Friday 30 March 2018

First Ph. Eur. monograph on a monoclonal antibody

The European Pharmacopoeia Commission has achieved an important milestone in the field of biotherapeutic products with the adoption of the monograph for Infliximab concentrated solution (2928).

The Ph. Eur. Commission embarked upon the setting of public standards for therapeutic monoclonal antibodies (mAbs) in 2014 with a pilot phase and following extensive consultation with its stakeholders.


Posted by Dr. Tim Sandle

Tuesday 27 March 2018

Benefits of Laboratory Glove Boxes with Gas Purging Option

At the time of experimenting in the laboratory, you may never know what would happen next. However, the fact is with the help of Laboratory Glove Boxes with Gas Purging Option, you can actually control the atmosphere glove boxes. It is known by many names. Some knows it by the name of inert atmosphere glove box, dry box, nitrogen box, and even the anaerobic box to name a few. For such type of box to function in the most convenient manner, there is an internal atmosphere which is first removed. It is then well replaced with the purified inert gas which is more commonly either argon or nitrogen.

A guest post by Naveen Kumar 

Understanding the operation of the Box:

The prime role of the Laboratory Glove Boxes with Gas Purging Option is to make sure you actually safeguard yourself from the harmful atmosphere that is likely to happen in the changing environment at the time of experimenting. This type of gas is based on the refill operation and gas removal process. The moisture level and oxygen level gets reduced to around 1% and is done either with the solution or through the displacement. If it is not used with the automatic purge control system then there is a requirement of the inert gas which is needed for better safety. With such box, the atmospheric pressure systematic position and the regulation of the same get introduced to the chamber through the internal ambient and inlet atmosphere.

Know the benefits of Inert Atmosphere Glove Boxes

The best part about Laboratory Glove Boxes with Gas Purging Option is the use of argon and nitrogen that would lessen down the concentration of the oxygen within the equipment that would reduce the effects of the oxidation. Such type of gas is mostly used because of the huge abundance and relatively less cost. It is most probably used for preventing the unwanted chemicals reaction such as hydrolysis and oxidation. This way the degrading process becomes a lot simpler. Besides, the reason such gloves is used is because of the inert gasses which gets naturally dried out and does not hold any kind of mistier.

Things you must not ignore:

Such type of Desiccator Box is usually kept under the high pressure which is then well with the surrounding air. This way the blocking of the ambient room is done along with the contamination blockage. Other alternative options do exist such as PVC, Acrylic and even the polycarbonate which is quite in demand. The air that usually passes through the membrane is then allows to absorb the moisture from the chamber’s outside and then pass it inside.

Laboratory Glove Boxes with Gas Purging Option is something that makes sure there is a regular pressure of course in a positive manner to make sure the contamination blockage is done while the moisture inflow is initiated. Besides, it also activates the high flow purge in response to the pressure that gets dropped to make sure it becomes effective and fast while the air lock gets opened up. It also works as the guard again the protection damage.

Posted by Dr. Tim Sandle

Sunday 25 March 2018

Different Type Of Laboratory Fume Hoods and Laboratory Glove Boxes

A laboratory fume hood can also be called an exhaust hood, it is a ventilation system which is designed to limit the exposure of hazardous and toxic fumes, vapours and dust. This is the primary function of a laboratory fume hood to act as a ventilation unit. The secondary function involves safeguarding or protecting against chemical spill over and unwanted runaway reactions. It also acts as aphysical barrier and helps in preventing fires.

A guest post by Naveen Kumar

There are basically two types of Laboratory Fume Hoods one is Ductless Exhaust Fume Hoods and the other one is Ducted fume hoods

Ductless Exhaust Fume Hoods ventilate and remover of hazardous chemical fumes or vapours through activated charcoal filters. Thus, allowing thesafe indoor release of exhaust. The HEPA / ULPA filters provide the clean and particle-free environment.

Ducted fume hoods, on the other hand, ventilate to theouter side and provide the more protection against chemically dangerous fumes. Now let’s look at the different variations in Ductless Exhaust Fume Hoods and Ducted Hume Hoods.

