Thursday, 31 January 2019

Special magnetic coating used to kill bacteria, an antibiotic alternative


The problems and limitations of antibiotics and antimicrobial substances have received a great deal of attention in the press. The main concern is bacterial resistance. As an alternative, a science group have developed a special coating which can destroy bacteria on contact.

A research team based at the Nanyang Technological University (NTU), Singapore, have developed a special coating which has a magnetic-like feature. The magnetic nature is used to attract bacteria and then kills them. The application could lead to an antibiotic 'alternative'.

According to an NTU press release, the special sponge-like coating is made from Dimethyldecylammonium Chitosan methacrylate. The coating is a type of polymer which holds a positive charge. The charge acts like a type of magnet which generates a force. The force draws bacteria, which possess a negative charge on their cell walls, towards the surface. When the bacterium comes in contact with the coating, the cell walls are 'sucked' into the nanopores, causing the cell to rupture, thus killing the bacterium.

The Alpha Galileo Foundation notes that the coating has been tested against bacteria like Pseudomonas aeruginosa, which can cause infections in the upper respiratory tract, gastrointestinal tract and the urinary tract; and Staphylococcus aureus, which can cause infections ranging from skin boils or abscesses to deadly diseases such as pneumonia and meningitis.

The research was led by Professor Mary Chan, Acting Chair of NTU's School of Chemical and Biomedical Engineering. The research findings were published in the journal Nature Materials.

Chan is quoted by the Meridian Institute as saying, in relation to the research:

"The coating can also be applied on biomedical objects, such as catheters and implants to prevent bacterial infections, which is a serious cause of concern as many bacteria are now developing resistance to antibiotics - currently our main source of treatment for infections. By developing novel materials which uses physical interaction to kill bacteria cells, we envisage this can be an alternative form of treatment for bacterial infections in the near future."

A key advantage with the coating is that it is harmless to human cells.

The application is thus far being used by two companies: a contact lens manufacturer and a company specializing in animal care products. The next wave of developments is likely to be with implants and surgical instruments.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 30 January 2019

Microorganism Confirmation and Identification with Mass Spectrometry


Microorganism confirmation and identification are critical in a number of industries, including pharma, cosmetics, and food. In the food industry, pressures from regulatory bodies and customers alike are continually tightening, making accurate, rapid microbiology testing crucial for manufacturers to make rapid decisions in regard to quality and safety, for example, to detect possible food spoilage organisms or foodborne pathogens, or monitor environmental contaminants or technological microflora.

Daniele Sohier has written an interesting artidle on MALDI_TOF, from the food microbiology perspective. Here is an extract:

In the routine laboratory, the incorporation of MS technology into the toolbox enables the laboratory to offer flexible options for turnaround time and cost to fit in with the client’s needs. This is particularly valuable as it creates a completely customizable service and provides the option of same-day results for rapid pathogen identification, for example. This was not available with previous methods. The confidence in results with the MALDI-TOF system and increased sensitivity means that fewer re-tests are required, so when an identification is provided for the first time, the client can make decisions immediately.

To view the article, see: Food Safety


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 29 January 2019

New method can quickly and accurately detect infections


Two chemistry researchers have developed a method that can show quickly and accurately whether a person has been infected with harmful bacteria or other pathogens. Additionally, this new method shows the exact severity of infection in a person.

A new study by Waldemar Gorski, professor and chair of the UTSA Department of Chemistry, and Stanton McHardy, associate professor of research in chemistry and director of the UTSA Center for Innovative Drug Discovery, describes a method that could show quickly and accurately whether a person has been infected with harmful bacteria or other pathogens. Additionally, this new method shows the exact severity of infection in a person.

The most common method of testing for infection in medical facilities is currently a strip that turns a certain color when infected fluids come into contact with it.

Gorski, seeing a need for an easier and more rapid method of testing for infection, resolved to test an electrochemical approach, and sought out McHardy, a medicinal chemist. Together, they created molecules that bind to leukocyte enzymes and produce an electrical current to signal the presence of an infection.

Their new molecules are housed on a testing strip. After being contacted with infected bodily fluids, the strip is connected to a computer monitor that displays a clear range of electrochemical responses demonstrating the severity of an infection.

