Friday, 31 October 2014

Risk-Based Environmental Monitoring | White Paper


Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting. The case study provided in this white paper highlights the need for automated EM software systems to analyze large amounts of data and recognize risks before a problem occurs.

Novatek are offering a white paper on the subject. To access, go to Novatek.

Posted by Tim Sandle

Thursday, 30 October 2014

Halloween Safety Tip: The SCARY truth about decorative contact lenses

It may seem fun to use colored contacts to complement the most creative costume; however, contacts worn for cosmetic purposes pose a threat to your eyehealth and vision if not properly fitted, even if there is no prescription in the lens.

A poor fit can cause serious eye damage, including:

• Scratches on the cornea

• Corneal infection

• Conjunctivitis (pink eye)

• Decreased vision

• Blindness

The FDA classifies contact lenses as “medical devices,” and they should be prescribed by a doctor of optometry. Vendors that advertise decorative contact lenses as cosmetic products or sell them without a prescription are breaking the law.

Scare your friends with your spooky colored lenses, but make sure to visit your local optometrist first!

Thanks to the California Optometric Association for the Infographic.







Posted by Tim Sandle

Wednesday, 29 October 2014

How does bacterial competition generate antibiotic resistance?


Antibiotic resistance is a serious public health concern. Resistance is mainly caused by antibiotic use, and is the result of specific genes harbored by microorganisms that reduce the impact of drug molecules.

Antibiotic use may not be the only culprit in the development of antibiotic resistance, however. A report in Cell shows that competition between methicillin-resistant Staphylococcus aureus (MRSA) bacteria in biofilms generates a vancomycin-resistant strain in the absence of vancomycin exposure. This new strain evolved to resist Bsa bacteriocin secreted by another MRSA strain in the biofilm, and is very similar to the vancomycin-intermediate S. aureus (VISA) strain that has been observed clinically. (2014 Cell 158, 1060.)

Posted by Tim Sandle

Tuesday, 28 October 2014

Staphylococcus aureus Discussed in New Online Video

From IAQ Video Network and Cochrane & Associates - the video discusses Staphylococcus aureus and potential exposure risks.

Staphylococcus aureus, commonly referred to as staph, is a type of bacteria that has long been recognized as a cause of disease in humans,” said Paul Cochrane, President of Cochrane and Associates, the company behind the IAQ Video Network. “Although most of the time it does not cause harm, it can sometimes cause infections.  These range from minor skin infections to more serious infections that can even be fatal in some circumstances.  We hope this new video helps to shed some light on this topic.”

This educational video was sponsored by a number of organizations and leading industry professionals that help to protect the public’s health. Sponsors include: EMSL Analytical, LA Testing, Clark Seif Clark, Zimmetry Environmental, Maine Indoor Air Quality Council, 2015 Northeast IAQ & Energy Conference and Healthy Indoors magazine to name a few.



Posted by Tim Sandle

Monday, 27 October 2014

Application of Single-Use Systems in Pharmaceutical Manufacturing

PDA Technical Report 66 (TR 66): Application of Single-Use Systems in Pharmaceutical Manufacturing has been released by the PDA.

PDA TR 66 discusses single-use systems that are in either direct or indirect contact with raw materials, intermediates, and pharmaceutical drug substances or drug products and is intended to provide the reader with critical concepts or points to consider when implementing an single use system strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.

The document does not intend to discuss disposable items related to laboratory activities, final delivery system to the patient, transfusion bags, packaging, or medical devices.
For details see: PDA

Posted by Tim Sandle

Sunday, 26 October 2014

ISO Standard 14001

The International Organization for Standardization (ISO) has announced that proposed revisions to ISO 14001, an international standard for environmental management systems, are open for comment.

The ISO 14000 standards focus on environmental management and provide the information that companies need to understand how to reduce their environmental impact and increase efficiency. ISO 14001 specifically targets environmental management systems; the proposed revision will expand the focus on environmental protection to include proactive solutions and top management responsibilities.

The standard is in the Draft International Standard (DIS) stage, fourth of six stages through which standard revisions move. In the three month-long DIS stage, any person can submit feedback and suggested changes to the revision committee. ISO standards are reviewed every five years to respond to trends and ensure that compatibility remains among all ISO standards.

An ISO report on emerging changes in the 14001 standard outlines seven specific areas that will be addressed in the revision. Each of the seven areas affects companies trying to commit to environmental protection as a business priority.


The proposed Strategic Environmental Protection clause features a requirement to  identify and leverage opportunities that benefit the organization and the environment, with a focus on issues or changing circumstances related to the needs and expectations of interested parties, regulatory requirements, and local, regional or global environmental conditions that can be affected by the organization.

The proposed Leadership clause adds assignments for specific responsibilities for individuals in leadership positions to increase the role of environmental management in an organization.

