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Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Sterisheet Sterilization Wraps are single use, non-sterile sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process, Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 months.

The Anprolene SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1.

The Anprolene® SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable BI receptacle. It is designed for monitoring the efficacy of the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. The SCBI, the EZTest - Gas Biological Indicator, consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure. Following manufacturer's instructions, the operator inserts the SCBI into the reusable BI receptacle on the purge probe of the Anprolene AN75 Ethylene Oxide Gas Sterilizer, and initiates a 12 hour cycle at 20-29°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30-35℃ for 48 hours, and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (failed cycle); no color change or turbidity indicates conditions for sterilization were achieved (passed cycle).

AN85/AN86 EO Indicators are single-use Type 1 process indicators used to distinguish between processed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1.

AN85/AN86 EO Indicators are adhesive-backed Type 1 process indicators for ethylene oxide sterilization that conform to AAMI/ANSI/ISO 11140-1. AN85/AN86 EO Indicators contain a pH indicator. The pH indicator ink is printed in dots on the AN85 and in stripes on the AN86. The indicator ink is laminated between two layers of plastic material and changes color from yellow-green to blue by chemical reactions when exposed to ethylene oxide.

The Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

The Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous high-density polyethylene (HDPE) fibers, with front material consisting of a clear, laminated polyethylene terephthalate (PET) / low density polyethylene (LDPE) or LDPE-ethylene-vinylacetate copolymers (EVA) film. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer. Devices are inserted into the pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, while the heat sealed pouches are heat sealed prior to the cycle. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days) or until used.