Tuesday 31 December 2013

Excellence in Pharmaceutical Microbiology

Pharmig (Pharmaceutical Microbiology Interest Group) presented its inaugural award for ‘Excellence in Pharmaceutical Microbiology’ to Tim Sandle at its annual conference in November 2013. Pharmig is an international professional organisation representing pharmaceutical microbiology.
The award is intended for an individual who was made a major contribution to the advancement of knowledge in pharmaceutical microbiology, and for promoting the discipline through communication and education.
The selection was made from a field of leading international pharmaceutical microbiologists and the eligibility criteria was that each candidate had to be nominated and that each nominated person must have made a significant contribution to the scientific discipline over a substantial period of time. The nominations were reviewed by a panel.
Although feeling a little too young for a ‘lifetime achievement’ award, Tim said: “I deeply honoured to have been recognised by my peers and to have received this award. The other people nominated are ones that I hold in high regard, so receiving this accolade is very special.”

Posted by Victor Grayson

Monday 30 December 2013

Why is Yersinia pseudotuberculosis so infectious?

Scientists have discovered what makes a specific strain of Yersinia pseudotuberculosis --  one cause of gastrointestinal infections -- so dangerous. The reason is that the bacteria produce a molecule called CNFy that facilitates the infection process for them.

Yersinia pseudotuberculosis is transmitted via contaminated food and can generate gastro-intestinal diseases.

The bacterium changes the host cells in a manner that enables the injection apparatus of Yersinia, which injects toxins into the cells, to work more efficiently. This strengthens the gastrointestinal infection and leads to inflammation of the tissue.

This finding was made by researchers based at the Helmholtz Centre for Infection Research (HZI) in Braunschweig and at the Hannover Medical School (MHH).

For further details, refer to the following paper:

Janina Schweer, Devesha Kulkarni, Annika Kochut, Joern Pezoldt, Fabio Pisano, Marina C. Pils, Harald Genth, Jochen Huehn, Petra Dersch. The Cytotoxic Necrotizing Factor of Yersinia pseudotuberculosis (CNFY) Enhances Inflammation and Yop Delivery during Infection by Activation of Rho GTPases. PLoS Pathogens, 2013; 9 (11): e1003746 DOI: 10.1371/journal.ppat.1003746

 Posted by Tim Sandle

Top microbiology and quality news stories for 2013

The most read news stories on Pharmaceutical Microbiology during 2013 have been:

1. Ten Rules of Good Manufacturing Practice

2. Propionibacterium acnes and clear skin

7. New book: Sterility Testing of Pharmaceutical Products

10. Microbial Risk Assessment (MRA) Guideline Published

If you missed one of these important news stories, please click on the link to access it.

I would like to take the opportunity to wish all readers of Pharmaceutical Microbiology a Happy New Year.

Tim Sandle

Sunday 29 December 2013

Why do bacteria respond quickly to external changes?

Understanding how bacteria adapt so quickly to changes in their external environment with continued high growth rates is one of the major research challenges in molecular microbiology. This is important for understanding of resistance to antibiotics.

A research study from Uppsala University has presnted a model of how bacteria can rapidly adapt to environmental changes through smart regulation of their gene expression.

The study, published in the journal of the American National Academy of Sciences PNAS (Proceedings of the National Academy of Sciences), presents a theoretical model that determines the ultimate limit for how quickly bacteria can adapt their protein levels to changes in their living environment.

For rapid growth in different environments, bacteria need to adjust their enzyme levels in order to rapidly benefit from the nutrient mix that is currently available in the surrounding. If the living environment undergoes rapid changes, the bacterium's own production of proteins has to conform to these changes in an effective way.

The growth of bacteria is determined not only by the composition of their surroundings but also by sudden changes in the living environment. This has been known since the middle of the 20th century. High levels of bacteria growth in a stable environment requires a certain kind of physiology, but environmental changes also require rapid adjustments of the bacteria's protein production. The newly developed model indicates the 'minimum' time such adjustments require.

For further details, see:

Pavlov, M.Y & Ehrenberg, M. Optimal control of gene expression for fast proteome adaptation to environmental change. PNAS, December 2013

Posted by Tim Sandle

Saturday 28 December 2013

Bacteria grow faster if they feed each other

Symbiotic relationships with bacteria are prevalent. Arguably, in the course of evolution, an association may get so close that the mutualistic partners merge into a new, multicellular organism.