See:

Douglas Hanson, Travis Menard, Teresa Blazek, Stanton McHardy, Waldemar Gorski. Synthesis and Characterization of Pyridine Compounds for Amperometric Measurements of Leukocyte Esterase. ChemBioChem, 2018; DOI: 10.1002/cbic.201800164
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 28 January 2019

Link between aging and microbiome diversity in exceptional mammalian longevity


"Is there a link between aging and microbiome diversity in exceptional mammalian longevity? This is an interesting question posed in a paper published in PeerJ. The abstract reads:

"A changing microbiome has been linked to biological aging in mice and humans, suggesting a possible role of gut flora in pathogenic aging phenotypes. Many bat species have exceptional longevity given their body size and some can live up to ten times longer than expected with little signs of aging. This study explores the anal microbiome of the exceptionally long-lived Myotis myotis bat, investigating bacterial composition in both adult and juvenile bats to determine if the microbiome changes with age in a wild, long-lived non-model organism, using non-lethal sampling.

The anal microbiome was sequenced using metabarcoding in more than 50 individuals, finding no significant difference between the composition of juvenile and adult bats, suggesting that age-related microbial shifts previously observed in other mammals may not be present in Myotis myotis. Functional gene categories, inferred from metabarcoding data, expressed in the M. myotis microbiome were categorized identifying pathways involved in metabolism, DNA repair and oxidative phosphorylation. We highlight an abundance of ‘Proteobacteria’ relative to other mammals, with similar patterns compared to other bat microbiomes. Our results suggest that M. myotis may have a relatively stable, unchanging microbiome playing a role in their extended ‘health spans’ with the advancement of age, and suggest a potential link between microbiome and sustained, powered flight."

See: PeerJ

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunday, 27 January 2019

Endotoxin Testing as a Detection Method for Bacterial Biofilms


Microbial biofilms - structured consortium of bacteria that are embedded in layers of self-produced polymer matrices, largely composed of polysaccharide, protein and DNA – are well described and known problems for pharmaceutical water systems and medical devices. What is less well-researched is the association of biofilms with endotoxin, especially within the pharmaceutical and medical device context. Here the association of biofilms and endotoxin is of significance to the risks presented by biofilms to water systems and for patient risks in relation to medical devices. With water systems the detection of endotoxin may provide an early warning of a biofilm problem. While the screening of Water-for-Injection systems for endotoxin is a GMP requirement, other types of pharmaceutical grade water are not commonly sampled for endotoxin testing. The introduction of this type of testing may prove useful where there is a concern about biofilm formation. The same may also apply to medical devices, especially given the risk posed from endotoxin. Detachment of cells or cell aggregates, production of endotoxin, increased resistance to the host immune system, and provision of a niche for the generation of resistant organisms are all biofilm processes which could lead to infection.

Tim Sandle has written a new paper for American Pharmaceutical Review:

This article discusses the association of biofilms and endotoxin; looks at the challenges this association poses for water systems and medical devices; and considers whether tests for endotoxin can function as part of a detection method to support an endotoxin control strategy.

The reference is:

Sandle, T. (2018) Endotoxin Testing as a Detection Method for Bacterial Biofilms, American Pharmaceutical Review, 21 (8), Endotoxin Supplement, pp1-3: https://www.americanpharmaceuticalreview.com/Featured-Articles/354079-Endotoxin-Testing-as-a-Detection-Method-for-Bacterial-Biofilms/



To access, see American Pharmaceutical Review.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday, 26 January 2019

