New book from Tim Sandle

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

New book: Blood, Plage and Smallpox

 

Elstree is a site of scientific excellence. Starting as laboratories as part of the Lister Institute of Preventative Medicine, research was varied, including pathogen safety and nutrition before the site’s first great success was through playing a pivotal role in the global eradication of smallpox. 

Blood, Plage and Smallpox - a new book from Tim Sandle

From Lister sprung the Blood Products Laboratory, a global innovator in plasma products (including immunoglobulins and the world’s first factor VIII for the treatment of haemophilia).

These three central elements are captured by this book’s title – Blood, Plague, and Smallpox.

This book documents the history of the site – criminals sought out by Scotland Yard; dedicated workers contracting the very pathogens they are experimenting on; periodic political and biological threats to the site remaining open (from Margaret Thatcher to mad cow disease), this is a history of twists, turns, survival and scientific excellence.

Dr. Tim Sandle is a scientist by profession (pharmaceutical microbiology) in addition to being an author of more than 30 books and a journalist. Sandle has authored some 1000 peer reviewed papers and technical articles and he has long been interested in the history of the ‘Elstree Labs’, both as an employee and a lover of history.

The book is available as a hardback, paperback and e-book via Amazon.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

GMP Validation - a book to guide you through the international requirements

Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations of different standards can be a bewildering project. This book seeks to provide a map and a compass for navigating the choppy waters of international regulations.

Available via Euromed

GMP Validation provides a text for those who need to assess validation and ensure that validation is conducted according to current GMP. These include the validation manager and personnel engaged in validation activities; quality assurance; quality control; R&D; and production personnel. Some of the scientific aspects will also appeal to students, especially those working within or aspiring to enter the pharmaceutical sector. The book also serves as a good starting point for those who are tasked with auditing validation systems or items of equipment or processes.

This comprehensive handbook is comprised of 30 chapters which are divided into two parts. The first part is dedicated to the management process, with an emphasis upon appropriate formality and risk-based approaches. The second part focuses on case studies, providing an overview of different GMPs and standards for different areas of validation and qualification. The book concludes with four useful appendices providing templates to aid the reader.

Part A: Essential tools for the validation manager

 
1. Qualification, Validation and the Formalised Approach
2. Validation Documentation
3. Hazard Identification and Assessment of Risk
4. Validation Project Management and Risk-based Problem Solving
5. The V-model and the Lifecycle Approach to Validation
6. Quality Risk Management and the Validation Process
7. Data and Statistics for the Validation Manager
8. Validation Errors: Concept and Case Study
9. Calibration Process and Setting Calibration Criticality
10. Setting the Standards for New Equipment Purchases
11. Process Validation: Maintaining Quality and Compliance

Part B: Case studies and GMP concepts for validation

 
12. Audit and validation requirements of single-use technologies
13. Containment system integrity: microbial challenges for sterile products
14. Cleanroom design, commissioning and verification
15. Qualification of disinfectants
16. Utility Design and Qualification for Efficient Pharmaceutical Operations
17. Pharmaceutical Water Systems
18. Equipment Design: Assessing Cleaning and Hygiene
19. Autoclaves and Steam Sterilisation
20. Pure Steam for Sterilisation
21. Cleaning Validation: Balancing GMPs and Risk
22. Compressed Air and Other Gases
23. Data Loggers and Temperature Mapping
24. Microbiological Method Validation
25. Data Integrity and Qualification
26. Isolator Sterility Validation
27. Analytical Method Development
28. Analytical Method Transfer
29. Computerised System Software Validation
30. Sterile Filter Validation

Part C: Appendices

 
Appendix 1: Validation Master Plan.
Appendix 2: IQ Protocol.
Appendix 3: OQ protocol.
Appendix 4: New equipment risk assessment.

Available via Euromed 

 

About the Author

 
Tim Sandle originally trained as a parasitologist before moving into microbiology. He took first degrees in microbiology and politics, and then proceeded to study for a master’s degree and a PhD part-time. Tim is currently Head of GxP Compliance and Sterility Assurance at Bio Products Laboratory. He is additionally a visiting tutor at the University of Manchester and University College London lecturing in pharmaceutical microbiology. He is a longstanding committee member of Pharmig and has served on several other international committees and editorial boards. Tim has written a number of books, and numerous papers, and technical articles relating to GxP concerns, microbiology and contamination control.

Available via Euromed 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

GMP Validation: A guide to international regulatory requirements

 

By Tim Sandle

ISBN: 978-1-917195-05-8 eBook, 650pp, £240
ISBN: 978-1-917195-06-5 Hardback, 650pp, £270

The book is scheduled for publication on 9/9/24.
Pre-publication 10% discount orders are available now using the code: GMP24.

Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations of different standards can be a bewildering project. This book seeks to provide a map and a compass for navigating the choppy waters of international regulations.

GMP Validation provides a text for those who need to assess validation and ensure that validation is conducted according to current GMP. These include the validation manager and personnel engaged in validation activities; quality assurance; quality control; R&D; and production personnel. Some of the scientific aspects will also appeal to students, especially those working within or aspiring to enter the pharmaceutical sector. The book also serves as a good starting point for those who are tasked with auditing validation systems or items of equipment or processes.

This comprehensive handbook is comprised of 30 chapters which are divided into two parts. The first part is dedicated to the management process, with an emphasis upon appropriate formality and risk-based approaches. The second part focuses on case studies, providing an overview of different GMPs and standards for different areas of validation and qualification. The book concludes with four useful appendices providing templates to aid the reader.

Part A: Essential tools for the validation manager
1. Qualification, Validation and the Formalised Approach
2. Validation Documentation
3. Hazard Identification and Assessment of Risk
4. Validation Project Management and Risk-based Problem Solving
5. The V-model and the Lifecycle Approach to Validation
6. Quality Risk Management and the Validation Process
7. Data and Statistics for the Validation Manager
8. Validation Errors: Concept and Case Study
9. Calibration Process and Setting Calibration Criticality
10. Setting the Standards for New Equipment Purchases
11. Process Validation: Maintaining Quality and Compliance

Part B: Case studies and GMP concepts for validation
12. Audit and validation requirements of single-use technologies
13. Containment system integrity: microbial challenges for sterile products
14. Cleanroom design, commissioning and verification
15. Qualification of disinfectants
16. Utility Design and Qualification for Efficient Pharmaceutical Operations
17. Pharmaceutical Water Systems
18. Equipment Design: Assessing Cleaning and Hygiene
19. Autoclaves and Steam Sterilisation
20. Pure Steam for Sterilisation
21. Cleaning Validation: Balancing GMPs and Risk
22. Compressed Air and Other Gases
23. Data Loggers and Temperature Mapping
24. Microbiological Method Validation
25. Data Integrity and Qualification
26. Isolator Sterility Validation
27. Analytical Method Development
28. Analytical Method Transfer
29. Computerised System Software Validation
30. Sterile Filter Validation

Part C: Appendices
Appendix 1: Validation Master Plan.
Appendix 2: IQ Protocol.
Appendix 3: OQ protocol.
Appendix 4: New equipment risk assessment.

About the Author
Tim Sandle originally trained as a parasitologist before moving into microbiology. He took first degrees in microbiology and politics, and then proceeded to study for a master’s degree and a PhD part-time. Tim is currently Head of GxP Compliance and Sterility Assurance at Bio Products Laboratory. He is additionally a visiting tutor at the University of Manchester and University College London lecturing in pharmaceutical microbiology. He is a longstanding committee member of Pharmig and has served on several other international committees and editorial boards. Tim has written a number of books, and numerous papers, and technical articles relating to GxP concerns, microbiology and contamination control.

See: https://euromedcommunications.com/collections/pharmaceutical-sciences-manuals/products/gmp-validation-a-guide-to-international-regulatory-requirements-1

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Industrial Pharmaceutical Microbiology: Standards and Controls

Reviewed by Melissa Patel, QA Compliance, Bio Products Laboratory

The modern microbiologist, be they based in healthcare, pharmaceuticals, or industry, should only spend part of their time at the laboratory bench. Modern industrial and pharmaceutical microbiology has moved beyond the quality control paradigm and requires the microbiologist to spend considerable time in the manufacturing environment.

This repositioning also requires the microbiologist to broaden their skill set and taken on aspects of validation, engineering, chemistry, experimental design, technology transfer and quality assurance.

Finding sources of advice to develop this skill set can be just as challenging as developing the skills. Fortunately, the latest edition of Industrial Pharmaceutical Microbiology: Standards and Controls (the 6th edition, published by Euromed and the PDA) offers an insight into the latest thinking.

Edited by the internationally famous microbiologist Tim Sandle, this book offers cutting edge insights beyond the QC microbiology space.

The book assembles a group of globally recognised experts and covers a range of essential topics.

These topics are presented as groups in a logical order. The book opens with areas around qualification and validation. This includes two cutting edge chapters relating to validation and the application of rapid microbiological methods. As Jeanne Moldenhauer expertly explains, alternative methods in particular are useful for taking into the industrial environment, enabling real-time assessments to be made. Such assessments are in tune with the notion of the contamination control strategy.

