Microbiology books by Tim Sandle

Tim Sandle

Dr. Sandle has written over six hundred book chapters, peer reviewed papers and technical articles relating to microbiology. In addition, Dr. Sandle has written several books. Dr. Sandle has also delivered papers to over fifty international conferences and he is an active journalist.

 

Microbiology books by Tim Sandle

Aseptic and Sterile Processing: Control, Compliance and Future Trends

https://store.pda.org/ProductCatalog/Product.aspx?ID=3850

Here is the most important text discussing aseptic and sterile manufacturing to be published in the last decade that looks at both today and tomorrow in regard to these two vital processing procedures.

The Editors realized that there was an urgent imperative for the relevant subjects to be reassessed and represented. To achieve this objective, along with many subject matter experts, they produced a book that is foremost practical. It has been designed for those involved with aseptic and sterile processing to take away many learning points and apply these principles to aseptic and sterile processing within the pharmaceutical and healthcare sectors.

Drawing on experience, they made every effort to incorporate sound science into the practices described, not least to emphasize why new paradigms are required but to provide wide-ranging guidance and offer depth and scope. This is why chapters on human error, risk assessment, depyrogenation, bioburden testing and so on, are extensively covered. It is the aim of the Editors to help readers reassess legacy definitions and historical understandings and move them toward concepts that will help them think in new ways about equipment and processes that will reach the highest standards and evaluate them through science-based risk assessments.

Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies

https://store.pda.org/ProductCatalog/Product.aspx?ID=3329

Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always be mindful of risk.

Tim Sandle's newest book incorporates regulatory perspectives, scientific methods and practical examples to describe approaches to problem solving when assessing, managing and reviewing risk. The book is divided into four sections that present a formal approach to risk. The first section provides a look at risk assessments and hazards, exploring the origins, looking at key concepts and philosophies and assessing the regulatory perspective. An overview of available tools for risk assessment and problem solving leads into specific 'soft skills' that can help to run an effective meeting, oversee a project and report root cause analysis and risk outcomes. The book concludes with an extensive set of case studies to show real-world applications of the tools and techniques presented. The wide range of topics presented throughout the four sections includes risk considerations for aging pharmaceutical facilities, application of quality risk management to cleanroom design and process incident investigation.

Sterilization: Practical Approaches

https://store.pda.org/ProductCatalog/Product.aspx?ID=3738

The book Sterilization: Practical Approaches offers practical approaches to sterility testing, Gamma Irradiation for single use disposables, sterilization using EtO and dry heat, ophthalmic preparations and contamination control.

Sterilization: Establishing the Process

https://store.pda.org/ProductCatalog/Product.aspx?ID=3737

The book Sterilization: Establishing the Process discusses compliance, regulatory inspections, containment system sterility, test failure investigations and many other basics.

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

Pharmaceutical Microbiology: Essentials forQuality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.

The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.

Industrial Pharmaceutical Microbiology: Standards & Controls - 2015 Edition

Edited by Geoff Hanlon and Tim Sandle

The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes and cleanrooms, and how to effectively evaluate microbial risks to products from personnel and processes.

To meet the latest regulatory expectations, the role of the microbiologist is essential. In addition there is important input requirement from quality assurance personnel, engineers, and process specialists. Whilst there is a continuing need for monitoring of the environment and conducting standardised laboratory tests, industrial pharmaceutical microbiology has moved on a great deal in the past decade. It now has to embrace microbiological audits; rapid microbiological methods; conducting risk assessments, both proactive in terms of minimising contamination, and reactive in terms of addressing microbial data deviations; and also ensuring that processes meet ‘quality by design’ principles. In this new 600 page book a team of 24 international authorities will assist you in all your questions.

Industrial Pharmaceutical Microbiology: Standards and Controls covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare. Connect instantly with regulations and current best practices on everything from disinfectants to sterility testing; environmental monitoring to hazard analysis; and from pharmaceutical processes to biological indicators. All of this is developed from an international perspective, where different regulations are compared and contrasted together with insightful commentary as to best practices.

Industrial Pharmaceutical Microbiology: Standards and Controls provides clear, practical and up-to-date guidance for handling virtually every compliance and operational challenge associated with pharmaceutical microbiology.

