Data Logging Solutions | MEDICAL AND PHARMACEUTICAL

Supplier: Pacific Sensor Technologies Pty Ltd By: Vidu Kodituwakku
21 May, 2021

Use MadgeTech Data Loggers to monitor and validate Steam Sterilization, Dry Heat Sterilization, Ethylene Oxide Sterilization (ETO/EO), Lyophilization, Vaccine Monitoring, Cryopreservation and more.

STEAM STERILIZATION

MadgeTech has designed a series of data loggers specifically for validating temperature and pressure within autoclaves. These rugged, stand-alone, fully-submersible devices can be placed directly inside the autoclave with the product(s), providing an overall temperature and pressure profile to validate the entire sterilization cycle.

High Temperature Data Loggers

The HiTemp140 series data loggers are MadgeTech’s solution for precise high temperature monitoring. These data loggers can indefinitely withstand temperatures of up to 140 °C (284 °F). The HiTemp140 features a rigid external RTD probe capable of measuring extended temperatures, up to 260 °C (500 °F). Varied probe lengths are available up to 7 inch. The HiTemp140-PT features a 24 inch flexible steel RTD probe capable of measuring extended temperatures, up to 350 °C (662 °F).

The HiTemp140X2 series of dual probe high temperature data loggers offer extreme flexibility for high temperature monitoring applications. This product is ideal for applications such as autoclave validation, sterilization processes and much more.

The HiTemp140-FR is a high temperature data logger with an ultra-fast response time, to record temperature during rapidly changing thermal processes. This high temperature data logger is capable of recording as fast as 4 Hz. The HiTemp140-FP probe design is narrow and lightweight making it ideal for placement within small vials, test tubes and other small diameter or delicate applications. The flexible lightweight probe with stainless steel tip minimizes the risks of breakage (both vial and probe) and makes placement of the probe easy to manipulate.

The HiTemp140-M12 is a high temperature data logger designed with a built in M12 probe connecter. This logger is compatible with dozens of M12 RTD probes and capable of measuring up to 850 °C (probe dependent).

 

Pressure Data Logger for High Temperatures

The PR140 is a pressure data logger that can withstand pressures up to 5 Bar and temperatures up to +140 °C (+284 °F). This rugged device is completely submersible. The PR140 is built with a precision pressure sensor, offering a calibrated accuracy of ±0.03 Bar.

 

Autoclave Validation Data Logging System

MadgeTech offers the AVS Autoclave Validation System, which provides all of the tools needed to validate, map and monitor autoclaves and washer disinfectors. The AVS comes with all components securely packaged in a sleek and protective aluminum briefcase, ideal for storage or transporting the system to multiple facilities or locations.

PST validation kits comes with 2 different selectable packages, 2 x Temperature + 1 x Pressure Loggers OR 3 x Temperature + 1 x Pressure Loggers, along with the MadgeTech Standard software, IFC400 OR IFC406 in a shock proof carry bag.

 

DRY HEAT STERILIZATION AND EXTREME TEMPERATURE VALIDATION

For applications that require extended exposure to high heat, MadgeTech has developed a line of thermal enclosures for use with the HiTemp140 series data loggers. These thermal shields and barriers expand the capabilities of the HiTemp140 series, making an ideal solution for monitoring the extreme temperatures and exposure time required for effective Dry Heat Sterilization.

Dry Heat Sterilization Data Logging System

The DHS Data Logging System for Dry Heat Sterilization is an all in one solution that comes equipped with:
• HiTemp140-M12, High Temperature Data Logger
• 36 inch Glass Braided RTD Dry Heat Sterilization probe with M12 connector and flat probe tip
• ThermoVault Max, Extreme Temperature Thermal Barrier


This system is capable of withstanding and measuring temperatures up to 400 °C for 60 minutes, allowing it to record throughout the entire dry heat sterilization process. The HiTemp140-M12 data logger features the popular rugged steel body design of the HiTemp140 data logger series with the flexibility to utilize dozens of RTD probe options with M12 connection compatibility.

 

High Temperature Data Logger with an M12 Probe Connector

The HiTemp140-M12 features the same rugged stainless steel body as the other HiTemp140 data loggers in the series, but offers interchangeable probe options using an M12 type connector. The M12 connectivity makes this versatile data logger compatible with the large variety of M12 RTD probes available today. The HiTemp140-M12 is capable of measuring and recording temperatures from -200 °C to +850 °C (-328 °F to +1562 °F) (probe dependent).

 

Extended High Temperature Monitoring

For applications above 140 °C, a thermal shield is available for most models of the HiTemp140 and HiTemp140-PT series data loggers. The thermal shield extends the operating temperature of the data logger, allowing it to be exposed to higher temperatures for a longer amount of
time. Flush and vented models are available to help provide probe protection.

 

ETHYLENE OXIDE STERILIZATION (ETO/EO)

In accordance with ANSI/AAMI/ISO 11135, it is required for temperature and humidity levels be monitored during an EtO/EO sterilization process. MadgeTech data loggers can be used to validate these parameters to ensure an environment in which sufficient sterility levels are achieved.

The Temp1000IS data logger measures temperature and the RHTemp1000IS measures both temperature and humidity. Both devices are designed to withstand harsh environments and record data at user selected time intervals, providing a complete temperature and humidity profile of each EtO cycle. The stand alone operation and compact size of these data loggers allows them to fit easily into the sterilization chamber with the product load.

