Autoclave Validation Logging System

AVS140-1 Autoclave Validation Logging System

Application

The AVS140-1 is a complete system used to perform autoclave validations. The AVS140-1 consists of one NIST Traceable HiTemp140 High Temperature Loggers, an IFC400 Multiplexer Interface and the MadgeTech 4 Secure Software providing tools to users to assist with FDA 21 CFR Part 11 compliance.

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.

Features

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.

AVS140-1 Set Includes

1  x  HiTemp140 - High Temperature Loggers with NIST Certification
1  x  IFC400 - Logger Interface for Downloading Data 
1  x  IQ/OQ/PQ Validation Protocol Workbook
1  x  Madgetech 4 Secure Software

HiTemp140 - High Temperature 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

IFC400 - Logger Interface

The IFC400 Data Logger Interface allows for a single device to be connected into one interface. 

MadgeTech 4 Secure Software

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.
MadgeTech provides on-site IQ/OQ/PQ services to help the user validate the data logging system. Our trained staff are extremely knowledgeable with the standard IQ/OQ/PQ protocols of the MadgeTech data logging system. This service is a cost-effective means to save time and ensure proper implementation of IQ/OQ/PQ of the MadgeTech data logging system with a minimal disruption to staff and operations. Get more information on our IQ/OQ/PQ On-Site Service.

IQ/OQ/PQ

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 Software package.

This enormous time and money saving feature eliminates the need to develop in-house software validation procedures. The MadgeTech IQ/OQ/PQ protocol is in support of FDA and cGMP guidelines. In addition, MadgeTech offers a Software Validation Workbook to help the user verify the functionality of the software.