The book is available from Euromed.

Cleanroom Microbiology by Tim Sandle and R. Vijayakumar

While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled environments limited coverage.

To the authors of Cleanroom Microbiology, these two domains, normally separated by different functions, are inseparable. This book is about cleanrooms and controlled environments in relation to the pharmaceutical and healthcare sectors and is applicable to both the sterile and non-sterile pharmaceutical sectors with its focus on cleanroom microbiology. The book is available from PDA/DHI here.

Sterility Testing of Pharmaceutical Products

'Sterility Testing of Pharmaceutical Products', published by DHI/PDA.

The central argument of the book is that control of the process and environmental control are considerably more important guarantors of sterility than the questionable comfort gained from a 'pass' result at the end of the incubation of a sterility test.

This book balances theoretical, and sometimes philosophical, discourses about the nature of sterility and the conceptual problems of microbial viability with sound practical guidance on how to validate the sterility test, problematic products as well as solutions on how to control the environment and review manufacturing process parameters, while navigating the regulatory minefield.

The aim of the book is to present the sterility test as a final product release test as seen in the past, the present and with a view towards the future and is aimed at quality assurance personnel, production staff, microbiologists, students and those with an interest in medicinal products.

The reference is:

Sandle, T. (2013). Sterility Testing of Pharmaceutical Products, DHI /PDA: Bethesda, MD, USA (ISBN: 1933722746)

Risk Management and Risk Assessment for Pharmaceutical Manufacturing: A contamination control perspective

A new book has been published titled “Risk Management and Risk Assessment for Pharmaceutical Manufacturing: A contamination control perspective”. The book has been written by Tim Sandle.

The book presents an overview of risk management and risk assessment for those working in the pharmaceutical and healthcare sectors. An understanding of risk management and risk assessment is today becoming a prerequisite for those working in quality control and quality assurance, and for those active in pharmaceuticals and medical devices, Quality Risk Management it is a mandatory requirement. The book expands upon this subject through a series of case studies, utilizing tools like HACCP and FMEA.

The core chapters are:

• Risk management and risk assessment
• Risk tool methods
• Case study: environmental monitoring
• Case study: aseptic processing
• Case study: non-sterile product manufacturing
• Case study: sterility testing isolator

The book balances regulatory guidance, theoretical concepts and practical examples.

The book is available from Amazon.

For Amazon U.S., go to Amazon US.

For Amazon U.K., go to Amazon UK

Data Review and Analysis for Pharmaceutical Microbiology

This book offers a guide, drawing upon 'real world' examples, for the review and assessment of microbiological data. The book includes examples drawn from water monitoring, bioburden assessment, and environmental monitoring. The book serves as a guide for quality control microbiologists, quality assurance personnel, students, and those with an interest in data, graphs and statistics in general.



See: Amazon U.S. or Amazon U.K.

Cleanroom Management in Pharmaceuticals and Healthcare

Edited by Tim Sandle and Madhu Raju Saghee.

Everything you need to know about the operation and management of cleanrooms. - Special offer for new book until 28 February 2013.

In 26 Chapters and over 600 pages this book provides a unique tool to help you achieve regulatory compliance. It first creates a foundation in history and established practice and then helps you understand how state of the art technology and engineering solutions can deliver the best practice and so provide reliable systems performance. View the contents here.

Available from Euromed.

Cleaning and Disinfection Handbook

Updated in 2016 - The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments.

The book is available as a paperback or as an e-book. For an independent review of the book, click here.

To order and for more details, see Amazon U.S. (paperback) / Amazon U.S. (e-book)

Amazon U.K. (paperback) / Amazon U.K. (e-book)

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: 

Technology, Validation and Current Regulations

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.

The book is available as a hardback edition.

To order and for more details, see Amazon U.K.

Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices

THE GOLD STANDARD FOR STERILE MANUFACTURING This book is a useful reference guide for the pharmaceutical sector and represents an unparalleled and unprecedented text in the field of pharmaceutical and medical device microbiology. 