The standard’s Protecting the Environment clause will be expanded to include proactive measures for companies to commit to when adopting a greener business strategy. The overall evaluation will place expectations on companies to “protect the environment” to the best of their ability and with consistency to the company’s mission. Protection of the environment is open to interpretation depending on the company’s directives, with paths including more stringent pollution standards, adoption of sustainable resources, and protection of affected ecosystems.

The proposed Environmental Performance clause shifts emphasis from improving the company management system to focusing on reducing emissions and waste that impact the environment. Similarly, the Lifecycle Thinking clause will be expanded from concerns of environmental impact of goods and services to the entire lifespan of the product, including use and disposal.

The Communication clause will be expanded to include individuals working within the company to make suggestions for a greener business strategy, improved communication with regulatory agencies, and other companies.

Finally, the Documentation section will be changed to give companies the resources to decide when measures need to be taken to “ensure effective process control.” This amendment to the original standard also takes into account compatibility with ISO 9001, which focuses on the requirements of a quality management system.

At the end of the DIS stage in November, the standard will move into the Final Draft International Stage. Publication is expected for the end of 2015

For a copy of the standard, contact ISO or an appropriate national standards body.

Reference: ISO

Posted by Tim Sandle

Saturday, 25 October 2014

High-throughput cell-sorting

A new, high-throughput method for sorting cells has been developed, capable of separating 10 billion bacterial cells in 30 minutes. The finding has already proven useful for studying bacterial cells and microalgae, and could one day have direct applications for biomedical research and environmental science -- basically any field in which a large quantity of microbial samples need to be processed.

The new method was described in a September 2014 publication in the scientific journal Analytical Chemistry, "Surface free energy activated high-throughput cell sorting."

The new method relies on a measurement principle that sorts cells by differentiating their characteristic surface free energies.

For liquid surfaces, surface free energy is equal to surface tension. But for solid surfaces, such as the surface of cells, surface free energy cannot be measured directly. Instead, surface free energy for solids was previously estimated using a contact angle measurement with complicated theoretical interpretations.

For details see:

Xinru Zhang, Qian Zhang, Tao Yan, Zeyi Jiang, Xinxin Zhang, Yi Y. Zuo. Surface Free Energy Activated High-Throughput Cell Sorting. Analytical Chemistry, 2014; 86 (18): 9350 DOI: 10.1021/ac503100a

Posted by Tim Sandle

Friday, 24 October 2014

Antibacterial resistance a cause for major concern

Professor Stuart Elborn, an international authority on respiratory medicine, said that more funding and further research are required into antibiotic resistance in order to improve patient outcomes for people with Cystic Fibrosis.

In his paper, Infections in chronic lung diseases 2, which was recently published in The Lancet, Professor Elborn reviews current research into infections in chronic lung diseases. Professor Elborn and his colleagues state that while not all resistance found in bacteria is caused by antibiotics, the increasing resistance to antibiotics is proving a major problem in treating people with Cystic Fibrosis.

Professor Elborn stated: “We need more research into how to improve cystic fibrosis patient outcomes while reducing antibiotic resistance. We need to look at the use of compounds that may work against bacteria in a way that helps our current antibiotics to be more effective. Such compounds are readily available for treatment of other conditions. At Queen's we are leading the way and are working on developing some of these compounds.”

For further details see:

Laura J Sherrard, Michael M Tunney, J Stuart Elborn. Antimicrobial resistance in the respiratory microbiota of people with cystic fibrosis. The Lancet, 2014; 384 (9944): 703 DOI: 10.1016/S0140-6736(14)61137-5

Posted by Tim Sandle

Thursday, 23 October 2014

PCR for food microbiology

Real-time PCR assays for food microbiology have been developed into commercial products whereby some or all of the steps can be automated to minimise the number of operations involved and reduce the risk of contamination. Automation requires a higher capital investment and so will depend on the sample throughput required. The reaction usually takes place inside a computer-controlled combined thermocycler/fluorescence detection instrument and uses pre-prepared reagents. For foodborne pathogen detection tests, the entire process can be completed within 20-30 hours with sufficient sensitivity to detect a single cell in a 25g sample.

The main advantage for PCR-based methods is in shorter detection times, but the high degree of automation built into PCR systems also allows relatively unskilled staff to run them without extensive training. The high specificity of PCR can also mean fewer repeat tests. The principal disadvantage is currently cost, both in terms of capital outlay and consumables. While larger laboratories can benefit from reduced labour costs, economies of scale and rapid results, the benefits for smaller labs may be less clear.

A number of commercial PCR systems are currently offered for food pathogen detection. One of the first into the marketplace was the Bax® system from Dupont Qualicon and this has been joined by TaqMan® and MicroSEQ® food pathogen detection kits from Life Technologies, iQ Check real-time PCR kits from Bio-Rad, foodproof® real-time PCR detection kits distributed by Merck, and several others.

