Season's Greetings!

Season's Greetings!

Thank you for supporting Pharmaceutical Microbiology over this past year. The website and the various groups continues to grow and feature a range of microbiology, pharmaceutical and healthcare related news stories.

All the best for the holiday season.



Dr. Tim Sandle

Draft EU GMP Annex 1 released

The PIC/S Secretariat has notified that the revised EU-PIC/S GMP Annex 1 on the Manufacture of Sterile Medicinal Products has reached Step 2 of the revision process and on 20 December 2017, the PIC/S and EMA published the draft revision of Annex 1 for public consultation.

The consultation period will last 3 months and run from 20 December 2017 to 20 March 2018.

The revised Annex 1 has been prepared in co-operation with the EMA, World Health Organization (WHO), and PIC/S in order to maintain global alignment of standards, and provide assurance of product quality. The document is subject to parallel public consultation by the European Commission (EC), WHO and PIC/S.

Key changes from the earlier PIC/S Annex are:

• Introduction of new sections: scope, utilities, environmental and process monitoring sections and glossary.
• Introduction of the principles of Quality Risk Management (QRM) to allow for the inclusion of new technologies and innovative processes.
• Restructuring to give more logical flow.
• Addition of detail to provide further clarity.

The revised Annex 1 is downloadable on the PIC/S website (site link) or via this direct link.

The draft has been formatted with prescribed line and page numbers to support a joint international consultation within TGA, PIC/S, WHO and the EC.



Posted by Dr. Tim Sandle

2017 Author of the Year – Journal of GXP Compliance

Tim Sandle has been awarded '2017 Author of the Year – Journal of GXP Compliance' by the Instiute of Validation Technology. This is for Dr. Sandle's contributions to the Journal of GXP Compliance, includig:

Biodecontamination of Cleanrooms and Laboratories Using Gassing Systems V21 #1

Matrix Approach for the Qualification of a Pharmaceutical Facility Autoclave V21 #4

Pharmaceutical Microbiology: Current and Future Challenges V21 #4

How the immune system identifies invading bacteria

The body's homeland security unit is more thorough than any airport checkpoint. For the first time, scientists have witnessed a mouse immune system protein frisking a snippet of an invading bacterium. The inspection is far more extensive than researchers imagined: the immune system protein, similar to those in humans, scans the bacterial protein in six different ways, ensuring correct identification.

See:

Jeannette L. Tenthorey et al. The structural basis of flagellin detection by NAIP5: A strategy to limit pathogen immune evasion. Science, 2017; DOI: 10.1126/science.aao1140

Posted by Dr. Tim Sandle

How to gown properly for cleanrooms

As shown below, three videos showing how to gown properly when entering cleanrooms.

Practical workshop on good cleanroom gowning from Simon Fiala – Key Account Manager, COMPREI Reinraum.

Posted by Dr. Tim Sandle

Strain Collection for Improved Expression of Outer Membrane Proteins

An article of interest in Frontiers in Cellular and Infection Microbiology. Here is the abstract:

Almost all integral membrane proteins found in the outer membranes of Gram-negative bacteria belong to the transmembrane β-barrel family. These proteins are not only important for nutrient uptake and homeostasis, but are also involved in such processes as adhesion, protein secretion, biofilm formation, and virulence. As surface exposed molecules, outer membrane β-barrel proteins are also potential drug and vaccine targets. High production levels of heterologously expressed proteins are desirable for biochemical and especially structural studies, but over-expression and subsequent purification of membrane proteins, including outer membrane proteins, can be challenging.

Here, we present a set of deletion mutants derived from E. coli BL21(DE3) designed for the over-expression of recombinant outer membrane proteins. These strains harbor deletions of four genes encoding abundant β-barrel proteins in the outer membrane (OmpA, OmpC, OmpF, and LamB), both single and in all combinations of double, triple, and quadruple knock-outs. The sequences encoding these outer membrane proteins were deleted completely, leaving only a minimal scar sequence, thus preventing the possibility of genetic reversion.

