliant devices meet the strict guidelines imposed by governing bodies, like the Food and Drug Administration (FDA) in the United States.
Several key considerations come into play when choosing the right seals for medical devices. First, consider the seal’s function. Will it be used to seal a certain fluid, provide structural support to the device, or both? Depending on the intended function and operating environment, choose the seal material that meets all the necessary requirements. The seal’s lifespan should also align with the medical device’s expected lifespan so that the seal does not fail prematurely.
Applications of Medical and Pharma Seals
Seals are used in a wide range of medical and pharmaceutical applications, each one chosen for their unique properties. The most common types of medical and pharma seals include:
- Medical O-rings: Commonly found in respiratory equipment, pumps, drug delivery devices, and fluid transfer systems, medical O-rings create tight, leakproof seals.
- Medical lip seals: These seals are used in hospital and clinic equipment, such as bedside machines, to keep contaminants out.
- Medical gaskets: Medical gaskets are found in many medical devices to prevent fluid, dust, dirt, and electromagnetic interference (EMI) from affecting performance.
- Custom medical seals: These seals are customized for specialized medical devices. Custom medical seals are tailored to customers’ unique needs and come with Production Part Approval Process (PPAP) documentation for regulatory compliance.
Regulatory Requirements for Medical Seals
Any seal used in the medical and pharmaceutical industries is required to adhere to stringent manufacturing regulations. Because of the sensitive nature of medical devices and the potentially catastrophic consequences of failure, seals must meet rigorous standards, including FDA, USP Class VI, GMP, and EU 1935/2004 requirements.
MSP Seals is committed to meeting these high standards. We have ISO 9001:2015 and ISO 14001:2015 certifications and offer full PPAP capabilities, ensuring our sealing products meet or exceed all necessary regulatory requirements for medical applications.
Choose Precision Sealing Solutions for Your Medical Devices
MSP Seals, Inc., has been a trusted supplier of seals since 1998. We recognize the importance of medical-grade seals for maintaining device integrity and patient safety, so we provide reliable seals that meet all necessary safety and hygiene requirements.
Our compliant, high-quality medical and pharma seals can be customized to contain harsh chemicals, prevent contamination, resist various temperature levels, and more.
Contact us or request more information to learn how MSP Seals can provide the perfect sealing solutions for your medical device.
