MULTICRITICAL PROCESS VARIABLE INDICATOR STRIP
For Monitoring Steam Sterilization Processes
(CLASS / TYPE 4)
NAMSA Code: TST4S-250
Product Image
Product Description
NAMSA Multicritical Process Variable Indicator Strips contain no lead or other toxic heavy metals. The indicator
strips are intended for use with individual materials (i.e. pouches, pack, tray) to demonstrate that the material has
been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The
Indicator strips will transition from an initial yellow color to a dark brown/black color when exposed to high
temperature steam.
Physical Properties
Process
Steam
Indicator Strip Dimensions
0.75” x 4.5” (19 mm x 115 mm)
Packaging
250 Strips/Package
Chemical Indicator
Initial Color : Yellow
Signal Color : Dark Brown/Black
Chemical Indicator Inks contain no lead or other toxic heavy metals.
Indications for Use
The following indications for use have been cleared by the US FDA under K132291:
 121°C for 30 minutes (gravity cycle)
 134°C for 3 minutes (pre-vacuum cycle)
NAMSA | Sterilization Products
6750 Wales Rd Northwood, Ohio 43619
Rev 10.30.15
T 800.860.1888 F 419.666.1715 E [email protected]
© 2015 North American Science Associates, Inc.
www.SterilizationProducts.com
Page 1 of 3
Instructions for Use
Use a strip in each pack, peel pouch, or tray to be steam sterilized. Process packages/items as instructed in the
autoclave/sterilizer validation or manual.
Upon exposure to high temperature steam, the chemical indicator will transition from a shade of yellow to dark
brown/black. The transition color may vary depending on the load configuration, length and conditions of exposure.
A color transition from a shade of yellow to a shade of dark brown or black provides indication of exposure to high
temperature steam. If signal color is not achieved, this may suggest ideal exposure conditions were not met.
Review the exposure conditions and investigate for sterilizer malfunction.
The chemical reaction which causes the color transition is a steam specific reaction and is irreversible.
Do not use the product if the indicator has transitioned from yellow to dark brown/black prior to
steam exposure.
Performance Characteristics
Result Availability
Immediately following exposure to high temperature steam processes
Unexposed*
Exposed to Steam 121°C, 10 minutes
The signal color achieved from exposure to steam may vary from the example above due to
differences in processing parameters (i.e. load content, steam quality, cycle time, temperature,
etc.).
Compliance
ISO 11140-1:2014 Sterilization of health care products – Chemical Indicators- Part 1: General Requirements for
Type 1 Chemical Process Indicators & Type 4 Multi critical Process Variable Indicators.
NAMSA | Sterilization Products
6750 Wales Rd Northwood, Ohio 43619
Rev 10.30.15
T 800.860.1888 F 419.666.1715 E [email protected]
© 2015 North American Science Associates, Inc.
www.SterilizationProducts.com
Page 2 of 3
Storage and Shelf-Life
15°C to 30°C
Protect from heat &
radioactive sources
10% to 50% relative humidity
Do not reuse
2 years from the date of manufacture
Shelf-life
The date of manufacture is based on the day the indicating ink is applied to the substrate. The
remaining shelf life upon receipt will be shorter than 2 years.
Do not use after expiration date.
Variation in storage conditions for short periods of time will not impact the product. Prolonged
storage of product at higher levels of temperature and humidity may cause premature color
transition of the product to a darker shade of yellow or light brown.
Disposal
Discard as general waste.
NAMSA | Sterilization Products
6750 Wales Rd Northwood, Ohio 43619
Rev 10.30.15
T 800.860.1888 F 419.666.1715 E [email protected]
© 2015 North American Science Associates, Inc.
www.SterilizationProducts.com
Page 3 of 3