Friday 30 June 2017

Another Major Ransomware Attack Spreading

Another major ransomware attack is currently spreading around the world. According to Motherboard, "a wide range of private businesses" were affected on this week, though it's unclear whether all the attacks are related.

Reuters Tech News posted on Twitter that pharmaceutical company Merck's computer network was compromised as part of a "global hack." In addition to Merck, the global law firm DLA Piper, UK-based advertising and public relations firm WPP, and an unnamed Ukranian media company may be among the victims of this outbreak, Motherboard reports.

Last month, hundreds of thousands of PCs were attacked by ransomware known as WannaCry, throwing government agencies and private businesses around the globe into disarray. WannaCry resurfaced just last week, infecting the network at a Honda factory in Japan and traffic cameras in Australia.

Security researchers say a strain of ransomware called Petya or Petrwrap, which has similarities to WannaCry, is spreading like wildfire, Motherboard reports. According to an image posted on Twitter (which you can see above), the malware encrypts the files on a user's system then demands victims pay $300 worth of bitcoin to recover access to their files.

"If you see this text, then your files are no longer accessible, because they have been encrypted," the message reads. "Perhaps you are busy looking for a way to recover your files, but don't waste your time. Nobody can recover your files without our decryption device."

The message goes on to "guarantee" victims will "safely and easily" recover all their files by submitting the payment.

Source: PC Mag

Tuesday 27 June 2017

Computer Systems Validation

The MHRA are continuing their series on data integrity and computer systems validation. The latest blog post has some useful information (this time from Balall Naeem), such as:

If you are able to obtain validation documentation here are some suggestions on what you do next as a minimum:
  1. If you receive a validation report check it, make sure it corresponds to the version of the software you are using. If it details the systems functionality then make sure all the functionality you are using is covered in the report.
  2. If you receive a validation pack does it show the system to be successfully validated, i.e. has all the functionality you intend to use been tested and passed? Is it evident who the tester was and have they signed and dated everything correctly? Is it evident how test fails have been rectified? Is there anything that might cause you concern such as a missing follow-up test after a fail or undecipherable testing?
  3. Are the dates sequential? Was all testing completed before the product was released? Were all the specification requirements and test scripts agreed and signed off before the build had been completed? Was the validation report issued prior to release?
  4. If you have concerns can you address them? Are you able to self-validate or mitigate them in another way?
  5. Do a formalised risk assessment, document your findings and record any mitigating action you are going to take.
For further details, see MHRA

Posted by Dr. Tim Sandle

Monday 26 June 2017

Microbiological monitoring of pharmaceutical water systems

Water is widely used in pharmaceutical manufacturing; either as a raw material, as an ingredient, or as a final product. Water is also used for rinsing equipment or for the preparation of disinfectants and detergents. These applications require water of pharmaceutical grade to be used. This is water that has been through a chemical purification step. Purification is undertaken so that the water is free of substances that might cause interaction with drug substances, as well as to obtain water of an appropriate microbiological standard. 

Tim Sandle has written a review article for monitoring pharmaceutical water systems for European Pharmaceutical Review. Here is the abstract:

“Microbiological risks are ever present with water systems; risks can arise through poorly maintained water generation systems; through badly designed distribution networks (such as the presence of deadlegs); or at user outlets (where ineffective tubing management can lead to contamination). Weaknesses in water systems are exacerbated by microorganisms being ubiquitous and varied in their ability to survive and grow under different conditions. This means that the monitoring of pharmaceutical grade water systems for bioburden is important. This article assesses the different approaches that can be taken for the microbiological assessment of pharmaceutical water systems, examining both cultural based methods and alternative methods, arguing that rapid methods offer significant advantages.”

The reference is:

Sandle, T. (2017) Microbiological monitoring of pharmaceutical water systems, European Pharmaceutical Review, 22 (2): 25-27

For a copy please contact Tim Sandle

Posted by Dr. Tim Sandle

Wednesday 21 June 2017

Test for Abnormal Toxicity

The scientific validity and rationale of the test for abnormal toxicity has been the subject of debate for some time in Europe. The test was originally developed for detecting external contaminants in biological products, but over time the introduction of Good Manufacturing Practices and the use of appropriate and stringent Quality Control measures have rendered their use less necessary. Current scientific evidence suggests that, in light of such debatable relevance, the omission of the test for abnormal toxicity would not compromise the safety of biological medicines.

