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White paper: FDA Regulated Sterilization Methods

The FDA regulates four critical forms of sterilization: autoclave, dry heat, ethylene oxide, and irradiation. Irradiation includes both gamma ray and electron beam methods. While there are other forms of sterilization, including hydrogen peroxide, high intensity light, and sound waves, these methods are not regulated or approved for use by the FDA at this time. Appropriate, FDA-approved sterilization methods ensure that products are consumable, healthier, and safer for everyone who uses them.


The final stage in the manufacturing process for medical devices and life sciences products is sterilization. When it comes to sterilizing your equipment, you want to be sure that you’re getting the job done right. The FDA regulates four critical forms of sterilization: autoclave, dry heat, ethylene oxide, and irradiation. Irradiation includes both gamma ray and electron beam methods.

While there are other forms of sterilization, including hydrogen peroxide, high intensity light, and sound waves, these methods are not regulated or approved for use by the FDA at this time. Appropriate, FDA-approved sterilization methods ensure that products are consumable, healthier, and safer for everyone who uses them.

 

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 Post Tags: Quality & Regulatory