Wednesday, 16 April 2014

Radiation resistant E. coli

Scientists have coaxed the model bacterium Escherichia coli to resist ionizing radiation and, in the process, reveal the genetic mechanisms that make the feat possible. The study provides evidence that just a handful of genetic mutations give E. coli the capacity to withstand doses of radiation.

The findings are important because they have implications for better understanding how organisms can resist radiation damage to cells and repair damaged DNA.

For further details, refer to the following paper:

R. T. Byrne, A. J. Klingele, E. L. Cabot, W. S. Schackwitz, J. A. Martin, J. Martin, Z. Wang, E. A. Wood, C. Pennacchio, L. A. Pennacchio, N. T. Perna, J. R. Battista, M. M. Cox. Evolution of extreme resistance to ionizing radiation via genetic adaptation of DNA repair. eLife, 2014; 3 (0): e01322 DOI: 10.7554/eLife.01322

Posted by Tim Sandle

Tuesday, 15 April 2014

International Biomedical Laboratory Science Day

Today is International Biomedical Laboratory Science Day.

International Federation of Biomedical Laboratory Science (formerly known as IAMLT) established BLS Day in 1996 at the World Congress in Oslo, Norway to promote and celebrate the key role of Biomedical Laboratory personnel in diagnostic and preventive health care systems.

The purpose with the BLS Day is to increase the awareness of the role that Biomedical Laboratory Scientists have in providing health care. BLS' play an important role in diagnosis, quality development and assurance, treatment, research, development, and public health care.

International BLS Day gives our profession a day to promote and celebrate ourselves as a profession.

The theme is selected by the International Body (IFBLS) related with health issues and support the WHO Millennium Development Goals.

BLS Day is the day for Laboratory personnel to promote awareness of our profession and the key role played by Biomedical Laboratory Scientists in the diagnosis and treatment of patients and research in the modern medical sciences.

For more details, see IFBLS.

Posted by Tim Sandle

Laboratory disinfectants: an introduction


The use of disinfectants in microbiology laboratories plays an important part in keeping areas under control and reducing levels of contamination. Tim Sandle has written an article for Lab World Magazine in which the best criteria for disinfectants are outlined.

The abstract reads:

“The quality control in microbiology investigations largely depends on control of source of contamination. The cleaning process, the cleaning, detergent and disinfection agents used in laboratories has been found to be major contributors of contamination. The article focuses on key concepts for selection and use of cleaning, detergent, disinfectants, sanitiser and antiseptic materials.”

For details, see Lab World Magazine

The reference is:

Sandle, T. (2014) Selection of Laboratory Disinfectants, Lab World Magazine, 3 (2): 17-22

For a copy of the article, please contact Tim Sandle

Posted by Tim Sandle

Monday, 14 April 2014

New Process Validation Guideline (EMA)

The European Medicines Agency has published the following concept paper ‘Guideline on process validation for finished products -information and data to be provided in regulatory submissions’.

Process validation can be defined as documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. Continuous process verification has been introduced to cover an alternative approach to process validation based on a continuous monitoring of manufacturing performance. These concepts form the basis of the new guideline.

The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged. This guideline does not introduce new requirements on medicinal products already authorised and on the market, but clarifies how companies can take advantage of the new possibilities given when applying enhanced process understanding coupled with risk management tools under an efficient quality system as described by ICH Q8, Q9 and Q10.

The EMA paper can be accessed here.

Posted by Tim Sandle

Sunday, 13 April 2014

Tips for Maximising Microscope Usage

Keyence have produced some interesting graphics relating to the use and care of microscopes.

The aim is to explore:
  • Concerns regarding the feasibility of effectively using the microscope once introduced
  • Concerns regarding the possible effect demonstrated by a digital microscope
  • The desire to improve the efficiency of analysis operations
  • The desire to capture clear, magnified images as targeted

For more details see: Keyence

Posted by Tim Sandle

Saturday, 12 April 2014

Cleanroom HVAC innovation


Heating, ventilation and air conditioning (HVAC) specialist, E-CO, has launched a product that could help cleanrooms and medical laboratories free of bacteria, viruses and other pathogens.

The stand-alone disinfectant product can be installed and fitted flush to the ceilings of individual rooms. It shines ultraviolet (UV) light on surfaces, sterilising them and reducing the spread of pathogens, such as MRSA and Clostridium difficile. E-CO says the UV light penetrates the cell walls of micro-organisms, damaging the DNA and preventing their ability to replicate.

The unit is automatically activated and cleanrooms and labs are equipped with motion and contact detectors to ensure doors are closed and rooms unoccupied when the UVC lights are operating. The units can also disinfect cleanrooms and labs overnight.

UVC technology has long been proven to kill bacteria, viruses and fungal pathogens. Hillary Spicer, Founder and Director of E-CO, said: “UVC technology has long been proven to kill bacteria, viruses and fungal pathogens and is effectively used in many US healthcare environments. We are delighted to be able to offer our UK customers this product. It is cost effective and simple to install but keeps surfaces free of contaminants. I’d like to see disinfectant technology like this used in every in cleanroom.”