This is the view of researchers from Research Group Experimental Ecology and Evolution at the Max Planck Institute for Chemical Ecology and their colleagues at the Friedrich Schiller University in Jena, Germany. The research team studied bacteria that were deficient in the production of a certain amino acid and therefore depended on a partner to provide the missing nutrient.

The researchers found that bacterial strains that complemented each other's need by providing the required amino acid showed a fitness increase of about 20% relative to a non-deficient strain without partner.

For further details see:

Samay Pande, Holger Merker, Katrin Bohl, Michael Reichelt, Stefan Schuster, Luís F de Figueiredo, Christoph Kaleta, Christian Kost. Fitness and stability of obligate cross-feeding interactions that emerge upon gene loss in bacteria. The ISME Journal, 2013; DOI: 10.1038/ismej.2013.211

Posted by Tim Sandle

Friday 27 December 2013

Mushrooms produce wind to spread spores

Mushrooms were thought to produce spores and for these to be carried in the wind in order to spread seeds around. Scientists have now shown mushrooms to be more sophisticated: they can make their own wind.
How do mushrooms spread their spores on a still day? Until recently biologists just assumed that they didn’t, and that on a still day mushrooms were not prone to passing spores to appropriate locations where they could reproduce.
It has now been shown that some species of mushroom have a mechanism whereby they can produce their own wind. This was discovered using high-speed videography and mathematical modeling of spore dispersal in commercially grown oyster and Shiitake mushrooms. Specifically mushrooms create their wind by releasing water vapor. The vapor cools the air locally, and this creates convective cells that move the air around in the mushroom’s vicinity.
The wind effect was shown by Emilie Dressaire, a professor of experimental fluid mechanics at Trinity College in Hartford, Connecticut. The findings were presented at the 66th Annual Meeting of the American Physical Society’s (APS) Division of Fluid Dynamics (DFD), held in November.

Posted by Tim Sandle

Thursday 26 December 2013

Fecal transplants are 'successful'

Fecal transplants have begun to be used as a treatment over the past year. Now a long-term study confirms transplants of stool microbes from healthy donors can successfully clear recurrent Clostridium difficile infections.
With fecal transplants (or 'fecal bacteriotherapy'), as the Digital Journal has previously reported, aim to restore the balance between good bacteria and bad bacteria in the colon.
The procedure involves either single to multiple infusions (e.g. by enema) of bacterial fecal flora originating from a healthy donor, or, as a recent Canadian study showed, fecal transplant in pill form.
Now further evidence has emerged, in a PLoS One paper, about the success of the method. The paper, the Scientist notes, showed that patients given fecal microbiota transplants to treat recurrent Clostridium difficile infections cleared the bacteria in just days, and their intestinal microbiota were restored nearly to a pre-C. diff state within a year.
The new study was undertaken by University of Maryland School of Medicine’s Institute for Genome Sciences and Sinai Hospital in Baltimore, who used advanced genetic sequencing to screen a range of patient samples.
The reference for the research paper is:
Y. Song et al., “Microbiota dynamics in patients treated with fecal microbiota transplantation for recurrent Clostridium difficile infection,” PLOS ONE, 2013

Posted by Tim Sandle

Wednesday 25 December 2013

Seasons Greetings

I would like to wish all readers of Pharmaceutical Microbiology, whatever their faith or culture, a peaceful time during this season.

Look forward to some interesting news items, research and comments for 2014.

Best wishes,

Tim Sandle

Tuesday 24 December 2013

New models predict where E. Coli will thrive

Bioengineers at the University of California, San Diego have used the genomic sequences of 55 E. coli strains to reconstruct the metabolic sequenced for each strain. These reconstructions predict the kind of environment where each strain will thrive.

The reconstructions map out all the genes, reactions and products of metabolism for each strain and allow the researchers to probe their coordinated functionality. Each strain's metabolic capabilities, the researchers discovered, correspond to specific environmental niches. Commensal or "friendly" E. coli strains also can be distinguished from pathogenic strains using this technique.