Importance of contact lens hygiene

Caught short without your contact lens case or care solutions? Lens unexpectedly falls out? What would you do? NBA star Ron Baker, faced with just this dilemma earlier this year chose to pop his lens in his mouth to wet it and then place it back on his eye. This was seen by countless people around the world as the video clip spread online, eliciting cringes from the eye health community and shrugs from wearers who have done the same.
During the holidays, when routines are disrupted and time is at a premium, contact lens wearers may also be tempted to skip regular hygiene practices. But is it wise? Scientists from the Centre for Ocular Research & Education (CORE) at the University of Waterloo conducted an eye-popping experiment to help consumers picture the risks.
To demonstrate the rapid growth of bacteria associated with mishandling contact lenses, CORE researchers exposed new, clean contact lenses to human saliva and then placed them into petri plates for monitoring. The action of putting a contact lens in the mouth resulted in significant growth of microorganisms after only two days of incubation (Figure 1).
They then examined the effect of handling contact lenses with both clean and unwashed hands. Unwashed hands were pressed into agar (Figure 2a), and also used to handle a new contact lens (Figure 2b). Scientists then repeated the procedure after following recommended handwashing practices, touching both the agar directly, along with applying and removing a contact lens (Figures 2c and 2d). The results clearly demonstrate the impact handling has on contact lenses. Samples that had been placed in the mouth or touched with unwashed hands showed significantly higher numbers of visible bacteria. By comparison, the contact lens touched with clean hands had only a minimal bacterial load.
“Contact lenses are a safe, highly effective form of vision correction used by millions of people, but ignoring good contact lens care can have a devastating effect on eye health and vision,” says CORE senior research associate Miriam Heynen, MSc, who conducted the experiment with laboratory research assistant Vivian Chan, Bsc., after hearing a news report on poor contact lens care habits.
She continued, “Bacteria are present on surfaces all around us and this simple experiment is a graphic demonstration of how they reproduce over just a short amount of time. Taking care of your contact lenses is a must, no matter how pressed for time you are. Handle with clean, dry hands, use a case and care solution as recommended by an eye care practitioner, and always keep spare contact lenses and spectacles with you. Proper care is simple, essential for good health, and after seeing these photos, a no-brainer for anyone who appreciates their eyes.”
Contact lens wearers can more easily resolve to practice better hygiene during the holiday season and the New Year, thanks to a printable, easy-to-read tip sheet available from CORE which covers good hand hygiene along with other reminders on safe contact lens wear.
# # #
About the Centre for Ocular Research & Education (CORE)
The Centre for Ocular Research & Education (CORE) – formerly known as the Centre for Contact Lens Research – was established in 1988 at the University of Waterloo’s DynEngagement=true&H=AqX%2Fyxxn%2FCsKfNEzXNs%2BvxKe7ZZW379%2BIapVVCHkcj06tGRioNXHyS6RO0n%2BXwpA2ueL0RLYg8jRuiwrJlxxa72CMcHQDLGr8Dh0O5fsiRjNSpAiXuFgoIJGRB6LiryA&G=0&R=https%3A%2F%2Fuwaterloo.ca%2Foptometry-vision-science%2F&I=20181219140533.000001c823f3%40mail6-60-usnbn1&X=MHwxMDQ2NzU4OjVjMTk3MGM5MjY3Y2ZjM2NlNDZkY2M0MTs%3D&S=YJ75rPeo_PodM-9xpIjJqBC0jywm9ys6JxNgiBIjjjk" rel="nofollow" style="color: blue;" target="_blank">School of Optometry & Vision Science
. Over the next three decades, the organization evolved from a three-person operation into a thriving hub of basic and applied research, collaborating with sponsors, agencies and academia on advanced biosciences, clinical research and education. Its uncompromising independence and results of the highest quality have been at the heart of many of the most prominent advances in eye health. Today, its approximately 50-person team serves a range of ophthalmic sectors, including medical devices, ocular pharmaceuticals, digital technology and others, with a focus on the anterior segment. For more information, please visit core.uwaterloo.ca.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 25 January 2019

Examining the reliability of manual plate colony counts in environmental monitoring


An interesting essay has been published on-line about colony counting by R. Hutchinson:

Plate counts of colony forming units (CFUs) are the gold standard of microbial enumeration and therefore essential to environmental monitoring in the pharmaceutical industry. There are strict regulations regarding bioburden at each stage of pharma production, from raw materials to finished products, but we often fail to question whether current methods are rigorous enough to fulfil these requirements.

The article can be accessed here.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Thursday, 24 January 2019

Toxin complex of the plague bacterium decoded


Bacteria have established various strategies to infect organisms and use them as sources of nutrients. Many microbes use toxins that break down membranes by simply piercing through the outer shell of the cells. Human-pathogenic bacteria such as the plague bacterium Yersinia pestis or other bacteria from the salmonella family developed a much more subtle mechanism: they inject their poison by applying a special toxin complex.

A team of researchers led by Stefan Raunser from the Max Planck Institute of Molecular Physiology in Dortmund has now been able to fully unveil the sophisticated mechanism using the bacterium Photorhabdus luminescens as an example.