Source: Cleanroom Tech

Posted by Tim Sandle

Friday, 11 April 2014

Regulation concerning the making available on the market and use of biocidal products


The EU directive covering the safe use of biocides and disinfectants was updated late year. The reference is: ‘Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance’.

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms

Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials. However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns.

The objective of the new Regulation is to improve the functioning of the internal market in biocidal products whilst ensuring a high level of environmental and human health protection. The new Regulation will also remedy a number of weaknesses that were identified during the 11 years of implementation of the current Directive 98/8/EC.

The purpose of this Regulation is to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. Particular attention should be paid to the protection of vulnerable groups, such as pregnant women and children.

The new text simplifies and streamlines the requirements for approving active substances and authorizing products. The new provisions will also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A dedicated IT platform (the Register for Biocidal Products) will be used for submitting applications as well as recording decisions and disseminating information to the public. The new Regulation is also the first piece of legislation to build in the new Commission definition on nanomaterials.

For further details see: EU directive

Posted by Tim Sandle

Thursday, 10 April 2014

FDA guidance: chemistry, manufacturing, and controls (CMC)

FDA released guidance providing recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. The guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality. FDA, therefore, states that applicants should document these changes in an annual report.

A list of examples of CMC postapproval manufacturing changes previously submitted under manufacturing supplements is provided that FDA has determined to be of low risk to product quality. The guidance also provides examples of minor changes to be documented in an annual report that were previously published in FDA’s Scale-up and Postapproval Changes (SUPAC) guidance documents and other postapproval change CMC guidance documents.

See: FDA

Posted by Tim Sandle

Wednesday, 9 April 2014

Ancient Giant Virus Discovered

A new species of giant virus discovered in the Siberian permafrost, where it’s been buried for 30,000 years, is reincarnated in the lab.

In PNAS of a new species of virus has been found by researchers at Aix-Marseille University in France discovered buried in the permafrost of Siberia.

The new virus, dubbed Pithovirus sibericum, measures 1.5 μm in length and 0.5 μm in diameter—even bigger than former record holders, the pandoraviruses, which are only 1 μm long and 0.5 μm in diameter. P. sibericum was identified as part of a survey of the virome of Siberian permafrost, isolated from a sample that’s more than 30,000 years old, according to the researchers. Nevertheless, when given access to an amoeba host in the lab, P. sibericum infected the cell, raising concerns about the possible risk such giant viruses might pose if they are released from the thawing Arctic ground.

The discovery also calls into question the veracity of some viral eradications, including smallpox and the livestock disease rinderpest.

Posted by Tim Sandle

Tuesday, 8 April 2014

Data Review and Analysis for Pharmaceutical Microbiology


'Data Review and Analysis for Pharmaceutical Microbiology' is a new book by Tim Sandle.

This book offers a guide, drawing upon 'real world' examples, for the review and assessment of microbiological data. The book includes examples drawn from water monitoring, bioburden assessment, and environmental monitoring. The book serves as a guide for quality control microbiologists, quality assurance personnel, students, and those with an interest in data, graphs and statistics in general.

The book is available from Amazon in either a print format or as an electronic version.

Amazon U.S. Paperback / E-copy

Amazon U.K. Paperback / E-copy

Amazon Austria Paperback / E-copy

Amazon Canada Paperback / E-copy

Amazon France Paperback / E-copy

Amazon Germany Paperback / E-copy

Amazon Italy Paperback / E-copy

Amazon Japan Paperback / E-copy

Amazon Spain Paperback / E-copy

Amazon India Paperback / E-copy

Amazon worldwide. Paperback / E-copy

Posted by Tim Sandle

Monday, 7 April 2014

2nd update to European Pharmacopeia 8th edition (8.2)


Supplement 8.2 to the Ph. Eur. has been issued.

Implementation date 1st July 2014

The main changes are:

2.2.32  Loss on drying            
                                                           
The user’s attention is drawn to the possibility of using a suitable certified reference material for instrument performance verification.

2.5.12  Water: semi-micro determination       
                                               
The user’s attention is drawn to the possibility of using a suitable certified reference material for instrument performance verification.

2.6.21  Nucleic acid amplification techniques
                                   
The chapter has been updated to take account of closed systems for nucleic acid amplification. Additional minor editorial changes have been made throughout the text, including updating the ICH guideline reference, removing an incorrect WHO HCV reference and removing the detail on operator qualification, which is part of GMP.

2.7.4    Assay of human coagulation factor VIII
                                               
Chapter revised to cover quantification of factor VIII activity in plasma preparations and in therapeutic concentrates, to refer to the International Standard for coagulation factor VIII in plasma and to add coagulation factors V, VIII, XI and XIII plasma BRP.

2.7.22  Assay of human coagulation factor XI
                                               
Chapter revised to include coagulation factors V, VIII, XI and XIII plasma BRP and to refer to the International Standard for coagulation factor XI in plasma.

Alanine (0752)
                                                                                               
Identification: sample preparation for IR deleted in accordance with current policy.
Ninhydrin-positive substances: TLC replaced by chromatography using an amino acids analyser that also allows quantification of ammonium; TLC kept for identification.
Assay: end-point determination by colour indicator replaced by potentiometry.
Impurities: section added.
Arginine hydrochloride (0805)
                                                           
Definition: scope of monograph added.

