Fluid-Air Products Inc. | Tech Tips

TECH TIPS - RESPIRATORS

What is the sterilization process used? *What does 10(-6)* Sterility Assurance Level mean? Who validates the sterilization of the product? What is the difference between sterilized and sterilization? Does the customer have to assemble the respiratory system? What documentation is provided to prove the product is sterile?**
Q.	What is the sterilization process used?
A.	Gamma-irradiation is a highly effective sterilization process used to eliminate microorganism counts from an item. Gamma rays are very penetrating and are commonly used for sterilization of disposable medical equipment.
Q.	*What does 10(-6)* Sterility Assurance Level mean?**
A.	This means that the possibility of organisms living on a Bullard hood or facepiece is one-in-a- million. That's a significant number when you consider the odds of being struck by lighting is 576,000 to 1; the odds of getting a hole in one is 5,000 to 1; and the odds of an organism on a Bullard sterile respirator is one-in-a-million!
Q.	Who validates the sterilization of the product?
A.	The CC20 and RT products are all FDA-validated. This validation occurs when the gamma-irradiated product reaches a level of sterility measurement that the FDA considers acceptable.
Q.	What is the difference between sterilized and sterilization?
A.	Sterilized means the item has been treated but no certificate has been issued. Sterilization is a pure process that effectively eliminates viable microorganisms from an item. A certificate of sterility is issued when this process meets the Sterility Assurance Level.
Q.	Does the customer have to assemble the respiratory system
A.	No, the sterile respirators are pre-assembled to ensure sterility of the system. Each assembly includes a hood or facepiece, breathing tube and if required, a clamp.

Q.	What documentation is provided to prove the product is sterile?
A.	The CC20 and RT sterile products ship with a Certificate of Sterility.