Friday 27 October 2017

Pharmaceutical Microbiology Book

Pharmaceutical Microbiology

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.

- 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

Title Index:

- 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

See below:

Or order from Elsevier.

Posted by Dr. Tim Sandle

Thursday 26 October 2017

Theory and Practice of Disease Diagnosis

A new book of interest:

The book provides theoretical and practical information for diseases diagnosis. It is a collaborative book to support IP Erasmus project MDHP, with partners from different countries from Europe. Thebook includes chapters by Professor Ilya Azizov, from Karaganda State Medical University, Kazakhstan, now Smolensk State Medical University, Russia, and Dr. Antonella Chesca and Dr. Tim Sandle.

The book has been written with support for professors and researches from prestigious universities.


Chesca, A., Cengiz, M. and Sandle, T. (Eds.) Theory and Practice of Disease Diagnosis, LAP LAMBERT Academic Publishing, Germany, ISBN-13: 978-3330084384

For details see: Amazon UK or LAP Publishing

Posted by Dr. Tim Sandle

Tuesday 24 October 2017

50+ FDA acronyms that matter to your business

The Vaisala Measurement & Monitoring Program is offering a list of useful FDA acronyms. For further details see: Vaisala.

Sunday 22 October 2017

An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments

Crystal Booth has written a useful article for Pharmaceutical Online looking at environmental monitoring and disinfection of aseptic processing environments. Here is an extract:

“Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. To prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology article series discusses some of those aspects. Parts 1 and 2 introduced cleanroom microbiology, discussed guidance documents and FDA observations, and summarized common sources of microbial contamination in cleanrooms. Part 3 provided an overview of cleanroom gowning procedures. This final article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning.”

The full article can be found here: Pharmaceutical Online

Posted by Dr. Tim Sandle

Friday 20 October 2017

Bacterial in-fighting provides new treatment for hospital infections

A bacteria that is a leading cause of death worldwide from hospital acquired infections following antibiotic treatment looks set to be brought down through its own sibling rivalry. New research from the University of Sheffield shows that Different strains of Clostridium difficile (C. diff) use tiny weapons to kill each other, and scientists from the UK and US have discovered how these work, enabling them to be engineered into an antimicrobial agent with the potential to prevent or cure C. diff infection.

Further study has shown when C. diff develops a resistance to these weapons, the bacteria can no longer cause infection, making them harmless. Like many bacteria, C. diff can make a weapon that is able to identify and kill competing C. diff strains. This weapon attaches to the surface of other C. diff cells and fires a harpoon-type needle through their membrane, causing the cell to die. The researchers have managed to engineer this weapon so that it can be mass produced in a stable form as a potential treatment or preventative for C. diff infections.


Joseph A. Kirk, Dana Gebhart, Anthony M. Buckley, Stephen Lok, Dean Scholl, Gillian R. Douce, Gregory R. Govoni, Robert P. Fagan. New class of precision antimicrobials redefines role of Clostridium difficile S-layer in virulence and viabilityScience Translational Medicine, 2017; 9 (406): eaah6813 DOI: 10.1126/scitranslmed.aah6813

Posted by Dr. Tim Sandle

Thursday 19 October 2017

Cilia: 'The bouncer' of bacteria

A new paper, from University of Southern California, elucidates the active role of cilia in regulating flow for bacteria filtering and enhancing chemical communication.

The paper, published in the Proceedings of the National Academy of Sciences, describes a framework for the role of fluid mechanics in letting symbiotic bacteria in an organism and enhancing chemical communication between the symbiont and the host organism. The results are contrary to previous research which assumes that cilia solely play a "clearance function." They could shed light on the role cilia -- which are the size of one hundredth of a single human hair -- play in human respiratory system and even in the reproductive systems and the brain. Their findings could also provide insights on how cilia dysfunction within organs affect for example, pulmonary conditions or infertility (how cilia help sperm reach eggs).

To learn about how cilia might work in the human body, Kanso, in collaboration with symbiosis expert McFall-Ngai and biofluid expert Janna Nawroth studied bobtail squid. The researchers examined how these squids in their nascent stage allow symbiotic bacteria Vibrio Fischeri to enter into their ciliated light organs, which play a crucial role in camouflaging the ink sacks of the otherwise translucent organism while they hunt for food at night. The scholars sought to know: why does this bacterium gain access and why do all bacteria fail to accumulate within the squid's light organ? In addition, they sought to explain what, if any, is the role of cilia in allowing access?