The European Pharmacopeia is considering the possible deletion from the European Pharmacopoeia. The European Pharmacopoeia Commission is seeking public feedback on its proposal to remove the requirements for a test for abnormal toxicity from 49 monographs of the European Pharmacopoeia (Ph. Eur.).

This consultation will run until June 2017 for all users, and will be extended until August for National Pharmacopoeia Authorities.


Posted by Dr. Tim Sandle

Monday 19 June 2017

Risk assessment and pharmaceutical processing hazards

Pharmaceutical medicines are expected to be efficacious and to perform according to the product licence or as directed by the medical practitioner. Medicines are also expected to be safe, and the basis of a safe medicine is one that has been manufactured consistently and with a review of potential manufacturing hazards completed.

In relation to the issue of hazards, Tim Sandle has written a review for Microbioz India of the types of hazards common to pharmaceutical manufacturing (including microbial and chemical) and the risk mitigations that can be deployed to address them. This includes consideration of risk assessment tools and techniques.

The reference is:

Sandle, T. (2017) Risk assessment and pharmaceutical processing hazards, Microbioz India 3 (3): 10-18

For further details, see Microbioz India.

Posted by Dr. Tim Sandle

Sunday 18 June 2017

Antibiotics are a potential link to bowel cancer precursor

A new study has found that people who take antibiotics over long time are more at risk of developing growths on the bowel that could be a precursor to cancer.
The research forms part of a wider line of scientific inquiry about the effect that antibiotics and other antimicrobials have on the human digestive tract and that microorganisms that live within it. Antibiotics are designed to kill harmful bacteria but they are not precise and they kill beneficial bacteria as well. If the balance slips too far and too many beneficial bacteria are killed, this imbalance has been linked to adverse health events. The likelihood of this change to the body's microbiome is greater the longer the period of time that a course of medication is taken for. The term microbiome refers to the microorganisms living in a given ecological niche - in this case the human intestines.

Data about long-term antibiotic use and bowel growths comes from a major U.S. trial called the Nurses' Health Study, which reviewed data from 16,000 nurses. The main findings, as summarized by BBC Science, were:
Nurses who took antibiotics for two months or more, aged between of 20 and 39 years, were more likely to be diagnosed with bowel polyps (called adenomas) compared with people who had not taken long-term antibiotics
Nurses who had taken antibiotics for two months or more in their 40s and 50s were even more likely to be diagnosed with an adenoma decades later.
This led the researchers to conclude: "Antibiotics fundamentally alter the gut microbiome, by curbing the diversity and number of bacteria, and reducing the resistance to hostile bugs." This led principal scientist Yin Cao of Harvard University to tell The Tribune: "The findings, if confirmed by other studies, suggest the potential need to limit the use of antibiotics and sources of inflammation that may drive tumor formation."
While the new research, which examines cases of long-term antibiotic use with signs of growth, signals a potential link to cancer, what is being reported is bowel polyps. These are tiny growths on the lining of bowel. These growths are common and they affect around one fifth of the population. In many cases these growths do not cause any symptoms and do not become cancerous. However, some can, if untreated, become cancerous.
The research is published in the journal Gut, in a paper titled "Long-term use of antibiotics and risk of colorectal adenoma."
This is an observational study so no firm conclusions can be drawn about cause and effect. Readers should be aware that this article refers to one study and that further research is needed in this area. Any person on antibiotics should continue with their course and raise any concerns with a medical professional.

Posted by Dr. Tim Sandle

Saturday 17 June 2017

Can airborne viruses survive in water?

A new study challenges the tenet that herpes viruses, like most enveloped viruses, are relatively unstable outside their host. Under a variety of conditions equine herpesvirus remained stable and infectious over a three week period. This suggests that untreated water could be a source of infection by some herpesviruses.