Expression tests in the quadruple mutant strain with four test proteins, including a small outer membrane β-barrel protein and variants thereof as well as two virulence-related autotransporters, showed significantly improved expression and better quality of the produced proteins over the parent strain.

Differences in growth behavior and aggregation in the presence of high salt were observed, but these phenomena did not negatively influence the expression in the quadruple mutant strain when handled as we recommend. The strains produced in this study can be used for outer membrane protein production and purification, but are also uniquely useful for labeling experiments for biophysical measurements in the native membrane environment.

For further details see: Frontiers

Posted by Dr. Tim Sandle

How Helicobacter pylori causes gastric cancer

Gastric cancer is one of the five most fatal types of cancer. According to the statistics of the World Health Organization (WHO), about 750,000 patients die each year after developing the disease. The main cause is thought to be the bacterium Helicobacter pylori (H. pylori). At present, there are no effective therapies for gastric cancer and growing spread of antibiotic resistances is further complicating treatment of the infection. Researchers at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) have now identified two mechanisms through which this bacterium can cause gastric cancer. Their findings could result in the development of new therapeutic approaches.

The international team of scientists headed by Dr. Nicole Tegtmeyer of the Chair of Microbiology at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) investigated how bacteria destroy the stomach's protective layer. This protective layer is composed of densely packed epithelial cells that protect the stomach against the effects of gastric acid. The researchers have now discovered that H. pylori secretes an enzyme, a protease called HtrA, which it uses much like a weapon to penetrate this protective layer. HtrA cleaves the three proteins occludin, claudin-8 and E-cadherin, rupturing the layer of epithelial cells. As a result, the H. pylori bacteria can access deeper, normally pathogen-free tissue layers, and inflict further damage. This is the first step towards gastric cancer starting to develop.

This first phase, however, is followed by one that is even more dangerous, as the team discovered. Needle-like protrusions, termed type IV secretion systems, are activated and function as 'molecular syringes'. Using a receptor-dependent mechanism, these inject a bacterial toxin, the CagA protein, through the basolateral membrane of the host cells. The injected CagA subsequently reprograms host cells, making them potentially cancerous. Another effect of this protein is that it prevents the human immune system from recognising and eliminating the bacteria -- a crucial mechanism for the long-term survival of H. pylori in the human stomach.

See:

Anne E. Robinson, Nathan E. Thomas, Emma A. Morrison, Bryan M. Balthazor, Katherine A. Henzler-Wildman. New free-exchange model of EmrE transport. Proceedings of the National Academy of Sciences, 2017; 201708671 DOI: 10.1073/pnas.1708671114

Posted by Dr. Tim Sandle

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.

See:

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

Pharmig News #69

A new edition of Pharmig News has been issued, edition 69. In this issue:

• Industry reflections by David Keen.
• Part 2 of Pharmig’s industry review of culture media practices.
• Review of MHRA deficiencies – trends and topics.
• Regulatory round-up
• New Pharmig courses
• And more…

For a copy or further details, contact Pharmig (info@pharmig.org.uk)

The articles by Tim Sandle in the new edition are:

Sandle, T. (2017) Industry practices relating to culture media use: The Pharmig survey (part 2), Pharmig News, Issue 69, pp2-5

Sandle, T. and Leavy, C. (2017) A focus on regulatory trends: MHRA annual deficiency review, Pharmig News, Issue 69, pp2-5

Posted by Dr. Tim Sandle

5 Keys To Aseptic Processing Improvement & Efficiency

Today, life science products should also be affordable to patients and a reasonable business proposition for manufactures. These objectives can present challenges to manufacturers as they strive to gain production and process efficiencies.

