Thursday, 31 March 2016

Ph. Eur. Commission adopts revised monograph on Water for Injections


During its 154th Session, the Ph. Eur. Commission adopted a revision of its monograph for Water for Injections (0169). Up to now, the production of Water for Injections (WFI) had been limited to distillation only. The revision allows for production of WFI by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques. The revised monograph will be published in the Ph. Eur. Supplement 9.1 and will become effective in April 2017.

For further details see: Ph. Eur.



Posted by Dr. Tim Sandle

Current Perspectives USP Microbial Identification


Microbial identification is the determination of the broad group (eg, bacteria, yeast, or mold) or narrow group (e.g., genus and / or species) to a qui microorganism belongs to.

Microbial characterization is the use of colony growth, cellular morphology, differential staining, and key diagnostic features to characterize a laboratory isolate for trending and investigative Purposes without identification, example, nonpathogenic Staphylococci.

Microorganisms, if detected in drug substances, excipients, water for pharmaceutical use, the manufacturing environment, intermediates, and finished drug products, UNDERGO typically characterization. This May include identification and strain typing, as considers.

In relation to the above, Radhakrishna S. Tirumalai, Ph.D. has written an interesting article for the magazine La Vague. The article can be found here.

Posted by Dr. Tim Sandle

Wednesday, 30 March 2016

Transmission of CJD and Variant CJD by Blood and Blood Products


A new FDA guidance document has been issued: “Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and Variant CJD by Blood and Blood Products.”

Tests are being developed to detect CJD and vCJD infections in blood and plasma donors. However, until suitable donor screening tests become available, FDA continues to recommend interim preventive measures based on the available scientific data and the evolving state of knowledge regarding these diseases. FDA may update this guidance in the future, in light of developments in testing technology, epidemiological information, and the impact of these recommendations on the supply of blood and blood-derived products.

For details see: FDA

Posted by Dr. Tim Sandle

Tuesday, 29 March 2016

Pharmig News No. 62


A new edition of Pharmig News (issue 62) has been issued. In this edition:
  • Use of rapid versus traditional microbiological methods by Lynne Murdoch
  • New standards and best practice for pharmaceutical manufacture by Susan Birks
  • The mycobiome – mapping fungi on human skin by Tim Sandle
  • Plus the usual regulatory round-ups and industry news.

Copies have been sent to member organizations. If you are not a member of Pharmig and wish to see a copy, please contact the Pharmig office.

Posted by Dr. Tim Sandle

Monday, 28 March 2016

New estimates of microbial numbers in our bodies


A new finding puts forward a more even ratio of one-to-one for the relationship between human cells in the body and microorganisms. To illustrate this, the researchers took a ‘typical man’ as a reference point. Imagine a man who weighs 70 kilograms, is aged between 20–30 years old and stands 1.7 metres tall. This man, microbiologists Ron Milo, Shai Fuchs and Ron Sender calculate is made up of around 30 trillion human cells and 39 trillion bacteria.

Tim Sandle explores the relationship between microorganisms and human cells in a new article published in Microbioz India. The reference is:

Sandle, T. (2016) New estimates of microbial numbers in our bodies, Microbioz India, Vol. 3, pp9-13

For details see: Microbioz India.




Posted by Dr. Tim Sandle

Sunday, 27 March 2016

New Species Of Lyme Disease Causing Bacteria


A new species of bacteria that causes Lyme disease has been discovered by Mayo Clinic scientists, in collaboration with the U.S. Centers for Disease Control and Prevention. The new species is provisionally named Borrelia mayonii. Before the discovery, the only other species known to cause Lyme disease was an organism called Borrelia burgdorferi.

Lyme disease is transmitted to people via the bite of a black-legged tick, called the deer tick. The disease leads to headache, rash, and neck pain. In serve cases it can lead to deliberating arthritis. Treatment is by antibiotics. In recent years, the disease has spread considerably across the U.S., covering a larger geographical area.

The discovery came about after medical researchers examined samples from U.S. patients taken during the period 2003 to 2014. For this, a molecular biology technique called polymerase chain reaction (PCR) was used. Of the samples screened, 6 of 9,000 samples, taken from residents of Minnesota, North Dakota and Wisconsin, showed a different pattern.

