Friday, 8 November 2013

New Microbe Found in Spacecraft Cleanrooms

A rare, recently discovered microbe that survives on very little to eat has been found in two places on Earth: spacecraft cleanrooms in Florida and South America.

Tersicoccus phoenicis is an aerobic, non-motile, Gram-reaction-positive cocci and is associated with two strains: 1P05MAT and KO_PS43. The bacteria is berry-shaped and found in spacecraft assembly clean room facilities: Tersi is from the Latin for clean, Coccus is from the Greek for berry and Phoenicis is derived from NASA's Phoenix Mars Lander, the spacecraft being prepared in 2007 when the bacterium was first discovered in the Florida clean room.

Microbiologists often do thorough surveys of bacteria and other microbes in spacecraft cleanrooms. Fewer microbes live there than in almost any other environment on Earth, but the surveys are important for knowing what might hitch a ride into space. If extraterrestrial life is ever found, it would be readily checked against the census of a few hundred types of microbes detected in spacecraft cleanrooms.

The work to keep cleanrooms extremely clean knocks total microbe numbers way down. It also can select for microbes that withstand stresses such as drying, chemical cleaning, ultraviolet treatments, and lack of nutrients. Perversely, microbes that withstand these stressors often also show elevated resistance to spacecraft sterilization methodologies such as heating and peroxide treatment.

"We want to have a better understanding of these bugs, because the capabilities that adapt them for surviving in cleanrooms might also let them survive on a spacecraft," says microbiologist Parag Vaishampayan of NASA's Jet Propulsion Laboratory, Pasadena, Calif., lead author of the 2013 paper about the microbe. "This particular bug survives with almost no nutrients."

This population of berry-shaped bacteria is so different from any other known bacteria, it has been classified as not only a new species, but also a new genus, the next level of classifying the diversity of life. Its discoverers named it Tersicoccus phoenicis. Tersi is from Latin for clean, like the room. Coccus, from Greek for berry, describes the bacterium's shape. The phoenicis part is for NASA's Phoenix Mars Lander, the spacecraft being prepared for launch in 2007 when the bacterium was first collected by test-swabbing the floor in the Florida cleanroom.

Some other microbes have been discovered in a spacecraft cleanroom and found nowhere else, but none previously had been found in two different cleanrooms and nowhere else. Home grounds of the new one are about 2,500 miles apart, in a NASA facility at Kennedy Space Center and a European Space Agency facility in Kourou, French Guiana.

A bacterial DNA database shared by microbiologists worldwide led Vaishampayan to find the match. The South American detection had been listed on the database by a former JPL colleague, Christine Moissl-Eichinger, now with the University of Regensburg in Germany. She is first co-author of the paper published this year in the International Journal of Systematic and Evolutionary Microbiology identifying the new genus.

The same global database showed no other location where this strain of bacteria has been detected. That did not surprise Vaishampayan. He says, "We find a lot of bugs in cleanrooms because we are looking so hard to find them there. The same bug might be in the soil outside the cleanroom but we wouldn't necessarily identify it there because it would be hidden by the overwhelming numbers of other bugs."

A teaspoon of typical soil would have thousands more types of microbes and billions more total microbes than an entire cleanroom. More than 99% of bacterial strains, as identified from DNA sequences, have never been cultivated in laboratories, a necessary step for the various types of characterization required to identify a strain as a new species.

Microbes that are tolerant of harsh conditions become more evident in cleanroom environments that remove the rest of the crowd.

"Tersicoccus phoenicis might be found in some natural environment with extremely low nutrient levels, such as a cave or desert," Vaishampayan speculates. This is the case for another species of bacterium (Paenibacillus phoenicis) identified by JPL researchers and currently found in only two places on Earth: a spacecraft cleanroom in Florida and a bore hole more than 1.3 miles deep at a Colorado molybdenum mine.
Ongoing research with Tersicoccus phoenicis is aimed at understanding possible ways to control it in spacecraft cleanrooms and fully sequencing its DNA. Students from California State University, Los Angeles, have participated in the research to characterize the newly discovered species.

Posted by NASA

Thursday, 7 November 2013

Understanding the microbiome

The new understanding of the role of microbial communities in human health, and the growing community of researchers studying the microbiome -- the totality of microbes and their genomes in a given environment -- could soon begin to emerge in the large longitudinal studies. The studies gather critical information about human health and well-being and how it changes over time.

Scientists have recognized that each individual human may be host to a unique composition of microbes, with as many as 1,000 species present in niches ranging from the gut to the belly button. An individual's microbiome, in fact, may be a more exact identifier for individuals than a fingerprint.

As part of this emerging theme, a recent workshop sponsored by the Center for the Demography and Health and Aging and the Center for Demography and Ecology, sought to bring UW-Madison biologists and social scientists together to explore the microbial dimensions of human health.

For more details, see the  University ofWisconsin-Madison.