Hal Baseman has written an interesting article for Pharmaceutical Online. Here is an extract:

• Science- and risk-based approaches should be used to obtain information needed to make decisions related to the evaluation, design, qualification, operation, and monitoring of sterile product manufacturing processes.
• Technology should be considered to mitigate or reduce the risk to product quality identified in sterile product manufacturing processes and operations.
• Traditional testing and monitoring methods as control strategies should be challenged to ensure they are the best means for aseptic processes.
• New products, therapies, and technologies will present challenges to traditional and existing methods for development, manufacture, validation, and testing of sterile products.
• Global health authority technical and regulatory guidance and requirements should be harmonized with regard to technical language and definitions.

The article can be accessed here: Pharmaceutical Online

Posted by Dr. Tim Sandle

Data-Driven Risk Management For Quality By Design

The main hope of ICH Q8-Q10 pertaining to operational excellence is to enable (bio)pharmaceutical companies to achieve product realization. The goal is to do so by establishing and maintaining a state of control and facilitating continual improvement while responding to pressures for efficiency and profitability improvements.

Peiyi Ko, Ph.D. and Peter Calcott, Ph.D. have written an interesting article on the subject for Pharmaceutical Online. Here is an extract:

“risk management is open to individual interpretations and at times has varied and been time-consuming and not-informative for prioritization, re-inventing risk assessments and leading to wasted resources and unsatisfactory outcomes. Therefore, it is proposed to use a quantitative approach with probabilistic calculations and monetized harm to account for occurrence and severity, respectively. Specifically, failure modes and effects analysis (FMEA) is a classic tool for summarizing the modes of failure, factors causing these failures, and the likely effects of theses failures to reduce process complexity for management. It generates a risk priority score for a failure mode by multiplying the ratings for severity, occurrence, and detection.”

To access the article, see Pharmaceutical Online.

Posted by Dr. Tim Sandle

Hand surgeons provide update on wild animal bites

The article was prompted by the authors' experience in treating an elderly man who developed a progressive infection of the hand after being bitten on the finger by an opossum. The patient recovered after hospitalization including treatment with intravenous antibiotics.

Dr. Rao and colleagues performed a research review to identify studies of rare animal bites and stings. While many reports have discussed treatment of dog, cat, and snake bites, there has been no recent, comprehensive review focusing on the recommended treatment and potential adverse effects of less-common types of animal bites and injuries.

The review identified 71 articles, including a total of 214 patients, describing less frequently seen bite and sting injuries of the upper limb (hand and arm). Most of the studies were case reports and patient series

Aquatic animals were by far the most commonly reported type of injury, accounting for two-thirds of studies. Stings from jellyfish, lionfish and sea anemones, as well as other venomous aquatic animals, can not only cause severe pain and swelling but may sometimes lead to severe or even life-threatening complications.

Ten percent of studies reported bites by reptiles. Bites by some of these animals, such as beaded lizards, can cause envenomation leading to systemic shock.

Other reports described serious complications resulting from bites caused by small mammals and rodents such as ferrets, skunks, and squirrels. Other categories, including just a few cases each, included serious injuries caused by large mammals, scorpions and centipedes and birds.

The studies suggested that most infections resulting from animal bites are "polymicrobial," caused by several different bacteria or other germs. Infections with multiple, often unfamiliar microbes have the potential to cause tissue destruction and systemic (body-wide) reactions.

Based on the available evidence, Dr. Rao and colleagues outline quick reference principles for the treatment of wild animal bites and stings. These include specific recommendations for preventive antibiotics, providing coverage for unusual bacteria that may be present in infected wounds.

See:

Jacqueline S. Israel, James E. McCarthy, Katherine R. Rose, Venkat K. Rao. Watch Out for Wild Animals. Plastic and Reconstructive Surgery, 2017; 140 (5): 1008 DOI: 10.1097/PRS.0000000000003754

Posted by Dr. Tim Sandle

Bacteria Have a Sense of Touch

Bacteria may not have a central or sensory nervous system as we know it, but they can still physically "feel" the world around them, according to a new study.