The differences led to the discovery of the new organism - B. mayonii. Although the bacterium has probably been present for some time, it has hitherto escaped detection. As well as the classic Lyme disease symptoms, B. mayonii causes nausea and vomiting, and a different type of rash. In addition, for those infected, the concentration of bacteria in the blood is higher.

The research is published in the journal The Lancet Infectious Diseases, in a paper titled ‘Identification of a novel pathogenic Borrelia species causing Lyme borreliosis with unusually high spirochaetaemia: a descriptive study.’

Posted by Dr. Tim Sandle

Saturday, 26 March 2016

Lab-on-chip technology to repair heart cells


Researchers have developed a "Muscle On-A-Chip" method to examine the best methods to repair damaged heart cells. A clearer understanding has been obtained for stem-cell derived treatment.

Heart attacks are a very real risk as people become older. When a heart attack happens, and the person survives, the cells that make up the heart – cardiomyocytes - are damaged. This occurs due a temporary lack of oxygen. The damaged cells, which acts as cardiac muscle cells, weakens the patient.

There are two types of cells within the heart: the cardiomyocytes and the cardiac pacemaker cells. Cardiomyocytes shape the fundamental contractile units of muscle cells.  Cardiac pacemaker cells help to control the hear rate.

Due to the damage and associated risks, biomedical scientists have examined whether heart cells can be repaired using stem cells. The theory is that stems cells could possibly be transplanted into the wall of heart muscle, together with native heart muscle cells, with the aim of improving contractile function.

Progress using stem cells has been slow, due to a number of ineffective results.  The pairing of the heart cells is structurally strong, but there is a difference with contractile strength, with the cells made from stem-cells being weaker.

In order to assist data review, Harvard University researchers have developed a system to measure the relationship between native heart cardiomyocytes and stem-cell derived cardiomyocytes. The researchers have deployed mouse models to examine the process. This has revealed that the two cell-types (native cardiomyocytes and stem-cell derived cardiomyocytes) combine to create “two-cell microtissue.” The researchers have dubbed this “muscle on-a-chip.”

This has led to the finding that the differences in contractile strength between the two cell-types is due to misdirected transmission of mechanical forces, with forces directed outwards rather than between the coupled cells.

The new knowledge about mechanical coupling of stem cells and native cells provides the basis for improving the use of stem-derived cells with an aim of improving patient outcomes.

The research findings are published in The Journal of Cell Biology. The research paper is titled ‘Coupling primary and stem cell–derived cardiomyocytes in an in vitro model of cardiac cell therapy.’

Posted by Dr. Tim Sandle

Friday, 25 March 2016

Legionella scheme: sample instruction


Legionellosis is a collective term for diseases caused by legionella bacteria including the most serious Legionnaires’ disease, as well as the similar but less serious conditions of Pontiac fever and Lochgoilhead fever. Legionnaires’ disease is a potentially fatal form of pneumonia and everyone is susceptible to infection. The risk increases with age but some people are at higher risk.

The bacterium Legionella pneumophila and related bacteria are common in natural water sources such as rivers, lakes and reservoirs, but usually in low numbers. They may also be found in purpose-built water systems such as cooling towers, evaporative condensers, hot and cold water systems and spa pools.

If conditions are favourable, the bacteria may grow increasing the risks of Legionnaires’ disease.

Public Health England have produced a Legionella isolation scheme: sample instruction sheet. This will be useful to clinical laboratories. The sheet, available in different languages, can be found here.

Posted by Dr. Tim Sandle

Thursday, 24 March 2016

Shiga toxin Escherichia coli scheme


Escherichia coli (E. coli) bacteria normally live in the intestines of people and animals. Most E. coli are harmless and actually are an important part of a healthy human intestinal tract. However, some E. coli are pathogenic, meaning they can cause illness, either diarrhea or illness outside of the intestinal tract. The types of E. coli that can cause diarrhea can be transmitted through contaminated water or food, or through contact with animals or persons.

