Steri rite™ gamma e-beam sterilization indicators (adv)

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 Process Gamma / E-beam Radiation Sterilization Dosage 5 KGy (1 Mrad) - 100 KGy Product ID LBRADDOT 125K Shape Round ø 0.5” (12 mm) Format 5000 dots per Reel Signature Color Change Orange to Red Storage Conditions The indicators must be stored in dark and cool between 2ºC and 22ºC or 35ºF and 72ºF. Shelf Life Unexposed indicators is 12 months after production date, when stored under proper conditions. Precautions 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 Home Products

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Transcript of Steri rite™ gamma e-beam sterilization indicators (adv)

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

Process Gamma / E-beam Radiation Sterilization

Dosage 5 KGy (1 Mrad) - 100 KGy

Product ID LBRADDOT 125K

Shape Round ø 0.5” (12 mm)

Format 5000 dots per Reel

Signature Color Change

Orange to Red

Storage ConditionsThe indicators must be stored in dark and cool between 2ºC and 22ºC or 35ºF and 72ºF.

Shelf LifeUnexposed indicators is 12 months after production date, when stored under proper conditions.

PrecautionsIndicators 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

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