Posted by Tim Sandle

Wednesday, 6 November 2013

New chemicals show promising bacterial kill


A new bacterial-killing chemical has been announced. The new antibacterial agent is called a PPMO and it appears to function as well or better than many existing antibacterial chemicals.
PPMO is an acronym for a peptide-conjugated phosphorodiamidate morpholino oligomer. The chemical is a synthetic analog of DNA or RNA that has the ability to silence the expression of specific genes within bacterial cells. PPMOs are completely synthesized in the laboratory.
In animal studies, one form of PPMO showed significant control of two strains of the bacteria Acinetobacter. This is a group of bacteria of global concern. Acinetobacter are widely distributed in nature, and commonly occur in soil. They can survive on moist and dry surfaces, including in a hospital environment. Some strains have been isolated from foodstuffs. In drinking water. In immunocompromised individuals, several Acinetobacter can cause life-threatening infections. Such species also exhibit a relatively broad degree of antibiotic resistance.
The success of the new agent is because it offers a fundamentally different means of attack on bacterial infection. PPMOs specifically target the underlying genes of a bacterium.
It is important to note that PPMOs have not yet been tested in humans, and that further development work is required.
The research into the new chemicals was undertaken at Oregon State University. The findings have been published in the Journal of Infectious Diseases, in a paper headed “Gene-Silencing Antisense Oligomers Inhibit Acinetobacter Growth In Vitro and In Vivo.”

Posted by Tim Sandle

Tuesday, 5 November 2013

New device to detect food pathogens

A system that concentrates foodborne salmonella and other pathogens faster than conventional methods has been developed. The device uses hollow thread-like fibers that filter out the cells, leading to faster detection.
The device is called a continuous cell concentration device. The device, if modeled commercially, will allow food or water samples to be analyzed in order to screen for pathogens. Foodborne pathogens can seriously affect anyone, but for pregnant women and their babies, certain pathogens can be particularly harmful, even fatal. An example are the bacteria Salmonella.
The device is said to be fast enough to produce a result within a single work shift at food processing plants. At present, many samples do not produce results for several days, meaning that many food processes continue ‘at risk’.
The first step in detecting foodborne pathogens is concentrating the number of cells in test samples. The new system enables researchers to carry out the concentration step within one hour.
In test runs, the machine was used to concentrate cells in a sample of chicken meat. The sample is first broken down into the consistency of a milkshake and chemically pre-treated to prevent the filtering membranes from clogging. The fluid is then passed through 12 hollow-fiber filters about 300 microns in diameter that are contained in a tube about the size of a cocktail straw. The filtering process continues until pathogens if present are concentrated enough to be detected.
The device was invented by scientists at Purdue University, led by Professor Michael Ladisch. The findings have been published in the journal Applied and Environmental Microbiology. The paper it titled “Rapid Sample Processing for Foodborne Pathogen Detection via Crossflow Microfiltration.”

Posted by Tim Sandle

Monday, 4 November 2013

Optimal recovery of bioburden from pharmaceutical products

Bioburden testing is an important part of pharmaceutical microbiology and provides data in relation to the quality of pharmaceutical products during manufacture. Little guidance is provided in relation to test methodology, culture media and incubation parameters. The quality control laboratory, therefore, needs to establish the most appropriate method.

With this in mind, Tim Sandle and colleagues have written a paper which outlines a case study for the selection of incubation parameters for the bioburden assessment of in-process samples using the Total Viable Count technique and pour plate method.

While the outcome of the experiment contained within the paper relates to a specific set of processes, the approach taken can be used by other laboratories to compare or to develop their test methods and techniques for bioburden determinations.

The reference is:

Sandle, T., Skinner, K. and Yeandle, E. (2013). Optimal conditions for the recovery of bioburden from pharmaceutical processes: a case study, European Journal of Parenteral and Pharmaceutical Sciences, 18 (3): 84-91

For those interested in reading the paper, please contact TimSandle.

Posted by Tim Sandle

Sunday, 3 November 2013

Pharmaceutical Regulatory Harmonisation

Tim Sandle interviewed as part of the article "The Slow Progression Of Pharma Regulatory Harmonization", written by Clifford Mintz and published by the Life Science Leader at LSL.

Posted by Tim Sandle

Saturday, 2 November 2013

Improving the safety of medical devices


The European Commission has adopted two measures for implementation to improve the safety of medical devices.

The new rules are a Commission Implementation Regulation clarifying the criteria to be met by notified bodies, which are responsible for inspecting manufacturers of medical devices, and a Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector.

For further details, see the following press release.

Posted by Tim Sandle

Friday, 1 November 2013

EU GMP Chapter 2 – personnel

The European Commission has published the final version of the revised EU GMP chapter. With the new chapter changes have been made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. A section has also been added on consultants.

The deadline for coming into operation: 16 February 2014.

For details see: EUGMP

Posted by Tim Sandle

Thursday, 31 October 2013

Micropod - microbiology podcast


The Society for Applied Microbiology provide benefits and resources online to raise awareness and knowledge of a diverse range of applied microbiology issues such as climate change and biofuels, food poisoning outbreaks and hospital acquired infection. The Micropod podcast, is an interesting podcast featuring interesting people. Some are microbiologists, some aren't scientists, but they all have one thing in common: everything they talk to us about is relevant to the lives of microbiologists across the globe.

