Autoclave Validation Data Logging System

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AVS140-6 Autoclave Validation Data Logging System

AVS140-6 Kits Includes HiTemp 140 HITemp 140 specs PR140 PR140 specs

AVS140-6 Autoclave Validation Data Logging System

The AVS140-6 is a complete system used to perform autoclave validations.

The AVS140-6 consists of six high temperature and pressure data loggers, an IFC406 Multiplexer Interface and the MadgeTech 4 Secure Software providing tools to users to assist with FDA 21 CFR Part 11 compliance.

Autoclave Validation System Includes:

(5) HiTemp140-1 data logger with Calibration Certificate
(1) PR140 with Calibration Certificate
(1) IFC406 Multiplexer Interface
(1) License of MadgeTech 4 Secure Software and IQ/OQ/PQ validation protocols, providing tools to users to assist with FDA 21 CFR Part 11 compliance.

MadgeTech 4 Secure Validation Software Package

IQ/OQ/PQ Secure Software Validation Workbook and Software Package.

To help customers comply with 21 CFR Part 11 requirements, MadgeTech has developed the MadgeTech 4 Secure Software Validation Package.

The software ensures standards in which electronic files are considered equivalent to paper records, saving time, and effort.

MadgeTech Secure Software contains criteria such as electronic signatures, access codes, secure data file, and an audit trail which meet the requirements of 21 CFR Part 11 and helps provide data integrity IQ/OQ/PQ protocols can be purchased and implemented to validate that the software has been installed and is operating correctly.

Additional support is available for full software training.

The layout of the secure software is similar to the Madgetech Standard Software version, allowing users to easily learn the additional features.

The AVS140-6 kit includes:

(5) HiTemp140 High Temperature Data Loggers with 1 in probe style, all with Calibration Certificates
(1) PR140 Pressure Data Logger, with Calibration Certificate
(1) IFC406 Multiplexer interface
(1) MadgeTech Secure Data Logger Software, complete with IQ/OQ/PQ validation protocols and workbook

(other data logger probe lengths and styles available, call for details)

The HiTemp140 is a rugged, high precision, temperature data logger that is built for use with autoclaves and harsh environments. This stainless steel device is submersible, can withstand temperatures up to 140 °C (284 °F) and has an accuracy of +/-0.1 °C (0.18 °F).

The PR140 is a pressure data logger designed for use in autoclave validation and mapping. This rugged data logger can withstand temperatures up to 140 °C and is completely submersible (IP68). The PR140 is built with a precision stainless steel pressure gauge. The data logger has an accuracy of ±0.03 Bar (±0.435 PSI), which can be achieved over a wide temperature range, from 20 °C to +140 °C (68 °F to 284 °F). The PR140 can be programmed to take readings as often as once per second (1 Hz), and has non-volatile memory that can store up to 32,700 measurements.

The MadgeTech 4 Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. MadgeTech 4 Secure Software contains criteria such as electronic signatures, access codes, secure data files, and an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity.

Also available, the AVS140-1, a single logger autoclave validation system.

HiTemp140 Data Logger

Rugged, high precision, high temperature data logger built for use in autoclaves and harsh environments. Includes ISO17025 accredited calibration certificate.

The HiTemp140 is a stainless steel temperature data logger built for use in harsh environments such as autoclaves. It is submersible, can withstand temperatures up to 140 °C and has an accuracy of +/-0.1 °C.

The HiTemp140 data logger can store up to 32,700 readings, and features a rigid external probe capable of measuring extended temperatures up to 260 °C .

Custom probe lengths up to 7 in are available.

The HiTemp140 records date and time stamped readings, and has non-volatile solid state memory. This allows the device to retain recorded data even if the battery becomes discharged.

The MadgeTech Software makes starting, stopping, and downloading the HiTemp140 simple and easy.

Graphical, tabular and summary data is provided for analysis and data can be viewed in °C, °F, K or °R.

The data can also be automatically exported to Excel® for further calculation

Temperature Sensor : 100 Ω Platinum RTD

Temperature Resolution : 0.01 °C

Temperature Calibrated Accuracy :

±0.1 °C (20 °C to +140 °C
±0.3 °C (-20 °C to +19.99 °C)
±0.4 °C (-40 °C to -20.01 °C)

Probe Temperature Range : -200 °C to +260 °C (Body of Logger Cannot Exceed 140 °C)

Memory : 32,700

Battery Life : 1 year typical (1 minute reading rate at 25 °C) User Replaceable Battery

Material : 316 Stainless Steel

Reading Rate : 1 reading every second up to 1 reading every 24 hours

Dimensions :

HiTemp140 Body : 40 mm x 25 mm dia.
HiTemp140-1 Probe : 25 mm x 3.2 mm dia. (4.8 mm transitional dia.)
HiTemp140-2 Probe : 51 mm x 4.8 mm
HiTemp140-2-TD : Probe 51 mm x 3.2 mm dia. (4.8 mm transitional dia.)
HiTemp140-5.25 : 134 mm x 4.8 mm)
HiTemp140-5.25-TD : 134 mm x 3.2 mm dia. (4.8 mm transitional dia.
HiTemp140-7 : 178 mm x 4.8 mm dia.

IP Rating : IP68

Submersible : Yes

Operating Environment :

-40 °C to +140 °C
0 %RH to 100 %RH (Body of Logger Cannot Exceed 140 °C)

Approvals : CE

PR140 HIGH TEMPERATURE PRESSURE DATA LOGGER

The PR140 is a pressure data logger designed for use in autoclave validation and mapping.

This rugged device can withstand temperatures up to 140 °C and is completely submersible (IP68).

The PR140 is built with a precision stainless steel pressure gauge.

The device has an accuracy of ±0.03 Bar (±0.435 PSI), which can be achieved over a wide temperature range, from 20 °C to +140 °C.

The PR140 can be programmed to take readings as often as once per second (1 Hz), and has non-volatile memory that can store up to 32,700 measurements.

The 1/8 inch NPT pressure port featured on the device allows for compatibility with a variety of fittings and adapters.

This is ideal for calibration purposes, as well as connecting the data logger to measure process pressure systems.

The PR140 is easy to use.

Simply place it in the IFC400 or IFC406 docking station (sold separately), connect to a computer, and the device can be started, stopped or downloaded using the MadgeTech software.

Graphical, tabular and summary data is provided for analysis and can be viewed in PSIA, mmHg, bar, Torr and kPa.

The data can also be automatically exported to Excel® for further calculations.

Pressure Sensor: Semiconductor strain gauge

Pressure Range: 0 to 5 Bar (0 to 72.5 PSIA)

Pressure Resolution: 0.0001 Bar

Calibrated Accuracy: +0.03 Bar (+0.435 PSI), +20 °C to +140 °C

Pressure Response Time: 0.1 ms (10 to 90 % FSR)

Reading Rate: 1 reading every second up to 1 reading every 24 hours

Memory: 32,700 readings; software configurable memory wrap

Start Modes: Software programmable immediate start or delay start up to six months

Real Time Recording: May be used with PC to monitor and record data in real time

Calibration: Digital calibration through software