0263–8762/04/$30.00+0.00# 2004 Institution of Chemical Engineers

www.ingentaselect.com=titles=02638762.htm Trans IChemE, Part A, February 2004Chemical Engineering Research and Design, 82(A2): 303

BOOK REVIEW

Pharmaceutical Production: An Engineering GuideEdited by Bill Bennett and Graham ColeIChemE, 2003451 pp, £90, ISBN 0 85295 440 9

Reviewed by Derek Russell(Consultant, Russell processþprojects)

The pharmaceutical business is one where people of manydisciplines work together, within a very tightly regulatedindustry. Production staff in a typical company may includechemical engineers, mechanical engineers, chemists, phar-macists, microbiologists and others. The combination ofskills and knowledge is equally broad, and includes not onlythe engineering of the equipment and the facility, but also awide understanding of the regulatory requirements, cGMP,and validation.

This guide covers a very wide subject matter, rangingfrom primary chemical synthesis to biopharmaceuticalproduction, with all the aspects of regulatory control andcGMP that are required for pharmaceutical production. Thisis a mammoth task, and overall the authors and the editorshave covered the ground extremely well. I admire them forsucceeding, and I can understand the amount of effort thatthe guide has required.

I am not aware of any comparable engineering guidewhich manages to cover such a breadth of content withinone volume, and which still goes into sufficient depth tomake the guide practical and useful. By comparison, thenotes for the postgraduate PEAT (Pharmaceutical Engineer-ing Advanced Training) course at UMIST comprises 12thick ring binders for a broadly similar scope. This guidecompresses the essential components of PharmaceuticalEngineering into one 450-page book.

Each section of the guide has been written by an expert(or experts) in their field, and the technical content isexcellent. Each of the authors has bought their own styleto the guide, and this enhances the readability. I congratulatethe editors for successfully co-ordinating the differentsections but still allowing this individuality. With so manydifferent subjects there is bound to be some overlap betweensections, but there is an excellent ‘visitors’ guide’ in theintroduction to steer the reader through the guide. Despite

this, there are some apparent anomalies (hvac is mainlyaddressed in the chapter on Secondary Production, ratherthan in the Utilities chapter) but this is almost inevitable insuch a wide-ranging reference.

Most engineers and other professionals in the industrywill turn first to the chapters which are common to allbranches of the pharmaceutical industry—RegulatoryAspects, Good Manufacturing Practice, and Validation.These present an admirable introduction to the subjects,and provide the background to the industry which isnecessary to any designer or production professional. Theguide includes practical guidance on GMP reviews andvalidation planning as well as the essential backgroundinformation.

Other chapters cover the separate areas of pharmaceuticalengineering, such as Primary Production, SecondaryProduction, Biopharmaceutical Pilot and Manufacturing,as well as the support facilities such as Laboratories andUtilities. The chapters on production facilities are wide-ranging and include good coverage of both the facilitydesign, and the equipment and unit operations used forproduction. Perhaps the chapters on Primary and SecondaryProduction could have included more diagrams and illustra-tions, especially as engineers are used to informationpresented pictorially. I also felt that the chapter on Labora-tory Design was aimed mainly at ‘wet chemistry’ at theexpense of analytical instrument laboratories and microbio-logical laboratories. However, these are minor criticisms.

This guide should be an indispensable addition to book-shelves in most departments in a pharmaceutical manufac-turing company. As well as providing practical informationfor the professionals within that department, it will providean understanding of the other activities that make up thecompany and provide the insight needed to enable depart-ments are to work well together. The guide will be invalu-able to process and facility designers, especially to providethem with the necessary understanding of the many aspectsof the pharmaceutical industry.

This book is available via IChemE’s Virtual Bookshop:www.icheme.org=shop (IChemE members receive a 25%discount).

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