Saturday, 31 December 2016

Gut bacteria and visceral body fat connection

Gut bacteria

A connection has been drawn between certain types of bacteria, as recovered in human feces, and levels of abdominal body fat. This could suggest a link between inherited bacteria and obesity.

The new research follows on from a series of studies looking at the heritable bacteria found in the fecal microbiome and different metabolic conditions. With the new study, microbiologists from King's College London have discovered that people with a high diversity of bacteria in their feces tended to carry lower levels of visceral fat. In contrast, those with a more narrow range of bacteria, tended to carry more fat.
Visceral fat refers to the body fat stored in the abdominal cavity, in close proximity to important internal organs. Higher levels of fat in this area have been connected with a greater chance of developing metabolic diseases, including cardiovascular disease and diabetes.
The experimental data was drawn from a study of twins, looking at 1,313 twins who agreed to participate in an on-going medical study called TwinsUK. The twins were mostly female and all were U.K. born. For the specific study, stool samples provided by participants and subjected to analysis.
The analysis focused on fecal microbes and the extraction of microbial DNA. The information about microbial diversity was correlated with various measures of obesity including body mass index.
The researchers are interpreting the findings as evidence of a possible genetic influence on obesity. However, given this was an observational study, while the findings do so a correlation between a person’s microbiome and visceral fat, additional studies will be needed to show if there is a specific influence of microbial genes in relation to obesity. If such a link was proven it could lead to new treatments and interventions.
In a research note, the lead scientist Dr Michelle Beaumont stated: 'This study has shown a clear link between bacterial diversity in feces and markers of obesity and cardiovascular risk, particularly for visceral fat.”
The findings are published in the journal Genome Biology. The research paper is titled “Heritable components of the human fecal microbiome are associated with visceral fat.”


Posted by Dr. Tim Sandle

Friday, 30 December 2016

Sodium hypochlorite: health effects, incident management and toxicology


Sodium hypochlorite is a commonly used disinfectant and sanitization agent. The U.K. government has recently updated safety information relating to use of the chemical.

Key points from the review are:
  • sodium hypochlorite is a green/yellow liquid with the characteristic smell of chlorine
  • it is a major ingredient in household bleach (present at up to 10%)
  • it is also used as a disinfectant for swimming pools, can be used to disinfect drinking water, in some medical treatments and in the manufacture of paper and pulp
  • accidental skin or eye exposures to sodium hypochlorite in domestic products are common
  • children may be exposed to sodium hypochlorite in bleach following accidental ingestion
  • mixing sodium hypochlorite bleach with other cleaning products may produce dangerous gases  ingestion of small amounts of household bleach is unlikely to cause any serious or long term health effects
  • ingesting large amounts of household bleach or any amount of industrial strength bleach is more likely to cause serious health effects

Further information can be found here.

Posted by Dr. Tim Sandle

Thursday, 29 December 2016

Upsalite® inhibits bacteria without penicillin


The mesoporous material Upsalite® is shown to inhibit growth of bacteria associated with acne and hospital acquired infections. In a study, researchers have shown that the mesoporous magnesium carbonate Upsalite® exerts strong bacteriostatic effect on Staphylococcus epidermidis.

Staphylococcus epidermidisis an opportunistic bacterium that that has received the most attention for causing hospital acquired infections (HAIs), and can readily become resistant to antibiotics. It is also associated with acne as well as infections of intravascular devices and complications in patients with implanted prosthetic material. The results open up for development of materials inhibiting bacterial growth without the use of antibiotics for e.g. dermal applications.

Porous materials are abundant in nature; wood, rocks and cancellous bone are some examples of such materials. In recent years, researchers have shown increased attention to porous materials, especially mesoporous materials where the pores are between 2 and 50 nanometers in diameter. Today such materials are developed for applications including delivery of medicines, moisture adsorption and wastewater cleaning. For many of these applications it is of importance to know how the materials affect biological entities such as different cells and bacteria.

Upsalite® is a mesoporous magnesium carbonate discovered in 2013 by researchers at Uppsala University.

