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The Sterilization Pouch/Roll is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.

The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization.

The Sterilization Pouch/Roll is composed of medical grade paper(60g/m2) and medical compound film(50μm), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process.

The recommended sterilization cycle parameter is:

Steam: 4 minutes at 132°C(270°F); 20 minutes dry time.

Ethylene oxide: 4 hours at 50 °C(122°F); relative humidity between 30%- 90%; ethylene oxide concentration is 695 mg/L, 7 days aeration time at room temperature.

The medical devices are inserted into the Pouch/ Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The pouch is self-sealed prior to sterilization processing. The roll is heat-sealed by a plastic sealing machine. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to yellow (EtO) or Blue to Black (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.

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