By MICHELLE STARR

It turns out the tiny microorganisms don't just respond to chemical signals - they also have a sense of touch, and can recognise surfaces and respond to them. Our sense of touch is a very important tool for living in the world. It helps avoid hazards and dangerous surfaces, and keeps you from crushing delicate objects.

For bacteria, it helps them determine which type of surface they're in contact with - such as a mucous membrane or intestinal wall - and therefore colonise and attack host cells.

It's what happens in the first few seconds after coming into contact with a surface that's crucial for successful infection, the researchers say.

To explore the mechanism by which bacteria sense surfaces, they studied a harmless species called Caulobacter crescentus.

"We have little knowledge of how bacteria read out mechanical stimuli and how they change their behaviour in response to these cues," says senior researcher Urs Jenal of the University of Basel's Biozentrum.

"Using the non-pathogenic Caulobacter as a model, our group was able to show for the first time that bacteria have a 'sense of touch'. This mechanism helps them to recognise surfaces and to induce the production of the cell's own instant adhesive."

Some bacteria have an appendage called the flagellum - whip-like structures that propel them around. Some have just one flagellum, others have many. The juvenile C. crescentus has a single flagellum that it sheds after a set period, or after it finds a suitable surface to adhere to.

By rotating this flagellum, the bacteria can travel through liquids. But these microorganisms don't have muscles - movement is enabled by energy generated by the transfer of protons down the cell membrane.

And it's this mechanism that allows the bacteria to "feel", the researchers have found. When cells come into contact with surfaces, the motor that drives the flagellum is interrupted. This in turn interrupts the proton flow.

Within seconds of this occurring, the bacteria responds, producing the adhesinthat will anchor it in place.

This knowledge could help us understand dangerous bacteria too, says Jenal.

"Even though Caulobacter is a harmless environmental bacterium, our findings are highly relevant for the understanding of infectious diseases," he explains. "What we discovered in Caulobacter also applies to important human pathogens."

The research has been published in the journal Science.

Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers

Did you realize that 90 percent of quality control microbiology remains reliant upon culture-based methods? Taking this fact into account, Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers serves as an excellent reference because it focuses on microbiological culture media as applied to pharmaceutical microbiology.

In 23 informative chapters, this book covers how media is used in the modern pharmaceutical microbiology setting and recaps the past, signals the future, and helps interpret the present. The book has been written by Tim Sandle.

Pre-order this book through Dec. 15 and save 15%. Enter campaign code MBCM to apply discount during checkout.

This book also takes into consideration that innovations continue to arise with new media recipes that are formulated for the selection of new strains for the application of media in conjunction with rapid microbiological methods.

If you are a microbiologist working in the pharmaceutical and healthcare sectors, you can’t afford not to own this book!

Contents:

1. Application of Culture Media in Pharmaceutical and Healthcare Microbiology
2. History and Development of Microbiological Culture Media
3. The Science of Culture Media
4. Common Types of Microbiological Culture Media for Pharmaceutical Microbiology
5. The Media Kitchen and the Preparation of Microbiological Culture Media
6. Sterilization of Microbiological Culture Media
7. Quality Control of Culture Media
8. Microbial Cultures
9. The Use of Environmental Isolates in Pharmaceutical Microbiology
10. The Colony Forming Unit
11. Microbial Identification and Visual Assessment of Colonies
12. Qualification of Culture-Based Environmental Monitoring Methods
13. Incubation Strategies for Environmental Monitoring
14. Culture Media for Sterility Testing
15. Culture Media for Media Simulation Trials
16. Culture Media for Microbial Controls During Pharmaceutical Manufacture
17. Assessment of Culture Media for Water Testing
18. Culture Media for Cell Culture Work
19. Diluents and Neutralizers Required for the Pharmaceutical Microbiology Laboratory
20. Data Integrity, Computerized Systems and Microbiological Culture Media
21. Auditing Culture Media Suppliers
22. Industry Practices Relating Culture Media Use
23. Growth and Culture Based Rapid Microbiological Methods

For more details see the PDA Bookstore

Posted by Dr. Tim Sandle

Risk Based Approach to Environmental Monitoring (webinar)

Regulators frequently cite concerns with environmental monitoring and the lack of a well-thought out rationale. This shortfall can be overcome through the application of risk assessment and scientific approaches. The application of risk assessment applies to selecting location for monitoring and frequencies of monitoring; and for data assessment. This presentation outlines the primary tools that can be used to achieve this.