One of the main reasons for the comparatively high capital cost of PCR-based detection systems is the need for thermocycling during the amplification step. Instruments must be capable of very accurate and precise temperature control throughout the cycle. In addition to the capital investment for the instrumentation, the chemistry is also expensive as it uses fluorescent probes. Novel developments in DNA synthesis have demonstrated alternative solutions for DNA amplification under isothermal conditions without the need for a thermocycler. There are several types of nucleic acid amplification technologies. Amongst the isothermal DNA amplification technologies that have been developed, loop-mediated isothermal amplification (LAMP) has been used widely to detect microorganisms and is a promising and suitable technology for the rapid detection of pathogen in the field. LAMP uses multiple primers and a bacterial polymerase, Bst polymerase, derived from Bacillus stereothermophilus to amplify DNA rapidly at a constant 63oC. This does away with the need for a thermocycler component in the instrument and can reduce the cost by up to two thirds.

A commercial isothermal amplification system has already been developed for food pathogen detection. The 3M™ Molecular Detection System uses a unique bioluminescence method to detect the amplification of DNA sequences and is designed to be simple to use. The amplification and detection processes are completed within 75 minutes with real-time positive results available as early as 15 minutes. An overnight single enrichment step is still required at present. Test kits for E. coli O157 including H7, Salmonella and Listeria spp. detection in food and environmental samples are currently available.

Portable PCR-based instruments have also been developed recently. For example, Idaho Technology markets the ‘Ruggedized Advanced Pathogen Identification Device’ or R.A.P.I.D.® System, which uses an air thermocycling process and a fluorimetric detection system to detect Salmonella, Listeria, E. coli O157 and Campylobacter in food samples.
Posted by Rapid Microbiology

Wednesday, 22 October 2014

Scientists Discover an On/Off Switch for Aging Cells

Scientists at the Salk Institute have discovered an on-and-off “switch” in cells that may hold the key to healthy aging. This switch points to a way to encourage healthy cells to keep dividing and generating, for example, new lung or liver tissue, even in old age.

In our bodies, newly divided cells constantly replenish lungs, skin, liver and other organs. However, most human cells cannot divide indefinitely–with each division, a cellular timekeeper at the ends of chromosomes shortens. When this timekeeper, called a telomere, becomes too short, cells can no longer divide, causing organs and tissues to degenerate, as often happens in old age. But there is a way around this countdown: some cells produce an enzyme called telomerase, which rebuilds telomeres and allows cells to divide indefinitely.

In a new study published September 19th in the journal Genes and Development, scientists at the Salk Institute have discovered that telomerase, even when present, can be turned off.

Posted by Tim Sandle

Tuesday, 21 October 2014

Analytical & Bioanalytical Testing

Effective analytical instruments, methods, and testing services are vital to all phases of drug development. In this special e-book experts explain methods of identifying viral contaminants, assays for comparability testing of biosimilars, method transfer, data management, and assessing protein purification.

This is the basis of a new, free e-book from BioPharm

The book contains the following articles:
  • Viral Contamination: The Challenge of Finding the Unknown
  • Testing the Quality, Safety, and Efficacy of Insulin Biosimilars
  • Keys to Successful Method Transfer
  • Standardizing Data Management
  • Using the Purity Quotient Difference to Assess Protein Purification

For details, see BioPharm

Posted by Tim Sandle

Cleanroom Clothing Practices in the Healthcare and Pharmaceutical Sector


Pharmig presents:
Cleanroom Clothing Practices in the Healthcare and Pharmaceutical Sector
Tuesday 28th October 2014
Best Western Plus Windmill Village Hotel, Golf & Spa, Coventry

09.00 – 09.30                       Registration with tea/coffee
09.30 – 09.45                       Chairs introduction
                               
                Dr. Tim Sandle – BPL and Pharmig Committee Member

09.45 – 10.30                       Microbiological regulatory aspects of garments and gloves
                                                Speaker: Greg Cochran – Micronclean

10.30 – 11.15                       Microbiological risk to cleanrooms and disinfection
-          Cleanrooms
-          Contamination and contamination sources
-          Selecting detergents and disinfectants
                                                Speaker: Dr. Tim Sandle – BPL & Pharmig Committee Member

11.15 – 11.45                       Morning break with tea/coffee

11.45 – 12.30                       Cleanroom garments for effective ongoing contamination control
                                                -      Personnel contamination and Regulatory Authority requirements
-          Requirements for effective cleanroom garments and assessment for garment lifetime
-          Gowning procedures and validation
-          Garments and cleanroom energy considerations
                                                Speaker: Tim Eaton – AstraZeneca

