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Books by Tim Sandle


Books by Tim Sandle

 

 

Biocontamination Control for Pharmaceuticals and Healthcare

 
 
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.  

See: Amazon
 

Recalls of Pharmaceutical Products: Eliminating Contamination and Adulteration Causes

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Are you prepared for recalls relating to pharmaceutical and healthcare medications and medical devices? This book contains details about recalls from start to finish, including advice on how to handle a recall and, more importantly, how they can be avoided. Read about regulatory perspectives, trends and primary causes for product recalls, notable recalls and lessons, quality metrics, and supply chain risk management. You can also find relevant information designed to help about labels, packaging, data integrity, methods to ensure GDP, and other industry best-practices.  

See: PDA
 

Audit and Control for Healthcare Manufacturers: A Systems-Based Approach

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Audits are an important part of quality assurance and the quality management system. With the help of PDA's newest book, Audit and Control for Healthcare Manufacturers: A Systems-Based Approach, you can ensure the quality and effectiveness of your processes, systems, and personnel is maintained throughout your organization! 
 
See: PDA 
 

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

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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.

 

Sandle's Pharmaceutical Microbiology Dictionary

 

 

 

 

 

 

 

 

 
Pharmaceutical Microbiology, an applied branch of Microbiolog, focused on study of micro-organisms associated with the manufacture of pharmaceuticals, primarily in minimizing the numbers in a process environment; ensuring that the finished product is sterile and excluding those specific strains that are regarded as objectionable from starting materials and water. The discipline is also associated with drug development, including the application of biotechnology. This dictionary provides definitions and descriptions of the leading terms association with pharmaceutical microbiology and related fields. The dictionary is designed to assist students and those who do not work directly in the field to understand the terminology; and as an aide-memoire for more experienced practitioners.

Available from Amazon here.

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised & Expanded

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Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth edition, Revised and Expanded.

As companies strive to harmonize global requirements for quality systems, the 5th edition of this text provides an overview of the 34 essential global cGMP requirements that are typically included in a modern pharmaceutical quality system, including data integrity and how they have evolved. Explore risk-related questions, delve into several expectations for each quality system element encompasses, and review real-world examples from cGMP regulations from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH).

If you're looking for an enhanced understanding of GMP in practice, this text is a must-have for your reference collection. 

See: PDA

Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers

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Taking into account that 90 percent of quality control microbiology remains reliant upon culture based methods, this unique text focuses on microbiological culture media as applied to pharmaceutical microbiology. This book takes into consideration that innovations continue to arise with new media recipes that are formulated for the selection of new strains for the application of media in conjunction with rapid microbiological methods. In 23 chapters, the book covers how media is used in the modern pharmaceutical microbiology setting and recaps the past, signals the future, and helps interpret the present.  
See: PDA

Sterility Testing of Pharmaceutical Products 



 
Tim Sandle's book is '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)

Theory and practice for diseases diagnosis

 
 
The book provides theoretical and practical informations for diseases diagnosis. It is a collaborative book after IP Erasmus project MDHP, with partners from different countries from Europe. Beside project, took part as lecturer in this project, Professor Ilya Azizov, from Karaganda State Medical University, Kazakhstan, now Smolensk State Medical University, Russia.The book has been written with support for professors and researches from prestigious universities.
 

“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


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


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.

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.

Histology Systems: Short Atlas

 
 
Histology is a field of study important for students. Using light microscope and electron microscope, students can study normal structures and ultrastructures related tissues, organs and systems. After well known related normal aspects, next step, on pathology , students can perform scientific informations related diseases. Samples preparing using different stainings, conduct to establishing a good diagnostic in pathology.
 
See: Amazon

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)

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.

Sterilization: Practical Approaches

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The focus of this book is on steriity assurance principles and pracrices.

Sterilization: Establishing the Process

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The 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.
Available here 

Cleaning and Cleanrooms

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In the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and biotech manufacturers stay abreast, streamline processes and comply with regulators.

We have now collected bestsellers and added materials that have not published before in electronic book form covering three vital topics:

  • Environmental Monitoring
  • Cleaning and Cleanrooms
  • Sterilization

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)

LABORATORY TECHNIQUES WITH APPLICABILITY IN ROUTINE PRACTICE: DIAGNOSIS OF DISEASES

 
 
The book is the result of a three-year long international collaboration within IP Erasmus project entitled Classic and Modern Methods for Molecular Diagnostics in Human Pathology (2011-2013).The book is recomended for all interested persons, such as PhD students and Master students from the Erasmus project, PhDs, medical doctors, young researchers and last but not least, students.In the chapters, researches from different European countries describe methods and techniques for proper diagnosis of diseases. Theoretical as well practical informations are presented.
 
See: Amazon

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.

E-guide to cleanrooms






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 to contamination control.

Risk Management Library Volume 4: Practical Approaches to Risk Assessment and Management Problem Solving: Tips and Case Studies

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Receive expert guidance on major topics, such as regulatory perspectives on risk and five insightful case studies to help develop the best approaches to problem solving based upon the "what if" and "five whys" method. 







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