Ducted Fume Hoods - High Clearance

High clearance construction laboratory fume hoods also referred as ducted exhaust hoods or chemical fume hoods are available in different sizes from 18″ to 72″ width, they include spill chemical tray/ polypropylene worksurface. These are ideal for applications which require exterior ducting for exhaust and require full visibility of the fume hood interior. These fume hoods have two optional fan modules with adjustable air speed. Ducted fume hoods are ideal for soldering or chemical processing that requires the removal of potentially hazardous fumes from low-level corrosive vapours. These can be made of Polycarbonate, non-dissipative PVC and ESD PVC construction materials.

Ductless Fume Hoods- Portable
Carbon & HEPA filtered enclosures are also known as filtered fume hoods. These are ductless laboratory enclosures that remove hazardous fumes, vapours and particles from the laboratory. These ductless containment hoods are available in sizes of 24″, 32″ width and can be used for removing chemical fumes, dust particles, pharmaceutical powder and solvent or acid vapour.

Ducted Fume Hoods - Polypropylene

Polypropylene laboratory fume hoods are very durable and chemical resistant are turnkey ventilation system designed for applications that require exterior ducting for exhaustion. These chemical fume hoods are bottomless that can be placed over the standard size worktables. These laboratory exhaust hoods can be equipped with fan module. These are agreat choice in cases in which chemical processing requires the removal of potentially hazardous fumes.

Ducted Fume Hoods- Stainless Steel

Stainless steel fume hoods have good resistance power to a wide range of chemicals and act as excellent moisture and heat resistants. They can be decontaminated and cleaned easily and they are ESD safe, that makes them suitable for electrostatic-sensitive applications. The sash is static dissipative PVC and worksurface is optional and removable. They come with or without exhaust blower unit depending on your need. Their Primary function is to provide personal protection against toxic fumes, vapours and dust but is not compatible with some acids.

Containment Ventilated Enclosures (CVE)

Containment ventilated enclosures are also known as HEPA filtered exhaust hood or powder containment hood. These are good for powder handling, such as non-sterile hazardous drug compounding in pharmacies. They can be used to protect theuser from particles at the same time while weighing, mixing, preparing, compounding, dispensing, administering HDs or low to moderately hazardous powders.

Ductless Down flow Workstations

The down flow hoods are constructed from polypropylene and have a removable stainless-steel work surface that can be easily removed and cleaned. They collect powders or vapours through perforations on the work surface. These are available in 24”, 32”, 36” width. They are perfect for handling pharmacy drugs & medicines, chemical latent print development, solvent and chemical preparations.

Check out the air lock features of Closed Laboratory Glove Boxes

It is a known fact that most of the laboratories in both commercial and domestic sectors used quality closed loop filtration globe options in an effective way. It is widely recommended for people to check for quality glow boxes because it plays a crucial role for people to improve the results on a regular basis. Most of the Laboratories have made it mandatory for people to use Laboratory Glove Boxes while examining a biological sample from time to time.

Why used Closed Loop Filtration Glove Boxes

Closed loop filtration boxes have been used widely in large-scale Laboratories because it helps them to perform necessary tests in order to find accurate results on a regular basis. Some of the quality closed-loop filtration boxes provide an easy option for people to work in a quick span of time. Closed loop filtration glow boxes are widely used because it provides a convenient option for people to adjust the temperature and features based on the requirement in an effective way.

Features of Closed Loop Filtration Glove Boxes

Effective air lock features - Air lock features plays a crucial role for every user because it helps them to adjust the glove box to find accurate results in a quick span of time. It is highly recommended for people to check for equality Laboratory Glove Boxes because it helps them to use the airlock features for a long span of time without compromising on the performance effectively.

Constant temperature adjustment - It is necessary for people don't look for a constant temperature adjustment while working on a Laboratory Glove Boxes because it helps them to find accurate results in a quick span of time. Most of the people would prefer to use a quality glove box because it helps them to adjust the temperature without causing any contamination of the sample in an effective way

Healthy option - It is evident that using quality Laboratory Glove Boxes plays a vital role while working in the laboratory because minor contamination could cause infection to the people from time to time. It is necessary for people to stay healthy and away from infections because of biological samples, as it could decrease the productivity and cause a lot of health problems in an effective way.

Low-contamination - It is necessary for people to check for the contamination levels while working in both commercial and domestic Laboratories on a regular basis. A Laboratory Glove Boxes provides efficient protection to biological samples without contaminating in an effective way.