Bacterial toxins are among the most effective natural poisons. The strongest toxins include e.g. the tetanus and botulinum toxins (botox), already toxic when only a thousandth of a gram is administered. Bacteria have developed highly varied strategies and mechanisms to introduce their poisons into organisms. The bacterium Photorhabdus luminescens, the plague bacterium Yersinia pestis, as well as germs from the salmonella family, use so-called Tc toxins which consist of several components (TcA, TcB, TcC). Until recently, it was unclear how these subunits work together.

In most cases, large bio-molecules such as the complex bacterial toxins cannot be structurally analysed using traditional X-ray crystallography, because they cannot be converted into the required crystalline state. Cryo-electron microscopy, however, does not require the samples to be crystallized. Imaging of even large complexes becomes possible, by freezing them extremely quickly and examining them directly under the microscope at minus 196 degrees. Using cryo-EM the team of Stefan Raunser was able to determine the three-dimensional structure of the Photorhabdus luminescens toxin for the first time in near-atomic detail. The structures showed, that the largest subunit of the poison complex, TcA, resembles a bell, consisting of a channel surrounded by a shell. The upper part of the bell binds the poison capsule formed by the subunits TcB and TcC. Receptors on the cell membrane recognize the lower part of the bell and the loaded poison complex is bound.


Once the pH value of the surrounding medium changes, the outer shell of the toxin opens up, thus revealing the channel. A protein chain kept under high pressure then snaps back and pushes the channel through the cell membrane like the needle of a syringe injecting the poison. The latter is an enzyme which catalyses the clumping of the cytoskeleton, resulting in the death of the cell.

Molecular gatekeeper

Scientists were still missing one last detail to fully understand how the injection of the poison. They needed to find out how this device is controlled. The team from Dortmund achieved this in collaboration with the research group of Manajit Hayer-Hartl from the Max Planck Institute of Biochemistry in Martinsried. The new investigations focused on a small hairpin structure also called the "gatekeeper." This controls the poison exiting in the direction of the TcA subunit channel -- a gateway which resembles a propeller with six blades. When the capsule binds to the channel this border area is restructured: The gatekeeper unscrews itself from the centre of the propeller and reveals the central opening which now precisely connects to the channel of the TcA subunit. The scientists were also able to demonstrate that the presence of the enzyme in the poison capsule is essential for the formation of the whole toxin complex. This points at a possible control mechanism which guarantees that the TcA subunit is charged exclusively with fully loaded poison capsules.

Even today bacterial infections are still among the most frequent causes of diseases with severe progressions (e.g. sepsis). The intensive use of antibiotics has led to the development of fatal resistances which have made it significantly more difficult to win the battle against human-pathogenic bacteria. Uncovering bacterial infection mechanisms will help to better understand the mode of action of human-pathogenic bacteria. The newly obtained insight into the extraordinary mechanism of the Tc-toxin injection could serve as a starting point for developing innovative therapeutic approaches.


See:

Christos Gatsogiannis, Felipe Merino, Daniel Roderer, David Balchin, Evelyn Schubert, Anne Kuhlee, Manajit Hayer-Hartl, Stefan Raunser. Tc toxin activation requires unfolding and refolding of a β-propellerNature, 2018; 563 (7730): 209 DOI: 10.1038/s41586-018-0556-6

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 23 January 2019

Depyrogenation


Ph. Eur. Is seeking feedback on general chapter covering depyrogenation in parenteral preparations The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated chapter covers specifically the inactivation of pyrogens and related endotoxin indicators.

See:  https://www.edqm.eu/sites/default/files/press_release_pheur_depyrogenation_october_2018.pdf 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 22 January 2019

How pneumococci challenge the body’s immune system


Pneumococci are the most common cause of respiratory tract infections, such as otitis and sinusitis, as well as of severe infections like pneumonia and meningitis. A new study from Karolinska Institutet in Sweden published in Nature Microbiology shows how the bacteria can inhibit immune cell reaction and survive inside cells to give rise to pneumonia.