E. coli consists of a diverse group of bacteria. Pathogenic E. coli strains are categorized into pathotypes. Six pathotypes are associated with diarrhea and collectively are referred to as diarrheagenic E. coli.

Shiga toxin-producing E. coli (STEC)—STEC may also be referred to as Verocytotoxin-producing E. coli (VTEC) or enterohemorrhagic E. coli (EHEC). This pathotype is the one most commonly heard about in the news in association with foodborne outbreaks.

Public Health England have produced a: sample instruction sheet. This will be useful to clinical laboratories. The sheet, available in different languages, can be found here.

Posted by Dr. Tim Sandle

Wednesday, 23 March 2016

Mycobacterium bovis (M. bovis): reducing the risk of human infection


TB in cattle is caused by the bacterium Mycobacterium bovis (M. bovis). Cattle, buffalo and bison are the natural hosts of M. bovis, but nearly all mammals are susceptible to the infection to a variable degree. The organism also has the capacity to infect and cause TB in humans. However, the risk of infection for the general public remains very low in industrialised countries with long-standing bovine TB control programmes and where pasteurisation of cows’ milk is either mandatory or commonly practised.

In relation to this disease, Public Health England has produced an information sheet. This will be of particular interest to those who are involved with agriculture.

Posted by Dr. Tim Sandle

Tuesday, 22 March 2016

Food Safety Consortium to Tackle Foodborne Illness


Bio-Rad Laboratories Inc., a life science research and clinical diagnostic products manufacturer has joined IBM Research and Mars Inc. in the Consortium for Sequencing the Food Supply Chain.  The consortium is harnessing the power of genomics and informatics to study microbiomes in food to help prevent contamination and foodborne illness at any step in the food supply chain.

The consortium was initially launched by IBM and Mars in January of 2015, and since joining the effort, Bio-Rad will contribute expertise in chromogenic and molecular tests for food pathogens and food quality indicators.

Further details on this initiative are discussed on the Bioscience Technology website.


Posted by Dr. Tim Sandle

Monday, 21 March 2016

ISO 45001 - occupational health and safety – new draft standard


ISO 45001 on occupational health and safety has been approved for Draft International Standard public consultation.

Designed to help organizations of all sizes and industries, the future standard is expected to reduce workplace injuries and illnesses around the world.

ISO 45001 is based on the common elements found in all of ISO’s management system standards, assuring a high level of compatibility with the new versions of ISO 9001, Quality management systems, and ISO 14001, Environmental management systems. It uses a simple Plan-Do-Check-Act (PDCA) model, which provides a framework for organizations to plan what they need to put in place in order to minimize the risk of harm.

For more information, see ISO.



 Posted by Dr. Tim Sandle

Sunday, 20 March 2016

Searching for Antimicrobials in the Unlikeliest of Places


The biggest challenge facing the world’s population is the shortage of antimicrobial compounds. This has arisen due to the overprescribing of antibiotics and other antimicrobials; as a consequence of bacterial resistance, arising from evolutionary mechanisms or plasmid transfer, to one or more antimicrobial compound; to add to this the threat of newly emerging pathogens remains ever-present.
To address these issues and to outline current research and developments in the search for new antimicrobials, Tim Sandle has written  a new paper for the Journal of Pharmaceutical Microbiology.


The reference is:

Sandle, T. (2015) Searching for Antimicrobials in the Unlikeliest of Places, J Pharm Microbiol, 1 (1): 1-3

If you are interested in reading this article, click here.

Posted by Dr. Tim Sandle

Saturday, 19 March 2016

ISO Draft International Standard (DIS) 14644-13: available



A new draft cleanroom standard has been produced: ISO Draft International Standard (DIS) 14644-13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classification.

Guidance is provided on the assessment of cleaning methods for achieving the required surface cleanliness levels specified in ISO 14644-9: Classification of surface cleanliness by particle concentration and ISO 14644-10: Classification of surface cleanliness by chemical concentration. Different cleaning methods may be necessary depending on the degree of cleanliness required. The selection procedure considers aspects such as surface description, cleanliness specifications, types of contamination, cleaning techniques, and material compatibility. Guidance is provided on assessing cleaning efficacy.