Posted by Dr. Tim Sandle

Bacteria Produce Gold by Digesting Toxic Metals

Bacterium C. metallidurans has found a way to extract valuable trace elements from a compound of heavy metals without poisoning itself.

The rod-shaped bacterium C. metallidurans primarily lives in soils that are enriched with numerous heavy metals. Over time some minerals break down in the soil and release toxic heavy metals and hydrogen into their environment. There is one interesting side-effect: the formation of tiny gold nuggets.

In nature, C. metallidurans plays a key role in the formation of so-called secondary gold, which emerges following the breakdown of primary, geologically created, ancient gold ores. It transforms the toxic gold particles formed by the weathering process into harmless gold particles, thereby producing gold nuggets.

To learn about this remarkable bacterium, see Laboratory Manager magazine.

Posted by Dr. Tim Sandle

Friday 23 March 2018

West Nile virus can cause fetal brain damage

Two viruses closely related to Zika -- West Nile and Powassan -- can spread from an infected pregnant mouse to her fetuses, causing brain damage and fetal death, according to a new study. The findings suggest that Zika may not be unique in its ability to cause miscarriages and birth defects.

Researchers injected female mice at day six of their pregnancies with one of the four viruses, then examined the placentas and fetuses a week later.

All four viruses infected the placentas and fetuses, but levels of West Nile virus were 23- to 1,500-fold higher than those of the other three viruses in the placentas, and 3,000- to 16,000-fold higher in the heads of the fetal mice.

In addition, brain tissue from West Nile-infected fetuses showed severe damage under the microscope, while brain tissue from chikungunya-infected fetuses appeared healthy.


Derek J. Platt, Amber M. Smith, Nitin Arora, Michael S. Diamond, Carolyn B. Coyne, Jonathan J. Miner. Zika virus–related neurotropic flaviviruses infect human placental explants and cause fetal demise in miceScience Translational Medicine, 2018; 10 (426): eaao7090 DOI: 10.1126/scitranslmed.aao7090

 Posted by Dr. Tim Sandle

Thursday 22 March 2018

World Water Day - global toxic algae bloom

To spotlight the global environmental and economic challenges caused by harmful algal blooms in fresh waterbodies, The Scotts Miracle-Gro Foundation today released a three-part docuseries with National Geographic photographer Andy Mann, coinciding with World Water Day.

Typically caused by excess phosphorus, harmful algal blooms pollute freshwater in more than 15,000 waterways in the U.S. and impact all 50 states. The issue threatens drinking water and wildlife and is estimated to cost the U.S. economy $2.2 billion annually.

Water Positive: Reflections on the Algal Bloom Crisis

National Geographic photographer Andy Mann visits U.S. watersheds to document the growing algal bloom crisis.

The three-part docuseries features Mann's perspective on the algae issue and captures stories of major watersheds impacted by algal blooms. Viewers will hear stories from farmers, fishermen, scientists, non-profit organizations, and families - all of whom are affected by and working toward a solution.

Water Positive: The Story of Lake Erie

Andy Mann connects with local farmers, fishermen, scientists, and families to understand how the algal blooms impact people and industry surrounding Lake Erie.

"When I visited these watersheds and started speaking with the people in the communities affected, I realized the severity of the algae bloom problem," said photographer Andy Mann. "I met parents afraid to give their children water to drink, fishermen losing businesses because the fish have left and scientists working around the clock to get ahead of the next bloom. I also uncovered stories of innovation and progress that gave me great hope that a solution is within reach."

The docuseries is the latest in an effort to create more visibility for challenges caused by harmful algae blooms and the work that is being done to solve for it. Last year on World Water Day, the Foundation announced that it would be the presenting sponsor of The George Barley Water Prize. The global competition, funded by the Everglades Foundation, will award $10 million to the organization that discovers a cost-effective way to remove phosphorus from freshwater and repurpose it for future use.

On World Water Day in 2011, The Scotts Miracle-Gro Company announced it would remove phosphorus from its lawn fertilizer products, a decision that reduced the amount of phosphorus used by consumers by more than 10,000 tons annually. The Company also has increased its use of slow release nitrogen and taken steps to redesign spreaders and other application devices to minimize the potential for misuse and runoff.