The material has previously been shown to be skin-friendly and to be a promising excipient for formulation of poorly soluble drugs.

In a just published article, in the journal ACS Omega, researchers at Uppsala University show that Upsalite® exerts strong bacteriostatic effect on Staphylococcus epidermidis. This open up new possibilities for Upsalite®, especially in certain dermal applications where an inhibition of bacterial growth is desirable.

"These newly found bacteriostatic properties combined with the ability to load and release molecules, for example fragrances from the pores in the material are highly interesting for many applications," says Maria Strømme, Professor at Department of Engineering Sciences, Nano Technology and Functional Materials one of the authors behind the study.

For further details see:

Ken Welch, Mushtaq Ahmad Latifzada, Sara Frykstrand, Maria Strømme. Investigation of the Antibacterial Effect of Mesoporous Magnesium Carbonate. ACS Omega, 2016; 1 (5): 907 DOI: 10.1021/acsomega.6b00124

Posted by Dr. Tim Sandle

Wednesday, 28 December 2016

Cleanroom Microbiology


There are books about cleanrooms and books about microbiology, but rarely are these two key subjects relating to contamination control brought together. The book 'Cleanroom Microbiology' applies the latest best practice to pharmaceuticals and healthcare.

For further details, please see the flyer below or go directly to the PDA Bookstore.

Posted by Dr. Tim Sandle

Tuesday, 27 December 2016

Modern Approaches to Pharma Cleanroom Design



The performance of a cleanroom is defined by a set of complex interactions between the airflow, sources of contamination and heat, position of vents, exhausts, and any objects occupying the space. Consequently, changes to any of these elements will potentially affect the operation of the cleanroom and could invalidate aspects of the room design.

With cleanrooms used in the pharmaceutical industry, there are additional considerations aimed at minimizing contamination. These are centered on the idea that cleanrooms should be constructed in a way which makes them easy to clean and disinfect.

This is an extract from an article written by Tim Sandle for Controlled Environments magazine. To access the full article, see CE.

Posted by Dr. Tim Sandle

Monday, 26 December 2016

Cleanroom Cleaning and Disinfection: Eight Steps for Success


Cleanrooms in healthcare and pharmaceutical facilities must be kept in a state of microbiological control. This is achieved in a number of ways, including the physical operation of Heating, Ventilation, and Air Conditioning (HVAC) systems, control of materials, properly gowned and trained personnel, and through the use of defined cleaning techniques, together with the application of detergents and disinfectants.

The object of cleaning and disinfection is to achieve appropriate microbiological cleanliness levels for the class of cleanroom for an appropriate period of time. Thus the cleaning and disinfection of cleanrooms is an important part of contamination control.

In an article for Controlled Environments magazine, Tim Sandle examines eight key steps to be followed, in relation to cleaning and disinfection, in helping to keep cleanrooms “clean.”

To view the article, see CE.