The contamination control strategy requires an appreciation and understanding of risk management and risk assessment processes. The next area of the book includes practical chapters by two leading industry gurus –Tim Eaton –and Tim Sandle both of which expertly apply risk based methodologies.

Risk assessment also requires control and detection. The book moves on to look at environmental monitoring strategies (by academic Rosalind Bird) and disinfection best practices (from Sandle, who is a specialist in this field). The text moves on to consider pharmaceutical water systems and takes a deep dive into biofilm control.

After Sandle’s review of microbial identification approaches, a review of cleanrooms and barrier technology is presented by John Neiger, the editor of Clea Air and Containment Review. There are few, if any, people who know more about airflow protection than Neiger.

Important industrial applications follow: media fills, sterile filtration, biological indicators and endotoxin. The latter is particularly detailed, in a chapter full of rich detail from Karen Zink McCullough. Again, Sandle has assembled a leading global subject matter expert.

The section ends with an overview of container-closure integrity technologies and cutting-edge pharmaceutical development in the form of advanced therapy medicinal products (ATMPs). Both of these chapters come from Sandle.

The next section assesses the regulatory space, considering biotherapeutics, non-sterile pharmaceuticals, pharmacopeial requirements and another cutting edge application in the form of bacteriophages. The non-sterile chapter is crafted by Edel Fitzmaurice, who is Ireland’s most in-demand microbiology consultant.

In all, the book is comprised of 25 chapters. The fact that it has reached a sixth edition and that the content is regularly reviewed and updated, with redundant chapters removed and new ones added, is testament to Sandle’s and the publisher’s commitment to being non-topic and current.

To be an advanced microbiologist in the modern age requires you to have this text on your bookshelf.

To order a copy, see PDA Bookstore 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

New books for your pharmaceutical microbiology library

Two key microbiology texts from Euromed and PDA, published in 2024:
 

Industrial Pharmaceutical Microbiology: Standards and Controls 6th Edition

 

Industrial Pharmaceutical Microbiology: Standards and Control covers the entire spectrum of industrial pharmaceutical microbiology, as applicable to pharmaceuticals and healthcare. 

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 700 page book a team of 20 international authorities will assist you in all your questions.

 

For details see Euromed

 

Industrial Pharmaceutical Microbiology: Quality Control

The reference text brings together the hitherto unavailable background, fundamental science, principles, development, intended purpose, and specific answers to questions of execution and qualification of compendial and related microbiological test methods. Key topics include the types of microbiological tests, reference strains and culture collections, and equivalence of reference strain.  

 

Industrial Pharmaceutical Microbiology: Quality Control with its 20 chapters, 19 international authors and over 500 pages, enables the practitioner to have a complete understanding of these microbiological methods, and to ensure better developed, compliant, appropriate procedures and accurate meaningful data.

 

For details see: Euromed

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Industrial Pharmaceutical Microbiology: Standards and Controls

New book

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 700 page book a team of 20 international authorities will assist you in all your questions.

Industrial Pharmaceutical Microbiology: Standards and Control 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.

Reviews of previous editions

"This is an excellent reference work for those working in industrial pharmaceutical microbiology. It covers all aspects of this complex subject with contributions from many leading figures in the field and is highly recommended."

European Journal of Parenteral and Pharmaceutical Sciences, Vol 19 No 4

"This book is not simply about the science of microbiology for it takes the science into to the industrial setting and offers invaluable advice on how to apply it to the manufacture of pharmaceutical and healthcare products, and for keeping such products within microbial control. A further strength with the book is its topicality, in having the most recent regulations and standards featured. The book features 25 chapters covering environmental monitoring, water systems, vaccines, safety, biological indicators and microbiology laboratory management. Picking the stand-out chapters is difficult, because there are so many good ones. … In summary this book is essential for every pharmaceutical laboratory: scientific, topical and practical"
Pharmig, January 2015

"The 2015 edition of Industrial Pharmaceutical Microbiology is a first-rate reference resource for any professional microbiologist, covering a wide range of topics of relevance to the whole industry. The book starts with the role of the microbiologist and the microbiology laboratory, before moving on to specific microbiological and industry controls. It closes with the issues facing some specialised areas of the industry with their own particular microbiological challenges. … Overall a very useful, well-edited book that will be an invaluable reference to anyone involved in pharmaceutical microbiology."
Clean Air and Technology Review Issue 21, January 2015