Identification: sample preparation for IR deleted in accordance with current policy. Ninhydrin-positive substances: TLC replaced by chromatography using an amino acids analyser that also allows quantification of ammonium; TLC kept for identification.

Assay: end-point determination by colour indicator replaced by potentiometry.

Impurities: section added.

Posted by Tim Sandle

Sunday, 6 April 2014

Data Review and Analysis for Pharmaceutical Microbiology



This book offers a guide, drawing upon 'real world' examples, for the review and assessment of microbiological data. The book includes examples drawn from water monitoring, bioburden assessment, and environmental monitoring. The book serves as a guide for quality control microbiologists, quality assurance personnel, students, and those with an interest in data, graphs and statistics in general.

The book is available as a paperback and as a handy e-book from Amazon.


The book is available from:

Amazon U.S. (paperback and e-book)

Amazon U.K. (paperback and e-book)

Amazon Canada (paperback and e-book)

Amazon India (paperback and e-book)

Amazon Germany (paperback and e-book)

Amazon France (paperback and e-book)

Amazon Austria (paperback and e-book)

Amazon Italy (paperback and e-book)

Amazon Japan (paperback and e-book)

Amazon Spain (paperback and e-book)

Amazon worldwide (paperback and e-book)

Posted by Tim Sandle

Did microbes trigger mass species extinction?


Some scientists think that 252 million years ago an estimated 96 percent of all species were wiped from Earth. One research group suspect that this was due to methane-belching bacteria.
The new thesis is that microorganisms of the family Methanosarcina evolved to become faster at making methane. This was through the acquisition of a gene from another microbe and then reproducing quickly.
Fueled by nickel spewing from Siberian volcanoes, the extra methane produced by the microorganisms would have made the oceans acidic and added sulfur compounds to the air, driving the extinction of many species at sea and on land.
The scientists' case builds upon three areas. First, geochemical evidence suggests a rapid increase of carbon dioxide in the oceans at the time of the so-called end-Permian extinction. Second, genetic evidence shows a change in Methanosarcina at that time, allowing the microorganism become a major producer of methane from an accumulation of carbon dioxide in the water. Finally, sediments show a sudden increase in the amount of nickel deposited at exactly this time. Much of the theory rests on the carbon isotope analysis.

Commenting further, scientist Dr Gregory Fournier from the Massachusetts Institute of Technology (MIT) told The Guardian: "A rapid initial injection of carbon dioxide from a volcano would be followed by a gradual decrease. Instead, we see the opposite: a rapid, continuing increase. That suggests a microbial expansion. The growth of microbial populations is among the few phenomena capable of increasing carbon production exponentially, or even faster."
The new theory has been reported to the journal Proceedings of the National Academy of Sciences. The paper is titled “Methanogenic burst in the end-Permian carbon cycle”.

Saturday, 5 April 2014

London skeletons reveal the 'Black Death'

Twenty-five skeletons uncovered in London last year appear to have been part of a larger burial ground for plague victims, according to laboratory tests.
DNA sequenced from teeth pulled from the remains of the skeletons confirmed the presence of Yersinia pestis, this is the bacteria that causes both bubonic and pneumonic forms of plague. The skeletons were found when tunnels were being dug for London’s new Crossrail train line. Before the discovery, it was unclear where the city’s plague victims had been buried.
Commenting on the finding, Jay Carver, Crossrail’s lead archaeologist said: "This discovery is a hugely important step forward in documenting and understanding Europe’s most devastating pandemic."

The Black Death peaked in Europe between 1348 and 1350, wiping out about 60 percent of London’s population. The Black Death was a pneumonic version of the disease—an airborne infection of the lungs, spread via coughing and sneezing—instead of bubonic—an infection that enters through the skin, infects the lymph system and is spread by rat fleas, according to a science paper by Digital Journalist Tim Sandle.
The London discovery follows on from a Digital Journal report from earlier this year. Here it was reported that dozens of skeletons had been found close to the Uffizi Gallery in Florence, and, according to archaeologists the medieval mass grave may stretch underneath the renowned museum.

Posted by Tim Sandle

Friday, 4 April 2014

What are modular cleanrooms?

Modular cleanroom construction offers an alternative to conventional construction for spaces that require flexibility in terms of future needs, a restricted build timeline, or the need to keep using the current facility, according to by MaryBeth DiDonna. 

Pre-engineering modular cleanrooms allow for the development of components that collaborate with each other but still work for a range of applications. Pre-engineering systems and components can cut down on design time and can incorporate standard, mass produced parts, such as wall systems as well as window/door/ceiling options.

The prefabricated design allows a modular room to be expanded, relocated, separated into several smaller rooms, or rearranged into a different shape. Modular cleanrooms, since they aren’t an integral part of a larger structure, can even be dissembled and moved to a different facility, unlike fixed wall cleanrooms. The rooms can also be expanded by removing a wall and adding on another module.

For further details and to read a detailed article, see Controlled Environments