Enveloped viruses such as herpesviruses can cause disease when spread from host to host by aerosol transmission. They are generally thought to be unstable in the environment, requiring rapid and direct transfer among hosts in order to 'survive' and remain infectious. A research team lead by scientists from the Leibniz Institute for Zoo and Wildlife Research in collaboration with the Institut für Virologie of the Freie Universität Berlin tested this assumption by spiking water with equine herpesviruses under different conditions over a three week period and examining whether viral DNA could be retrieved and to what extent the virus remained infectious after having been in the water.

The results demonstrate that the virus does remain stable and infectious for up to three weeks, with pH and temperature being the two most important factors to determine how long the virus 'survived'. Surprisingly, the addition of soil to the water appeared to "pull" the virus out of the water and stabilize it in the soil, suggesting that in natural water bodies viruses may persist for an extended time without infecting additional hosts. Therefore, in the case of equine herpesviruses, horses or other mammals susceptible to these viruses could be infected by herpesviruses from water bodies long after the animals that shed the virus had left the area.

These results suggest that viruses such as equine herpesviruses may become a part of the environmental "virome" and remain infectious. Equine herpesviruses have spread among mammals such as polar bears and rhinos without direct contact with horses or their relatives in both the wild and in captivity, often resulting in fatal consequences. Shared water sources may be a source and potential vector for infection.

For further details see:

Anisha Dayaram, Mathias Franz, Alexander Schattschneider, Armando M. Damiani, Sebastian Bischofberger, Nikolaus Osterrieder, Alex D. Greenwood. Long term stability and infectivity of herpesviruses in water. Scientific Reports, 2017; 7: 46559 DOI: 10.1038/srep46559

Posted by Dr. Tim Sandle

Friday 16 June 2017

Foods as a potential source of spread of Clostridium difficile

Foods should be investigated as a potential source of spread of Clostridium difficile, according to research presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

C. difficile causes gut infections and can be particularly dangerous for elderly patients. Because it is resistant to commonly used antibiotics it can emerge in patients who are already being treated in hospital for unrelated conditions.

The new research used DNA fingerprinting to examine which particular types of the bacteria were causing infections in patients and how widely they are distributed in Europe.

Some strains were found clustered within a particular country, suggesting they were possibly being passed around within hospitals -- a well-recognised route of transmission. However, because some other strains were found dispersed in several different countries, this adds weight to the idea that C. difficile could also be transmitted via our food.

The research was presented by Dr David Eyre, a clinical lecturer at the University of Oxford, United Kingdom. He explained: "We know that C. difficile lives in the gut in a small proportion of healthy people, where it causes no symptoms. However, its resistance to antibiotics means it can grow uncontrollably in patients treated with the drugs, causing diarrhea that can be severe or even fatal. It is the most frequent cause of infectious diarrhea in hospitalised patients, and the increase in the use of antibiotics has allowed C. difficile to spread more effectively.

Posted by Dr. Tim Sandle

Thursday 15 June 2017

Ocean acidification impairs the nitrogen-fixing bacteria

While increased carbon dioxide levels theoretically boost the productivity of nitrogen-fixing bacteria in the world's oceans, because of its "fertilizing" effect, a new study reveals how increasingly acidic seawater featuring higher levels of this gas can overwhelm these benefits, hampering the essential service these bacteria provide for marine life.

The new data help explain disparities in previous studies exploring the effects of ocean acidification on nitrogen fixation. The abundant cyanobacteria Trichodesmium is estimated to contribute up to 50% of marine nitrogen fixation; therefore, understanding how this species will respond to a changing environment is critical.

Some studies have reported that, under acidified conditions, Trichodesmium significantly increases its rates of nitrogen fixation, photosynthesis and growth, whereas others have documented significant decreases in these processes. Haizheng Hong et al. studied Trichodesmium under controlled conditions, correcting for ammonium and copper contamination (which they say affected some previous results).

