EtO Sterilization - Senze-Instruments

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Process & Quality Control

EtO Sterilization

Temperature > Sterilisation
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MadgeTech’s Ethylene Oxide (EtO) sterilization data loggers can be used to monitor, record and validate sterilization cycles. These rugged devices are capable of withstanding temperatures up to 80 °C, and are available in a temperature or temperature and humidity model. The EtO sterilization data loggers record measurements at a user-selectable interval, providing validation for the entire cycle. The MadgeTech software makes it easy to create validation reports and prove compliance with federal regulations.

EtO sterilization is an alternative to high temperature steam sterilization found in medical and pharmaceutical industries. EtO sterilization validation or testing allows users to accurately sterilize and maintain regulatory requirements. Rugged and durable, MadgeTech’s EtO data loggers makes retrieving data fast and easy to use.
RHTemp1000IS
Intrinsically Safe Humidity and Temperature Data Logger
Rated as Intrinsically Safe by FM Approvals for use in Class I, Division 1, Groups A, B, C and D and non-incendivefor Class I, Division 2, groups A, B, C and D indoor and outdoor.
Utilizes a new thermoset-polymer capacitive sensor that provides the longest operating life in an ethylene-oxide based sterilization process.
The stainless steel body with new sintered cap provide increased accuracy and more resistance to harsh environments.
Maintains resistance against various chemical liquids and vapors like isopropyl, benzene, toluene, formaldehydes, oils and common cleaning agents.

Applications:
EO/EtOSterilization, Environmental Studies, Hostile Environmental Monitoring, Medical & Pharmaceutical
RHTemp1000IS
Intrinsically Safe Humidity and Temperature Data Logger
Features & Benefits
•Temperature:
>Temperature Measurement Range:-20 °C to +80 °C (-4 °F to +176 °F),
>Temperature Sensor: Resistance Temperature Detector (RTD)
>Temperature Response Time: 10 minutes (free air)
>Calibrated Accuracy: ±0.5 °C (0 °C to 55 °C)
•Humidity:
>Humidity Sensor: Capacitive Digital Humidity Sensor
>Humidity Response Time: τ = 2 minutes to 63% of change
>Calibrated Accuracy: ±3 %RH maximum±2 %RH typical at 25°C
>Specified Accuracy Range: 10 %RH to 90 %RH; ±5 °C to +55 °C
>Start Modes: Software programmable immediate start or delay start up to 24 months in advance

Temp1000IS
Intrinsically Safe Temperature Data Logger

Rated as Intrinsically Safe by FM Approvals for use in Class I, Division 1, Groups A, B, C and D and non-incendivefor Class I, Division 2, groups A, B, C and D indoor and outdoor.

Precision 100 Ω(ohm) platinum RTD sensing element.

External RTD for fast response time.

Sterilization Units and Pasteurization Units are available in MadgeTech Software with the click of a button.

Applications:
EO/EtOSterilization, Implement HACCP Programs, Food Preparation and Processing, Environmental Studies, Well Monitoring, Dishwasher Testing, Hazardous and Hostile Environment Monitoring, Medical and Pharmaceutical
Temp1000IS
Intrinsically Safe Temperature Data Logger
Features & Benefits
•Temperature:
>Temperature Measurement Range:-40 °C to +80 °C ,
>Temperature Sensor: Resistance Temperature Detector (RTD)
>Temperature Resolution: 0.01 °C
>Calibrated Accuracy: ±0.5 °C (0 °C to 55 °C)
>Start Modes: Software programmable immediate start or delay start, up to 2 years in advance
>Lethality Equations: Sterilization Units and Pasteurization Units are available in software with the click of a button
IFC406
Multiplexer Data Logger Interface
Features & Benefits
•Simply place the loggers in the docking station to automatically establish communication with the PC.
•Each IFC406 allows for 6 data loggers to be connected and up to 3 IFC406 units can be daisy-chained together for communication with a total of 18 devices through 1 USB port.
•Engraved Label
•LED Indicators:
>Blue: Indicates unit has power
>Amber: Channel is busy or searching for a device
>Green: Operation successful or complete
•Dimensions:  241 mm x 49.5 mm x 44.5 mm
•Weight: 750 g
Features
•Customizable Graphs
•Exporting
•Data Annotation
•Digital Calibration
•Automatic Statistics Calculation
•Graph Overlays, Data Summary, Reports
•Audit Trails
•Electronic Signatures
•Real time wireless alarming
Data Logger Software
MadgeTech 4 Secure Data Logger Software
•MadgeTech4 Secure aids in compliance with 21 CFR Part 11 requirements.
•Full IQ/OQ/PQ validation documentation comes included.
•Quantity discounts are available.
•Don’t need 21 CFR Part 11? MadgeTech has a standard version of this same software available for free.

Data Analysis
Graphs, Statistics & Tabular Data
The MadgeTech Software provides powerful data analysis and reporting tools to aid in sterilization validation and compliance.

Simple, Easy-to-use, Windows-based Software
The MadgeTech 4 Data Logger Software is designed to streamline the   process of downloading data and reviewing it in a user-friendly, time   efficient manner. The software offers many customizable features and  options, including the  ability to change engineering units (dependent  upon specific data logger  models), conforming to the needs of the user.
All MadgeTech data loggers operate in a similar fashion and are  simple and easy to use. Each class of logger has a unique device type  and is automatically identified within the MadgeTech Software on the  host computer.
MadgeTech 4 Data Logger Software comes standard with any MadgeTech  Data  Logger and free updates are available to download from the  MadgeTech  website.
Technical Requirements

The MadgeTech Data Logger software requires an IBM or compatible PC with the following:
  • PC-compatible Pentium(R)-class system
  • Windows XP, Vista, Windows 7 (32 and 64 bit), Windows 8* and Windows 10
  • Color SVGA monitor (1024 x 768 resolution)
  • 1GB RAM
  • At least 30MB free hard disk space (for installation)
  • Available 9 pin male serial (COM) port (for serial logger interface cable)
  • Available USB port (for USB logger interface cable)
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