Top 10 most influential Microbiologist of 21st Century

The current edition of Microbioz India magazine carries an article on 'Top 10 most influential Microbiologist of 21st Century', written by Tim Sandle.

"In selecting ten eminent researchers I have attempted to cut across the various sub-branches of microbiology, taking in clinical, pharmaceutical, marine microbiology and so on."

For further details see Microbioz India.

Sandle, T. (2015) 10 Most influential microbiologists of the 21st Century, Microbioz India, Vol. 2, Issue 21, pp8-14: http://www.microbiozindia.com/top-10-most-influential-microbiologist-of-21st-century.htm



Posted by Tim Sandle

Chemical hazards and poisons report

Public Health England has issued the 25^th edition of the chemical hazards and poisons report, surveying incidences in England. This edition focuses on chemical incident management, evidence base development and the provision of chronic exposure health risk advice.

This edition presents two papers with examples of PHE’s involvement in the management of waste fires. The first paper discusses the impact of complex fire fighting strategies and centres on the provision of public health advice to the multiagency partners. Two air quality cells were convened: the first one during the early stages of the fire and the second was needed due to the change in fire fighting strategy by the fire and rescue services. The second article highlights how a fairly routine fire at a peanut factory can raise some unusual issues as a result of uncommon allergens in smoke during the acute and recovery phases.

The report can be accessed here: PHE

Posted by Tim Sandle

MALDI-TOF - under consultation

Public Health England have announced the matrix assisted laser desorption ionisation time of flight mass spectrometry test procedure is undergoing consultation.

Matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) is a soft ionisation technique used in mass spectrometry, allowing the analysis of biomolecules (such as DNA, proteins, peptide and sugars) and large organic molecules (such as polymers, dendrimers and other macromolecules), which tend to be fragile and fragment when ionised by more conventional ionisation methods. The ionisation is triggered by a laser beam. It is a rapid and highly reliable analytical tool for the characterisation of a diverse collection of microbes encountered in the clinical laboratory.

This technique can be used to analyse the protein composition of a microbial cell, and has emerged as a new technology for species identification. It has been shown to be a powerful technique because of its reproducibility, speed and sensitivity of analysis. The advantage of MALDI-TOF MS as compared with other identification methods is that the results of the analysis are available within minutes to a few hours rather than several days. With prior knowledge of microorganism type (through using conventional and supplementary tests); users find it easier to know whether a bacterium or yeast is being tested. Without this, identification attempts usually fail. The speed and the simplicity of sample preparation and result acquisition associated with minimal consumable costs make this method well suited for routine and high throughput use.

The consultation asks for feedback in relation to the Standards for Microbiology Investigations TP 40: Matrix assisted laser desorption ionisation time of flight mass spectrometry test procedure.

The consultation document can be found here: MALDI

Posted by Tim Sandle

Disease Spotlight

A new website of interest has been launched, called DiseaseSpotlight.com

The DiseaseSpotlight.com website will focus on a number of specific conditions each week, bringing the patient and healthcare provider perspective together. These events will be enhanced further by sponsored content from commercial organisations to deliver 360 degree insight on unmet needs and new innovation. We will be covering both major and niche disease areas from Q4 2015 onwards, aligning activities to existing disease days, weeks and months, with content disseminated via our own and partner channels.

Posted by Tim Sandle

Pharmig News #61

A new edition of Pharmig News has been issued. Pharmig News is the quarterly publication from the Pharmaceutical Microbiology Interest Group (Pharmig).

In the latest issue:

• Chairman’s Newsletter
• Revised Guidance for Analytical Method Validation by Tim Sandle
• A tribute to Scott Sutton
• Review of Pharmig’s inaugural Indian conference
• Latest regulatory updates
• Bacterial Endotoxin Case Study from Wickham Laboratories

Copies have been distributed to member organisations. If you are interested in seeing a copy, please contact the Pharmig office.

Posted by Tim Sandle

Clean Air and Containment Review (sample issue)

For readers who have not yet subscribed to the journal Euromed are offering a free e-version of CACR 23 so that you can try the journal for yourself.

To receive your free e-version please send an email to:

jill.monk@euromedcommunications.com

Mentioning the code number CACRe23.



Posted by Tim Sandle

How Gram-negative bacteria deliver toxins to kill neighboring bacteria

Certain microbes exploit proteins in nearby bacteria to deliver toxins and kill them. The mechanisms behind this “bacterial warfare” could be harnessed to target pathogenic bacteria.

Researchers have detailed how Gram-negative bacteria use contact-dependent growth inhibition (CDI) systems to infiltrate and deliver protein toxins into neighboring cells. By studying the bacterium Escherichia coli, scientists were able to document how CDI "translocation domains" can use multiple pathways to transfer those toxins into a cell. By understanding that mechanism it could be possible to use it as a model for pinpoint targeting of bacteria.

