Anprolene

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Anprolene is a registered trade name for ethylene oxide that belongs to Andersen Sterilizers.

Harold W. Andersen invented Anprolene in 1967[1] and used plastic bags and small ampoules, hence, substantially less ethylene oxide (EtO) than traditional chamber type sterilizers. The "bag method" of using ethylene oxide was particularly useful to Andersen whose invention of the first double lumen nasogastric tube was being used by his colleagues at Bellevue Hospital in New York, NY, where he was chief resident. At that time a single lumen Levin tube was employed clean and packaged, but not sterile. Andersen recognized the need and the Andersen Tube was packaged and sterilized with ethylene oxide. The US EPA registered Anprolene in 1968. Another bag method, Sterijet, was invented and used to sterilize Andersen Tubes and other medical devices.

Plastic, latex and rubber, and the like are "pourous" to Ethylene oxide so that EO or EtO diffuses through a series of bags containing the gas. The bag containing the items for sterilization concentrates the gas for enough time which is why it is called the "bag method" or "gas diffusion method" [2]. It is also referred to as "micro-dose sterilization" since each sterilization cycle uses less than 18g of EtO, hence different than the traditional EtO chamber type sterilization that relies on tanks containing pounds of EO.

The gas diffusion bag method is widely used where small quantities of goods require sterilization.

EtO Sterilizer Comparison
MODEL Type Load

Management

 Capacity Typical User Emissions

Abatement

 Price range
Anprolene AN74i Standard tabletop Single load 2 cu.ft. Small Practices Yes Starting at

$3,950
Anprolene AN74ix Long tabletop 3 cu.ft.
Anprolene AN74j Large tabletop 4 cu.ft.
Anprolene AN2000 Standard tabletop 2 cu.ft.
EOGas AN306 Tabletop cabinet

(optional pedestal)

 Multi-load

Batch, Industrial

 6 cu.ft.

Large Practices, Hospitals, Medical Device Manufacturers

 Yes Starting at

$19,000
EOGas AN310 Stand-alone

cabinet

 10 cu.ft.
EOGas AN333 33 cu.ft.
Sterijet Industrial High capacity Custom Medical Device Manufacturers,

Industrial

 Yes Starting at

$150,000




[edit] References

  1. ^ Andersen Products: Product Name
  2. ^ Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA

[edit] External links