Water Positive: The Story of the Long Island Sound
To help document the most troubled waterbodies in the U.S. and uncover how this crisis is affecting communities across the nation, the Foundation has worked collaboratively with Mann and his team of photographers for the past year, creating a series of short videos that will be distributed beginning today on social media and the Foundation’s website. Mann and his crew filmed several sites and conducted dozens of interviews in reporting on the issues affecting Lake Erie, Long Island Sound and the Chesapeake Bay.

"We're proud of the steps that our company has taken to improve the environment as well as the support that our foundation is providing to groups who share our goals," said Jim King, president of The Scotts Miracle-Gro Foundation. "Water is our world's most precious resource and it's everyone's job to protect it. Through the art of storytelling and the power of Andy's amazing videography, the goal of this series is to help the public better understand the magnitude of this issue and to shine a light on the world-class efforts that are underway to help solve it."

To view the full docuseries or learn more about water quality issues and solutions, visit Follow Andy Mann at

Monday 19 March 2018

Data Integrity Considerations for Conventional and Rapid Microbiological Methods

Despite the current high profile, the subject of data integrity in the pharmaceutical microbiology laboratory has not been afforded very much attention in terms of regulatory guidance. This article looks at two data integrity concerns within the microbiology laboratory, one relating to conventional methods and one to rapid methods, and considers some of the steps that can be taken to address identified weaknesses.

Tim Sandle has written a short article on data integrity and microbiology for Rapid Microbiology. The reference is:

Sandle, T. (2018) Data Integrity Considerations for Conventional and Rapid Microbiological Methods, online:

The article can be accessed here.

Posted by Dr. Tim Sandle

Sunday 18 March 2018

Outbreak of fungal central nervous system and osteoarticular infections

A new research article of interest:

A multistate outbreak of fungal central nervous system (CNS) infection and septic arthritis was detected in the United States in late September 2012. Over 700 patients who received epidural injections of methylprednisolone produced at a single compounding center (New England Compounding Center) developed meningitis with or without posterior circulation stroke and/or spinal or paraspinal infections, and more than 30 patients who received intraarticular injections of the same drug developed osteoarticular infections [1-3]. Exserohilum spp, a dematiaceous (brown-black) fungus, has been the most commonly identified fungus (picture 1).

The United States Centers for Disease Control and Prevention (CDC) issued recommendations for the diagnosis and management of patients affected by the outbreak. These recommendations can be found on the CDC website.

This outbreak highlights the importance of suspecting environmental contaminants as a cause of infection introduced by a potentially contaminated drug or other compound in patients with a suggestive clinical presentation. This is particularly relevant in patients who have received products prepared by compounding pharmacies, which have substantially less federal oversight than traditional pharmaceutical companies. (See 'Compounding pharmacies'below.)

The epidemiology, clinical manifestations, and diagnosis of fungal CNS and osteoarticular infections associated with the outbreak will be discussed here; the treatment of such infections is presented separately. Infections due to dematiaceous fungi and Aspergillus spp that are not associated with the outbreak are also discussed separately. (See "Outbreak of fungal central nervous system and osteoarticular infections in the United States: Treatment" and "Central nervous system infections due to dematiaceous fungi (cerebral phaeohyphomycosis)" and "Epidemiology and clinical manifestations of invasive aspergillosis", section on 'Central nervous system infection' and "Diagnosis of invasive aspergillosis".)

Posted by Dr. Tim Sandle

Saturday 17 March 2018


A new article of interest:

Beyond the usual engineering aspects of validation with regard to specification, installation, commissioning, qualification, and calibration, the two important aspects of validation of dry heat processes are thermal validation and endotoxin validation. Sterility is the most important and absolutely essential characteristic of a parenteral product. Sterility means the complete absence of all viable microorganisms. Depyrogenation devices, such as tunnels, are used in the pharmaceutical industry to prepare components for aseptic filling. To qualify such devices, various pharmacopoeias require depyrogenation devices to be periodically challenged with high levels of bacterial endotoxin. Although the pharmacopoeias state the acceptance criteria, little consideration is given to the practical approach. The review highlight the theoretical concept of depyrogenation and the various tests performed for the qualification of Depyrogenation Tunnels.

