MadgeTech AVS140-6 Hoja de especificaciones

AVS140-6

Autoclave Validation Data Logging System

Product User Guide

To view the full MadgeTech product line, visit our website at madgetech.com.

Autoclave Validation Data Logging System ..........2

Hardware ............................................................ 3-5

Software .............................................................. 6-7

IQ/OQ/PQ Validation Protocol ............................. 8

System Installation ................................................ 9

Device Operation....................................................10

Data Logger Maintenance ....................................11

Recalibration ...........................................Back Cover

Support ....................................................Back Cover

Table of Contents

Autoclave Validation System

Data Logger Interface & USB Cable Certificate of Calibration

IQ/OQ/PQ

Validation Protocol

Software

MIcro USB Cable (1)

(Included accessory with IFC406)

Power Adapter (1)

(Included accessory with IFC406) Calibration Certificates (6)

PR140 (1)

IFC406 (1)

HiTemp140 (5) MadgeTech 4 Secure Software (1)

Data Loggers

IQ/OQ/PQ Validation

Protocol Workbook (1)

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.

AVS140-6 Product User Guide | 3

BATTERY WARNING: FIRE, EXPLOSION, AND SEVERE BURN HAZARD. DO NOT SHORT CIRCUIT, CHARGE, FORCE OVER DISCHARGE,

CRUSH, PENETRATE, OR INCINERATE. BATTERY MAY LEAK OR EXPLODE IF HEATED ABOVE 150 °C (302 °F).

The HiTemp140 data logger is MadgeTech’s solution for high precision, rugged

temperature monitoring. It can withstand temperatures from -40 °C to 140 °C and has

an accuracy of ±0.1 °C.

The HiTemp140 can store up to 65,536 readings, and features a rigid external probe

capable of measuring extended temperatures, up to 260 °C (500 °F). Custom probe

lengths up to 7 inches are available. Also available, is the HiTemp140-PT that features a

24 inch flexible stainless steel probe for measuring extended temperatures up to 350 °C

(662 °F). The probe is durable and can be spiraled, bent or angled in any direction,

making it easy to log temperatures within bottles, vials or other hard to reach places.

HiTemp140 Product Overview

HiTemp140 Specifications

Hardware

Temperature Sensor: 100Ω Platinum RTD

Probe Measurement

Range:

HiTemp140:

-200 °C to +260 °C (-328 °F to +500 °F)

HiTemp140-PT:

-200 °C to +350 °C (-328 °F to +662 °F)

Temperature Resolution: 0.01 °C (0.02 °F)

Calibrated Accuracy:

±0.1 °C/±0.18 °F

(20 °C to +140 °C/68 °F to +284 °F)

±0.3 °C/±0.54 °F

(-20 °C to +19.99 °C/-4 °F to +67.98 °F)

±0.4 °C/±0.72 °F

(-40 °C to -20.01 °C/-40 °F to -4.02 °F)

Reading Rate: 1 second up to once every 24 hours

Memory: 65,536 readings

Battery Life: 2 years typical

(1 minute reading rate at 25 °C/77 °F)

Time Accuracy: ±1 minute/month at 20 °C to 30 °C

(68 °F to 86 °F) (Stand alone mode)

Operating Environment: -40 °C to +140 °C (-40 °F to +284 °F),

0 %RH to 100 %RH

Dimensions (Body): 1.6 in x 0.970 in dia. (40 mm x 24.6 mm dia.)

Submersible: Yes (IP68)

Weight: 4.2 oz (120 g)

Material: 316 Stainless Steel

Approvals: CE

High Temperature Data Logger

HiTemp140-1 HiTemp140-2 HiTemp140-5.25 HiTemp140-7 HiTemp140-PT-1

The PR140 is a data logger designed to validate if appropriate pressure levels have been achieved

during the steam sterilization cycle. It 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 tem-

perature range, from 20 °C to +140 °C (68 °F to 284 °F). The PR140 is available in either a Flush Top

or NPT Pressure Port Top design, with an optional female luer fitting accessory.

PR140 Product Overview

PR140 Specifications

Hardware

Pressure Sensor: Semiconductor (Strain Gauge)

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

Pressure Resolution: 0.1m Bar (0.0015 PSIA)

Calibrated Accuracy: ±0.03 Bar (± 0.435 PSI)

(20 °C to +140 °C/68 °F to 284 °F)

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

Reading Rate: 1 second up to once every 24 hours

Memory: 65,536 readings

Battery Life: 2 years typical, 1 minute reading rate at 25 °C

(77 °F)

Time Accuracy: ±1 minutes/month at 20 °C

Operating Environment: -20 °C to +140 °C (-4 °F to +284 °F), 0 %RH to 100 %RH

Note: The PR140 may be used above 60 °C for up to 8 hours, per 24 hour period.

Dimensions: 2.3 in x 1.0 in dia. (58.2 mm x 25.4 mm dia.)

