Sunday 31 January 2016

World Leprosy Day

Many of us might have lost the thought of the word ‘Leprosy’, thinking the disease eradicated long back. Unfortunately, suffering still remains. For over more than 60 years, last Sunday of January is observed as World Leprosy day across the world to increase public awareness of the disease.

French writer & humanitarian, Raoul Follereau, initiated this great thought with a vision to spread global awareness about the disease & ways to prevent & cure it.

It may also interest you to know that this day coincides with the assassination day of Indian freedom fighter, Mahatma Gandhi. He once said, “Eliminating leprosy is the only work I have not been able to complete in my lifetime.”

Leprosy is a disease caused by a bacillus, M. Leprae (Mycobacterium leprae, a relative of tuberculosis germ). It is chronic, affecting the skin & nerves – especially those going to the legs, arms & face.
Health Records
Leprosy is curable still we have millions suffering from this diseases. If detected early, disabilities can be prevented. It is curable with multi-drug therapy (MDT) which was developed in the early 1980s. MDT consists of 3 drugs: rifampicin, clofazimine & dapsone. Treatment takes from 6 months to 2 years depending on the severity of the case.

Posted by Dr. Tim Sandle

Pharmeuropa - Useful information

EDQM has published a document outlining useful updates edition 8.8 of the European Pharmacopeia.

Areas of change include:

2.2.3. Potentiometric determination of pH
2.2.46. Chromatographic separation techniques
2.4.22. Composition of fatty acids by gas chromatography
2.4.32. Total cholesterol in oils rich in omega-3 acids
2.6.8. Pyrogens

·         The text has been revised to include a reference to general chapter 2.6.30. Monocyte activation test as a potential replacement of the test for pyrogens, therefore avoiding the use of live animals.

5.1.10. Guidelines for using the test for bacterial endotoxins

·         A section has been added (section 2-4) to include aspects to be considered when establishing an endotoxin limit for a specific substance or product; also, the text has been revised to reflect the fact that an endotoxin limit is not always provided in a specific monograph.
·         Reference is made to general chapter 2.6.30. Monocyte-activation test as an alternative to the rabbit pyrogen test.
·         Reference is made to the use of alternative reagents to the Limulus amoebocyte lysate, such as recombinant factor C.
·         Method A is no longer declared as the reference method, and all methods A to F of general chapter 2.6.14. Bacterial endotoxins can be used.
·         The expression ‘threshold endotoxin concentration’ has been replaced by the more appropriate expression ‘endotoxin limit concentration’ to harmonise with general chapter 2.6.30. Monocyte-activation test.
·         A new entry has been included in Table 5.1.10.-1 for formulations administered per square metre of body surface.

5.3. Statistical analysis of results of biological assays and tests

5.4. Residual solvents

Radiopharmaceutical preparations (0125)

Substances for pharmaceutical use (2034)

Posted by Dr. Tim Sandle

Saturday 30 January 2016

Software Identifies Drug Resistance from Bacterial Genomes

Scientists have developed an easy-to-use computer program that can quickly analyze bacterial DNA from a patient's infection and predict which antibiotics will work, and which will fail due to drug resistance. The software is currently being trialed in three UK hospitals to see whether it could help speed up diagnosis of drug-resistant infections and enable doctors to better target the prescription of antibiotics.

The Mykrobe Predictor software, developed by Dr. Zamin Iqbal and colleagues at the Wellcome Trust Centre for Human Genetics, University of Oxford, runs on a standard laptop or tablet without the need for any specialist expertise. The program can analyze the entire genetic code of a bacterium in under 3 minutes, once a bacterial sample has been cultured and its DNA sequenced.

A study on more than 4,500 retrospective patient samples, published in Nature Communications, shows that Mykrobe Predictor accurately detects antibiotic resistance in two life-threatening bacterial infections: Staphylococcus aureus (one form of which causes MRSA) and tuberculosis (TB).

The paper is titled “Rapid antibiotic resistance predictions from genome sequence data for S. aureus and M Tuberculosis.”