Foe details see: Micropod.

Posted by Tim Sandle

Pharmaceutical Microbiology Glossary (new edition)


A new edition of the Pharmaceutical Microbiology Glossary is now available: expanded and revised.

This hand reference guide clearly explains the key terms relating to pharmaceutical microbiology as applied to pharmaceuticals, healthcare, medical microbiology, cleanrooms and contamination control.

The glossary has been written by Dr. Tim Sandle, an experienced pharmaceutical microbiologist. The book is ideal for students and as a reference guide for experienced practitioners.

The book is structured as a handy A-Z of pharmaceutical microbiology terms and definitions.

The glossary is available as a paperback or as an e-book, via Amazon. The links are:

Amazon U.S. / worldwide:

Paperback
E-book



Amazon U.K.:

Paperback
E-book

Amazon India:

E-book

Amazon Canada:

E-book

Amazon Austria:

Paperback
E-book

Amazon Germany:

Paperback
E-book

Amazon France:

Paperback
E-book

Amazon Spain:

Paperback
E-book

Amazon Italy:

Paperback
E-book

Posted by Tim Sandle

Practical tips on mitigating risk of your pathogens – Complimentary articles available


Dear Reader,

I thought you would be interested to read the top 3 articles that Heads of QA/QC, Process Development, Microbiologists and Viral Specialists are reading on the Pathogen Safety Summit Resource Centre.

   * WHITEPAPER: Pathogen Safety Today 2013 – Your one page round up articles and interviews surrounding viral security and strategy
   * INTERVIEW: What Would You Do in the Event of Contamination? - Lada Laenen, Managing Principal Scientist, Head, Cell Culture and Microbiology, Genzyme
   * 2012 PRESENTATION: U.S. FDA’s Regulatory Perspective on Viral Safety for Vaccines – Arifa Khan, Senior Investigator, FDA/CBER

  >> Download your copy at http://bit.ly/PSSinterview
  >> Or email enquire@iqpc.co.uk for your copy of all 3 pieces

This interview was created in collaboration with Pharma IQ’s upcoming Pathogen Safety Summit, taking place in Munich, 18 – 20 November 2013 – Have a look at the event agenda here: http://bit.ly/PSSAgenda.

A 15% discount is available for members of this group – To get more information on this or to request a copy of the interview please get in touch with John Shah on the details below:

John Shah
Summit Director
Phone: +44 (0) 207 036 1305
Email:
enquire@iqpc.co.uk

I hope you find the interview valuable, please feel free to share it with your colleagues.

Kind regards,

Tim Sandle
Group Manager: Pharmaceutical Microbiology


Wednesday, 30 October 2013

Control of hospital water systems


Several factors are involved in the contamination of hospital water systems and there are a variety of good practices that should be considered for maintaining control. Invariably various contamination events are featured in news reports, and at times these have both clinical and economic significance.

To explore some of the origins of contamination and to consider some of the ‘good practices’ that can be adopted to reduce contamination incidences, Tim Sandle has written a discussion article for The Clinical Services Journal.

The article covers such areas as: staff practices, good system design, sanitisation methods, equipment segregation, control of tubing, point-of-use issues and the primary types of contaminants.

The reference for the article is:

Sandle, T. (2013). Avoiding Contamination of Water Systems, The Clinical Services Journal, 12 (9):  33-36

For a copy of the article, please contact TimSandle.

Posted by Tim Sandle

Tuesday, 29 October 2013

Textiles, cleanrooms and contamination control

ISO/TC 38 Textiles has introduced four new projects to develop test method standards for evaluating the electrostatic properties of textiles. Part of the justification for these projects is that there are currently no standards for evaluating textiles for contamination control purposes.

ISO/TC 38 has formed a Joint Working Group (JWG 26) with IEC/TC 101 to develop these standards.

Posted by Tim Sandle

Monday, 28 October 2013

USP issues mobile app

In keeping with the trend towards more online content, the USP Standard is now available as an online app as a new interactive format for the online newsletter.

The USP Standard can be downloaded on various mobile devices. The app can be downloaded to a mobile device through the Apple Store, Google Play or Amazon.

See the following links:

Apple (for iTunes).


Amazon

Posted by Tim Sandle

Polio

The Society for General Microbiology has an interesting profile on polio.

Polio is a serious viral infection that can cause paralysis. It has been eliminated in the majority of the world due to effective vaccination, while on-going vaccination campaigns are driving it towards extinction in the tiny handful of countries where it still persists, notably Afghanistan, Nigeria, and Pakistan. The polio vaccines, originally developed in the late 1950s and early 1960s, represent one of the great success stories in microbiology. The fact that these vaccines eliminated the disease in Britain and other countries demonstrates the public health benefit of concerted vaccine research.

To read the full piece, go to SGM.

Posted by Tim Sandle

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