Sterile Hoods Provide Protection and Assurance

10(-6)

Sterile Hoods Provide Protection and Assurance

The CC20 and RT Sterile Respirator hoods and loose-fitting facepieces provide the perfect solution for customers who work in sterile environments. Bullard is leading the way in this market as the only manufacturer to offer sterile hoods and facepieces.

To ensure the products’ sterility, the hoods are gamma-irradiated, pre-assembled and double-bagged. What does all this mean? Gamma-irradiation is one of the most effective sterilization processes used to “zap” microorganisms. To further ensure sterilization, the products are pre-assembled with a hood or facepiece, breathing tube and clamp (not all assemblies require clamps) and double-bagged. Each product assembly is FDA-validated and shipped with a Certificate of Sterility giving a Sterility Assurance Level of 10-6, that’s a one-in-a-million chance that a microorganism is present.

This sterilization process does not change the design features or added protection of the traditional CC20 and RT headtops. These products continue to feature an Assigned Protection Factor of 1,000 for full hoods, a patented inflatable neck cuff to help ensure positive pressure, loose-fitting facepieces that provide 150 percent more protection than N95 masks and DuPont™ Tychem® QC construction that offers superior protection.

The CC20 and RT sterile products help users eliminate the added work of wiping down hoods and facepieces prior to use and provide a high level of assurance that environments are remaining sterile. Both products can be paired with a Bullard Powered Air Purifying Respirator (PAPRs), however the Bullard PAPRs are not gamma-irradiated and therefore not sterile.

 

Here are a few questions and answers about Bullard’s Sterile Respirator hoods.

1. What is the sterilization process used?
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.
2. What does 10-6 Sterility Assurance Level mean?
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!
3. Who validates the sterilization of the product?
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.
4. What is the difference between sterilized and sterilization?
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.
5. Does the customer have to assemble the respiratory system?
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.
6. What documentation is provided to prove the product is sterile?
The CC20 and RT sterile products ship with a Certificate of Sterility.



Dupont™ Tychem® is a registered Trademark of E.I. DuPont de Nemours & Company.