From Automation Applications in Bio-Pharmaceuticals

In order to more easily understand the information presented in this
chapter, it may be helpful for the reader to consider the activities that are
involved with making, operating, and maintaining a reliable automobile.
Automobiles are designed and tested to meet functional requirements; are
manufactured with assembly lines, properly trained personnel and use of
SOPs to ensure that a consistent product is created; then depend upon
owners to ensure that periodic oil changes and other maintenance activities
are conducted to keep the car in a reliable state. Many parallels exist
between this paradigm and that of computer validation. Specific examples
are included in this chapter.

5.1 Introduction

Overview

Processes used in the manufacture of pharmaceuticals for human
consumption must be validated. The scope of validation includes not
only the chemical processing unit operations themselves but also the
supporting aspects of manufacturing operations such as assay validation,
cleaning validation, utility validation (e.g., use of purified water), and
computer validation.

A validated process is one that reproducibly meets expectations. It is generally
perceived as containing four key elements:

  • Process Definition; i.e., a description of the process when it runs
    correctly.
  • Demonstration; i.e., via the successful execution of test lots.
  • Documentation; i.e., if...

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Topics of Interest

6.1 Introduction: “To Batch or Not to Batch” The automation of processes had its theoretical and practical application origins in the continuous petrochemical industries, starting in the...

Medical Device & Diagnostic Industry Ashweni Sahni and Curtis L. Larsen Process validation is required to meet the current good manufacturing practices (GMP) regulation for medical devices.

Assay of products such as pharmaceutical suspensions and tablet coatings is a critical part of the Quality Assurance process. In some cases every batch of each product has to be tested, requiring 100%...

By Joseph Alford, Ph.D., P.E., CAP, ISA Fellow At least two universally accepted principles characterize alarms. Alarm systems should be designed to alert, inform and guide operators to help them do...

Medical Device & Diagnostic Industry The use of computer-controlled equipment and processes in the creation of finished medical devices has been increasing since the early 1980s. Even small...