Researchers discovered that a vortical or "donut-like" flow generated by the cilia was kicking away most particles. The role of the fluid motion in filtering particles by size was verified using a physics-based mathematical model. One of the core findings was that there were two distinct flows taking place by two different types of cilia. Longer cilia move in a "wave-like" fashion which creates a vortical flow field that filters particles and then shorter cilia which beat randomly keep the particles in place and gently mix the local flow. This random motion by the cilia and fluid mixing enhance the chemical screening of bacteria. To further prove the important role played by cilia, the researchers also found that if cilia are "killed," particles will accumulate everywhere in the organism.


Janna C. Nawroth, Hanliang Guo, Eric Koch, Elizabeth A. C. Heath-Heckman, John C. Hermanson, Edward G. Ruby, John O. Dabiri, Eva Kanso, Margaret McFall-Ngai. Motile cilia create fluid-mechanical microhabitats for the active recruitment of the host microbiomeProceedings of the National Academy of Sciences, 2017; 114 (36): 9510 DOI: 10.1073/pnas.1706926114

Posted by Dr. Tim Sandle

Sunday 15 October 2017

Solutions for the automated infeed and loading of medical products

Wolfertschwenden– Presentations from MULTIVAC at this year's Compamed will include solutions for the automated infeed and loading of medical products within the packaging procedure. In addition to a syringe infeed system for loading pre-filled glass or plastic syringes with process reliability and control, these will also include handling modules and carrier systems. They ensure that optimum product protection is achieved, as well as raising the efficiency of the entire packaging line and increasing process reliability.

A packaging line for the GMP-compliant thermoforming packaging of medical products will give an example of how intelligently used automation components can make the packaging procedure more secure, hygienic and reliable. The line is equipped with an automatic syringe infeed system. The infeed system consists of a product infeed conveyor, a separating wheel, a trapezoidal belt, a 3-axis robot and a H 242 handling module. It enables up to 300 pre-filled glass or plastic syringes per minute to be loaded into the pack cavities with process reliability and control. All the modules are synchronised with the thermoforming packaging machine and can be operated via its control terminal in a very convenient way.

But there are also many other automation components available for orientating, separating and infeeding a wide range of medical products. MULTIVAC's wide product range comprises a large number of belt and carrier systems as well as specific infeed systems, which can be designed individually to the product-related requirements depending on the products being packed and the particular upstream processes. As an example, needles and syringe plungers , which are supplied to the line as bulk products, can be separated by means of vibrating units and centrifuges, before being transferred in single or even several rows to the packaging machine. Syringes, bags, ampoules and vials can be presented to the machine by means of separating units and transport conveyors, which are specifically matched to the product. The examples mentioned above show, how the individual products are prepared by the infeed system in such a way, that they can be precisely positioned for picking up by a robot and loading into the pack cavities.

In addition to this, MULTIVAC will also be exhibiting at the trade fair a wide range of handling modules, which can be equipped individually with a variety of kinematics and easy-change gripper systems for loading the pack cavities accurately and hygienically. These handling modules can also be used for unloading the finished packs from the machine and transferring them to downstream equipment. The grippers are matched exactly to the particular product, which is frequently very light or sensitive. This minimises the fault rate and ensures that a high level of pack quality is achieved.

Thanks to their design and particular features, all the system components are characterised by their high level of GMP compliance. They can easily be integrated into the control unit of the particular packaging machine.

Posted by Dr. Tim Sandle

Friday 13 October 2017

WHO Specifications for Pharmaceutical Preparations

The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations meets now annually and their reports (Technical Report Series) include all adopted guidelines in the form of Annexes. The 51st report has now been published.

See: WHO

Special book offer for readers:

Posted by Dr. Tim Sandle

Thursday 12 October 2017

Microbial Identification strategy for pharmaceutical microbiology

Microbial identification represents an important part of the microbiology function. This includes screening products for objectionable organisms, profiling the environmental microbiota, and investigating out-of-limits events with a view to assigning a probable point of origin. In deciding what and when (and subsequently to which level) to identify, and by the way of which methods, requires an identification strategy. This is a document each microbiology laboratory should develop.

