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SteriRITE™ Gamma/E-beam Sterilization Indicators

Data Sheet
SteriRITE™ Gamma / E-beam radiation process indicators are designed to use as process indicator (Class 1) for Gamma / E-beam sterilization operating at 5 kGy with increased color density up to 100 kGy of Cobalt-60 irradiation. The indicator ink will change color from orange to red to distinguish Gamma / E-beam exposed products from non exposed products.
SteriRITE™ Gamma / E-beam 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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Gamma / E-beam Radiation Sterilization
5 KGy (1 Mrad) - 100 KGy
Product ID
Round ∅ 0.5" (12 mm)
5000 dots per Reel
Signature Color Change
Orange to Red
Storage Conditions
The indicators must be stored in dark and cool between 2°C and 22°C or 35°F and 72°F.
Shelf Life
Unexposed indicators is 12 months after production date, when stored under proper conditions.
Indicators must be protected from exposure to UV light, sunlight, excessive heat, chemicals or chemical vapors.
• 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 Gamma plant