12.30 – 13.30                       Lunch

13.30 – 14.15                       Gloves and standards
-          What are the ideal properties of gloves for aseptic properties
-          Weaknesses of gloves
-          Use of gloves in isolators
-          Comparisons between American and European standards
-          Chemical and microbiological testing
-          Cytotoxic testing
-          Practical approach to gloves and standards
                Speaker: Mark Oldcorne – Wrexham Maelor Hospital

14.15 – 15.00                       Validation and Application of Hand Hygiene Products
                Speaker: Laura Guardi – ECOLAB

15.00 – 15.20                       Afternoon break with tea/coffee

15.20 – 16.00                       Q&A with the Expert Speaker Panel & Conducting a Cleanroom Clothing Survey
                                               
This session will be dedicated to delegates where they can ask speakers additional                                                                                questions relating to Cleanroom Clothing issues.                                          
                                                We also ask that within this session you kindly take the time to complete a questionnaire                                                    on Cleanroom Clothing –the aim of which is to look to produce a ‘Best Practice and Issues                                                   around Cleanroom Clothing in the Healthcare and Pharmaceutical Sectors’ as an article                                                                     and/ or publication

16.00 – 16.15                       Chair’s closing remarks

For details contact Pharmig

Posted by Tim Sandle

Monday, 20 October 2014

Exploring pulmonary pathology


The test of the pulmonary function represents an auxiliary method for the specialty medical examination the patient to determine if there are signs and symptoms relevant to a pulmonary pathology. This is the basis of a new article by Antonella Chesca and Tim Sandle.



The abstract runs:

“This study evaluates the respiratory parameters associated with pulmonary diseases. The study was centred on a comparative evaluation of the pulmonary function during the same two periods of two different years: January - February 2013 and January – February 2014. The data was analysed and comparison was undertaken between the severity of the pulmonary diseases symptoms requiring spirometries, during the cold season in two succeeding years. The study applied to symptomatic patients suffering from COPD or asthma who were referred to the Specialty Outpatient Department of the Pneumophthisiology Hospital of Brasov. To determine the diagnosis and to apply the appropriate medication, the study examined the function tests by spirometry for each of the patients in the study group. As applicable, spirometry was carried out by tests using salbutamol, according to the orders of the specialty doctor. The analysis of the study data enabled the creation of the profile of the symptomatic patients.”

The reference is:

Chesca, A. and Sandle, T. (2014) Data on the examination of functions in pulmonary disease, Acta Medica Transilvanica, 2 (3): 208 – 210

For a copy, please contact Tim Sandle

Posted by Tim Sandle

Antibiotic resistance continues to rise

“Antibiotic resistance continues to rise,” BBC News reports as, despite warnings, the number of antibiotic prescriptions in the UK continues to soar, as do new cases of resistant bacteria.

The news follows the publication of a new report by Public Health England on the English surveillance programme for antimicrobial utilisation and resistance (ESPAUR), which reports the change in antibiotic prescribing and resistance over recent years.

The report highlights a number of key findings, including a year on year increase in antibiotic prescribing in England, with the majority of antibiotic prescribing taking place in general practice. There also seems to be variation across the UK, with areas with higher antibiotic prescribing also having higher rates of resistant infections.

Public Health England hopes this report will enable general practices and hospitals to compare their data with regional and national trends. They could then see if their rates are higher than other areas, and investigate why and if they can reduce these. This will also provide a baseline measure from which to track changes in both prescribing and resistance in England.

Posted by Tim Sandle

Sunday, 19 October 2014

Entire genome of a Klebsiella pneumoniae strain sequenced

Microbiologists, for the first time, recently sequenced the entire genome of a Klebsiella pneumoniae strain, encoding New Delhi Metallo-beta-lactamase (NDM-1).

Assembling an entire genome is like putting together a puzzle. Klebsiella pneumoniae turned out to have one large chromosome and four plasmids, small DNA molecules physically separate from and able to replicate independently of the bacterial cell's chromosomal DNA. Plasmids often carry antibiotic resistant genes and other defense mechanisms.

The researchers discovered their Klebsiella pneumoniae bacteria encoded 34 separate enzymes of antibiotic resistance, as well as efflux pumps that move compounds out of cells, and mutations in chromosomal genes that are expected to confer resistance. They also identified several mechanisms that allow cells to mobilize resistance genes, both within a single cell and between cells.

For further details, see:

Corey M. Hudson, Zachary W. Bent, Robert J. Meagher, Kelly P. Williams. Resistance Determinants and Mobile Genetic Elements of an NDM-1-Encoding Klebsiella pneumoniae Strain. PLoS ONE, 2014; 9 (6): e99209 DOI: 10.1371/journal.pone.0099209

Posted by Tim Sandle