Medical seals are used in various applications, including pumps, IV components, feeding devices, and implant material. The purpose of medical seals is to protect both people and devices from harmful leakage. They are applied when liquids or gases are pumped, drained, transferred, contained, or dispensed.
There are many factors to remember when choosing the proper seal for a medical device. Here are some of the top factors to consider when making the decision.
Choose the right elastomer material
To choose the right seal, you need to first understand the application at hand. You should consider potential contact, temperature, motion, pressure, and how long the seal needs to last.
Medical seals must demonstrate resistance to harsh, toxic chemicals. There may be specific quality requirements for the seal's elastomer material. To withstand and ensure chemical resistance, the seal must be manufactured from elastomers with the highest performance and quality. We use Liquid Silicone Rubber, Viton® Fluoroelastomer, and Ethelyne-Propylene. These elastomers have improved chemical resistors, excellent heat resistance, and low permeability to gas.
Be aware of biocompatibility
Medical devices do not always come in contact with living tissue. However, when devices and seals do touch human tissue and other vital substances like bodily fluids, drugs, or medical fluids, it is important to note the biocompatibility of the sealing compound.
Biocompatibility means that the properties of materials are biologically compatible and do not give off a reaction or response to living tissue. To ensure that no reactions will occur during a medical application, it is critical to assess the biocompatibility of the seal and choose a material based on the application type and function.
Some materials have impurities
It is always crucial to consider the impurities of the sealing material. Over time, impurities can leach out of the seal with toxic or carcinogenic matter. In medical applications where devices and seals are directly in contact with human tissue, sometimes even implanted, it is extremely important to be aware of the potential toxicity of a material. For this reason, engineers should choose a sealing material with little to no impurities.
Under the same light, it is important to note if the material should be subjected to sterilization. For applications involving contact with living tissue, the entire medical device should be sterile to prevent infection.
Rely on a certified cleanroom
Many medical devices are required to be sterile before use, especially those that come in direct contact with patients. When producing sterilized medical components, manufacturers must use a certified cleanroom to ensure no outside dirt, debris or unfiltered air contaminates the devices.
Uses a Class 10,000 ISO 7 certified cleanroom to develop and manufacture medical solutions that are trusted for patient care. This classification guarantees that our cleanroom is a protected, clean environment that follows filtration and cleanliness protocols, as well as minimized contamination from airborne and surface particles, oil and gas, or static electricity.
Conclusion
Medical device seals are critical components to ensure device performance and safety. They prevent the leakage of liquids and gases as well as the intrusion of external contaminants. Therefore, choosing the right seal is crucial to ensure the performance of medical devices and the safety of patients.