Posted by Dr. Tim Sandle

Friday 29 January 2016

EN 14885:2015

A European Standard, providing an overview of disinfectant testing, has been updated and published. It is EN 14885 and it is titled “Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics.”

Key words are: Disinfectants, Antiseptics, Cleaning materials, Disinfectant tests, Microorganisms, Bacteriocide-activity determination, Bacteriocides, Viruses, Fungicides, Eumycophyta, Testing conditions, Medical equipment, Veterinary science, Food industry, Industrial, Domestic, Marking, Terminology.

The standard was last revised in 2006.

See: EN 14855

Posted by Dr. Tim Sandle

Thursday 28 January 2016

A Practical Approach to the Selection of Cleanroom Disinfectants

Cleanrooms play an important role in hospitals, from special environments for the preparation of medicines in pharmacies to providing clean air zones for operations. Cleanrooms are designed with special air filters (high efficiency particulate air) to provide ‘clean air’, have positive pressure differentials to prevent the ingress of less clean air, and have strict entry and clothing requirements for personnel. Nevertheless cleanroom surfaces can become contaminated with microorganisms, transported in from consumables and equipment or shed from personnel. Surfaces pose a risk if they harbour high numbers of bacteria and fungi as such microorganisms can be readily transferred. Thus, an important part of contamination control within a cleanroom requires the use of cleaning and disinfection agents. A second risk arises within hands. Hands, whether gloved or ungloved, are one of the main ways of spreading infection or for transferring microbial contamination and the use of hand disinfectants is also part of the process of good contamination control.

In relation to this, Tim Sandle has written an article for Pharma Focus Asia.

The reference is:

Sandle, T. (2014) A Practical Approach to the Selection of Cleanroom Disinfectants, Pharma Asia Online.

The article can be accessed for free here

Posted by Dr. Tim Sandle

Wednesday 27 January 2016

Antibiotic Resistance and You

Public Health England wants to hear from members of the public about their views on antibiotic resistance. This public event is taking place in London on 24th February at the UCL John Hunbury Theatre, Russel Square, London.
  • This free to attend event will cover:
  • antibiotics and why they are so valuable
  • what is antibiotic resistance and how it affects you and your family
  • what we can all do to help solve the crisis of antibiotic resistance
You, your friends and family are invited to book your free spot today.

Posted by Dr. Tim Sandle

Bromate Determination in Water

The determination of the bromate content of water is a challenge that can be met either by using an elaborate ion chromatography system or a photometric method. Both approaches demand careful handling and a critical appraisal of the result that is yielded. If the necessary working steps are carefully followed, photometry constitutes a true alternative to chromatography for those laboratories that do not possess ion chromatography systems.

Laboratory Manager is offering a free white paper on this subject, which can be requested here.

Posted by Dr. Tim Sandle

Biocidal Products Regulation

The European Chemical Agency has issued “Transitional Guidance on Efficacy Assessment for Product Types 1-5, Disinfectants”. This legislation will affect the number and types of disinfectants registered in the European Union.

The document states: “This Transitional Guidance deals with the evaluation methodology of efficacy tests for disinfectants for the national and Union authorisations of products under the EU Biocidal Products Regulation 528/2012 (BPR).”

The types of efficacy claims made for a disinfectant/ biocidal product depend upon, among other things, the types of micro-organisms the disinfectant targets (e.g. fungal spores, yeasts, mycobacteria, bacteria or bacterial spores) and the disinfectant’s intended use (e.g. in hospitals, in contact with food, in animal houses, in homes). Label claims and recommendations for use, including concentration and contact time, must be supported by the results of bactericidal, fungicidal, etc. tests appropriate to the area of application, which are normally performed on the basis of the specific standards. Complete instructions for use are an integral part of the label.

The document can be accessed via the ECA.