The analysis has been published in the Proceedings of the National Academy of Sciences. For further details see U of C.

Posted by Tim Sandle

Monday 23 December 2013

Disinfection Qualification Testing (white paper)

ATS Labs have an interesting new white paper titled "Disinfection Qualification Testing: Considerations for the Aseptic and Cleanroom Manufacturing Environment".

"This white paper, featuring an illustrative table on microorganism reduction of disinfectant active ingredients on routine surfaces, is intended to provide an overview of disinfection qualification testing and the considerations that must be addressed when designing and executing these studies."

For further details, see ATS Labs.

Posted by Tim Sandle

Sunday 22 December 2013

Bruker's MALDI Biotyper Gets FDA Clearance to Identify Gram Negatives

Bruker Corporation has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.

The MALDI Biotyper CA System includes the bench-top microflex™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra. Bruker has conducted a multi-site clinical trial comparing performance of the MALDI Biotyper CA System to 16S ribosomal RNA gene sequencing. The overall accuracy of the MALDI Biotyper CA System was comparable to that of nucleic acid sequencing. FDA clearance of the MALDI Biotyper CA System is the latest achievement in Bruker's continuous efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.

In 2009, Bruker launched a MALDI Biotyper system in compliance with the European in vitro diagnostic directive EC/98/79, making the CE-IVD labelled IVD-MALDI Biotyper the first MALDI-TOF based product registered for use in European clinical microbiology laboratories. Since then, Bruker has continued to expand into routine clinical microbiology and other markets throughout the world. Currently there are more than 1,000 systems sold or leased worldwide.

Posted by Tim Sandle

Saturday 21 December 2013

Video: Mechanism of Resistance in Gram-negative Bacteria to Beta-Lactam Antibiotics

Gram-negative bacteria [such as Pseudomonas aeruginosa, Klebsiella pneumoniae and Escherichia coli] are becoming more resistant to the antibiotics we have available, leaving doctors with limited options to manage patients with infections caused by these organisms.

An interesting new video outlines some of the mechanisms involved.

Posted by Tim Sandle

Friday 20 December 2013

ISO cleanroom working groups

Here is a list of the working groups that come under the ISO that are looking at cleanroom standards, primarily in relation to ISO 14644:

ISO/TC 209 Working Groups (WG)

WG 1 — Airborne particle cleanliness classes (active)
WG 2 — Biocontamination (active)
WG 3 — Metrology and test methods (active)
WG 4 — Design and construction (standby)
WG 5 — Cleanroom operation (standby)
WG 6 — Terms, definitions and units (standby)
WG 7 — Enhanced cleaning devices (standby)
WG 8 — Chemical contamination (active)
WG 9 — Clean surfaces (active)
WG 10 — Nanothechnology (active)
WG 11 — Assessment of suitability of equipment and materials for cleanrooms (active)
WG 12 — Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classification (active)

Posted by Tim Sandle

Thursday 19 December 2013

New generation of biocides

A new generation of antibacterial materials have been developed. These are synthetic materials covered in nano-spikes resembling those found on insect wings. The material is an effective killer of microorganisms.
As reported in the Scientist, the material is a type of black silicon. The synthetic material is studded with needle-shaped nanostructures which serve as a potent antibacterial agent. Test have shown that the material can kill some 450,000 cells per minute in just one square centimeter.
Remarkably, what has been shown is that certain nanostructures can kill bacteria based on texture alone. The particles physically distort the microbial cell wall and break open the cell, thereby killing the microorganism.
The idea for the material, Sci News notes, came about after researchers recognized that dragonflies (Diplacodes bipunctata) also have similar nanopillars on their wings, and that black silicon was known for a similar nano-texture. The material is manufactured using bespoke ion-beam technology.
The importance of the new material is that it is potentially transferable to any material or fabric, and thus it has a great potential application in hospitals. A key advantage is that, unlike antibiotics, it would be far more difficult for bacteria to evolve structural resistance to black silicon.
The research was led by Elena Ivanova of Swinburne University of Technology in Australia, and the findings have been published in the journal Nature Communications. The article is titled "Bactericidal activity of black silicon".