Contents

Part A: The Role of the Microbiologist and the Microbiology Laboratory

1. Safety in Microbiology

Nigel J Silman 1.1–1.42

2 Best Practices in Microbiology Laboratory Training

Tim Sandle 2.1–2.24

3 Validation and Qualification Approaches for Microbiological

Methods

Amy Marflitt, Joanna Wolodkowicz and Tim Sandle 3.1–3.16

4 The Use of Culture Media in Pharmaceutical Microbiology

Tim Sandle 4.1–4.26

5 Rapid Microbiological Methods and Process Analytical

Technology (PAT)

Jeanne Moldenhauer 5.1–4.42

6 Microbial Risk Assessments for Operational Cleanrooms

Tim Eaton 6.1–6.18

7 Product Release and Microbiological Quality Assurance

John Dolman and Tim Sandle 7.1–7.14

8 Auditing the Pharmaceutical Microbiology Department

Andy Martin 8.1–8.23

Part B: Microbiological Control and Industrial Processes

9 Microbiological Environmental Monitoring

Rosamund M Baird and Tim Sandle 9.1–9.30

10 Selection and use of Cleaning and Disinfection Agents in

Pharmaceutical Manufacturing

Tim Sandle 10.1–10.32

11 Microbiology of Pharmaceutical Grade Water

Tim Sandle 11.1–11.20

12 Biofilm Contamination in Pharmaceutical Facilities

Alex P Blanchard 12.1–12.36

13 Strategies and Approaches for Microbial Identification

Tim Sandle 13.1–13.20

14 Cleanrooms, Isolators and RABS: Basic Principles, Design,

Testing, Operation and Regulatory Aspects

John Neiger 14.1–14.74

15 Aseptic Process Simulations/Media Fills

Francesco Boschi 15.1–15.34

16 Filtration

Claire Jarmey-Swan 16.1–16.18

17 Sterilisation Technologies

Eric Dewhurst and Eamonn Hoxey 17.1–17.45

18 Biological Indicators

Tim Sandle 18.1–18.27

19 Endotoxins and Depyrogenation

Karen Zink McCullough 19.1–19.26

20 Containment System Integrity: Microbial Challenges for

Sterile Products

Tim Sandle 20.1–20.16

21 Advanced Therapy Medicinal Products: A contamination

control perspective

Tim Sandle 21.1–21.21

Part C: Regulatory Aspects of Industrial Pharmaceutical Microbiology

22 Microbiological Quality and Regulatory Requirements for

Biotherapeutics

Daniel Galbraith 22.1–22.13

23 Regulatory Microbial Expectations for Non-Sterile Manufacture

of Pharmaceutical Dose Forms

Edel Fitzmaurice 23.1–23.9

24 The Pharmacopoeias and Microbiology

Barbara Gebala 24.1–24.15

25 Challenges of Bacteriophage Therapy

Alexander Sulakvelidze 25.1–25.16

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Hugo and Russell's Pharmaceutical Microbiology 9th Edition

 Microbiology is one of the essential pharmaceutical sciences upon which the study and practice of pharmacy is built. It has a bearing on all aspects of the manufacture of medicines and sterile products, from their design and development to their delivery as quality products. Few interventions are more central to modern medicine than the treatment of infection, where antibiosis, vaccination and hygienic practices have essential roles to play. The COVID-19 pandemic, the appearance of new pathogens and the rise of antibiotic resistance have demonstrated most completely the need for pharmaceutical practitioners, researchers and industrial scientists to be fully conversant with this field.

The 9^th edition of Hugo and Russell’s Pharmaceutical Microbiology has been updated to meet this need. Having long served as the sole comprehensive textbook covering this subject, it has now been adapted to a critical new period in the advancement of medical and pharmaceutical research and development. Its experienced editors have incorporated contributions from subject experts and created a text which will serve the next generation of pharmacy students, pharmaceutical industry scientists and researchers. 

_______________________________________________________________________

Special offer ($56, via this link):

 

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In this ninth edition of Hugo and Russell’s Pharmaceutical Microbiology, readers will find:

• A mix of established and new authors bringing practical and research experience to their chapters
• Material covering the fundamentals of microbiology, microbial behavior and laboratory investigation
• Revised chapters incorporating new material on microbe-host interactions, antibiotic resistance, emerging pathogens, public health microbiology, healthcare-associated infection and pharmaceutical manufacture
• Emerging understandings from the COVID-19 pandemic on infection prevention and control and vaccine development
• Practitioners providing their insights on clinical practice and pharmaceutical production
• An accompanying website incorporating teaching resources

Hugo and Russell’s Pharmaceutical Microbiology, 9^th edition promises to remain the essential text for pharmacy and medical students, as well as researchers and industry professionals.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Clinical Laboratory book

 

The medical laboratory, as a field of activity, involves teamwork. The specialization of Laboratory Medicine is obtained by studying the following medical disciplines: Biochemistry, Microbiology, Hematology, Genetics, Molecular Biology, Biology, Immunology to which is added the study in a series of fields necessary for a complete professional training It includes vast types of combined subdomains.

