Thesis for the Degree of Master of Science


Year 1998
Riina Tölli

Streamlining Validation in Automation Projects in the Pharmaceutical Industry

In the literature part of this study the principle of validation of automated systems in the pharmaceutical industry is introduced. The latest developments in the validation of automated systems are reviewed by examining material from validation authorities, as well as industry guides, from the years 1995-1998. The purpose is to provide persons involved in validation work with an overall view of the current situation concerning the validation of automated system.

The validation of automated systems is a relatively new field of engineering. It encompasses a large number of domains that need to be studied. The experimental part creates a basis for this development. An attempt has been made to develop the relationship between process and automation engineering in order to create a basis for reliable, functioning design work. In addition, the currently difficult item related to validation, the Functional Specification, has been studied.

The experimental part is divided into three parts. The first part concentrates on the content of one important validation document, the Functional Specification, and its relationship to on-site testing (Operational Qualification). The purpose is to provide the engineer with a concept of the entity which the Functional Specification and Operational Qualification establish.

The second part defines information entities and the form of information which the automation engineering requires from process engineering for configuring an automation system. The standard, ISA-S88.01 Batch Control Part 1: Models and Terminology, is introduced in the context of the information entities. The standard represents a model for physical structuring of the process which is one of the information entities. The purpose of the information entities is to give guidelines to process engineers, of how their information and design would better serve the automation design and project lifecycle from an automation designer’s point of view.

As third, an attempt is made in the case to use the information entities. The emphasis has been on couple information entities: unit structuring, operation description and position identification, which need more explanation and are possible to deal with this case.

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