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

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

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

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

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

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

Saturday 12 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

Friday 11 March 2016

Explaining antibiotic resistance

Antimicrobial resistance (AMR) occurs when bacteria in our bodies adapt and find ways to survive the effects of an antibiotic medicine. When this happens, antibiotics lose their effectiveness and no longer work in fighting off infection caused by these bacteria. The more we use antibiotics, the greater the chance that bacteria in our bodies will develop resistance to these vital medicines.

If our antibiotics can no longer fight bacteria that cause infections, in the future this could mean that routine operations such as knee surgery or caesarian sections could become deadly. It is estimated that there are 400,000 cases of reported antibiotic resistant infections with 25,000 deaths each year in the European Union.

It is recommended to:
  • Keep surfaces clean
  • Wash your and your children’s hands regularly
  • Carry tissues and use them to catch coughs or sneezes; make sure you bin tissues and kill the germs by washing your hands
  • If you or your family start to feel unwell, even if it is just a cough or cold, don’t wait until it gets worse, seek immediate advice from your pharmacist
  • Keep yourself warm - heat your home to least 18°C or (65°F) if you can
  • If you have been prescribed antibiotics or other medication, make sure you take them as directed
  • Remember that sore throats, colds, coughs and earaches are self-limiting, usually getting better on their own but pharmacists can recommend over-the-counter remedies to help. 
In relation to the above information, from Public Health England, Chief Medical Officer for the U.K., Dame Sally Davies said:

“Resistance to antibiotics is putting people’s lives at risk, as well as creating extra pressure on our healthcare system, with drug-resistant strains of common diseases emerging here in the UK. We need to ensure that we only use antibiotics when clinically relevant, so I urge everyone to visit a pharmacist first before going to their GP, and to always complete courses of antibiotics if they are prescribed. These simple actions will help preserve these precious drugs and help to save modern medicine as we know it.”



Posted by Dr. Tim Sandle

Thursday 10 March 2016

MALDI-ToF Mass Spectrometry

A valid alternative for microbial identification

Rapid and accurate identification of pathogenic microorganisms in areas such as pharmaceutical and medical device manufacturing are of paramount importance. Traditional identification techniques often require subcultures on selective medium, colony isolation, Gram staining or biochemical testing, which are labour intensive and time consuming.
Posted by Dr. Tim Sandle

Wednesday 9 March 2016

Increasing The Reproducibility Of Serial Dilutions


Pipetting serial dilutions reproducibly can be difficult because it is a time consuming and consequently error prone methodology, especially in 384 well plates. Based upon the assumption that your pipettes are properly maintained and calibrated, the human influence has the largest impact on pipetting results. Observing good pipetting practice helps immensely to improve reproducibility and accuracy. In this article we focus on a selection of good pipetting techniques, which if maintained offer the best chance of increasing and maintaining the reproducibility of your serial dilutions. Mixing is a key component of dilution protocols and in this article we additionally discuss different mixing parameters to help you achieve a homogenous sample. To maximize consistency of dilution assays, automating the process offers many benefits. For ensuring highly reproducible serial dilutions we outline what features an automated pipetting system should have and introduce the VIAFLO ASSIST – a product purpose designed for this task.

Source: Laboratory Network

Posted by Dr. Tim Sandle

Tuesday 8 March 2016

Performance Comparison Of Low Retention Pipette Tips


Pipetting accuracy and precision are the key factors for successful experiments in the laboratory. The best pipetting performance is achieved, when the pipette and the tip match perfectly with each other, and the tip being used is optimal for the liquid being transferred.

When pipetting liquids with low surface tension (e.g. detergents), they tend to leave a film of liquid on the inner surface of standard polypropylene pipette tips, leading to inconsistency and inaccuracy in pipetting as well as loss in volume of valuable samples.


Various technologies are being used to modify the standard pipette tips to mitigate this issue. This application note describes the comparison of various manufacturers’ low retention tips, when handling liquids that contain detergents. The results show that Sartorius Low Retention Tips ensure near complete recovery of the sample, when pipetting liquids of low surface tension. When comparing to other low retention tips from various manufacturers, Sartorius tips secured the best sample recovery and the best chemical resistance.

For further details, see Laboratory Network



Posted by Dr. Tim Sandle

Monday 7 March 2016

Calling time on the General Safety Test


The General Safety Test is an animal test for  the detection of extraneous toxic contaminants and one which is sometimes undertaken for biological products intended for administration to humans. In the European Pharmacopoeia, the test is referred to as the ‘Abnormal Toxicity Test’; whereas in the United States Pharmacopeia, the test is the ‘General Safety Test’. Aside from some relatively minor differences relating to the size of the animals used, the numbers required, and with the interpretation of animals that appear ‘distressed’, the two compendial tests are essentially the same.

In relation to this test – long past its usefulness – Tim Sandle has written a review article for GMP Review. The reference is:

Sandle, T. (2016) Calling time on the General Safety Test, GMP Review, 14 (4): 11-13

For a copy, please contact Tim Sandle



 Posted by Dr. Tim Sandle

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