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Chemical indicators and biological indicators for controlling the sterilization process of reusable medical devices
Cisa Group cares about people’s health: every day we take care of the safety of patients and healthcare workers.
That is why we provide chemical and biological sterilization indicators that help control the right conditions for an effective sterilization.
How chemical and biological sterilization indicators work
Sterilization indicators are systems that have a physicochemical reaction rate that varies with temperature and are sensitive to the parameters required for sterilization. These indicators must be placed inside the packages to be sterilized.
Chemical indicators only indicate that the RMD has been subjected to sterilization: the final color change in the chemical indicator does not certify the sterility of the product.
Chemical indicators are divided into two types: Process indicators. and Sterilization indicators.
How biological indicators work and what they are
Biological indicators allow to assess the effectiveness of sterilization, therefore whether microorganisms in the vegetative or spore phase have been eliminated. They can be in the form of a strip or vials and contain spores.
Cisa Group, as world-leading innovator in CSSDs and infection control systems since 1946, offers a full range of control products: chemical and biological indicators for all types of sterilization solutions, steam and plasma.
Daily Machine Release Indicators
Load Release Indicators
Pack Release Indicators
Cisa Safe | Steam
TEST BOWIE – DICK | Chemical indicator Type 2 Ready-to-use test package to test the efficiency of the vacuum pump during the pre-vacuum stage in the autoclave.
It indicates the complete and adequate air removal and steam injection.
134°C – 3.5 MIN – from blue to pink.
Cisa Safe Bowie & Dick Test is conform to the requirements of EN ISO 11140-4.
MULTIPARAMETRIC INDICATOR | Chemical indicator Type 4 Chemical indicator is developed to monitor two or more parameters of the steam sterilization process.
121°C – 15 MIN; 134°C – 5 min – from pink to green.
Cisa Safe Multiparametric Indicator is conform to the requirements of EN ISO 11140-1.
CHEMICAL INTEGRATOR | Chemical indicator Type 5 Chemical integrator monitors all critical variables of the steam sterilization process. It reacts only with optimal steam condition.
It is developed to be equivalent to the death curve of microorganisms, reaching the minimum level necessary for the sterilization.
The integrator is laminated to avoid the transfer of the chemical reagent to other materials during the sterilization process. 121°C – 15 min; 134°C – 5 min – from blue to pink.
Cisa Safe Chemical Integrator is conform to the requirements of EN ISO 11140-1.
BIOLOGICAL INDICATOR | Biological Indicators 20 minutes, 1 hour, 3 hours and 8 hours CISA has four different models of biological indicators for the steam line.
The main difference is in the response time: 20 minutes, 1 hour and 3 hours for fluorescence, or 8 hours for color / pH change, depending on the user biological indicator.
The yellow color on the processed indicator indicates the
bacterial growth and failure of the sterilization process, without any change in color (the medium remains purple) indicates a correct sterilization process.
Cisa’s biological indicators for steam technology are produced according to the requirements of the quality -management systems standard EN ISO 11138-1 and EN ISO 11138-3.
PROCESS INDICATOR | Chemical Emulator Tipo 6 The device was developed to monitor and control saturated steam sterilization cycles at 121 ° C and 134 ° C, this allows for easy verification and viewing of the result.
Chemical Indicator, Chemical Emulator Type 6 (Steam) works by changing the color of the indicator sheet.
121°C – 15 min; 134°C – 5 min – from yellow to black.
Type 6 Chemical Emulators (Steam) are produced according to the ISO 11140-1: 2014 standard.
Cisa Safe | Plasma
MULTIPARAMETRIC INDICATOR | Chemical indicator Type 4 Multiparametric indicator monitors the penetration and the exposition time of the sterilizing agent. It checks if the Hydrogen Peroxide has penetrated in packages/sets.
From orange to yellow.
Cisa Safe Multiparametric Indicator is conform to the requirements of UNI EN ISO 11140-1.
BIOLOGICAL INDICATOR Self-contained Biological indicator
It contains Geobacillus Stearothermophilus ATCC 7953 spores with a minimum population of 10^6.
A label with chemical indicator type 1 is applied to the vial.
Yellow colour for failure in the sterilization process.
Cisa Safe Biological Indicator is conform to the requirements of UNI EN ISO 11138-1.