Posted by Tim Sandle

Wednesday 18 December 2013

Endotoxin detection: techniques and developments

American Pharmaceutical Review has issued a special supplement dedicated to endotoxin testing.

The supplement features interesting articles on the endotoxin concern of biologics (by Kevin Williams); regulatory issues pertaining to endotoxin testing (by Michael Dawson); a comparative study examining different methods of endotoxin destruction (by Tim Sandle); an examination of future developments in endotoxin testing (by Karen Zink McCullough); and preparation of a naturally occurring endotoxin challenge study (by Kim Bowers and Lynn Johnson).

The supplement also contains other information relating to endotoxin and LAL testing, and makes for a useful and interesting read in relation to more advanced aspects of the bacterial endotoxin test.

For further details, see APR.

Posted by Tim Sandle

Tuesday 17 December 2013

U.S. aims to limit antibiotics for farm animals

The U.S. Food and Drug Administration (FDA) has laid out a plan so that farmers will no longer use antibiotics to fatten up animals.
The overuse of antibiotics for minor medical conditions (as reported by Digital Journal earlier this year) is not the only concern in relation to the rise of antibiotic resistant microbes. Antibiotic resistance is also occurring in fields and with farm animals.
Many farmers add antibiotics to animal feed or drinking water of cattle, hogs, poultry and other food-producing animals to help them gain weight faster or use less food to gain weight. One side-issue is that antibiotics can often end up in the environment - for example ending up in streams, being spread to crops as fertilizer, or getting carried around by birds - and so they are potentially a threat to public health. This relates to health issues with the human body and the accelerated rate of bacteria becoming resistant to the very drugs that are designed to kill them. This is a serious issue. According to the Washington Post, at least 2 million people in the United States become infected with antibiotic-resistant bacteria each year. At least 23,000 people die as a result.
Across the U.S., agricultural practices have been blamed for making this worse by using concentrated feed operations that leak antibiotics into surrounding waterways. This is not a new argument. Back in 1977, the FDA first pointed out that the non-therapeutic use of penicillin and tetracycline in livestock could give rise to new super-bugs resistant to antibiotics.

To slow the problem of antibiotic resistance, the FDA has announced new guidance for farmers. No longer will farmers be able to give animals antibiotics to make livestock or poultry grow bigger. Moreover, if an antibiotic is needed to treat a sick animal, farmers will have to get a prescription from a veterinarian. Importantly, this measure starts as a voluntary plan with industry and not a piece of legislation. Companies have 90 days to write to the FDA, saying they intend to follow the new program. After that, they’ll have three years to phase in the changes.
To explain why, Michael Taylor, deputy commissioner for foods and veterinary medicine at the FDA, told CNN: "With these changes, there will be fewer approved uses, and the remaining uses will be under tighter control."
As to whether pharmaceutical companies will co-operate, Taylor thinks that they will do so, adding "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort."
statement from the FDA expands on this further: “Once manufacturers voluntarily make these changes, the affected products can then only be used in food-producing animals to treat, prevent, or control disease under the order of or by prescription from a licensed veterinarian."
Reactions from the farming community have been mixed. The American Meat Institute and the Animal Health Institute supports the move as apparent in a quote from Clinton Lewis, Jr., the executive vice president and president of U.S. operations for Zoetis, the country’s largest animal pharmaceutical company, who told POLITICO: “We agree with [FDA] that this is the fastest way to address their questions and concerns.”
As to whether the measures will work Rep. Louise Slaughter (D-N.Y.), is unsure. She has issued a statement where she says: "The FDA’s voluntary guidance is an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success."
In support, Keeve Nachman, who studies food production at the Johns Hopkins Bloomberg School of Public Health, told Popular Science: "Even if it were observed by the industry, there’s no guarantee that the usage profile for these drugs would change."
With the FDA taking measures, calls have been made in Canada for a similar reduction in the use of antibiotics for farm animals. Dr. Doug Weir President Ontario Medical Association has told Medical News: "Ontario's doctors are concerned about the growing rate of antibiotic resistant bacteria. Patients are at risk of becoming sicker, taking longer to recover and it some cases dying from previously treatable diseases. Data shows that we can reduce antibiotic resistant bacteria when the use of antibiotics is modified. Adopting the recommendations in the report will help us achieve this."

