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Batch TOC

The document outlines the ISA Batch Systems Standards, including various ANSI/ISA standards related to batch control, data structures, and recipe management. It also lists technical papers and federal documents relevant to batch processing and compliance. Additionally, it references the World Batch Forum's Business to Manufacturing Markup Language (B2MML) schemas for various operational aspects.

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20 views2 pages

Batch TOC

The document outlines the ISA Batch Systems Standards, including various ANSI/ISA standards related to batch control, data structures, and recipe management. It also lists technical papers and federal documents relevant to batch processing and compliance. Additionally, it references the World Batch Forum's Business to Manufacturing Markup Language (B2MML) schemas for various operational aspects.

Uploaded by

muhammad-farhan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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ISA Batch Systems Standards - Table of Contents

ANSI/ISA-88.01-1995, Batch Control Part 1: Models and Terminology


ANSI/ISA-88.00.02-2001, Batch Control Part 2: Data Structures and Guidelines for Languages
ANSI/ISA-88.00.03-2003, Batch Control Part 3: General and Site Recipe Models and
Representation
ANSI/ISA-88.00.04-2006, Batch Control Part 4: Batch Production Records
Applying S88: Batch Control from a User’s Perspective; Introduction
Applying S88: Batch Control from a User’s Perspective; Chapter 1 - Basic Concepts
ISA-TR88.0.03-1996, Possible Recipe Procedure Presentation Formats
Technical Papers on Batch Control
Achieving Increased Batch Plant Productivity by the Application of Multi-Level DCS Solutions -
ISA EXPO 1998
Advanced Control of Batch Reactor Temperature
Applying XML for Integrating Batch Management with the Enterprise - ISA 2001
Automated Execution of Bio Tech Batch Manufacturing - INTERKAMA 1999
Avoiding Pitfalls in Determining Quantitative Safety Integrity Levels for Batch Processing - ISA
2002
Batch Data Exchange Using XML - ISA EXPO 2000
Batch Design Techniques - ISA Automation West
Dynamic Data Analysis and Automatic Knowledge Acquisition for Improving Batch Management
- INTERKAMA 99
Heuristic Reasoning in Batch Processing - ISA EXPO 2005
How PC-Based Batch Technologies Can Enhance Conformance with 21 CFR Part II in FDA Reg-
ulated Industries
How S88 Provides Consistency in Design and Terminology Beyond Batch Processing
Improved Temperature Control In Batch Production Systems - ISA 2002
Integrated MMI for Batch Process Operations - ISA TECH 99
A Methodology for Successful Batch Projects - ISA EXPO 2000
Models and Support for Alarm Operation; Batch vs. Continuous - INTERKAMA 99
On-line Quality Analysis Integration in Batch Process Operations - INTERKAMA 99
S88 and Material: What is Going on Beyond the Process Cell? - Process Control Conference
2003
S95 in Real Time - ISA EXPO 2005
Safety in Batch Production - ISA 2001
Scheduling in Batch Process Plant Perspective - IMS 1999
Simulation and Scheduling of Recipe-Driven Batch Processes Based on a Single Data Model -
INTERKAMA 1999
Special Application of S88 Batch Standard Using Atomic Phases - ISA 2002
Validation (GAMP, FDS,...) and S88 Standards for Batch and Recipe Management Systems -
INTERKAMA 1999
Federal Documents*
21 CFR 11 Electronic Records; Electronic Signatures*
21 CFR 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or
Holding of Drugs; General*
21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals*
WORLD BATCH FORUM Business to Manufacturing Markup Language B2MML**
Common Schema Documentation**
Equipment Schema Documentation**
Maintenance Schema Documentation**
Material Schema Documentation**
Personnel Schema Documentation**
Process Segment Schema Documentation**
Product Definition Schema Documentation**
Production Capability Schema Documentation**
Production Performance Schema Documentation**
Production Schedule Schema Documentation**

*Note: At the time of this publication, these were the most current versions available. Users are
encouraged to download updated editions by going to: http://www.gpoaccess.gov/cfr/index.html

**Note: At the time of this publication, these were the most current versions available. Users are
encouraged to download updated editions by going to: http://www.wbf.org

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