Posted by Dr. Tim Sandle

Tuesday 26 January 2016

Disinfection of active air-samplers

Avoiding cross-contamination when using microbiological air-samplers is a key activity. But how effective is the procedure? To evaluate this, Tim Sandle and Ravikrishna Satyada have written a paper based on test data. The abstract reads:

Active (volumetric) air-sampling is an important component of the environmental monitoring of cleanrooms. It is important that the results of such monitoring are accurate. One aspect of ensuring that the result is ‘valid’ is through minimising cross-contamination. The ‘at risk’ part of the sampler is the head. There are three alternatives to control cross-contamination during active air sampling contamination control: using multiple air sampler, autoclaving the sampler head in-between samples, or disinfecting the sampler head intermittently. This paper summarises a study where a disinfectant (70% isopropyl alcohol) was used to disinfect the head of an impaction air sampler between sampling sessions (spray-and-wipe technique). The study examined two factors: disinfectant decontamination effectiveness and the potential for the inhibition of microbial growth. With decontamination effectiveness, successive operations of an air sampler were examined within different cleanroom grades; with microbial growth inhibition studies, different disinfection time points were assessed. The paper concludes that this method of contamination control is effective and applicable to most cleanroom monitoring situations: it is unlikely to allow carry-over of microbial contamination and it is not shown to cause inhibition of microbial growth.

The paper is published in the European Journal of Parenteral and Pharmaceutical Science. The reference is:

Sandle, T. and Satyada, R. (2015) Assessment of the disinfection of impaction air sampler heads using 70% IPA, as part of cleanroom environmental monitoring, European Journal of Parenteral and Pharmaceutical Science, 20 (3): 94-99

For a copy, please contact Tim Sandle

Posted by Dr. Tim Sandle

Monday 25 January 2016

ISO 16075-1 - new wastewater standard

A new standard for wastewater has recently been issued - ISO 16075-1:2015 Guidelines for treated wastewater use for irrigation projects -- Part 1: The basis of a reuse project for irrigation.

The standard covers:

ISO 16075-1:2015 contains guidelines for the development and the execution of projects intending to use treated wastewater (TWW) for irrigation and considers the parameters of climate and soil.
The purpose of these guidelines is to provide specifications for all elements of a project using TWW for irrigation, including design, materials, construction, and performance, when used for the following:
  • unrestricted irrigation of agricultural crops;
  • restricted irrigation of agricultural crops;
  • irrigation of public and private gardens and landscape areas, including parks, sport fields, golf courses, cemeteries, etc;
  • irrigation of private individual gardens.
These guidelines are intended to provide assistance for the benefit of users of TWW for irrigation. The guidelines relate to the widespread and common ranges of water quality rather than exceptional or unique ones and are intended for the use by professionals, such as irrigation companies (designers and operators), agricultural extension officers or advisors, water companies (designers and operators), and local authorities. The use of these guidelines by farmers might require additional specifications.

Posted by Dr. Tim Sandle

Sunday 24 January 2016

Current Developments with Disposable Technology and Single-Use Systems for Aseptic Processing

"Pharmaceutical drug products are produced to be efficacious; however the presence of microorganisms or microbial by-products in these products may have adverse effects on their efficacy. Contamination of aseptically filled biotechnological products is costly and it can pose serious harm..."

In relation to this technology, Tim Sandle has written an article for BioPharma Asia magazine. The reference is:

Sandle, T. (2015) Current Developments with Disposable Technology and Single-Use Systems for Aseptic Processing, BioPharma Asia, 4 (6): 1-10

See: BioPharma Asia

 Posted by Dr. Tim Sandle

Saturday 23 January 2016

Borderlines between medical devices and medicinal products

What is the difference between a medical device and a medicinal product? The definitions are often blurred.

To help to interpret this, the U.K. MHRA have a document that sets out, in broad terms, the regulation of specific products and distinguishes those which are regulated as medical devices and those which are regulated as medicinal products, particularly where the regulation may be on the borderline between the two sets of regulations.

Whilst there are other ‘borderlines’ with medical devices (for example with cosmetics, personal protective equipment, biocides etc) this document relates specifically to the differentiation between medical devices and medicinal products.

To access the document, see: MHRA.