Posted by Tim Sandle

Monday 16 December 2013

Single use technology

Single-use, sterile disposable technologies (also referred to as biodisposable technologies or SUTs) are available in many formats and confer various advantages for pharmaceutical manufacturers. They comprise products generally manufactured from plastic polymers via the processes of injection moulding, extruding and blow moulding.

Single-use disposable items are most commonly used in aseptic processing as a contamination control measure. The applications include devices for making aseptic connections, sampling devices, mixing devices, product-hold bags and disposable manifold systems.

In relation to this technology, Tim Sandle has written an article for Cleanroom Technology. The reference is:

Sandle, T. (2013). Single-use technology for biopharma, Cleanroom Technology, December 2013, pp27-28

Dr. Sandle has also examined the advantages of single-use technology and some of the testing requirements for the Clean Air and Containment Review:

Sandle, T. (2013). Trends in healthcare cleanroom practice: single-use sterile disposable technology, Clean Air and Containment Review, Issue 16, pp18-20

If you are interested in reading either article, please contact Tim Sandle.

Posted by Tim Sandle

Sunday 15 December 2013

BD study highlights risks of injectable medication errors

BD has published data from a new study that underlines the need for safer drug delivery practices in healthcare systems.

The company commissioned a US-based survey showing that preventable adverse drug events associated with injectable medications negatively impact more than one million inpatients each year.

This results in costs of $2.7 to $5.1 billion (1.68 to 3.17 billion pounds) in annual costs to US healthcare payers each year, or an average of $600,000 for every hospital.

According to the report, the types of medications and illnesses most associated with these harmful errors are already known, meaning measures can be taken to combat this trend.

For more details, see BD.

Posted by Tim Sandle

Saturday 14 December 2013

Insight into anthrax infection

An anthrax infection can be fatal even when the infectious agent is no longer detected. Research carried out at EPFL reveals the way its lethal factor manages to turn invisible to the immune system.

The bacterium responsible for anthrax develops a strategy reminiscent of the Trojan horse tale. Its pathogenic factor is able to penetrate inside a cell in such a way that it becomes completely invisible to both the immune system and medical analysis. Furthermore, it manages to exit the cell several days later, and then it continues to poison other cells.

In a new study, researchers focused in the way the anthrax toxin was able to get inside the cell. Composed of two elements -- a "protective antigen" and a "lethal factor," the toxin does not merely create a passage across the cellular membrane. Instead, it introduces itself by endocytosis, a process by means of which the pathogen is "swallowed" by the cell. Once inside the cell, anthrax's lethal factor is sheltered by the cell's membrane, forming an "endosome," in which it can wait for several days. Then, it can either be released inside the cell, causing it to malfunction, or it can be released towards the external environment inside small vesicles -- called exosomes -- and get into another cell.

For further details, refer to the following paper:

Laurence Abrami, Lucia Brandi, Mahtab Moayeri, Michael J. Brown, Bryan A. Krantz, Stephen H. Leppla, F. Gisou van der Goot. Hijacking Multivesicular Bodies Enables Long-Term and Exosome-Mediated Long-Distance Action of Anthrax Toxin. Cell Reports, 2013; DOI: 10.1016/j.celrep.2013.10.019

Posted by Tim Sandle

Friday 13 December 2013

Action required for antibiotic resistance

Antibiotic resistance is an international reality whose solution includes better educating physicians about using bacteria-fighting tools, says an infectious disease physician. In a statement, Dr. Josѐ A. Vazquez, Chief of the Section of Infectious Diseases at the Medical College of Georgia at Georgia Regents University, has said:

“The big problem is the overuse of antibiotics in hospitals and communities because not only can they lead to side effects like rashes and colon damage, one of those side effects is development of multidrug-resistant organisms.”

Emerging initiatives include antimicrobial stewardship programs that keep tabs on the antibiotics physicians prescribe and following up with education when inappropriate trends surface. Dr Vazquez adds: "We keep track to make sure patients are on the right antibiotic for the bug they have and use, when possible, a narrow spectrum antibiotic, instead of a broad-spectrum antibiotic.”

Furthermore: “Medical schools and residency training sites also need to beef up their educational efforts on the topic of appropriate antibiotic selection.”