Submersible: Yes (IP68)

Weight: 3 oz (85 g)

Material: Stainless Steel

Approvals: CE

BATTERY WARNING: FIRE, EXPLOSION, AND SEVERE BURN HAZARD. DO NOT SHORT CIRCUIT, CHARGE, FORCE OVER DISCHARGE,

DISASSEMBLE, CRUSH, PENETRATE OR INCINERATE. BATTERY MAY LEAK OR EXPLODE IF HEATED ABOVE 140 °C (284 °F).

Pressure Data Logger

NPT Pressure Port TopFlush Top Luer Fitting

AVS140-6 Product User Guide | 5

The IFC406 Multiplexer Data Logger Interface allows for

multiple devices to be connected into one interface. Each

IFC406 allows for 6 data loggers to be connected.

IFC406 Product Overview

IFC406 Specifications

Hardware

Operating Environment: +10 °C to +35 °C; 0 %RH to 95 %RH non-condensing

Connection Type: USB (to PC)

Weight: 1.65 lb (750 g)

Material: 6061 Aluminum (PTFE impregnated hard anodized coating),

ABS Plastic

Dimensions: 9.5 in x 1.95 in x 1.75 in (241.3 mm x 49.5 mm x 44.5 mm)

Maximum Input Voltage: 6 Volts (V)

Approval: CE

Battery: This device does not use a battery

LED Indicators

Blue: Indicates unit has power.

Amber: Channel is busy or searching for a device

Green: Operation successful or complete

Multiplexer Data Logger Interface

TheMadgeTech4SecureSowareaids customersin compliancewith21CFR Part 11 requirements.

The soware ensures standards in which electronic files are considered equivalent to paper

records, saving time and eort. MadgeTech 4 Secure Soware 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.

MadgeTech provides on-site IQ/OQ/PQ services to help the user validate the data logging system.

Our trained sta are extremely knowledgeable with the standard IQ/OQ/PQ protocols of the

MadgeTech data logging system. This service is a cost-eective means to save time and ensure

proper implementation of IQ/OQ/PQ of the MadgeTech data logging system with a minimal

disruption to sta and operations. Get more information on our IQ/OQ/PQ On-Site Service.

MadgeTech 4 Secure Software

Software

Cooling Flags Copy to ExcelAutomatic Statistics

Calculation

Tabular Data ViewCustomizable Graphs

AVS140-6 Product User Guide | 7

Workflows

Configure routine data logging tasks to run

while you are free to do other things. The

Workflows feature enables the automation of

tasks such as creating reports, downloading

data, starting and stopping devices or even

sending email notifications!

Time Markers

Easily mark a desired point in time on any

report using Time Markers. Time Markers

appear as a vertical line in a graph or a colored

row in a data table, Time Markers can help

to organize dierent stages or cycles within

your process or any reference points critical to

interpreting your data as desired.

Advanced Statistics

MadgeTech 4 Secure Soware has expanded

to oer more options and statistics available

for data analysis.

• Time until threshold statistics

• Sterilization Data (F0 and A0)

• Default statistic settings

Great New Features

The MadgeTech 4 Secure Soware is a powerful, intuitive tool containing features that are designed to save on both time

and headaches. Both management and users will find MadgeTech’s new soware exciting: users will love the familiar

interface and numerous shortcuts, while management will appreciate the increased data security and time-saving

elements. Some of the most highly-anticipated new features include:

Administrator & User Settings

Users can be given two levels of access,

either administrator or user. Administrators

have access to all the security settings, while

users only have access to communicate with

the data loggers and analyze data.

be assigned within the Login tab. There are

numerous password and account settings

for the administrator to set such as the

complexity of the password and status of

each user account. The user management

tab is only available to administrative users.

Groups

Users and Administrators can be assigned to

Groups and can be easily maintained using a

variety of permissions.

Audit Trail

An Audit Trail is kept automatically with

information such as who has logged in and

out, what files were downloaded, save, printed

etc. Each record is date and time stamped and

includes the user information.

Electronic Signature

By clicking the Electronic Signature button,

users and administrators can add electronic

signatures. The electronic signature contains

the printed name of the signer, date and

time of the signing and the meaning of the

signing.

IQ/OQ/PQ

Installation Qualification (IQ)

• A description of the MadgeTech system

• Verification that all MadgeTech system equipment, soware and accessories are

received in good condition

• A check for complete documentation

• Verification that the installation of MadgeTech equipment is completed properly

• Verification that MadgeTech 4 Secure Soware is installed properly on the target

workstation

• Verification of basic communication between MadgeTech data logger(s) and the

target workstation(s)

Operational Qualification (OQ)

• Functional verification of MadgeTech data loggers

• Handling and maintenance information for the use of MadgeTech equipment

• MadgeTech operating procedures for primary functions

• Verification of proper communication between the MadgeTech data logger(s) and the

workstation(s)

• Verification that the data logger hardware is operational

Performance Qualification (PQ) Recommendation

• Additional handling precautions for maintaining the accuracy of MadgeTech equipment

• Periodic maintenance information for the use of MadgeTech equipment

• Periodic calibration verification in the field

• Comparison of the reported values to a known good standard

• Verification of acceptable performance in the target system

Meeting compliance with regulations for the FDAs Good Manufacturing Practices, or those set forth in Quality Plans, has become increasingly

complex. MadgeTech has simplified this process by including IQ/OQ/PQ protocols with its MadgeTech 4 Secure Soware package.