Instructor: Tim Sandle
Product ID: 504486

Date: Tuesday, 19 December 2017 | Time: 10:00 AM PST, 01:00 PM EST | Duration: 60 Minutes

• Understanding what environmental monitoring sets out to show, in relation to environmental control
• Appreciating the limitations of monitoring
• Understanding risk assessment tools like FMEA and HACCP and how they can be applied to environmental monitoring
• Worked examples of how to apply risk based approaches for setting monitoring frequencies
• Worked examples of how to apply risk based approaches for determining monitoring locations
• Understanding how risk assessment can assist with out-of-limits investigationsWhy Should you Attend
• To understand different approaches for environmental monitoring through the adoption of risk based methodologies. These tools can either be applied to the workplace or used to benchmark current practice against. The approaches discussed have been presented to FDA and European medicines inspectors.

Areas Covered

• An overview of environmental monitoring and a biocontamination control strategy
• Discussion of environmental monitoring methods
• Introduction to risk concepts, hazard identification and risk assessment
• Introduction to FMEA
• Introduction to HACCP
• Application of risk tools to elements of the environmental monitoring program, such as assessing contamination risks, setting monitoring frequencies, assessing monitoring locations
• How to determine if too little or too much monitoring is being undertaken

Who will Benefit

• Microbiologists (QA and QC)
• QC managers
• Production managers
• Quality Assurance personnel
• Cleanroom engineer

For details se: Online Compliance

The people factor: investigating the gown

An effective environmental monitoring programme is designed to estimate the microbial content of the room air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment. While individual results are rarely of significance, a well-designed environmental monitoring programme signals conditions contributing to rises in microbial levels. Shifts in microbial trends can be due to ineffective cleaning, disinfection, faulty air handling systems, material and equipment transfer, and the result of personnel related issues. With this latter point the majority of contaminants dispersed into cleanrooms derived from personnel.

Based on this, Tim Sandle has undertaken a review of cleanroom gowns, gown use and gown locations, in relation to microbial contamination. The detection of contamination on the gown either indicates a concern with the practices of an individual operator or a problem with the gown itself. The paper looks at several aspects of gown wearing through a review of data collated over a one year period. The data was studied for four considerations:

Locations most likely to indicate contamination.

Differences between re-laundered and single-use gowns.

Variations of gowns when re-laundered.

Variations in efficiency of gowns when worn over time.

The reference of the paper is:

Sandle, T. (2017) The people factor: investigating the gown, European Pharmaceutical Review, 22 (4): 23-26

For further details, please contact TimSandle

Posted by Dr. Tim Sandle

Technical Guide for Design, Control and Monitoring of Single-Use Systems

The Bio-Process Systems Alliance (BPSA) announced today that its new technical guide to Design, Control and Monitoring of Single-Use Systems for Integrity Assurance is now available for download at http://bpsalliance.org/technical-guides.

The uptake of single-use technologies (SUT) in more critical good manufacturing practices (cGMP) processes and applications has made assurance of integrity a critical quality attribute for both suppliers and end-users.

"I expect this to be one of the most significant documents written in the last five years to support our mission of driving the adoption of single-use technologies worldwide," said Kevin Ott, BPSA Executive Director.

The document provides recommendations to both suppliers and end-users in the single-use technology industry regarding strategies, tools and procedures that can assist in providing enhanced assurance of integrity of single-use systems. It can help end-users convey their specific requirements to the supplier. In turn, suppliers can use the document to demonstrate what they can provide to the end-user.

