Introduction
Scope
The scope of this document is to describe the functions that are to be supported by the EO Control System for AccuSOLO.
Purpose
This User Guide covers the operation of the AccuSOLO EO control system. It gives users guidance on working with the EO control system administrative functions, user interfaces, and control functions.
Terms and Definitions
The following are common terms and definitions used in this document:
|
Terms |
Definitions |
|---|---|
|
AAMI |
Association for the Advancement of Medical Instrumentation. |
|
AH |
Abbreviation for Absolute Humidity |
|
cGMP |
Current Good Manufacturing Practices – outdated reference to 21 CFR Part 820 regulated by the US-FDA to establish documented evidence of control of manufacturing processes such as sterilization. |
|
CSV File Format |
ASCII file format that is delimited or separated by tab characters, commas, or spaces. |
|
EO |
Abbreviation for Ethylene Oxide |
|
Exposure Time |
The total time that product spends in the Chamber being exposed to the EO |
|
FDA |
US Food and Drug Administration, a regulatory body for medical products. |
|
Installation Qualification (IQ) |
Documented verification that all key aspects of the installation adhere to approved design intentions according to the system specifications and that the manufacturers' recommendations are suitably considered. |
|
LAN |
Local Area Network. |
|
Operational Qualification (OQ) |
Documented verification that each unit or subsystem operates as intended throughout its anticipated operating range. |
|
PLC |
Programmable Logic Controller, a microprocessor based control system consisting of a microprocessor unit, and I/O (input / output device). A PLC is normally programmed in Ladder logic and other specialized languages. |
|
QSR |
Quality System Regulation – 21 CFR Part 820 regulated by the US-FDA to establish documented evidence of control of manufacturing processes such as sterilization. |
|
RH |
Abbreviation for Relative Humidity |
|
SCADA |
Supervisory, Control and Data Acquisition System |
|
Time Stamp |
The date and time that an event occurred. |
|
UPS |
Uninterruptible Power Supply. |
|
Validation |
Establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product, meeting its predetermined specifications and quality attributes. |
|
Validation of software |
The process of evaluating software to ensure compliance with specific requirements |
|
VPN |
Virtual Private Network – provides means of creating secure connections to private networks over public network infrastructure such as the Internet |