This enormous time and money saving feature eliminates the need to develop in-house soware validation procedures. The MadgeTech IQ/OQ/

PQ protocol is in support of FDA and cGMP guidelines. In addition, MadgeTech oers a Soware Validation Workbook to help the user verify the

functionality of the soware.

IQ/OQ/PQ Validation Protocol

AVS140-6 Product User Guide | 9

Installing the Software

System Installation

1. Inserting the MadgeTech 4 Secure Soware CD into the CD drive on the Windows PC.

An autorun window should appear. If the autorun does not appear, locate the drive on the

computer by selecting the Start menu and choosing Computer or My Computer. Browse to the

CD drive and select the autorun.exe file. For Windows 7 and Windows 8 users, a dialog box may

appear with a list of options. Select Open Folder to View Files and select the autorun.exe file.

2. The MadgeTech 4 Secure Soware Setup Screen will display with options as shown to the le.

3. Installing the Windows Driver

To install the drivers for the IFC406, click on the Install USB Interface Drivers link on the MadgeTech

Installer Options window panel. A window will appear prompting for a directory and to start the

installation. The default directory is C:\Program Files\MTI-USB\Datalogger Interface. If you choose

to change the location of the install directory, select the Change Install Location button. Once you

have the install location set click the Install button to start the installation.

4. Installing the .NET 4.0 Framework

If the Windows PC doesn’t already have .NET 4.0 Framework, installation may be required. If you are running Windows 8, these components are

already installed. To see if the .NET 4.0 Framework is already installed on the Windows PC, go to the Windows Control Panel and select Programs.

“Microso .NET Framework 4.0” would be listed as a Windows program. If the Windows PC doesn’t already have .NET 4.0 Framework, click on

MadgeTech Secure Soware and then select Install .Net 4.0 Framework to install.

5. Installing the MadgeTech 4 Secure Soware

Click on MadgeTech Secure Soware and then select Install MadgeTech Secure Soware. Follow the MadgeTech 4 Secure Setup Wizard on-screen

prompts to complete the installation. The installation of MadgeTech 4 Secure Soware is complete!

Connecting the Data Logger Interface

Test the Data Logger Interface Operation

1. Remove the Warning Label on the IFC406 to expose the USB connector.

2. Connect one end of the USB cable to the USB port of the IFC406.

3. Connect the other end to a USB port on your PC. When the IFC406 is plugged in, a New Hardware Found message will appear in the lower right

corner of your screen. The new drivers will automatically configure themselves for use with the interface cable. A message will then appear that

the new hardware is installed and ready to use.

4. The installation of the USB data logger interface is complete!

To verify that the USB Interface drivers are installed properly, check to ensure the Data Logger Soware can recognize a device.

1. When the interface cable is connected to the PC the blue LED power indicator light should be on.

If the indicator light is not on, unplug the interface cable, wait 5 seconds and plug it back into the PC.

2. Start the MadgeTech 4 Secure Soware.

3. Your device(s) should be listed in the Connected Devices Panel.

Connecting the Data Logger

1. Once the soware is installed and running, plug the interface cable into the docking station.

2. Connect the USB end of the interface cable into an open USB port on the computer.

3. Place the data logger into the docking station.

4. The data logger will automatically appear under Connected Devices within the soware.

Starting the Data Logger

1. For most applications, select Custom Start from the menu bar and choose the desired start method, reading rate and other parameters

appropriate for the data logging application and click Start.

• Quick Start applies the most recent custom start options

• Batch Start is used for managing multiple loggers at once

• Real Time Start stores the dataset as it records while connected to the logger

2. The status of the device will change to Running, Waiting to Start or Waiting to Manual Start, depending upon your start method.

3. Disconnect the data logger from the docking station and place it in the environment to measure.

Note: The device will stop recording data when the end of memory is reached or the device is stopped, unless user selectable memory wrap is enabled.

At this point the device cannot be restarted until it has been re-armed by the computer.

Downloading Data from a Data Logger

1. Place the logger into the docking station.

2. Highlight the data logger in the Connected Devices list. Click Stop on the menu bar.

3. Once the data logger is stopped, with the logger highlighted, click Download. You will be prompted to name your report.

4. Downloading will oload and save all the recorded data to the PC.

Device Operation

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