The technical guide divides best practices into two separate but complementary sections – a risk-based approach and practical tests for SUTs.

The document was written by a working group of end-users and suppliers who recognized the need to provide guidance in the absence of industry standards.

Cleanroom Management in Pharmaceuticals and Healthcare - special offer

Dear Reader,

Euromed Communications have recently brought out a new 2017 edition of the Cleanroom Management in Pharmaceuticals and Healthcare. Since the first edition of this book in 2013 there have been many changes to the approach and methods for cleaning and certifying cleanrooms, most notably the revisions to Parts 1 and 2 of the ISO 14644 series of global cleanroom standards. In addition to setting out the principal changes in these revised standards, many of the other chapters in the book have been updated to reflect their requirements, bringing current practices and Good Manufacturing Practice regulations up-to-date. The book is edited by Tim Sandle and Madhu Raju Saghee.

This book was reviewed in the May issue of Pharmig News and full details of the book can be found on the Euromed Communications website.

The publishers are offering a special discount to readers of this site and of the Pharmig, Sterility Assurance & Pharmaceutical Microbiology LinkedIn Groups at 20% off the cover price.

Thus the special offer costs for the new manual are as follows:

Hard back: £196 (~$260)

Paperback: £152 (~$200)

If you wish to take up this offer simply send an email to jill.monk@euromedcommunications.com mentioning the code ‘Pharmig20’ and you or your company will be invoiced accordingly.

Please note this offer ends on 10 December 2017.

Tim Sandle, on behalf of Euromed Communications

Examining the lifestyles of microbes

Scientists are identifying and characterizing more microbes each year using DNA sequencing technologies. As each new species is sequenced, scientists add it to the microbial "tree of life," creating a virtual census of what's there.

Turns out it's not an easy job. To put things in perspective, scientists aren't sure how many microbes even exist. Estimates vary widely from millions to trillions.

University of Delaware professor Jennifer Biddle and Rosa Leon-Zayas, who completed post-doctoral work at UD earlier this year, recently described new details about microbes known as Parcubacteria in a paper published in Environmental Microbiology.

The Parcubacteria were found in sediment samples collected by James Cameron within the Challenger Deep region of the Mariana Trench during the Deepsea Challenge Expedition. Leon-Zayas' doctoral advisor, Doug Bartlett at Scripps Institution of Oceanography, was a chief scientist on the expedition.

"From a scientific perspective, Challenger Deep was an invaluable opportunity to collect samples from the deepest part of the ocean," said Leon-Zayas, the paper's lead author, now an assistant professor at Willamette University.

Scientists traditionally have learned how microbes work by growing and studying them in petri dishes and beakers. It wasn't until DNA sequencing advanced to include the ability to separate and test microbes present in environmental samples (such as soils or sediments) that scientists realized they had missed a huge portion of bacteria now called the Candidate Phyla Radiation (CPR).

One group of CPR microbes called the Parcubacteria had been seen in the groundwater and shallow sediments of a few places on land, but it had only been intensively studied in sediment samples from an aquifer near Rifle, Col.

When Cameron collected sediment samples at the bottom of the trench, the scientists discovered that many different species of Parcubacteria live there, too.

"We were interested in seeing if the microbes living at the bottom of the ocean had the same lifestyle as the microbes living in soils in Rifle, Colorado," said Biddle, a marine microbiologist and associate professor in the College of Earth, Ocean, and Environment's School of Marine Science and Policy.

Leon-Zayas used a sorting technique to separate the microbial cells from the sediment particles so that scientists could amplify and sequence the microbe DNA. The researchers then characterized the individual microbial genomes. Based on the genes that are present in the genome -- sections of DNA that define what metabolisms a cell is capable of -- scientists can infer what the bacteria is doing.

This genomic sequencing revealed that Parcubacteria from the deep sea have a fairly simple metabolism; but the genomes were larger than that of their terrestrial cousins and even had a few extra features. In particular, these features indicated the bacteria may be able to perform anaerobic respiration, using things like nitrate to breathe instead of oxygen.