Source: Medical College of Georgia at Georgia Regents University
Posted by Tim Sandle

Thursday 12 December 2013

Skin cleaning before catheterization

There are microbial risks associated with catheterisation and there has been a long running debate as to whether simple skin cleaning or the use of an antimicrobial is the most effective method. The concern is with reducing the risk of CAUTIs (catheter urinary tract infections). One risk is that bacteria can colonise a catheter and form biofilms, which involve clusters of cells covered in a protective matrix of polysaccharide polymers.

The purpose of urinary catheterisation is to drain urine from the bladder into a collection device, such as a catheter bag. The catheter itself comprises a flexible tube, usually manufactured from silicone, which is inserted through the urethra or sometimes via an abdominal incision (suprapubic catheterisation).

In an article for Inside Hospitals, Dr. Tim Sandle has presented a study looking at the efficacy of an antimicrobial cleaning solution prepared from octendine dihydrochloride. The study looked at the ability of the solution to reduce levels of bacteria on human skin.

The reference is:

Sandle, T. (2013). Skin cleaning before cathererisation, Inside Hospitals, October 2013, pp40-41

Copies can be requested from Tim Sandle

Posted by Tim Sandle

Wednesday 11 December 2013

Birds carry resistant bacteria

Researchers from Tufts University in Massachusetts, Binghamton University in New York, the University of California, Davis, and the University of Veterinary and Pharmaceutical Sciences Brno in the Czech Republic have found vancomycin-resistant Enterococci (VRE) in fecal samples from American crows (Corvus brachyrhynchos), which live in close proximity to humans in urban areas.

The research team collected 590 samples crow feces from four different locations in the United States—in California, Kansas, New York, and Massachusetts. They found that Enterococci in 2.5 percent of the samples carried vanA, one of nine vancomycin-resistance genes. In addition to being resistant to vancomycin, bacterial strains that the research team isolated were also resistant to other antibiotics, including erythromycin, ampicillin, and ciprofloxacin.

The findings have been published online in Environmental Microbiology.
Posted by Tim Sandle

Tuesday 10 December 2013

Use of nanotechnology to fight fungal infections

Researchers have converted recycled plastic bottles into non-toxic and biocompatible materials designed to specifically target and attack fungal infections.
With this breakthrough, a research team used nanotechnology and converted common plastic materials like polyethylene terephthalate (PET), which is the plastic used to make drinks bottles.
The newly formed anti-fungal agents self-assemble through a hydrogen-bonding process, sticking to each other like molecular Velcro in a polymer-like fashion to form nanofibers. Infection Control notes that this novel nanofiber carries a positive charge and can selectively target and attach to only the negatively-charged fungal membranes based on electrostatic interaction. The new compound then breaks through and destroys the fungal cell membrane walls, preventing the fungus from developing resistance.
The in vivo antifungal activity of the nanofibers was evaluated in a mouse model using a contact lens-associated yeast infection, according to Controlled Environments.
The reason behind the new nano tech is because traditional anti-fungal therapeutics need to get inside the cell to attack the infection but have trouble targeting and penetrating the fungi membrane wall. This process is complex and not always successful.
The research was conducted by IBM and the Institute of Bioengineering and Nanotechnology. The findings have been reported in the journal Nature Communications. The article is titled “Supramolecular high-aspect ratio assemblies with strong antifungal activity”.

Posted by Tim Sandle

A new standard for bioburden testing

The USP has proposed a new standard for bioburden testing (USP chapter 1115). The main basis of the chapter is setting out a risk based approach to monitor and control a manufacturing facility for the processing of non-sterile products.

To examine the implications of the proposed chapter, and in a review of bioburden issues in general, Tim Sandle has written an article for the GMP Review.

The reference is:

Sandle, T. (2013). A new standard for bioburden testing: USP chapter in development, GMP Review, 12 (3): 10-12

For further details, please contact Tim Sandle

Posted by Tim Sandle

Monday 9 December 2013

Are Cleanrooms Clean?

In the current edition of the Gold Sheet, Bowman Cox addresses some of the findings raised at the recent PDA Microbiology conference (October 2013, Bethesda MD, USA).