They found that increasingly acidic water negatively impacted the bacterium's ability to fix nitrogen. The negative impacts were even more pronounced if iron, an essential nutrient for Trichodesmium, was limited. Further analysis of key bacterial proteins revealed that acidification under iron-limited conditions requires a reallocation of iron among proteins to compensate for the loss of nitrogen-fixation efficiency.

The researchers also sampled Trichodesmium at three stations in the northern South China Sea, where surface iron concentrations are very low; nitrogen fixation was also limited in these locations.


Haizheng Hong, Rong Shen, Futing Zhang, Zuozhu Wen, Siwei Chang, Wenfang Lin, Sven A. Kranz, Ya-Wei Luo, Shuh-Ji Kao, François M. M. Morel, Dalin Shi. The complex effects of ocean acidification on the prominent N 2 -fixing cyanobacterium Trichodesmium. Science, 2017; eaal2981 DOI: 10.1126/science.aal2981

Posted by Dr. Tim Sandle

Tuesday 13 June 2017

Novel antibiotic resistance gene in milk

A new antibiotic resistance gene has been found in bacteria from dairy cows. This gene confers resistance to all beta-lactam antibiotics including the last generation of cephalosporins used against methicillin-resistant Staphylococcus aureus. A transfer to S. aureus which is likely according to the researchers would jeopardize the use of reserve antibiotics to treat human infections caused by multidrug-resistant bacteria in hospitals.

Macrococcus caseolyticus is a harmless bacterium naturally found on the skin of dairy cows which can spread to milk during the milking process. It can also be present in dairy products made from raw milk like e.g. cheese. Researchers of the Institute of Veterinary Bacteriology of the University of Bern have identified a new methicillin resistance gene in strains of M. caseolyticus isolated from milk. Transfer of the gene to Staphylococcus aureus, a bacterium found on the skin and mucosa of animals and humans, would have dramatic consequences for public health. This methicillin resistance gene would turn this bacteria into a hazardous methicillin-resistant S. aureus (MRSA), which is known to cause difficult-to-treat infections in hospitals. Acquired methicillin resistance in bacteria is associated with genes mecA, mecB, or mecC. However, none of these genes were present in the M. caseolyticus strains -- they carried the novel resistance gene mecD.


Sybille Schwendener, Kerstin Cotting, Vincent Perreten. Novel methicillin resistance gene mecD in clinical Macrococcus caseolyticus strains from bovine and canine sources. Scientific Reports, 2017; 7: 43797 DOI: 10.1038/srep43797

Posted by Dr. Tim Sandle

Monday 12 June 2017

Chronic fatigue syndrome linked to imbalanced microbiome

Scientists at the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health have discovered abnormal levels of specific gut bacteria related to chronic fatigue syndrome/myalgic encephalomyelitis, or ME/CFS, in patients with and without concurrent irritable bowel syndrome, or IBS. Findings are published in the journal Microbiome.

The study is among the first to disentangle imbalances in the gut bacteria in individuals with ME/CFS and IBS. ME/CFS is a complex, debilitating disorder characterized by extreme fatigue after exertion and other symptoms including muscle and joint pain, cognitive dysfunction, sleep disturbance, and orthostatic intolerance. Up to 90 percent of ME/CFS patients also have IBS.

The researchers followed 50 patients and 50 matched healthy controls recruited at four ME/CFS clinical sites. They tested for bacterial species in fecal samples, and for immune molecules in blood samples.


Dorottya Nagy-Szakal, Brent L. Williams, Nischay Mishra, Xiaoyu Che, Bohyun Lee, Lucinda Bateman, Nancy G. Klimas, Anthony L. Komaroff, Susan Levine, Jose G. Montoya, Daniel L. Peterson, Devi Ramanan, Komal Jain, Meredith L. Eddy, Mady Hornig, W. Ian Lipkin. Fecal metagenomic profiles in subgroups of patients with myalgic encephalomyelitis/chronic fatigue syndrome. Microbiome, 2017; 5 (1) DOI: 10.1186/s40168-017-0261-y

