MadgeTech AVS140-1 User Guide

Product User Guide

AVS140-1

Autoclave Validation Data Logging System

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Table of Contents

Autoclave Validation Data Logging System ..........3

Hardware ............................................................ 4-5

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

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

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

Maintenance ....................................................10-11

Autoclave Validation System

The AVS140-1 is a complete system used to perform autoclave validations. The AVS140-1 consists of a
NIST traceable high temperature data logger, an IFC400 Interface and the MadgeTech 4 Secure Software
providing tools to users to assist with FDA 21 CFR Part 11 compliance.

Data Logger

Software

IQ/OQ/PQ

Validation Protocol

HiTemp140 MadgeTech 4 Secure Software

Data Logger Interface & USB Cable Certificate of Calibration

USB Cable NIST Calibration CertificatesIFC400

IQ/OQ/PQ Validation

Protocol Workbook

AVS140-6 Product User Guide | 3

Hardware

HiTemp140 Product Overview

High Temperature Data Logger

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 32,700 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.

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

HiTemp140 Specifications

Temperature Sensor: 100 Ω Platinum RTD

HiTemp140:

Probe Measurement

Range:

Temperature Resolution: 0.01 °C (0.02 °F)

Calibrated Accuracy:

Reading Rate: 1 second up to once every 24 hours

Memory: 32,700 readings

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

HiTemp140-PT:

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

±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)

Battery Life:

Time Accuracy:

Operating Environment:

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

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

±1 minute/month at 20 °C to 30 °C
(68 °F to 86 °F) (Stand alone mode)

-40 °C to +140 °C (-40 °F to +284 °F),
0 %RH to 100 %RH

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).

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