See: Depyrogenation article

The article cites: Tim Sandle, A Practical Approach to Depyrogenation Studies Using Bacterial Endotoxin.; J GXP Compli. 2011; 15(4): 90-96

Posted by Dr. Tim Sandle

Wednesday 14 March 2018

Most U.S. electricity demand can be met by renewables

A new study shows that up to 80 percent of the U.S. business and home energy demands can be met through the use of renewable energy sources, especially wind and solar power. The main limitation is with energy storage.

In fact, it is theoretically possible to meet the entire U.S. energy demand through renewable sources. However, the 100 percent aspirational target in terms of electrical demand would require huge investment in investment in greater storage capacity and power transmission capabilities. Efficient storage solutions are essential with renewable sources due to the cycle of natural variability.

The assessment of energy comes from a collaborative effort from the University of California, Irvine; the California Institute of Technology; and the Carnegie Institution for Science. The group of scientists analyzed thirty-six years of hourly U.S. weather data (collected during the period 1980 to 2015). This analysis allowed the researchers to understand the primary geophysical barriers in place that would affect supplying electricity to U.S. homes and businesses only using solar and wind energy sources.

One of the researchers, Professor Steven Davis explains to Laboratory Manager magazine: “We looked at the variability of solar and wind energy over both time and space and compared that to U.S. electricity demand.”

He proceeds to outline: “What we found is that we could reliably get around 80 percent of our electricity from these sources by building either a continental-scale transmission network or facilities that could store 12 hours' worth of the nation's electricity demand."

The researchers said that such expansion of transmission or storage capabilities would mean very substantial—but not inconceivable—investments. They estimated that the cost of the new transmission lines required, for example, could be hundreds of billions of dollars. In comparison, storing that much electricity with today's cheapest batteries would likely cost more than a trillion dollars, although prices are falling.

Posted by Dr. Tim Sandle

Monday 12 March 2018

Liquid Immersion Microbial Challenge Tests

The container closure system for pharmaceutical products intended to be sterile is critical and this criticality relates to the physical properties of the container closure system in that a poorly designed or manufactured system will result in microbiological penetration. Factors to take into account with, for example, rubber-stoppered glass vials include having the correct dimensional specifications for the internal diameter of the neck opening and its depth, the internal and external diameters of the flange. Other factors are the concentricity of the flange, the neck and the body of the vial. Any angularity of the flange versus the vertical center line of the vial must be specified; so must the physical finish of the surface of the flange and internal neck bore to ensure satisfactory mating with the closure. Closures must be specified in terms of diameters, depth, thickness and elasticity.
This is the basis of a new article by Tim Sandle.

Tests to verify the container-closure can be grouped as microbial tests or non-microbial (physical) tests. Physical tests include the dye test; vacuum testing (typically leak testing with sensitivity to detect leaks down to approximately 5-10 microns); gas leakage determined using a bubble test; liquid leakage detected by atomic absorption of a copper ion tracer solution; laser-based gas headspace analysis using a frequency modulation spectroscopy; high voltage leak detection (which detects package defects using an electrical current); or a helium leak rate test (which quantitates the flow rate of helium from leaks in packaging after having been flooded with helium as a tracer gas).

Where microbial tests are required, there are various factors to consider. These form the basis of the paper.

Then reference is:

Sandle, T. (2017) Liquid Immersion Microbial Challenge Tests: Microbial Testing for Container Closure Integrity, Journal of Validation Technology, 23 (6): 1-10 (see:

Posted by Dr. Tim Sandle

Friday 9 March 2018

Lab-on-a-chip for tracking single bacterial cells

Researchers at the Biozentrum of the University of Basel, together with researchers from the Max Planck Institute in Dresden, have set up a novel lab-on-a-chip with accompanying automatic analysis software.

Using the new system the researchers can now study precisely how genes are regulated in single cells under changing environmental conditions. This way, they do not only gain insights into gene regulatory processes but also an overview of the diversity of adaptive responses of bacteria to varying environments.

For example, it is possible to investigate how individual bacterial cells respond to a sudden exposure to an antibiotic: whether they die, stop growing, or simply continue to divide undisturbed. It is also possible to observe the antibiotic's increasing effect duration on the cells. This is important to understand why antibiotics do not always kill all pathogens.