 Posted by Dr. Tim Sandle

Friday 22 January 2016

HVAC and Outdoor Humidity Sensors

HVAC systems often rely on outdoor relative humidity measurements, or calculated parameters based on humidity, to optimize the energy efficiency of the cooling equipment. Changing weather conditions can make measuring outdoor humidity a challenge, so selecting the right sensor is essential to the performance of a building’s HVAC system.  If the outdoor humidity sensor is inaccurate, building controls, energy efficiency, and human comfort are sub-optimized.

In relation to this, Vaisala have produced a newsletter exploring the subject further. The newsletter can be accessed here.

 Posted by Dr. Tim Sandle

Thursday 21 January 2016

Biocontamination Control in Pharmaceutical Production

Merck have provided a guide to “Biocontamination Control in Pharmaceutical Production.” This comes in the form of a white paper.

The introduction reads:

“Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these microorganisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi, respectively. When designing a biocontamination control strategy, which is based on the manufacturing process, there are three components to take into consideration, each of which requires risk assessment: 1) designing process systems to avoid contamination; 2) monitoring process systems to detect contamination; and 3) reacting to contamination events and putting proactive measures in place. The design of process systems is where maximal effort should be placed.”

The paper is written by Tim Sandle, Tony Ancrum, and Anne Connors.

The paper can be accessed here.

 Posted by Dr. Tim Sandle

Wednesday 20 January 2016

Microbiology Links

Useful Links Microbiology

  • British Infection Association exists to promote the science and practice of medicine in relation to infection, to support all infection specialists and trainees, and to further research into infection.
  • British Society for Antimicrobial Chaemotherapy exists to facilitate the acquisition and dissemination of knowledge in the field of antimicrobial chemotherapy.
  • Infectious Disease Research Network activities include organisation of research strategy workshops and training events, designing and hosting study webpages and surveys, producing comprehensive funding and training bulletins, and hosting an online researchers database
  • Public Health England was established on 1 April 2013 to bring together public health specialists from more than 70 organisations into a single public health service.
  • Society for Applied Microbiology is the voice of applied microbiology and oldest microbiology society in the UK. Its object is to advance, for the benefit of the public, the science of microbiology in its application to the environment, human and animal health, agriculture and industry.
  • Society for General Microbiology provides a common meeting ground for scientists working in research and in fields with applications in microbiology, including medicine, veterinary medicine, pharmaceuticals, numerous industries, agriculture, food, the environment and education.
  • UK Clinical Virology Network provide a comprehensive, cutting-edge, quality-driven virology service for patients and public health.
Posted by Tim Sandle

Tuesday 19 January 2016

Methods for micronutrient testing of infant formula

Eight new International Standards specifying methods for testing vitamins and other micronutrients in infant formula will help ensure their nutrient content conforms to their declaration.

News from ISO:

Infant formulas need to provide essential nutrients (including vitamins and minerals) for the adequate growth and development of babies and young children. This is why the nutritional quality of infant formula is laid down in international standards1 (Codex Alimentarius2) and national regulations.

To verify that infant formulas deliver all the necessary nutrients, accurate analytical test methods are required. The development of such test methods is ever evolving, but to date not many methods for micronutrients have been internationally harmonized. This lack of harmonization can cause problems in international trade due to different methods being used by different parties, producing different results.

Although some methods are listed in the Codex-recommended Methods of Analysis and Sampling and referenced in the Codex Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants, many are outdated, not validated for infant formula specifically, or not globally harmonized.

Read more....

Monday 18 January 2016

Advances in Rapid Pathogen Detection

Microbiological analysis has progressed considerably in the twenty-first century through the advent of rapid microbiological methods. This is most apparent within the clinical, and pharmaceutical sectors . One area of much needed advancement is with pathology. Here clinical investigators can take samples from the field, from patients or from the environment, and undertake rapid analysis, obtaining results within hours rather than the days or weeks required with conventional methods. Time is often a consequence of slow-growing, difficult to culture, and unculturable microorganisms. Time-to-result is critical when making decisions about patient health.

