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


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
  • Demonstration; i.e., via the successful execution of test lots.
  • Documentation; i.e., if...

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Programmable logic controllers (PLC) are the control hubs for a wide variety of automated systems and processes. They use a wide variety of inputs and outputs and provide network capability.
Automation Equipment and System Integrators
Automation equipment and system integrators provide equipment and solutions for automating manufacturing processes. 
Automation Controls Design and Installation Services
Automation controls design and automation controls installation services design, manufacture and install controls for automated industrial equipment and systems.
Process Equipment and System Integration Services
Process equipment and system integration services provide modular systems and components used to process fluids, oil, gases, sea water and powders. This product area includes process skids, distillation equipment, evaporators, desalination systems, secondary recovery systems, chemical injection systems, and solvent recovery systems. 
Biotechnology Services
Biotechnology services modify living microorganisms to provide biotechnology products on a contract or custom basis to medical, pharmaceutical, and scientific laboratories.

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 mid-...

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.

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...

9.2 Drug tablet testing for mechanical properties and defects 9.2.1 Drug tablet as a composite structure: structure of a typical drug tablet The most fundamental and critical objective of a tablet is...