Parcubacteria also seemed to have more proteins and enzymes associated with cold environments, not surprising since the bottom of the Mariana Trench is cold and dark.

"It makes sense that organisms at the bottom of the ocean might have to be more self-sufficient. The environment is extreme and there isn't as much food," Biddle said.

See:

Rosa León-Zayas, Logan Peoples, Jennifer F. Biddle, Sheila Podell, Mark Novotny, James Cameron, Roger S. Lasken, Douglas H. Bartlett. The metabolic potential of the single cell genomes obtained from the Challenger Deep, Mariana Trench within the candidate superphylum Parcubacteria (OD1). Environmental Microbiology, 2017; 19 (7): 2769 DOI: 10.1111/1462-2920.13789



Posted by Dr. Tim Sandle

ISO/IEC 17025 moves to final stage of revision

Calibration as well as testing and analysing a sample is the daily practice of more than 60 000 laboratories worldwide, but how can they reassure customers about the reliability of their results?

Over the years, ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, has become the international reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver trusted results. The International Standard, published jointly by ISO and IEC (International Electrotechnical Commission), contains a set of requirements enabling laboratories to improve their ability to produce consistently valid results.

News from ISO:

However, the laboratory environment has changed dramatically since the standard was last published, leading to the decision to revise the standard and integrate significant changes. Steve Sidney, one of the Convenors of the working group revising the standard, explains: “The last version of ISO/IEC 17025 was published in 2005. Since then, market conditions have changed and we felt we could bring some improvements to the standard.”

Heribert Schorn, working group Convenor who also participates in IECEE (System of Conformity Assessment Schemes for Electrotechnical Equipment and Components), adds: “The revision was needed to cover all the technical changes, technical developments and developments in IT techniques that the industry has seen since the last version. Additionally, the standard takes into consideration the new version of ISO 9001.”

This standard is of high significance for the IEC Conformity Assessment Community as it outlines the basic requirements for testing within all Conformity Assessment Schemes and Programmes operating within the IECEE, IECEx, IECQ and IECRE Conformity Assessment Systems.

The review was started in February 2015 as a result of a joint proposal by the International Laboratory Accreditation Cooperation (ILAC) and the South African Bureau of Standards (SABS), who is a member of ISO and hosts the IEC National Committee. The standard’s revision process has now reached the Final Draft International Standard (FDIS) stage, the last leg of development before publication.

The main changes:

The revision of ISO/IEC 17025 takes into account the activities and new ways of working of laboratories today. The main changes are as follow:

The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies). The revised standard puts the emphasis on the results of a process instead of the detailed description of its tasks and steps.

With a stronger focus on information technologies, the standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic results and reports. Modern-day laboratories work increasingly with information and communication technologies and the working group felt it was necessary to develop a chapter on this topic.

The new version of the standard includes a chapter on risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality management systems – Requirements.

The terminology has been updated to be more in step with today’s world and the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions. Examples include changes to the International Vocabulary of Metrology (VIM)and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.

A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment.

The scope has been revised to cover all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing.

Using ISO/IEC 17025 facilitates cooperation between laboratories and other bodies. It assists in the exchange of information and experience and helps harmonize standards and procedures, as Warren Merkel, another Convenor of the working group, explains. “ISO/IEC 17025 impacts the results delivered by laboratories in a number of ways. The standard requires them to meet criteria for competence of their personnel, the calibration and maintenance of their equipment and the overall processes they use to generate the data. This requires laboratories to think and operate in a way that ensures their processes are under control and their data are reliable.” Results also gain wider acceptance between countries when laboratories conform to the standard.

Developed jointly by ISO and IEC in the Committee on conformity assessment (CASCO), the new version of ISO/IEC 17025 will replace the 2005 version and is scheduled for publication at the end of this year.

Posted by Dr. Tim Sandle