For further details, see:

Julia L. E. Willett, Grant C. Gucinski, Jackson P. Fatherree, David A. Low, Christopher S. Hayes. Contact-dependent growth inhibition toxins exploit multiple independent cell-entry pathways. Proceedings of the National Academy of Sciences, 2015; 201512124 DOI: 10.1073/pnas.1512124112

Posted by Tim Sandle

Application of European Standards for chemical disinfectants and antiseptics

The European standard which provides an overview of the methods for undertaken disinfectant efficacy testing has been updated. The new standard reference is:

EN 14885:2015 “Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics.”

The new standard replaces the previous 2006 version.

The standard cross-references the following EN disinfectant standards: EN 1276, EN 1499, EN 1500, EN 1650, EN 1656, EN 1657, EN 12791, EN 13610, EN 13623, EN 13624, EN 13697, EN 13704, EN 13727, EN 14204, EN 14348, EN 14349, EN 14476, EN 14561, EN 14562, EN 14563, EN 14675, EN 16437, EN 16438, 93/42/EEC, EN 12353, EN 1040, EN 1275, EN 14347

Key words are: Disinfectants, Antiseptics, Cleaning materials, Disinfectant tests, Microorganisms, Bacteriocide-activity determination, Bacteriocides, Viruses, Fungicides, Eumycophyta, Testing conditions, Medical equipment, Veterinary science, Food industry, Industrial, Domestic, Marking, Terminology.

The new standard is available from national standards bodies.



Posted by Tim Sandle

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

A book of interest has been published – “Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control” – written by Dr. Tim Sandle.

This book provides pharmaceutical microbiologists with everything they need to know, from regulatory filing and GMP information, to laboratory design and management, compendia tests, and the risk assessment tools and techniques for both sterile and non-sterile products.

Key Features

• Contains the applications of pharmaceutical microbiology in sterile and non-sterile products
• Presents the practical aspects of pharmaceutical microbiology testing
• Provides contamination control risks and remediation strategies, along with rapid microbiological methods
• Includes bioburden, endotoxin, and specific microbial risks
• Highlights relevant case studies and risk assessment scenarios

Description

Pharmaceutical Microbiology: Essentials for Quality 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.

Table of contents

Chapter 1: Introduction to Pharmaceutical Microbiology

Chapter 2: Microbiology and Pharmaceuticals

Chapter 3: GMP, regulations and standards

Chapter 4: Laboratory management and design

Chapter 5: Microbiological culture media

Chapter 6: Basic microbiological laboratory techniques

Chapter 7: Bioburden testing

Chapter 8: Assessment of raw materials

Chapter 9: Microbial identification

Chapter 10: Assessment of pharmaceutical water systems

Chapter 11: Endotoxin and pyrogen testing

Chapter 12: Sterilisation and sterility assurance

Chapter 13: Biological indicators

Chapter 14: Antibiotic effectiveness testing and preservative efficacy testing

Chapter 15: Disinfection

Chapter 16: Cleanroom microbiology and contamination control

Chapter 17: Rapid microbiological methods

Chapter 18: Risk assessment and microbiology

Chapter 19: Manufacturing and validation

Chapter 20: Microbiological batch review

Chapter 21: Microbiological audits

Chapter 22: Microbial Challenges in the Pharmaceutical Industry

Conclusion

Readership

The audience for this book includes Pharmaceutical companies, pharmacies, Biotechnology companies and students primarily undertaking MSc courses.

About the author:

Dr. Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor at the University of Manchester.

Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); active within the Parenteral Drug Association (PDA); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle’s current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

Reference:

Sandle, T. (2016) Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control, Woodhead Publishing, Cambridge, UK

Availability

The book is available from Elsevier or via:

Amazon U.K.

Amazon U.S.

Or from other Amazon stores and booksellers



Posted by Tim Sandle

Sterility Testing Book

Sterility Testing - for details about this book, see PDA Books

Posted by Tim Sandle

Food Safety in Manufacturing

New FDA Rules Focus on Food Safety in Manufacturing: Food manufacturers are facing an update to equipment and facility designs to comply with the newest U.S. Food & Drug Administration’s (FDA) safety rules, which focus on the prevention of foodborne illness.

In reaction to a string of recent outbreaks of listeria and salmonella, the FDA announced it has finalized the first two of seven major rules under the Food Safety Modernization Act (FSMA), which focus on implementing modern food manufacturing processes for both human and animal foods that are produced domestically or are imported. Food manufacturers are facing an update to equipment and facility designs to comply with the newest U.S. Food & Drug Administration’s (FDA) safety rules, which focus on the prevention of foodborne illness. In reaction to a string of recent outbreaks of listeria and salmonella, the FDA announced it has finalized the first two of seven major rules under the Food Safety Modernization Act (FSMA), which focus on implementing modern food manufacturing processes for both human and animal foods that are produced domestically or are imported.



 Posted by Tim Sandle

New ISO Cleanroom Classification and Monitoring Standards

ISO 14644 Parts 1 and 2 have finally been approved!

Official notice from the IEST:

The Institute of Environmental Sciences and Technology (IEST) announces the international approval of the new revisions to the cornerstone cleanroom standards—ISO 14644, Cleanrooms and associated controlled environments, Part 1: Classification of air cleanliness by particle concentration and Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. IEST serves as the Secretariat organization for ANSI for ISO Technical Committee 209 (ISO/TC 209), which is responsible for the cleanroom standards’ development.