The review centers on presentations made around the subject of the Human Microbiome project and the implications that this raises for cleanroom microbiology. The presentations reviewed are by Tim Sandle and Karen Nelson.

Nelson’s presentation presented an overview of the human microbiome findings, whereas Sandle’s presentation addressed the microbial ecology of human skin and some of the issues that this raises for cleanroom contamination control. Sandle’s focus was upon the role of skin shedding, the limitations of microbiological culture media, the viable-but-non-culturable issue, the need to expand media and disinfectant panels with environmental isolates, and the anaerobic microorganism issue. Dr. Sandle also raised considerations for the investigation of microbial data deviations.

The reference for this informative overview is:

Cox, B. (2013). Are Cleanrooms Clean? Human Microbiome Project Raises Some Questions, The Gold Sheet, 47 (11): 16-18

Posted by Tim Sandle

Microorganism fact sheets

Microbial Examination of Non-Sterile Products

To help as a training aid and to remind laboratory staff about the different types of microorganisms associated with the microbial examination of non-sterile products (as described in USP 62 and Ph Eur 2.6.13), Pharmig have produced eight fact sheets. The sheets were written and prepared by Tim Sandle

Seven of the fact sheets profile each one of the key microorganisms (or microbial groups), using color photographs illustrating growth on agar and by Gram-stain.

A series of 8 Microorganism Fact Sheets

The microbial enumeration test and test for specified microorganisms can represent a challenging area for pharmaceutical microbiology (these are the tests for the ‘Microbiological Examination of Nonsterile Products’ as described in USP and Ph. Eur. 2.6.12. One of the main challenges with the test relates to identifying and characterising the specific microorganisms required by the test. To act as a training aid for new staff, and an aide memoire for more experienced staff, Pharmig have produced eight fact sheets. Seven of the fact sheets profile each one of the key microorganisms (or microbial groups), using color photographs illustrating growth on agar and by Gram-stain. These are supported by facts relating to the organism’s profile and methods for identification. The eighth sheet offers some useful guidance about the interpretation of the test. The sheets are presented in a pack and together provide a unique, informative and colorful guide to an important area of quality control microbiology.

For further details, see Pharmig.

Posted by Tim Sandle

Sunday 8 December 2013

New anti-fungal treatment

An anti-fungal composition with pharmacological applications in agriculture and food industry, has been developed.

The composition, developed and patented by the UA Research Group in Plant Pathology, is based on the combined use of chitosan, or chitosan oligosaccharides (COS), antifungal agents and additives that synergistically affect the growth of a variety of pathogenic fungi.

The various experiments carried out by the research group are proof of the significant synergistic effect of the combination of chitosan (or COS) and other antifungals and ARL1 gene inhibitor, in inhibiting the growth of mould and yeast.

The compound has been developed by researchers based at the University of Alicante. For further details see UA Research.

Posted by Tim Sandle

Saturday 7 December 2013

South Africa joins the European Pharmacopoeia

The 37 signatory states of the European Pharmacopoeia Commission and the Commission of the European Union have unanimously decided to grant The Medicines Control Council of South Africa Observer Status to the European Pharmacopoeia. This brings the number of observers to twenty-five, including the World Health Organization (WHO).

South Africa’s application and acceptance as an Observer by EDQM for the European Pharmacopoeia is recognition of the large strides South Africa has made in the past decade and will allow the regulator and ultimately the local pharmaceutical industry to gain more expertise in the specialised field of plasma fractionation through the Ph.Eur. structures. It comes soon after the South African Medicine Control Council’s acceptance into PIC/S, once again, highlighting significant development taking place within the regulatory framework to the benefit of the patients of South Africa receiving PDMP.
For details, see SA EP

Posted by Tim Sandle

Friday 6 December 2013

Rapid diagnosis of typhoid from blood cultures

Typhoid fever is a life-threatening illness caused by the Gram-negative bacterium, Salmonella enterica subsp. enterica serovar Typhi. This foodborne pathogen is commonly contracted though the consumption of food or water that has been handled by a person shedding S. Typhi, or through the contamination of these products with sewage. Once ingested, the bacteria will inhabit the intestinal tract and bloodstream, resulting in a variety of complications including high fever, stomach pains, septicemia, and death.