 The results of 45 years of scientific and technological development are laid down in these 33 chapters. These chapters, all written by international experts, give a vivid picture of today s pharmaceutical microbiology. The high standard of the chapters makes it an essential reference guide that should be on the shelf of everyone who is involved or interested in this field. Experts from top pharmaceutical companies like Baxter, Johnson and Johnson, Amgen, Pfizer, Patheon, Sartorious, Gador, Catalent, British NHS, GE Healthcare and many more top experts from industry and academics have come together to create this collection of knowledge of Microbiology as related to Pharmaceuticals, Medical Devices and Biotechnology. The list of authors includes chair and members of USP expert committee on Microbiology and Sterility Assurance, president and senior experts in Parenteral Drug Association, ISPE and ASTM. 

The book is available as a hardback edition.

To order and for more details, see Amazon U.S.

Guide to Cleanrooms

An introduction to cleanrooms and contamination control for the life science sector (pharmaceutical, healthcare and biotechnology). The book is useful for microbiologists, laboratory staff, processing personnel, engineers, quality assurance and quality control.

The book is available as a paperback and as an e-book.

Amazon U.S. (paperback)

Amazon U.S. (e-book)

Amazon U.K. (paperback)

Amazon U.K. (e-book)

Pharmaceutical Microbiology Glossary

A glossary of common terms used in pharmaceutical microbiology, cleanrooms and healthcare. The book contains over 300 definitions. The book is aimed at new and experienced microbiologists, students, quality personnel and general readers.

This book is available as an e-book.

Amazon U.S. (e-book)

Amazon U.K. (e-book)

Current Perspectives on Environmental Monitoring

The aim of this booklet is to survey some of the current practices, trends and approaches to environmental monitoring and present these as technical articles in a way which will be of interest to those with some experience with pharmaceutical microbiology. In doing so note of the current interest in risk assessment is accounted for and several chapters directly or indirectly describe how risk assessment is an advantage for environmental monitoring, using practical examples.

Available from Amazon U.K.

Best Practices for the bacterial Endotoxin Test: A Guide to the LAL Assay

Edited by Tim Sandle, the Pharmig guide to the Bacterial Endotoxin Test (BET) has been written by industry experts, including Anna Upton, and it provides the reader with an overview of the history, regulation and practical use of the different BET assays. Information on the method development, validation and routine testing are discussed as well as more advanced subjects such as depyrogenation, medical devices, trouble shooting and problem samples. This guide should provide a useful reference document for LAL users and laboratory management.

The guide is available from Pharmig.

LAL Fact Sheets

A series of Limulus Amoebocyte Lysate (LAL) laminated Fact Sheets on pyrogen/ endotoxin testing have been produced by Tim Sandle. The series of 6 LAL fact sheets (as a package) currently available are:

• What is LAL/BET?
• Calculation of Endotoxon Limits
• Medical Devices
• Gel Clot Methods
• Photometric Methods
• Product Validations Quantitative Methods

The fact sheets are only available from Pharmig.

Guide to Microbiology Laboratories in the Pharmaceutical Industry

Written by Julie Roberts and Tim Sandle, guide details best practice for microbiology laboratories associated with all aspects of supporting the manufacture of medicinal products. These guidelines are applicable to any pharmaceutical microbiology testing laboratory and supplements already existing regulations and guidance documents by providing additional specific detail on current practices and recent regulatory expectations.

The guide is only available from Pharmig.

Electronic Training Pack 1: Setting up & managing an effective training programme in the Micro Lab and Electronic Training Pack 2: Best practices in Microbiological Documentation

These two electronic packs have been written by Tim Sandle and Brian Alexander. The first training pack aims to help you gain a clear understanding of the structure of a regulatory acceptable and compliant training programme and includes example documents to assist companies in improving / aiding their current training programmes. The pack is available from Pharmig.

The second, presents an overview of the most efficient, as described by quality and microbiology personnel, practices in maintenance of the QC aspect of the microbiology laboratory and its associated documentation with reference to current regulatory expectations.

Example documents are also included to assist companies in improving their documentation practices. The pack is available from Pharmig.

The E-Guide to Cleanrooms (an Amazon e-book)

Written by Tim Sandle, this e-book provides an overview of how cleanrooms work, how they should be certified, and what is required for on-going compliance in relation