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The SafeSecure Steam Sterilization Process Indicators are chemical process indicators intended for use by healthcare professionals to accompany individual units (e.g., wrapped packs) and to demonstrate that the unit has been exposed to a steam sterilization process.

The indicator changes color to signal exposure to sterilization conditions.

The indicators are validated for use in the following saturated steam sterilization cycles:

The product includes both label and tape indicator. The labels can be printed or written on prior to application. The tapes are designed to adhere to common sterilization wraps, including untreated woven, non-woven, paper, and paper/plastic wraps.

The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators are chemical process indicators intended to accompany individual packages and visually confirm that the pack has been exposed to a validated Vaporized Hydrogen Peroxide sterilization cycle.

The indicator changes color to signal exposure to sterilization conditions.

The indicators are validated for use in the following Vaporized Hydrogen Peroxide sterilization systems:

• Standard Cycle of STERRAD® 100S
• Standard cycle and Advanced cycle of STERRAD® NX
• Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
• Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX

The product includes both label and card indicator. The labels can be printed or written on prior to application. The card is designed to be placed inside the sterilization package, next to the items being sterilized.

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
The SafeSecure Steam Sterilization Process Indicators are Type 1 chemical process indicators compliant with ISO 11140-1:2014, designed for use in steam sterilization processes. These are external, single-use indicators intended to verify exposure to the sterilization cycle and distinguish between processed and unprocessed packs.

The product is available in two formats:

• Label-type indicators (4013, 4014): consisting of coated paper or synthetic paper backing, pressure-sensitive adhesive, chemical indicator, and a glassine release liner for easy application. 4013 allows for handwritten labeling, while 4014 features a pre-printed label format.

• Tape-type indicators (4012, 4016): composed of masking tape backing, pressure-sensitive adhesive, and a chemical indicator.

The adhesive is formulated for strong adhesion to untreated woven, non-woven, paper, and paper/plastic sterilization wraps, and allows clean removal after steam exposure.

Upon exposure to steam sterilization conditions, the indicator exhibits an irreversible color change:

• From off-white/yellow to dark brown/black (for 4012, 4013, and 4014)
• From green to gray/black (for 4016)

SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator(4211, 4212, 4213)
The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators are Type 1 chemical process indicators, compliant with ISO 11140-1:2014, designed for monitoring exposure to vaporized hydrogen peroxide sterilization cycles.

The product is available in two formats:

• Card-type indicator (4211): intended to be placed inside the sterilization package, adjacent to the medical device. It consists of a printed indicator on a plastic substrate, membrane layer, and chemical indicator agent.

• Label-type indicators (4212, 4213): intended to be affixed on the outside of the packaging. Each consists of a self-adhesive polypropylene (PP) base, glassine release liner, and an indicator agent.

The Vaporized Hydrogen Peroxide indicator undergoes a distinct, irreversible color change from red to light orange/yellow upon exposure to sterilization conditions, allowing visual confirmation of processing.

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