Labeled for your safety, and our legal team’s peace of mind.
– Anonymous marketer
Products Can Be Labeled as Sterile, Irradiated, or both... what’s the difference?
The answer to the above is usually quite literal. Irradiated product is what it implies: the product has been treated with some form of irradiation (e.g. E-Beam, X-ray, or Gamma processing). There is no specific information as to how much dose was used, and whether that dose can be certified as having met a quantitative objective (e.g. the magnitude of microbial reduction, etc.).
Sterile product refers to product that has been validated as sterile. While sterile product validations differ in approach based on the sterilization modality (e.g. radiation vs. Ethylene Oxide sterilization), a sterile product validation generally follows a standard which describes how the product line’s bioburden is measured, the sterilization process scaled to the specific microbiological / product needs, and then shown via experiment to be sufficient for delivering the target Sterility Assurance Level (SAL).
So – “irradiation” describes something done to the product, while “sterile” describes an end state of the product. These are not mutually exclusive:
Is “Sterile” Better Than “Irradiated?”
It very much depends on the product and use case. Answer: for the vast majority of products, sterility is not needed… our world, of course, is primarily nonsterile. The question of whether “sterile” vs “irradiated” is better doesn’t typically come up because, for instances where sterility is helpful, it is typically mandated in the standards for that industry (e.g. medical devices, which specify a SAL of 10-6).
Does My Product Need to Be Sterile? How Can I Understand That?
The regulations that govern your particular industry demand sterility when it is appropriate. The medical device industry is a classic example, but even medical devices can have a range of sterility assurance levels. While 10-6 is most common for devices that are implantable, exceptions can be made.
What’s a Non-Regulated Product and How Do I Know If I Have One?
A non-regulated product has no published standard for sterility, and so irradiation can be used to enhance the microbial cleanliness of that product, even if there is no overall “bar” for this. These types of industries can massively benefit from irradiation (fairly minimal amounts of dose can yield strong microbial reduction), even if there isn’t a high bar for what is required.
Non-regulated products can be trickier to handle, as clients have far more choice on how to handle sterility requirements – yet the choice is part of the challenge.
Contact us at NextBeam for help exploring options on answering the above.
Additional Articles We Think You Might Like
Have a question? Speak with a sterilization expert today, at your own convenience.