Typhoid fever is common throughout most of the developing world, particularly in parts of Asia, Africa, and Latin America. Unfortunately, a number of people within these countries do not have access to a reliable laboratory diagnosis as the appropriate clinical facilities and techniques are not available. Thus, there is an urgent need for an inexpensive, easy-to-use, portable technique that can rapidly and safely diagnose typhoid fever independent of a hospital setting.

In a recent study, Castonguay-Vanier et al. investigated the accuracy and efficacy of a technique combining blood culture amplification of S. Typhi with a S. Typhi antigen rapid diagnostic test (RDT) developed by Standard Diagnostics (Cat. No. 15FK12). When tested against 23 Gram-negative reference pathogens, this assay was able to detect S. Typhi, as well as Salmonella enterica serovar Enteritidis and Salmonella enterica serovar Ndolo. The precision of this assay was further analyzed through the examination of 6,456 blood cultures from 3,028 patients. From this prospective study, the group found that the sensitivity, negative predictive value, specificity, and positive predictive value were 96.7%, 99.5%, 97.9%, and 87.9%, respectively, for patients with proven S. Typhi bacteremia. Overall, these results suggest that the combination of blood culture amplification of S. Typhi with an S. Typhi RDT is promising as an effective, sensitive, and inexpensive tool for the rapid diagnosis of typhoid fever.

This news was via ATCC. To access the research study, click here.

Posted by Tim Sandle

Thursday 5 December 2013

Water Quality Concerns

Hospital water systems are of importance for a number of applications, including supplying equipment, irrigation, washing patients, and for staff hand washing. It follows that managing a hospital water system plays a key part in contamination control. The risks are foremost to the patient, with a secondary risk to the healthcare worker. Contamination also presents an economic burden to the hospital, especially the cost of rectifying the contamination within the water system.

 Water presents a ‘dual problem’ because it not only provides a medium for microorganisms to grow, it is also easily spread and contamination can pass over large areas through the spread of water droplets and via aerosols. To explore the issues of good water system management, Tim Sandle has written an article for the magazine European Medical Hygiene.

 In the article, Dr. Sandle addresses the types of microorganisms found in water systems; the types of organisms that might be considered as ‘objectionable’; good control practices for water systems; biofilm risks; and good design principles.

The reference is:

Sandle, T. (2013). Water Quality Concerns: Contamination control of hospital water systems, European Medical Hygiene, pp14-19

Copies of the article were distributed at Medica in November 2013. If you would like to obtain a copy, please contact Tim Sandle

Wednesday 4 December 2013

Pharmig News #53

A new edition of Pharmig News has been issued (number 53). The highlights in the new issue are: 
  • An article on cleanroom gloves and the required criteria, by Derek Watts
  • An article about genotypic microbial identification, by Vikki Mitchell
  • A book review of ‘Cleanroom Management in Pharmaceuticals and Healthcare’
  • A regulatory roundup by Tim Sandle
  • And more…

Copies will have been sent to Pharmig members. If you would like a copy, please contact Maxine Moorey at Pharmig.

Posted by Tim Sandle

Tuesday 3 December 2013

Bacterial Endotoxins Test

The FDA has published Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 14 Bacterial Endotoxins Test General Chapter This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry.

The analytical procedures described in the official pharmacopoeial texts, European Pharmacopoeia (Ph. Eur.): 2.6.14. Bacterial Endotoxins, Japanese Pharmacopoeia (JP): 4.01 Bacterial Endotoxins Test, and United States Pharmacopeia (USP) General Chapter <85> Bacterial Endotoxins Test, can be used as interchangeable in the ICH regions subject to the following conditions:

Any of the three techniques can be used for the test. In the event of doubt or dispute, the gel-clot limit test should be used to make the final decision on compliance for the product being tested.

The USP, JP, and Ph. Eur. reference standards are considered interchangeable because they have been suitably calibrated against the WHO (World Health Organization) International Standard for Endotoxin.

In the section Photometric quantitative techniques, Preparatory testing, Test for interfering factors, the user should perform the test on solutions A, B, C, and D on at least two replicates using the optimal conditions as recommended by the lysate manufacturer.

For further details, see BET.

Posted by Tim Sandle

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