Matthias Kaiser, Florian Jug, Thomas Julou, Siddharth Deshpande, Thomas Pfohl, Olin K. Silander, Gene Myers, Erik van Nimwegen. Monitoring single-cell gene regulation under dynamically controllable conditions with integrated microfluidics and softwareNature Communications, 2018; 9 (1) DOI: 10.1038/s41467-017-02505-0

Posted by Dr. Tim Sandle

Wednesday 7 March 2018

Annex 1 calls for a contamination control strategy

A new draft of the European Union (EU) Guidelines to Good Manufacturing Practice (GMP) Annex 1, for sterile medicinal products manufacture, has been issued for public comment. The draft calls on each pharmaceutical manufacturing facility to have a holistic contamination control strategy in place. The points for inclusion in such a strategy are alluded to in the draft; this article draws these points out and provides some examples of what should be included. This may prove to be a useful framework for GMP facilities to review their practices against.

Tim Sandle has written an article for GMP Review on one of the main elements of the new draft guidance for sterile drugs manufacturers, from the European Commission.

The reference is:

Sandle, T. (2018) Annex 1 calls for a contamination control strategy, GMP Review, 16 (3): 4-7

For further details please contact Tim Sandle

Posted by Dr. Tim Sandle

Tuesday 6 March 2018

Pharmaceutical Companies Impacted by New Data Laws

Processing of personal data is of the utmost importance for pharmaceutical companies for their operations, which are highly dependent on collecting, classifying, and analyzing personal data of patients, physicians, and other healthcare professionals.

The DP Code and Its Application to Pharmaceutical Companies

OVER the last decade, the Turkish Grand National Assembly made repeated attempts to enact a data protection law, but only found success after final ratification of a longstanding treaty. Signed in 1981, Turkey finally approved the ratification of the Council of Europe’s Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data ("Convention 108") on February 18, 2016, which ultimately led to passage of the Personal Data Protection Code[1] ("DP Code") on March 24, 2016. The DP Code became fully effective in its entirety on October 7, 2016 following the end of the grace period in relation to the enforcement certain provisions.

For more, see: LEX

The processing of personal data includes any operation that is performed upon personal data such as collection, recording, storage, preservation, alteration, adaptation, disclosure, transfer, retrieval, making available for collection, categorization, or blocking its use, wholly or partly, by automatic means or by means other than automatic means, which form part of a filing system. Storage and use of data relating to customers, patients, healthcare professionals, or employees, which constitute a significant part of a pharmaceutical company’s operations, are likely to fall within the scope of processing of personal dataunder the DP Code. Therefore, pharmaceutical companies must implement necessary measures in order to comply with the principles and procedures set forth under the DP Code while conducting their daily operations.

Posted by Dr. Tim Sandle

Sunday 4 March 2018

'Forgotten' antibiotic offers hope against superbugs

An antibiotic overlooked since its discovery 40 years ago could help develop new drugs against life-threatening infections caused by some of the world's most dangerous superbugs.

University of Queensland Institute for Molecular Bioscience (IMB) researchers synthesised the antibiotic, and increased its effectiveness against extensively drug-resistant bacteria, then collaborated with Monash University to evaluate the drug using animal models of infection.

Professor Matt Cooper, Director of IMB's Centre for Superbug Solutions, said the study was prompted by the urgent need for new drugs to counter widespread resistance to last-resort treatments.

"Octapeptins were discovered in the late 1970s but were not selected for development at the time, as there was an abundance of new antibiotics with thousands of people working in antibiotic research and development," Professor Cooper said.

"Given the very few researchers left in this field now, and the sparse pipeline for new antibiotics, we've used modern drug discovery procedures to re-evaluate its effectiveness against superbugs."

Professor Cooper said there were no new classes of antibiotics available for Gram-negative bacteria, with increasing incidence of extensive drug resistance around the world.


Tony Velkov, Alejandra Gallardo-Godoy, James D. Swarbrick et al Structure, Function, and Biosynthetic Origin of Octapeptin Antibiotics Active against Extensively Drug-Resistant Gram-Negative BacteriaCell Chemical Biology, 2018; DOI: 10.1016/j.chembiol.2018.01.005

Posted by Dr. Tim Sandle

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