Posted by Dr. Tim Sandle

Sunday, 25 December 2016

Better Data Integrity



Guest post on data integrity -  by Natalia Román López, Mettler Toledo
One of the primary motives driving organizations to purchase a laboratory information system (LIMS), electronic lab notebook (ELN), or laboratory execution system (LES) is the appeal of connecting laboratory instruments for electronic data collection. When a laboratory instrument is directly connected, costs in time, labor, and potential error associated with manual data transfer are essentially eliminated. However, even with the compelling advantages, many instruments and systems still remain disassociated with data entry and transfer largely handled manually.
Manual data transcription and report creation keep laboratory users from focusing on his or her science. Frequently, transcribed data lacks certain elements as well as the traceability needed to satisfy internal quality management or regulatory mandates. The end result is loss of time and revenue as time is lost gathering missing data, re-transcribing results, documenting missing controls, and preparing reports. Additionally, laboratory staff must often comply with standard operating procedures (SOPs) for each analysis and document the entire process as well.
More than aggregating results
To the SOP point, while many labs have turned toward LIMS and ELN systems with the idea of replacing the manual workflow, the fact remains that these systems are designed primarily to aggregate data from an array of analytical tests, not to automate and document bench-top workflows or bind instrument metadata with results for traceability purposes. Yet these are the aspects of a truly integrated system that can deliver heightened SOP adherence, easier workflow management and better traceability.
What is needed is a ready-made, configurable solution that drives the workflow SOP directly through the balance or instrument, delivering automatic, integrated instrument management and data capture, allowing to focus on the analysis. The instrument control and workflow support provided by such a system forms an ideal foundation to the IT hierarchy. This layer interacts on a unidirectional or bi-directional basis with the others using standardized integration approaches, offering a practical, cost-effective, single-system solution for managing instruments that can be integrated with a lab's core scientific system such as an ELN or LIMS.
In essence, centrally maintained SOPs are driven to respective instruments to guide measurement and store all raw and processed data with corresponding metadata sets for future analysis.
Flexible data management
In a system of this type, no computer or tablet PC is needed on or near the bench top. The balance or instrument touchscreen is able to deliver real-time, step-by-step guidance to the user according to SOPs using flexible workflow tools that take advantage of instrument-specific firmware. When ready to begin, the operator simply touches a shortcut or selects a workflow from the instrument. As noted, this type of bench-top management system eliminates significant error potential that comes both with routine performance of SOPs and manual data entry.
Typically, generated reports can be communicated directly to the oversight lab informatics system (LIS). Information can also be drop-transferred to an open Excel cursor, making all metadata immediately available for analysis. Metadata can also be exported as a .csv or XML-formatted file. Finally, using API web services, extensive data sets can be exchanged bi-directionally with a platform of this type and other software systems, instruments and mobile devices. This, in effect, creates one functional system for truly flexible processing.
A two-way (data) street
Perhaps most importantly, this two-way street offers more than just results-management. It allows the sending of product data and sample series data from the lab informatics system (LIS) to the instrument. Information can be imported from a file location and exported to an open folder. This creates seamless instrument and task control, as seen in the graphic below:
As described, this kind of robust communication of workflows, transfer of results and immediate access to metadata eliminates manual transcription and transcription error-checking (the so-called “four eyes” principle). The elimination of a paper process also assures a coherent audit trail. This makes it easier for labs in regulated industries to comply with Good Laboratory Practice, Good Manufacturing Practice and Food and Drug Administration guidelines and standards.
An easier, faster process to operate instruments
In addition to compliance enhancements, common processes become easier and faster. A process starts when a user selects a substance to be handled then logs onto the system at the instrument touchscreen. There is no need to log onto a separate workstation to access each instrument, allowing single point process strat. All actions and results are recorded in the database against the user’s identity, using a time and date stamp. An attached printer can produce a label for the sample in process that contains requisite quality or regulatory information such as identity, concentration, and expiry date. The process can be further simplified if enabled for an attached barcode reader.
In conclusion, integrating instrument control software with informatics systems using .csv files, XML structures or API web-services closes gaps in traceability, simplicity, and efficiency. This lets labs take full advantage of instrument technology which, in many cases, already resides on their bench top to generate improvements in results tracking, quality compliance, data integrity and workflow efficiency.
Download the 'Data Integrity' guide.

Hydrogen chloride/ hydrochloric acid: health effects, incident management and toxicology


Hydrogen chloride/ hydrochloric acid is a commonly used in laboratories. The U.K. government has recently updated safety information relating to use of the chemical.

Key points from the review are:

  • hydrogen chloride is a colourless or slightly yellow gas
  • hydrogen chloride gas dissolves readily in water to give hydrochloric acid
  • it has many industrial uses, is found in consumer products and may be used in swimming pools to alter the pH
  • low levels of naturally occurring hydrogen chloride may occur in the air, however most is removed by the rain; it is also produced by some human activities
  • hydrogen chloride is highly irritating and corrosive breathing hydrogen chloride for a short period of time can cause irritation to the nose and throat, causing coughing and shortness of breath
  • higher concentrations can also cause headache, fever wheeze, a rapid heart rate and confusion; in serious cases the airways and lungs may be damaged
  • hydrogen chloride gas can form hydrochloric acid on the skin which is highly irritating and corrosive
  • hydrochloric acid solutions are highly corrosive and can cause skin burns on contact; they may also damage the eyes
  • drinking hydrochloric acid will burn the mouth, throat and stomach
Further information can be found here.

