SteriRITE™ Gamma/E-beam Sterilization Indicators (Ø15mm)
SteriRITE™ Gamma / E-beam radiation process indicators are designed to use as process indicator (Class 1) for Gamma / E-beam sterilization
operating at 10 kGy with increased color density up to 100 kGy of Cobalt-60 irradiation. The indicator ink will change color
from yellow 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
Manufactured by PMA
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Process
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Gamma / E-beam Radiation Sterilization
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Dosage
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10 KGy (1 Mrad) - 100 KGy
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Product ID
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LBRADDOT YR15K
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Shape
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Round ø 0.59” (15 mm)
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Format
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5000
dots per Reel
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Signature Color Change
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Yellow to Red
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Storage Conditions
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The indicators must be stored in dark and cool between 2ºC and 22ºC
or 35ºF and 72ºF.
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Shelf Life
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Unexposed indicators is 12 months after production date, when stored under proper conditions.
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Precautions
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Indicators
must be protected from exposure to UV light, sunlight, excessive heat, chemicals or chemical vapors.
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• 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
• 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