 

The results of the laboratory work are part of the paraclinical investigations that help establish the diagnosis. This book explores these fields.

 

Chesca, A. and Sandle, T. (2021) Clinical Laboratory, Edizioni Sapienza, Italy ISBN 978-620-3-60359-0

See here (click on image):

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics

This second of two volumes details how pharmaceutical and healthcare manufacturers have been embracing digital technologies as part of the transformation of their business models. It contextualizes current developments and future advancements in terms of the COVID-19 situation of 2020 and specific measures that were taken.

Topics and laboratory functions that will be explored include:

• New model healthcare
• Ways to use digital data, including root cause investigations
• Office technology
• Protecting ownership security
• E-learning and virtual inspections
• And many more

The first volume of this two-part collection addresses building a digital company, big data analytics, advances in Process Analytical Technology electronic batch records, Block Chain, and more. Taken together, these volumes provide a clear picture of where things currently stand, where they are likely to develop, and the challenges that digital technology adopters face, in terms of practicalities and in maintaining GMP compliance.

See: https://www.pda.org/bookstore/product-detail/5949-digital-transformation-volume-2

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Conducting Compliant Investigations

A new book of interest (edited by Jeanne Moldenhauer), covering different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents.

Conducting Compliant Investigations

The information it provides on conducting investigations that will be acceptable to regulatory investigators will be instrumental in helping you to significantly reduce regulatory risk.

Select topics covered in this book include:

• Why should we perform investigations?
• What should be determined in the investigation?
• Detailed background on U.S. FDA 483 and U.S. FDA Warning Letters investigations
• What types of regulatory actions are taken in response to failure investigations?
• Chapters on investigating various types of failures (e.g., data integrity, sterility test, media fill, environmental monitoring)
• Descriptions of appropriate corrective and preventative actions
• Writing a good investigation report
• Tracking and trending investigations
  

The book includes two chapter written by Tim Sandle:

  Sandle, T. (2021) Getting to the heart of the matter: Approaching root cause analysis. In Moldenhauer, J. (Ed.) Conducting Compliant Investigations, DHI/PDA, River Grove, IL, USA pp45-108 ISBN 978-942911-57-9

Sandle, T. (2021) Investigating sterility test failures. In Moldenhauer, J. (Ed.) Conducting Compliant Investigations, DHI/PDA, River Grove, IL, USA pp227-268 ISBN 978-942911-57-9

 

Conducting Compliant Invest... by Tim Sandle

For details, see the PDA Booksore: https://www.pda.org/bookstore/product-detail/6061-conducting-compliant-investigations

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Digital transformation in pharmaceuticals and healthcare - new books

The only digital twins you'll need: Two new books covering the digital disruption in pharmaceuticals and healthcare - the technological, cultural, and organizational impacts. From automation to predictive analytics, to blockchain for supply chain to AI in drug discovery.

See:

Vol,. 1: https://www.pda.org/bookstore/product-detail/5897-digital-transformation-volume-1

Vol. 2: https://www.pda.org/bookstore/product-detail/5949-digital-transformation-volume-2

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Cleanroom Contamination Prevention & Control: A Practical Guide to the Science

A new cleanroom contamination control and microbiology book from PDA / DHI books, edited by Ziva Abraham and Morgan Pollen, has been issued. I have contributed two chapters. One is on cleanroom commissioning, and the other is jointly written with my Pharmig colleagues Racjel Kirkham, Laura Guardi and Kim Moorwood,and it is about the validation of disinfectants.

Cleanroom Contamination Prevention & Control: A Practical Guide to the Science by Tim Sandle on Scribd

 My chapters are:

Sandle, T. (2021) Designing, commissioning and risk assessing cleanrooms for biocontamination control. In Abraham, Z. and Polen, M. (Eds.) Cleanroom Contamination Prevention & Control: A Practical Guide to the Science, DHI/PDA, River Grove, IL, USA, pp219-285. ISBN Number: 9781942911548

Sandle, T., Gaurdi, L., Kirkham, R. and Moorwood, K.(2021) Validation of disinfectants. In Abraham, Z. and Polen, M. (Eds.) Cleanroom Contamination Prevention & Control: A Practical Guide to the Science, DHI/PDA, River Grove, IL, USA, pp383-416. ISBN Number: 9781942911548

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)