In a new article Tim Sandle considers, some of the most recent advances with rapid methods for pathogen detection.

The reference is:

Sandle, T. (2015) Advances in Rapid Pathogen Detection, Journal of Microbiology & Experimentation, 2 (5): 00063. DOI: 10.15406/jmen.2015.02.00063

For a copy, please contact Tim Sandle

 Posted by Dr. Tim Sandle

Sunday 17 January 2016

Antimicrobial resistance resources

Public health professionals have been given access to new resources aimed at reducing the unnecessary prescribing of antibiotics.

The second edition of Public Health England's Health Matters resource sets out how healthcare professionals can deal with patient demand and reduce unnecessary antibiotic prescribing.

“Public Health England has released new resources for public health professionals to help them tackle the growing problem of antibiotic resistance.“
It outlines key measures such as using government-approved prescribing toolkits, involving patients in shared decision-making, issuing delayed prescriptions, encouraging good hygiene practices and sharing best practice with peers.

The resource is designed to bring together local and national level data, as well as campaigning and social marketing resources, in an easy-to-use, engaging format.

Public Health England chief executive Duncan Selbie said: "We rely heavily on antibiotics and the pressure on healthcare professionals to prescribe is great, even when they are not needed. We need to conserve antibiotics and use them appropriately, or we risk losing the power of these medicines."

The latest official data indicates that although the total number of antibiotic prescriptions dispensed decreased between 2011 and 2014, total antibiotic consumption in primary care increased by 6.5 percent.

See: Public Health England

 Posted by Dr. Tim Sandle

Friday 15 January 2016

EMA Director Outlines Five-Year Plan

At a press briefing held Dec. 10, 2015, the European Medicines Agency’s (EMA) new Executive Director, Guido Rasi, presented is five-year vision for the agency. Rasi, who took office on Nov. 16, 2015, addressed globalization of the drug market and pressures on healthcare systems. "I am confident that EMA, working closely with the national competent authorities in Member States, is ready to successfully address these new challenges," he stated.

Among the director’s goals for the agency was a focus on R&D to address healthcare needs, a commitment to transparency, a directive to increase patient involvement, a dedication to use all available safety and efficacy data, and a reinforcement of the agency’s commitment to working as a “global reference authority”. Rasi stressed the importance of working with Member States, the European Commission, and other European and international partners in order to achieve these goals.

Source: EMA

 Posted by Dr. Tim Sandle

Thursday 14 January 2016

Pharmeuropa 27.4

A new edition of Pharmeuropa has been issued (October 2015), with the deadline for comments 31 December 2015.

Pharmeuropa is a free online EDQM publication. Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months.

Draft Monographs and General Texts for Comment

2.2.38  Conductivity

This draft corresponds to Stage 4 within the Pharmacopoeial harmonisation process (Ph. Eur., JP, and USP). The coordinating pharmacopoeia is the USP.
A general revision of the text is proposed

2.2.1   Clarity and Degree of Opalescence of Liquids

General revision to restructure the text and eliminate unnecessary repetition. Based on comments from users and manufacturers, the requirements for accuracy and repeatability of the instrument have been changed

4.2.1    Primary Standards for Volumetric Solutions

Sodium carbonate has been replaced by trometamol and a new primary standard has been introduced to allow more single-step standardisations. Additional recommendations for the use of primary standards have been added

4.2.2    Volumetric Solutions

General revision in order to introduce more single-step standardisations using a primary standard. Use of potentiometric end-point determination has also been emphasised and the conditions for the use of commercial solutions have been changed.3Wherever possible, toxic reagents have been replaced

Glossary (1502)

Basis: the definition has been reworded, including the notion of single-phase and multiphase systems.
Colloidal dispersion, Emulsion, Suspension: it has been decided to include under the term ‘dispersion’ the definition of colloidal dispersion, emulsion and suspension, and to revise each of these definitions.
Solution: some additional information on the state of the dissolved substances has been included.
Standard Term: a more detailed definition has been elaborated.

Posted by Dr. Tim Sandle

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