The Temp1000IS and RHTemp1000IS are designed to be placed directly inside the sterilization chamber and meet the required regulation equipment standards. These devices have been certified by FM Approvals as intrinsically safe for Class I, Division 1, groups A, B, C, D, and non-incendive for Class I, Division 2, groups A, B, C, D, hazardous environments.

Intrinsically Safe Temperature Data Logger

The Temp1000IS provides an Intrinsically Safe solution for temperature monitoring in hazardous locations and features a highly accurate precision 100 O platinum RTD sensing element. The external 1 inch RTD probe provides a faster response time in comparison to most standard internal sensors.
The Temp1000IS comes housed in a 316 Stainless Steel enclosure. An optional key ring attachment is available for additional installation configurations.

Intrinsically Safe Humidity & Temperature Data Logger

The RHTemp1000IS is MadgeTech’s most robust temperature and humidity data logging solution and features a cutting-edge thermoset-polymer capacitive sensor, that provides the longest operating life in an ethylene oxide-based (EtO) sterilization process. With the ability to maintain resistance against various chemical liquids and vapors like isopropyl, benzene, toluene, formaldehydes, oils and common cleaning agents, this sensor is ideal for EtO processes, as well as continuous, long term use.
The RHTemp1000IS enclosure is made of 316 Stainless Steel. Its small size and sleek design allows it to be placed precisely in critical  locations for temperature and humidity mapping.

 

COLD CHAIN AND STORAGE

MadgeTech’s cold chain and storage data loggers monitor and record the temperature of items in storage or during
transit. They efficiently collect data to aid in maintaining product quality and compliance.

Compact Ambient Temperature Monitoring

The Temp101A is second to none in the compact, portable, and lowcost data logger class. This device can measure and record ambient
temperature from -40 °C to 80 °C (-40 °F to +176 °F) and is approximately the size of a matchbox which allows for easy placement even in tight spaces.
Combined with the ability to store over 2,000,000 readings makes the Temp101A the ideal solution for long term temperature deployment and monitoring cycles.


-20 °C to +70 °C Applications

The TransiTemp-EC temperature data logger is designed for high volume, low cost in-transit recording. It has a custom molded case with a
handle for convenient attachment and comes in single and multi use versions. This compact, portable, easy to use device will measure and record up to 8,191 readings. The storage medium is non-volatile solid state memory, providing maximum data security even if the battery becomes discharged or when the device stops taking data.

LYOPHILIZATION

The LyoTemp is designed to be a rugged, reliable, cost-effective solution for temperature monitoring inside lyophilizers. The ease of use and simple setup provide a significant time and cost savings over traditional thermocouple based systems.

Lyophilization Data Logger

The LyoTemp data logger is designed for use in ultra-low operating temperatures for processes such as lyophilization. The LyoTemp has an
operating range of -60 °C to +75 °C (-76 °F to +167 °F), enabling the entire device to be placed inside the lyophilizer chamber. It features a hermetically sealed thermistor with a flexible cable and stainless steel tip, offered in a 48 inch length, to allow for temperature monitoring inside vials and ampoules.

The compact size and simple operation make the LyoTemp user friendly and reliable. The LyoTemp has three LED indicators to alert or inform the user of the logging status and manual start and stop options available at the device. Other features of the LyoTemp include delayed start configuration, user configurable alarms and password protection.

 

CRYOPRESERVATION

MadgeTech’s cryogenic data loggers monitor and record the temperature of items in storage or during transit providing the necessary quality control to maintain effective standards of service.

-86 °C Cryogenic Storage & Transport

The CryoTemp is a stand alone, ultra low temperature logger that can measure as low as -86 °C without the need for external probes. The enclosure is designed with a handle for easy attachment and is IP64 (splash-proof). It is equipped with three LED’s to signify logging, indicate when user-set warning limits have been breached and when temperature alarm limits have been exceeded. The features of this device make it ideal for monitoring pharmaceutical shipments, blood-bank storage, stem-cell samples and any other substance that requires dry-ice shipments or storage.

-196 °C Liquid Nitrogen-based Applications

MadgeTech’s LNDS, Liquid Nitrogen Data Logging System, is an ultra-low temperature measurement system created specifically for the monitoring of temperature sensitive substances that need to be preserved at cryogenic temperatures. 

The LNDS can be mounted to the top or outside of a cryo-shipping container or freezer, and the probe sheath can be inserted into the tank. The user can then directly view the internal temperature through the LCD on the logger, in addition to minimum, maximum, and average statistics.

 

WIRELESS CONTINUOUS PROCESS MONITORING

For real-time continuous monitoring, MadgeTech’s wireless (RF) series is a time-saving and cost effective solution for validating temperature, humidity, pressure levels and more. A selection of models are available for use in a multitude of applications.

Environmental & Process Monitoring

MadgeTech’s 2000A two-way wireless series of data loggers is designed for users who want an automated, reliable monitoring solution. Ideal for monitoring environments such as laboratories, warehouses, refrigerators, and freezers, a selection of models are available to meet the needs of a variety of applications. The device takes readings at user-specified intervals, with data being transmitted back to a central PC for a real-time update of temperature and/or humidity readings. A local LCD display also provides an instant readout of min, max, average, and current readings.

The 2000A series also includes audible and visual alarms for users close by. If the temperature, humidity, pressure or CO2 levels exceed the user defined safe range, the alarm will sound enabling the user to take immediate action. Email and text message alarms can be programmed in addition to the audible alarm, ensuring real-time notifications regardless of location.