Posted by Dr. Tim Sandle

Friday, 18 March 2016

New microbes thrive deep in the Earth



By sequencing genomes of a newly discovered group of microbes, the Hadesarchaea, an international team of researchers have found out how these microorganisms make a living in the deep subsurface biosphere of our planet. The Hadesarchaea belong to the archaea.

To find the microorganisms, researchers sequenced the genomes of several Hadesarchaea. They were able to determine how these microbes should be classified and what physiologies they use to survive under these extreme conditions. Hadesarchaea have the ability to live in areas devoid of oxygen and the scientists suggest that they are able to survive there by using carbon monoxide to gain energy. Interestingly, the chemical pathways the Hadesarchaea cells use to metabolize carbon monoxide are unique to what has been seen before.

To read more see:

Baker et al (2016) Genomic inference of the metabolism of cosmopolitan subsurface Archaea, Hadesarchaea, Nature Microbiology, DOI: 10.1038/NMICROBIOL.2016.2 

Posted by Dr. Tim Sandle

Thursday, 17 March 2016

Ancient and modern human microbiome


Anthropologists are studying the ancient and modern human microbiome and the role it plays in human health and disease. By applying genomic and proteomic sequencing technologies to ancient human microbiomes, such as coprolites and dental calculus, as well as to contemporary microbiomes in traditional and industrialized societies, Researchers are advancing the understanding of the evolutionary history of our microbial self and its impact on human health today.

For further details see: University of Oklahoma.

Posted by Dr. Tim Sandle

Wednesday, 16 March 2016

Mosquito bite avoidance for travellers

In many tropical countries, mosquitoes can spread diseases such as dengue, chikungunya, West Nile, malaria, yellow fever and Zika. Here are five simple rules you should follow to reduce your risk of infections spread by mosquitoes.

Public Health England have produced an information leaflet:


Posted by Dr. Tim Sandle

Tuesday, 15 March 2016

World's first microbiology museum

Microbiology museum - Micropia
The world's first public museum about all things microbial is in Amsterdam, in The Netherlands. It is called Micropia.

Micropia is the world's first museum dedicated to microbes and micro-organisms, which actually make up two-thirds of all living matter.

At a cost of €10 million, Micropia opened in October 2014 and is part of the Royal Artis Zoo complex in the Plantage district of Amsterdam.

The museum is located on Artisplein which is a public square also recently opened at Artis. On entering you can purchase tickets on the ground floor and then take the lift ride up to the first floor - as you ascend look up to watch an animation about the mites living on your eyelashes and the even smaller bacteria and viruses living on those mites!

Micropia Essential Info

Opening Times: Daily 0900-1800 (Sun-Wed) and 0900-2000 (Thu-Sat).

Admission Prices (2016): €14 for adults, €12 for children 3-9, €7.50 for students, free for children 0-2. Note that Museumkaart and Iamsterdam City Card are NOT valid at Micropia. Combined Artis+Micropia tickets are €27.50 for adults, €23.50 for children 3-9.

Getting There: Artis/Micropia can be reached from the centre of Amsterdam on foot - head towards Waterlooplein and continue further east along the Plantage Middenlaan. By public transport you can take tram 14 from Dam Square or tram 9 from Central Station to stopPlantage Kerklaan.

Micropia, Artisplein, Plantage Kerklaan 36-38, Amsterdam
T: +31(0)900-2784796 (Artis number, €0.55 per call in Netherlands)

Posted by Dr. Tim Sandle

Cleanroom Microbiology Book - PDA Distinguished Author Award

The book 'Cleanroom Microbiology' by Tim Sandle and R. Vijayakumar has won the PDA Distinguished Author Award 2016, as selected by PDA members.

The book is about cleanrooms and controlled environments in relation to the pharmaceutical and healthcare sectors. The book is applicable to both the sterile and non-sterile pharmaceutical sectors and its focus is upon cleanroom microbiology.

Modern approaches to contamination control place a greater emphasis upon environmental control than they do on upon monitoring. This requires an understand of risk assessment; hence risk management and contamination control strategies feature strongly in the text.

