ExpoSure Sterrad^® Biological Indicator

ExpoSure^® has received its 510(k) making it suitable for healthcare and non-healthcare settings and usage. Its 24-hour incubation time and flexibility make it a powerful tool to help your facility maintain compliance and patient safety.

ExpoSure^® is a direct replacement product and can be used in conjunction with existing incubators out in the field (55-60 °C). The on-board chemical indicator confirms that it has been exposed to hydrogen peroxide by changing from red to blue upon exposure.

ExpoSure^® BI to be used to monitor the efficacy of the following STERRAD^® sterilization cycles:

STERRAD^® 50
STERRAD^® 100S (Short & Long*)
STERRAD^® 200 (Short & Long*)
STERRAD^® NX® (Advanced & Standard)
STERRAD^® 100NX® (STANDARD, FLEX, DUO, and EXPRESS)

* ”Long” applies to industrial cycles only

510(k) Product
30 Indicators per Box
12 Month Expiry
Fits Existing Incubators
Dry Bath Incubator Available

Activation

After the sterilization cycle, crush the media ampoule with the tool provided or by squeezing the sides of the plastic tube by hand. The unit is properly activated when the media has been released from the ampoule and the spore disc is in contact with the released media.

Labeling

Each unit is labeled with lot number, expiration, manufacturer and species of organism. Unit has a process indicator on it to assist the user in distinguishing an exposed from an unprocessed unit. Refer to box label and product insert for storage conditions, species, manufacturer contact information and instructions for use.

Control

The control unit should exhibit a color change to or toward yellow and/or turbidity. If the control unit does not show signs of growth, consider the test invalid.

Test

A failed sterilization cycle is indicated by a color change to or toward yellow and/or turbidity. A test unit that retains its original purple color indicates that sterilization parameters have been met. ExpoSure is manufactured and tested in accordance with ISO 11138 and current USP.

*Sterrad^® is a registered trademark of Advanced Sterilization Products.

Technical Specifications

Incubation: 24 Hours
Expiry: 12 Months from date of manufacture
Certification: Each lot of ExpoSure is certified for population, species, D-value, purity and expiry