The revised 14644-1 and -2 Standards were approved by a significant majority of the 20 member nations participating in the ISO/TC 209 final vote. The International Standards will be available from IEST following editorial revision and international translation. ISO’s recent measures to bring standards to industry more quickly is expected to lead to published versions within a period of weeks. Cleanroom industry customers and suppliers are encouraged to check www.iest.org for updates on availability of the International Standards. IEST is offering several course options to educate stakeholders regarding the requirements and use of the new revisions.

ISO 14644-1 and -2 are so critical to the estimated $14 billion cleanroom industry that the revision efforts by the lead ISO/TC 209 Working Group lasted more ten years, with the ISO Technical Management Board providing a perhaps unprecedented second extension of the drafting period. The Standards are part of a concurrent adoption as American National Standards, which would take effect in tandem with the international publication.

ISO 14644-1 specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations. A major focus in revising ISO 14644-1 (1999) was development of a refined statistical approach regarding the selection and number of sampling locations. The underlying assumption in the 1999 version held that particle counts follow a similar distribution across the room. The new revision discards the previous assumption in order to allow more accurate sampling where particle counts may vary in a more complex pattern.

Another revision in ISO 14644-1 addresses the issues surrounding ≥ 5 μm particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S, and WHO GMPs. An adaptation of the macroparticle descriptor is included in the Standard to accommodate the particle size.

ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the execution or evaluation of the classification provisions of ISO 14644-1. The requirements of a monitoring plan are detailed, including additional guidance on risk assessment as part of an informative annex.

The mission of ISO/TC 209 is to develop international standards for cleanrooms and associated controlled environments encompassing standardization of equipment, facilities, and operational methods. The committee defines procedural and operational limits and testing procedures to achieve desired attributes to minimize contamination. IEST serves as the Secretariat for ISO/TC 209 and is also the Administrator for the United States Technical Advisory Group (US TAG) to ISO/TC 209. ISO Standards and IEST Recommended Practices for cleanrooms and controlled environments are available through IEST at www.iest.org.

Posted by Tim Sandle

Biopharma Operational Excellence

Pharmaceutical Manufacturing has issued an e-book on “Biopharma Operational Excellence”.

Operationally, biopharmaceutical manufacturing is challenging and complex. Fortunately, process innovation and new upstream and downstream technologies are allowing drug makers to take formulations from development to commercial scale faster and more cost-efficiently.

The articles that follow offer information and practical advice on navigating the biopharma space to deliver more successful operations and safer drugs:

• Time for a New Prescription
• Critical Trends Driving Biomanufacturing Production Strategies
• Applying Single-Use Efficiences to Room-to-Room Fluid Transfer
• Value Delivery's Next Chapter
• Where is Biopharma in the PAT Picture?

For details see: Pharma Manufct

Posted by Tim Sandle

ISO 14644 Parts 1 and 2 approved

Via a tweet, IEST announces that the revised ISO 14644-1 and -2 cornerstone cleanroom standards have been approved as International Standards.

ISO 14644-1, the first document in the 14644 series, was published in 1999, and ISO 14644-2 was published the following year. The documents have been subject to revision for several years. ISO 14644-1 specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations.

ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the execution or evaluation of the classification provisions of ISO 14644-1.

Revisions of ISO 14644-1 and -2 were released In December 2010 as Draft International Standards. Four years later, a second round of revisions to ISO 14644-1 and -2 was released as Draft International Standards. These revisions provided a clearer classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles of a designed size range. Final Draft International Standards of both documents were released in August 2015.

The improved sampling method in the revised ISO 14644-1 document along with the enhanced guidance for particle counter calibration and performance will provide improved confidence to cleanroom users that their cleanroom is delivering the preferred level of quality-controlled environment for critical life science applications.

Posted by Tim Sandle

Sulfolobus

Sulfolobus is part of the Archaea kingdom -- a single-cell organism similar to bacteria -- which was isolated in hot springs on the island of Hokkaido, Japan.

Some Archaea live ordinary lives in mundane environments such as lakes, seas and insect and mammal intestinal tracts, while others live extraordinary lives pushed to extremes in incredibly harsh habitats such as deep sea hydrothermal vents, volcanic mud and the Dead Sea.

Archaea have been instrumental in evolutionary studies on the origins of life and have revealed to scientists that the boundaries of life as we know it can be pushed much further than previously thought.

For details about the organisms:

M. A. Schumacher, N. K. Tonthat, J. Lee, F. A. Rodriguez-Castaneda, N. B. Chinnam, A. K. Kalliomaa-Sanford, I. W. Ng, M. T. Barge, P. L. R. Shaw, D. Barilla. Structures of archaeal DNA segregation machinery reveal bacterial and eukaryotic linkages. Science, 2015; 349 (6252): 1120 DOI: 10.1126/science.aaa9046

Posted by Tim Sandle