The book fills a much needed gap in the microbiology and contamination control spheres. While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled environments limited coverage.

To the authors of Cleanroom Microbiology, these two domains, normally separated by different functions, are inseparable. This book is about cleanrooms and controlled environments in relation to the pharmaceutical and healthcare sectors and is applicable to both the sterile and non-sterile pharmaceutical sectors with its focus on cleanroom microbiology.

The book contains 16 chapters which cover a range of key topics. These include cleanroom standards, environmental monitoring, cleaning and disinfection, staff behaviours, understanding the microbiome of human skin, culture media, microbial identification and more.

The book has been published by PDA / DHI and details can be found here.

Monday, 14 March 2016

Food Safety Consortium to Tackle Foodborne Illness


Bio-Rad Laboratories Inc., a life science research and clinical diagnostic products manufacturer has joined IBM Research and Mars Inc. in the Consortium for Sequencing the Food Supply Chain.  The consortium is harnessing the power of genomics and informatics to study microbiomes in food to help prevent contamination and foodborne illness at any step in the food supply chain.

The consortium was initially launched by IBM and Mars in January of 2015, and since joining the effort, Bio-Rad will contribute expertise in chromogenic and molecular tests for food pathogens and food quality indicators.

Further details on this initiative are discussed on the Bioscience Technology website.

Posted by Dr. Tim Sandle

Sunday, 13 March 2016

Why Combating Fake Medicines in Africa Is a Must


Counterfeit drugs have become a major worldwide issue. These types of drugs compromise the current pharmaceutical industry in a way that is dangerous for providers and patients alike. Fake medicine often has altered potencies, which can lead to unsafe dosages and medication therapies that are simply dangerous and ineffective.

This issue is particularly prominent in Africa, due to the lack of medical infrastructure. Here is a little bit more about what counterfeit drugs are, why they are being produced, and was is being done to combat this problem.

Counterfeit Drugs

Counterfeit drugs are being produced in large quantities in Africa. Last year alone, in Ghana, 90 percent of the drug oxytocin was found to be substandard and counterfeit. The majority of these substandard drugs were found in hospital and clinic environments. A good number of these drugs were produced by Chinese manufacturers. The major problem with these drugs is that they cause patient outcomes to become unpredictable, or downright negative.

For example, counterfeit or poorly produced drugs were the cause of 100,000 deaths of children who had consumed them for protection against malaria. Because the active ingredients were not present, the drugs simply did not work. Seventy percent of medications in Africa are imported. The counterfeiting process is similar to the process for other types of manufactured products, with one key difference: the drugs are manufactured without using the appropriate levels of potent materials, and are therefore ineffective.

Why Are They Being Produced

The obvious reason why these drugs are being produced is that they make money, and at a lower cost than full-potency drugs. Because there are not very many African countries that produce the drugs on native soil, this creates an opportunity for foreign companies to gain market share in an untapped area.

Combatting Fake Drugs

Making sure these drugs are regulated is an essential effort on the part of African regulatory agencies. These agencies have beef up their efforts to ensure these drugs meet certain standards. Further, the United States Pharmacopeial Convention’s (USP) Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana, worked to expand its quality control testing and training capacities. The group opened a new pharmaceutical microbiology laboratory to engage in quality control efforts.

According to the World Health Organization, medical products should meet certain safety, quality and effectiveness standards. The dishonest distribution of these types of products is prohibited by the World Health Organization, yet illegal activity still occurs. Furthermore, these substandard products are dangerous for consumers, which is what motivated the WHO to prohibit their distribution. In fact, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was created in 2006 to reduce the manufacturing, distribution and consumption of counterfeit drugs.

Counterfeit drugs are a huge problem in Africa. These drugs cause negative health outcomes and create major gaps in the healthcare delivery system. Combatting efforts of substandard manufacturers is necessary in order to sustain the quality of the delivery system and protect the health of the African public.

Megan Nichols is a science writer who specializes in health and wellness topics. She also enjoys writing about other science fields on her blog. When she isn’t writing, Megan enjoys hiking, and stargazing.