Posted by Dr. Tim Sandle

Saturday, 24 December 2016

Season's Greetings


No matter where you are in the world or which belief system you subscribe to, as the year draws to close, I'd like to wish you all the best for the holiday period. Thank you for supporting Pharmaceutical Microbiology.

Thanks,

Tim Sandle



For the microbiologist - gifts Under $20.00
3.   Lab Equipment Cookie Cutters ($6.21 – $13.90, etsy.com)
4.   E. faecalis on SBA and E.coli on EMB Soap ($7.00, etsy.com)
7.   Microbiology Coasters ($10.50 – $11.95, zazzle.com)
10. Agar Plate Necklace ($12.47, etsy.com)
12. Growth Bandana ($15.95, zazzle.com)
16. The Invisible ABCs Children’s Book, By Rodney P. Anderson  ($19.95, amazon.com)

Friday, 23 December 2016

Chile’s agar stocks at risk


Red algae (Gracilaria chilensis) are used to make agar-agar — a jelly-like substance used in a plethora of products, including ice cream, dietary supplements and cosmetics. Once the seeds grow into tangles of red algae, the plants are harvested and processed to make agar-agar. This versatile substance acts as a gelatin substitute and is used in textile dyes, plastics and cosmetics. Another important application is microbiological culture media.

Chile is one of the world’s largest producers of the algae. Chile exports 1,800 tons a year, and along with Spain and Japan, is one of the world’s top producers, who together account for 60 percent of agar-agar output, according to the Food and Agriculture Organization.

However, demand for Chile’s algae and pressure on the ecosystem have grown so great that now the algae are under threat. Last year, a study by the biology department at Catholic University of Chile with French research institute CNRS warned Chile’s red algae were in danger of extinction.

Over-exploitation is not the only thing threatening the seaweed: A worm that feeds on the algae has also hit the region. Waste from nearby salmon farms is likewise threatening the plants.

For further details on this story, see Japan Times.

Posted by Dr. Tim Sandle

Thursday, 22 December 2016

Skin bacteria could protect against disease


New research has shown that the most common bacteria on human skin secrete a protein which protects us from the reactive oxygen species thought to contribute to several skin diseases. The protein has an equally strong effect on dangerous oxygen species as known antioxidants such as vitamin C and vitamin E.

The skin bacterium is called Propionibacterium acnes. The "acne-causing bacterium" secretes a protein called RoxP. This protein protects against what is known as oxidative stress, a condition in which reactive oxygen species damage cells. A common cause of oxidative stress on the skin is UV radiation from the sun.

Oxidative stress is considered to be a contributing factor in several skin diseases, including atopic dermatitis, psoriasis and skin cancer.

Since Propionibacterium acnes is so common, it is present in both healthy individuals and people with skin diseases. According to Rolf Lood, however, people have different amounts of the bacterium on their skin, and it can also produce more or less of the protective protein RoxP.

This will now be further investigated in both patients and laboratory animals by Lood and his team. The human study will compare patients with basal cell carcinoma, a pre-cancerous condition called actinic keratosis and a healthy control group. The study will be able to show whether there is any connection between the degree of illness and the amount of RoxP on the patient's skin.

The study on laboratory animals will also examine whether RoxP also functions as protection. Here, mice who have been given RoxP and others who have not will be exposed to UV radiation. The researchers will then observe whether the RoxP mice have a better outcome than those who were not given the protective protein.

For further details see:

Maria Allhorn, Sabine Arve, Holger Brüggemann, Rolf Lood. A novel enzyme with antioxidant capacity produced by the ubiquitous skin colonizer Propionibacterium acnes. Scientific Reports, 2016; 6: 36412 DOI: 10.1038/srep36412

Posted by Dr. Tim Sandle

Wednesday, 21 December 2016

Overview of global initiatives on medicine regulation


The European Medicines Agency (EMA) has published recently an overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The report lists all international projects and provides international regulatory agencies with comprehensive details on the number and scope of global initiatives that can support decision-making regarding future engagement, prioritisation and coordination.