"This is a paradigm shift that increases our understanding of how pneumococci cause disease, and might explain the long term consequences of pneumococcal infections such as for example heart disease," says Professor Birgitta Henriques-Normark at the Department of Microbiology, Tumour and Cell Biology, Karolinska Institutet. "This is an important discovery that will lead to new strategies for tackling pneumococcal infections."

Pneumococci are found in the normal flora of healthy individuals, and up to 60 percent of pre-school children have the bacteria in their noses. Usually, these bacteria are harmless but they are also a common cause of otitis, pneumonia, septicaemia and meningitis. Globally, some two million people die from pneumococcal infections every year.

To find out why the bacteria only sometimes cause disease, the researchers looked more closely at the toxin pneumolysin, which is produced by the pneumococcus. This cytolethal toxin enables pathogenic effects of the bacteria.

"We made the very surprising discovery of a new property of pneumolysin," says Professor Henriques-Normark. "We found that pneumolysin is able to interact with a special receptor, MRC-1, that is found in certain immune cells, and in so doing trigger an anti-inflammatory response."

Once inside the immune cells, the bacteria can hide from further attack and possibly even grow, to eventually give rise to pneumonia.

"It has been thought that pneumolysin only induces a pro-inflammatory response, but we now show that it can also have an anti-inflammatory role" she continues. "This is because the bacteria can use pneumolysin as a means to survive the attacks of the immune system."

The study was conducted on both mouse and human cells, and when the researchers studied mice lacking the MRC-1 receptor, they observed that lower numbers of pneumococci were found in the upper respiratory tract. The researchers believe that the findings may be of importance for development of treatment and vaccines against pneumococcal infections.

See:

Karthik Subramanian, Daniel R. Neill, Hesham A. Malak, Laura Spelmink, Shadia Khandaker, Giorgia Dalla Libera Marchiori, Emma Dearing, Alun Kirby, Marie Yang, Adnane Achour, Johan Nilvebrant, Per-Åke Nygren, Laura Plant, Aras Kadioglu, Birgitta Henriques-Normark. Pneumolysin binds to the mannose receptor C type 1 (MRC-1) leading to anti-inflammatory responses and enhanced pneumococcal survival. Nature Microbiology, 2018; DOI: 10.1038/s41564-018-0280-x

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 21 January 2019

Personnel Monitoring for Controlled Environments


Cleanroom contamination can arise from a number of sources. Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. The paper discusses staff gowning and personnel behavior in pharmaceutical cleanrooms, and how cleanroom risk can be minimized. The human skin ecosystem is discussed.

Tim Sandle has written a new book chapter:

The Human Microbiome Project (HMP) from the US NIH characterized microorganisms found in association with both healthy and diseased humans. Information from this project has great impact on cleanroom activities including gowning practices. Topics associated with cleanroom garments are discussed including fabric types, garment lifespan, recycling, laundering, human changing procedures, training, behavior, hand sanitization, ongoing assessments, and associated topics.

The reference is:

Sandle, T. (2018) Personnel Monitoring for Controlled Environments. In Masden R. E. and Moldenhauer, J. M. (Eds.) Contamination Control in Healthcare Product Manufacturing, Vol.5, pp357-400

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunday, 20 January 2019

Studying microorganisms that degraded a 400-year-old painting


The wide variety of organic and inorganic materials that comprise a painting, such as canvas, oil, pigments, and varnish, can provide an ideal environment for colonizing bacteria and fungi, increasing the risk for biodegradation. To characterize the microorganisms on one such painting, "Incoronazione della Virgine" by Carlo Bononi, completed in 1620, the authors removed a 4 mm2 section of the painted surface adjacent to a damaged area.

Using a combination of microscopy and microbial culture techniques, the authors identified a variety of microbes which had colonized the painting. They isolated multiple strains of Staphylococcus and Bacillus bacteria as well as filamentous fungi of the Aspergillus, Penicillium, Cladosporium, and Alternaria genera. The authors note that some of the 17th century paint pigments used, notably red lac and red and yellow earths, may be nutrient sources for the microbes. They also tested a decontaminating biocompound which contained spores of three Bacillus bacteria and found that these could inhibit growth of both the bacteria and the fungi isolated from the painting.

The authors conclude that a wide range of bacterial and fungal species may inhabit such ancient paintings, but biocompounds potentially represent a novel approach for preserving works of art at risk of biodegradation.


