Proper sterilization during the medical device manufacturing process is required for FDA approval. Modern technology offers a variety of methods for eliminating pathogens and preventing the spread of dangerous diseases, but not all techniques are appropriate for every device. Its use, material composition, and design all have to be carefully considered. The guide below looks at some of the most common sterilization methods and when they are most appropriate.

Steam Sterilization

Commonly used in hospitals to disinfect surgical implements, steam sterilization employs high heat and extreme pressure to kill microorganisms and pathogens. While this method is highly effective, it’s only suitable for devices made of heat-resistant materials, such as steel scalpels, and may damage delicate electronic components. After sterilization, the products will have to dry for several hours, so most medical device manufacturing companies prefer faster methods that can be used on a wider variety of materials.

Dry Heat Sterilization

A similar approach to steam, dry heat uses ovens to heat the device in a low-moisture environment, making it ideal for heat-resistant materials containing elements that may be damaged by water exposure. Dry heat sterilization is typically used to remove pathogens from vials, Petri dishes, and laboratory glassware.

Ethylene Oxide Gas Sterilization

Unlike the previous two methods, ethylene oxide relies on toxic chemicals rather than heat to kill pathogens. This approach can be used on a wide variety of materials, including plastics and thin metals susceptible to heat, and can disinfect devices with small spaces and intricate designs.

Radiation Sterilization

Using gamma rays or electron beam radiation is a clean, efficient method of sterilization, capable of destroying microorganisms through packaging and inside dense materials. Radiation sterilization is ideal for medical device manufacturing of single-use products, such as pacemakers, syringes, and artificial joints.
 

Offering high-quality medical device manufacturing for countries across the globe, Pacific Integrated Manufacturing, based in Bonita, CA, provides products developed to the highest industry standards. Their manufacturing plant features a variety of sterilization facilities, along with precision injection molding equipment to produce even the most complex devices. Learn more about their services online or call (619) 921-3464 to discuss your project and request an estimate.