The aim of the mapping exercise was to raise awareness of ongoing international regulatory activities, help establish a basis for a more strategic coordination to avoid duplication of efforts, and identify possible gaps.

The report can be found here.



Posted by Dr. Tim Sandle

Tuesday, 20 December 2016

Risk Assessment and Management for Healthcare Manufacturers


Risk assessment is a core requirement for pharmaceuticals and healthcare. One difficulty with implementing risk methodologies is in taking abstract tools and applying these to 'real life' situations. This is where the new book "Risk Assessment and Management for Healthcare Manufacturers" comes in. The book is packed full of case studies, illustrating how FMEA, HACCP, 5Whys and a range of other tools can effectively be applied.

For details about the book, please see the flyer below or go directly to the PDA Bookstore.


Posted by Dr. Tim Sandle

Monday, 19 December 2016

PDA Europe Pharmaceutical Microbiology


PDA Europe 8th Conference on Pharmaceutical Microbiology,Porto, Portugal on 14-15 February 2017.

The conference theme will be “Microbiology in Pharmaceutical Manufacturing” and a comprehensive scientific program will include presentations from regulatory, industry and technology representatives from around the world.

The conference program is tailored to address the current issues and opportunities our industry faces every day. For example, topics of interest will include how to maintain process water systems to prevent contamination and biofilms, how to validate new technologies and microbiological methods, prevention of contamination in sterile and non-sterile products, and of course, new trends in endotoxin testing.



Posted by Dr. Tim Sandle

Good Manufacturing and Distribution Practice Inspectors Working Group


The European Medicines Agency has published a report titled “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015”.

The report provides an overview of the activities of GMP inspectors across Europe. As the report indicates: “This document is the annual report of the GMP/GDP Inspectors Working Group (GMDP IWG) for the year 2015. This group was established at EMA in 1996.

The GMDP IWG provides input and recommendations on all matters relating directly or indirectly to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The GMDP IWG focuses on harmonisation and co-ordination of GMP and GDP related activities at EU level. The group's role and activities are described in more detail in its mandate, which was revised in 2013. This annual report is set out in line with the format and objectives of the 2015 work plan.”

The report can be accessed here.



Posted by Dr. Tim Sandle

Sunday, 18 December 2016

New EMA draft guideline on sterilisation of the medicinal product


Given the importance of sterile products, in providing both a therapeutic medicine and with regards to the necessity of being free from viable microorganisms, pyrogenic substances and visible particulates, no new guidance has been issued by a regulatory authority in recent years. This has changed with a new draft guidance document from the European Medicines Agency. Issued in April 2016 for public comment, the document is titled Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container.

Tim Sandle’s review of the new European Medicines Agency guideline has been published in Industrial Pharmacy.

The reference is:

Sandle, T. (2016) New EMA draft guideline on sterilisation of the medicinal product, Industrial Pharmacy, 51: 14-15

The paper can be viewed here.



Posted by Dr. Tim Sandle

Saturday, 17 December 2016

Containment Laboratory Glossary


Bioquell have put together a series of reference guides that contain:
  • A glossary of common terms and acronyms;
  • A selection of useful links to HSE, other regulatory bodies
  • Links to appropriate industry bodies.

To view the guide, see Bioquell.

Posted by Dr. Tim Sandle

Microbial Risk and Investigations


Book feature - 'Microbial Risk and Investigations'.

The investigation of microbiological laboratory findings (a.k.a. microbiological data deviations - MDD) - is of great importance for understanding the root causes of contamination and for assessing the risk on products, processes and environments.

The new book, edited by Karen Zink McCullough and Jeanne Moldenhauer, provides comprehensive coverage of microbiological investigations and is a must read for microbiologists and quality assurance personnel. 

Please see the flyer below or go directly to the PDA bookstore


Posted by Dr. Tim Sandle