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SteriRITE™ Autoclave / Steam Sterilization Indicators

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Data Sheet
SteriRITE™ steam sterilization process indicators designed to use as process indicator for dry steam and subjected for 10 mins at 121°C (250°F) / 1 bar or 3 mins at 134°C (272°F) / 2 bar. The indicator ink will change color from red to black to distinguish steam exposed products from non-exposed products.
 
SteriRITE™ steam sterilization process indicators meet the performance specification in
ISO11140-1 "Sterilization of Health Care Products - Chemical Indicators - Part 1: General
Requirements," Section 6 for Class 1 Process Indicators.
 

Manufactured by PMA
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Process
Autoclave / Steam Sterilization
Temperature
10 mins at 250ºF (121ºC) / 3 mins at 272ºF (134ºC)
Pressure
1 bar / 2 bar
Product ID
LBSTMDOT 125K
Shape
Round ø 0.5” (12 mm)
Format
5000 dots per Reel
Signature Color Change
Red to Black
Storage Conditions
The indicators must be stored in dark and dry conditions at room temperature.
Shelf Life
Unexposed indicators is 18 months after production date, when stored under proper conditions.
Precautions
Indicators must be protected from exposure to sunlight, chemicals or chemical vapours.
• Compliance with RoHS (2002/95/EC) directive requirement
• Non-toxic, lead free water based ink
• Compliance with ISO 11140-1 Class 1 Process Indicator general requirement
• Available in removable and permanent adhesive
• Thermal Transfer Printable
• Custom design to customers’ requirement
• Each batch is independently validated in a recognized ETO plant