The authors add: "Clarification of biotederioration processes in artworks is important, as it could help in preventing or solving the associated damages. This study investigated such aspects in a 17th century painting, by analyzing both microbial communities and chemical composition of painting, also evaluating a possible biological way to counteract these phenomena."

See:

Elisabetta Caselli, Simonetta Pancaldi, Costanza Baldisserotto, Ferruccio Petrucci, Anna Impallaria, Lisa Volpe, Maria D’Accolti, Irene Soffritti, Maddalena Coccagna, Giovanni Sassu, Fabio Bevilacqua, Antonella Volta, Matteo Bisi, Luca Lanzoni, Sante Mazzacane. Characterization of biodegradation in a 17th century easel painting and potential for a biological approach. PLOS ONE, 2018; 13 (12): e0207630 DOI: 10.1371/journal.pone.0207630

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday, 19 January 2019

Flows that help bacteria feed and organize biofilms


Under threat of being scrubbed away with disinfectant, individual bacteria can improve their odds of survival by joining together to form colonies, called biofilms. What Arnold Mathijssen, postdoctoral fellow in bioengineering at Stanford University, wanted to understand was how stationary biofilms find food once they've devoured nearby nutrients.

Leading an international team of researchers in creating simulations of how fluids move, Mathijssen found that individual bacteria and biofilms can generate currents strong enough to draw distant nutrients.


When bacteria move, they disturb the liquids that surround them in the microscopic world. The researchers explored the strength of that disturbance in a single bacterium that moves in a way that is similar to many pathogenic species, including those that cause gastritis and cholera. They found that as this bacterium swims forward, it creates a tiny but stable current in the surrounding liquid with fluid moving toward its center and away from the head and tail.

Then, they calculated the flows produced by a colony of randomly arranged bacteria and were surprised to see that it created a strong, consistent tide capable of pulling in nutrients. This occurred regardless of the orientation of each bacterium so long as the colony was thicker in some areas than others, which causes fluid to move from high points to low points. Simulations of more orderly bacteria resulted in even stronger circulation.

Within organized biofilms, the researchers found two common patterns of movement: vortexes and asters. In a vortex pattern, the bacteria move in concentric circles and produce a flow that brings nutrients down to the biofilm's center and then pushes the fluid out the sides. In an aster pattern, the bacteria move toward a central point, creating a flow that moves from the edge of the biofilm until it rises back up, over the center.

"The powerful thing about this is you can add these patterns up," Mathijssen said. "Rather than having to know the position and orientation of every single bacterium, you only need to know the basic patterns that make up the colony and then it's very easy to derive the overall transport flow."

The researchers were able to combine vortex and aster patterns within a single biofilm to determine how the bacteria would push, pull and whirl the fluids around them. As a final test, the researchers took calculations representing the complex, realistic motion of bacteria swarming -- as they might on the surface of a table -- and predicted the strength of that swarm's transport flow. The result were large vortices that spanned distances beyond the boundaries of the biofilm, suitable for keeping the colony fed.

See:

Arnold J. T. M. Mathijssen, Francisca Guzmán-Lastra, Andreas Kaiser, Hartmut Löwen. Nutrient Transport Driven by Microbial Active Carpets. Physical Review Letters, 2018; 121 (24) DOI: 10.1103/PhysRevLett.121.248101

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 18 January 2019

Consultation on two major texts for the testing of parenteral drugs


The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2)

The pivotal dosage form monograph Parenteral preparations (0520) prescribes the mandatory requirements and tests for preparations intended for injection, infusion or implantation.

The monograph has been modernised to meet current testing requirements e.g. for (sub) visible particles, bacterial endotoxins, uniformity and release, particularly as applied to liquid parenteral preparations.

The monograph also refers to the newly elaborated informative non-mandatory chapter 5.17.2. Recommendations on testing of particulate contamination: visible particles. The requirements for the test method are laid down in chapter 2.9.20, which is also under revision, and a revised text is planned for publication in 2019 (a draft was published in Pharmeuropa 30.2).


The new text highlights the many sources of particulate contamination and states that every effort should be made to avoid their presence.

The two texts have been published for public consultation in Pharmeuropa 30.4 (October issue) and the commenting period ends on 31 December 2018.

See EDQM - https://www.edqm.eu/en/node/16561

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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