Posted by Dr. Tim Sandle

Saturday 10 June 2017

Oldest ever microbial fossils discovered

Remains of microorganisms, said to be over 3,770 million years old, have been discovered. These remnants provide conclusive evidence of the age of one of the oldest life forms on Earth.#
The discovery of the microbial fossils, in Canada, has been made by scientists from University College London. The discovery takes the form of tiny filaments and tubes formed by bacteria that once lived on iron. The find was made within quartz layers recovered from the Nuvvuagittuq Supracrustal Belt, which is located in Quebec. The Nuvvuagittuq Supracrustal Belt is a rich source of fossils and it contains the oldest sedimentary rocks known on Earth. These rocks were formed from an iron-rich deep-sea hydrothermal vent system. This are provided the habitat for the first life forms on the planet, dating to around 3,770 and 4,300 million years ago.
The discovery is not only important in terms of the dating of the fossils it also adds support to the theory that life on Earth originated from hot, seafloor vents. The earliest life forms – bacteria - emerged not long after Earth’s formation.
The new discovery pre-dates the previous earliest discovered microfossils. These were found in Western Australia and were dated at around 3,460 million years. These microfossils have also been a point of dispute with some scientists believing them to be artifacts in the rocks of a non-biological origin. This area of science is termed micropaleontology, and microfossils are a common feature of the geological record, from the Precambrian to the Holocene.

The new Canadian find was examined carefully to see if the haematite tubes and filaments were likely to have been of a biological or non-biological origin. To assess this various methods of formation were studied, including the effects of temperature and pressure. These analyses pointed to the fossils being of biological origin. One particular aspect which swayed things was the haematite structures (the mineral form of iron(III) oxide) having the same characteristic branching of iron-oxidising bacteria found near hydrothermal vents today. Hydrothermal vents are commonly found near volcanically active places, areas where tectonic plates are moving apart, ocean basins, and hotspots.
Discussing this, lead researcher Dr Dominic Papineau explains: “We've found direct evidence of one of Earth's oldest life forms. This discovery helps us piece together the history of our planet and the remarkable life on it, and will help to identify traces of life elsewhere in the universe."
Speculating further the researchers state that the discoveries demonstrate life developed on Earth at a time when Mars and Earth had liquid water at their surfaces. This raises the possibility of extra-terrestrial life on Mars, or at least life forms that existed sometime in the past on the red planet.
The discovery has been reported to the journal Nature. The research is titled “Evidence for early life in Earth’s oldest hydrothermal vent precipitates.”

Posted by Dr. Tim Sandle

Tuesday 6 June 2017

New Microscopy Method Breaks Color Barrier of Optical Imaging

An innovative technique allows for the imaging of up to 24 biomolecular structures at a time
Researchers at Columbia University have made a significant step toward breaking the so-called "color barrier" of light microscopy for biological systems, allowing for much more comprehensive, system-wide labeling and imaging of a greater number of biomolecules in living cells and tissues.

Product Image 

For further details see: Lab Manager

Posted by Dr. Tim Sandle

Sunday 4 June 2017

USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published a proposal for a general chapter <1224>.

The new USP chapter will become official with USP 35.

Posted by Dr. Tim Sandle

Saturday 3 June 2017

Ozonated water

Ozonated water systems are available in handwashing sinks, mobile portable ozonated water generators, and in-line skid systems. Some of the portable ozonated water units have been used to clean walls, tanks, filling lines, floors, and the actual solution or powder processing line. Some companies have found cost savings by using this technology in place of other sporicidal cleaners due to the reduced cost, no residues, and no corrosiveness. Additionally, the only ongoing cost for the ozonated water system is replacement of a few items as part of the yearly maintenance, and the use of purified water to operate the system.

This is an extract from a new article by Jeanne Moldenhaurer for Controlled Environments. In the article Jeanne calls on a new paradigm for cleaning and disinfection, pointing out that cleaning and disinfection technologies have advanced ahead of the practices adopted by the pharmaceutical sector and that to safeguard predicts and environments account needs to be taken of what is currently available.

The article can be accessed here: CE

Posted by Dr. Tim Sandle

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