FDA-cleared Gas Sterilizer Anprolene AN75i
MADE IN THE USA
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OEM: AN75.64i
The only FDA-cleared room temperature sterilizer on the market!
Building on Anprolene’s established reputation for efficiency and dependability, the next generation AN75 series achieves even more consistent sterilization results. An interactive touchscreen menu combines with component updates to provide the most versatile and effective sterilization system on the market. Now FDA-cleared, all facilities can achieve hospital-level sterility assurance (10-6 SAL) at a reasonable price point.
Optional abator model
Features:
- Easy Touchscreen: Interactive touchscreen guides user through FDA-cleared instructions for use – reducing the risk of user error. After selecting desired exposure and aeration, sterilizer displays exact time the cycle will complete. Sterilization status and cabinet temperature shown throughout the cycle. Built in Quality Check of components is part of standard equipment operation. Sterilizer automatically performs verification testing before each use.
- 17.6g EO Cartridge: Interactive touchscreen guides user through FDA-cleared instructions for use – reducing the risk of user error. After selecting desired exposure and aeration, sterilizer displays exact time the cycle will complete. Sterilization status and cabinet temperature shown throughout the cycle. Built in Quality Check of components is part of standard equipment operation. Sterilizer automatically performs verification testing before each use.
- Smart Cabinet Design: An interior ventilation port in the back of the chamber actively draws fresh air from the room throughout the entire cycle. Ensuring air flow in one direction and minimizing potential operator exposure.
- Active Aeration Chamber: Andersen’s purge probe flushes the liner bag with a constant flow of fresh air at the end of the cycle – no need to transfer items to a separate area. Two hours of aeration standard. EO-absorbent items may require additional aeration. Active aeration continues indefinitely until products are removed.
- Process Challenge Device: Built into the purge probe handle to ensure the 10-6 biological indicator is consistently placed in the most difficult location for EO to reach in every cycle – providing data driven results, regardless of the operator.
- 12 hour Exposure Cycle: Achieves FDA-required 10-6 sterility assurance level for terminal sterilization of medical devices.
- 35L Sterilization Bag: Made of gas impermeable materials to maintain consistent gas concentration throughout the cycle. Liner bag cleared for up to 24 lb.
- Make Your System Zero Emissions: Andersen abators are a simple, cartridge-based system that employ a dry catalyst resin. The resin converts ethylene oxide to biodegradable organic compounds. Replaceable abator cartridge has a 200 cycle capacity. Spent cartridges are non-hazardous.
- Unmatched Sterilization Capability: Anprolene’s 100% EO system sterilizes at room temperature without external vacuum lines or steam generator. Protects your most delicate instruments, electronics, drills, fiber optics, hand pieces and cameras. As well as those plastic, fabric, cellulose or rubber items that you can’t sterilize with other methods. Most any item with the exception of food, drugs or liquids can be sterilized.
- Easy Installation: Requires only a 120v or 240v outlet and a 1″ dedicated exhaust line.
- Free Operator Training: It’s like having a sterilization expert on staff! Free operator training for the life of your sterilizer and free 24/7 support.
- Shelf Life: The FDA has cleared AN75 sterilization loads wrapped with Sterisheet® or Tyvek® Sterilization Pouches with Chevron Seal – both have a shelf life of at least three months.
- Large capacity: 19.25"L x 13.75"W x 12.75"H
- Exterior: 21" L x 14" Wx 20.5"H
- Weight: 56 Lbs
- Capacity (cabinet): 1.9 cu ft
- Capacity (bag): 35L
- Ampoule/ Cartridge: 17.6 g cartridge
- Sterilization Cycles: 12-24 hours
- Aeration Cycle: 2 hours
- Standard Aeration: 2 Hours
- Temperataure: Room temp. (68° - 91° F)
- Application: Small footprint is suitable for most instruments.
- Installation: 1" OD, 3/4" ID Reinforced PVC Hose The allowable Exhaust Hose Length is 200 feet.
- FDA 510(k) Clearance
A. The Anprolene AN75i ethylene oxide sterilizer is approved for medical use. Here are just some of the surgical instruments FDA-cleared to be sterilized with the Anprolene AN75i:
- Cystoscopes
- Ureterscopes
- Brochoscopes
- Duodenoscopes
- Colonoscopes
- Gastrovideoscopes
- Choledocoscopes
- Delicate hand-pieces and associated cording
- Mix-material instruments or trays
- Volk lenses/loops
- Implants
- Sharps
- Plastic
- Rubber
- Non-wovens/Celulose
- Fiber optics
- Other Electronics
- Batteries
Note: These are just some, but not all, of the FDA-cleared instruments.
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How do I look up disinfectant on List N?
How do I look up disinfectant on List N?
First, find the product registration number. This can be found on the product label or safety data sheet. Duraline posts most registrations in the Product Description field of the product page in our website. Second, go to the epa.gov website: https://cfpub.epa.gov/giwiz/disinfectants/index.c... and enter the first 2 parts of the registration number and click enter.
My product has 3 parts on the registration number and I can't find all 3 on the approved website for List N. Why?
My product has 3 parts on the registration number and I can't find all 3 on the approved website for List N. Why?
The first 2 parts of the EPA Registration Number are the primary numbers and represent the primary registration. Since different companies sell products with the same chemical composition and efficiency, only 1 brand or product name receives the primary number. The third part represents the distributor of the primary registration and is still on List N and is proven effective against SARS-CoV-2 (COVID-19).
I can't find Swovo disinfectant wipes on List N. Where is it?
I can't find Swovo disinfectant wipes on List N. Where is it?
The EPA Registration number for Swovo is 59894-10-98425
To find this on the epa.gov website, you only need to enter the first 2 parts of this number, "59894-10"
This primary registration number is on the list, and so it is approved! See screenshot below.