Many parts of pharmaceutical microbiology are outlined in compendia or in guidance documents issued by regulators; included within these are the importance of bioburden assessments of intermediate and finished products, and the need to monitor the environment using standard environmental monitoring methods. What is less clear is with microbial identification. For identification there are established and emerging methods, based around the microbial phenotype or genotype, yet the choice between systems is not straightforward and the selection depends, in part, on what needs to be identified. Deciding which types of samples to identify; which level of identification is appropriate (morphology, genus, or species); and what can be done with the collected information needs careful thought. A further decision point is whether the testing laboratory carries out the testing ‘in house’ or contracts out the function. This article addresses these points and provides a basis of the microbiologist in each pharmaceutical or healthcare organization to develop a microbial identification strategy.

This is the introduction to an article by Tim Sandle for the Journal of GxP Compliance (a special edition devoted to Microbiology).

The reference is:

Sandle, T. (2017) Microbial Identification strategy for pharmaceutical microbiology, Journal of GxP Compliance, 21 (4): 11-20:

For further details, please contact Tim Sandle.

 Posted by Dr. Tim Sandle

Wednesday 11 October 2017

A new estimate of biodiversity on Earth

To date, about 1.5 million species have been formally described in the scientific literature, most of them insects. Proportionally, bacteria comprise less than 1% of all described species.

Scientists generally agree that many more species exist than are formally described, but they disagree about how many there really are. Some studies have estimated 2 million or fewer, whereas others suggest as many as 12 million (one recent study even suggested the planet could be home to a trillion species).

In a new paper published in The Quarterly Review of Biology (September 2017), researchers from the University of Arizona have estimated that there are roughly 2 billion living species on Earth, over a thousand times more than the current number of described species.

In coming up with their estimate, the researchers took advantage of the fact that many estimates now agree on the projected number of insect species, around 6.8 million. They incorporated new estimates of species boundaries revealed by DNA sequences, which suggest there might be six times as many insect species, increasing the total to 40 million for insect species alone.

They then reviewed all groups of organisms associated with insects as parasites or symbionts. They found that each insect species most likely hosts a unique species of mite, roundworm (nematode), a one-celled fungus called a microsporidian, and a one-celled organism called an apicomplexan protist (which cause malaria in humans).

Most importantly, the researchers estimated that each insect species is likely to host at least 10 bacterial species found nowhere else. Based on these estimates, they deduce that there should be around 2 billion species on Earth.

The authors also suggest that the diagram of which taxonomic groups contain the most species, or the "Pie of Life," is very different from traditional estimates. Rather than being dominated by insects, as traditionally shown, their estimates show a pie dominated by bacteria (70 to 90% of all species), with insects (and animals in general) having a much smaller slice.


Brendan B. Larsen, Elizabeth C. Miller, Matthew K. Rhodes, John J. Wiens. Inordinate Fondness Multiplied and Redistributed: the Number of Species on Earth and the New Pie of LifeThe Quarterly Review of Biology, 2017; 92 (3): 229 DOI: 10.1086/693564

Posted by Dr. Tim Sandle

Tuesday 10 October 2017

A Guide to Applying the Four Pillars of ICH Q10

A white paper of interest from Pharmaceutical Manufacturing:

This White Paper will detail not only the applications of the four pillars and their corresponding QMS applications, but also additional QMS functions that help to ensure ICH Q10 compliance. These include:

A Guide to Applying the Four Pillars of ICH Q10 flexibility, allowing the end user to better adapt to the system; integration, which enables processes to collaborate with others across the enterprise; and traceability, which essentially provides user with “breadcrumbs” allowing them to look back throughout all the steps that were taken in a process.

For details see: Pharmaceutical Online

Posted by Dr. Tim Sandle

Friday 6 October 2017

Europe and U.S. Regulators Increase Cooperation on Inspections

The European Commission, the FDA, and the European Medicines Agency (EMA) have signed a new confidentiality agreement that allows regulators on both sides of the Atlantic to share non-public and commercially confidential information, including trade secrets about inspections.

The new agreement formally recognizes that FDA's EU counterparts have the authority and demonstrated ability to protect the relevant information, according to the EMA statement.

“This step now allows the sharing of full inspection reports, allowing regulators to make decisions based on findings in each other’s inspection reports and to make better use of their inspection resources to focus on manufacturing sites of higher risk.”

Posted by Dr. Tim Sandle

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