Saturday, 31 March 2018

Mixing, diluting, or repackaging biological products outside the scope of an approved Biologics License Application


This final guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging
of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product’s approved biologics license application (BLA) as described in the approved labeling for the product.



Posted by Dr. Tim Sandle

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.

See: https://www.edqm.eu/en/node/16070

Posted by Dr. Tim Sandle

Thursday, 29 March 2018

Technical Guide on 2D Measurement System


A useful guide on improving productivity with the Image Measurement System. It includes implementation examples and customer reviews about the benefits of
  • Automatic report generation,
  • Unified measurement results regardless of the user ,
  • Simple operation. 
Download the Image Dimension Measurement Guide here

Posted by Dr. Tim Sandle

Wednesday, 28 March 2018

New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States


New program to reduce animal testing relating to toxicology in the U.S.

This strategic roadmap is a resource to guide U.S. federal agencies and stakeholders seeking to adopt new approaches to safety and risk assessment of chemicals and medical products that improve human relevance and replace or reduce the use of animals. This document was developed with input from members of 16 federal agencies, multiple interagency workgroups, and input from the public. As such, it represents a consensus perspective that does not necessarily reflect opinions or policy of any specific agency or workgroup, and should not be taken as a commitment by any federal agency.

Activities to implement the strategic roadmap goals are already underway. ICCVAM workgroups will develop detailed implementation plans to address roadmap goals, tailored to specific toxicological endpoints of concern.


To expedite the use of 21st-century science to protect and improve public health, federal agencies and stakeholders will work together to build a new framework to enable development, establish confidence in, and ensure use of new approaches to toxicity testing that improve human health relevance and reduce or eliminate the need for testing in animals. The successful development and implementation of these new approaches will require coordinated efforts that address the three strategic goals described below.

(1) Connect end users with the developers of NAMs
(2) Foster the use of efficient, flexible, and robust practices to establish confidence in new methods
(3) Encourage the adoption and use of new methods and approaches by federal agencies and regulated industries

Posted by Dr. Tim Sandle

Tuesday, 27 March 2018

Process Analytical Technology (PAT)


Pharmeuropa Volume 30, Issue 1 (January 2018) contains a new monograph on ‘Process Analytical Technology’.

The introduction reads:

“Process analytical technology (PAT) can be defined as a system for designing, analysing and controlling manufacturing processes through timely measurements (i.e. during processing) of critical quality attributes (CQA), and critical performance characteristics of raw materials, in-process materials and processes, in order to ensure the quality of the final product. It is important to note that the term ‘analytical’ in PAT is used in a broad sense to include chemical, physical and microbiological measurements conducted in an integrated manner and combined with data analysis. The goal of PAT is control of the manufacturing process and enhanced process understanding, guided by risk management. Interfacing manufacturing processes with analytical techniques is therefore essential in PAT, as it facilitates process development in accordance with quality by design (QbD) principles, enables real-time release testing (RTRT) and supports continuous manufacturing processes.

Time delays between obtaining a sample for testing, analysis of that sample and any consequent outcomes must be taken into consideration when applying PAT. When the analytical results are used on a continuous basis to monitor and control a process, it is important to minimise such delays. This can be achieved most effectively with sensor-based continuous measurement systems directly interfacing with the process stream during a specific unit operation. The sensors continuously measure the process conditions and material characteristics within the process environment (in situ) and send the measured data (e.g. a spectrum) to an operating system where it is recorded and analysed, and where any necessary adjustments to processing conditions can be determined on a continuous basis. These in situ measurements can generate very large volumes of data representative of the process.”

For details see: Pharmeuropa

Posted by Dr. Tim Sandle

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

Monday, 26 March 2018

Combining copper with effective hygiene


Copper – for many centuries known for its antimicrobial properties – is increasingly being used in hospitals and other healthcare facilities worldwide as an aid to infection control and reducing healthcare associated infections. This article discusses how antimicrobial surfaces incorporating copper can assist with hospital infection control programmes and the fight against nosocomial infection.
Tim Sandle has written a new article on the antimicrobial properties of copper:

Sandle., T. (2017) Combining copper with effective hygiene, Health Estate Journal, October 2017, pp43-46

For a copy, please contact Tim Sandle

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

Saturday, 24 March 2018

Pharmeuropa Volume 30 No 1, January 2018


Certificate of suitability of Monographs of the European Pharmacopoeia (CEP).

A manufacturer of a substance can provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by a CEP granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). The CEP confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the EP. The CEP bridges between European Pharmacopoeia monographs and the need to prepare a file for licensing and thus it also bridges between industry and health authorities.

Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31 March 2018.

See: EDQM

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.

See:

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

https://www.youtube.com/watch?time_continue=4&v=jFfETQCXV5s

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

https://www.youtube.com/watch?time_continue=29&v=Y09TD9KzY6A

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

https://www.youtube.com/watch?v=X2guFaGh8tY
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 www.ScottsMiracleGroFoundation.org. Follow Andy Mann at www.instagram.com/andy_mann/

Ph. Eur. Supplement 9.5


Supplement 9.5 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of July 2018, and to follow the instructions given in the document.

The need to submit information to EDQM following a revised monograph depends on the changes made to the monograph. Updates to the monographs are classified by EDQM into “Case A” and “Case B” and this influences the information required.

For details, see EDQM.

Posted by Dr. Tim Sandle

Wednesday, 21 March 2018

Know about the importance of using lab fume hoods


If you work under laboratory chemicals and have conscious about the chemicals, it is always better to choose some reliable and safe laboratory equipment. The lab equipment has specially made to offer a safe place to preserve the chemicals. Once we start preserving the chemicals, we may need to keep it in the sterile environment. This is the basic requirement for all kinds of lab chemicals. In this case, definitely one need to use additional equipment to preserve the chemicals, and that named as Laboratory Fume Hoods. This fume hood is the place where the chemicals can preserve carefully without any germ attack.

Guest post by Naveen Kumar

You may still wonder why does one has to use a fume hood. Here is your answer to the above question. How many of you agree that inhalation is the major route for the entry of chemicals into the body. Vapors or fumes from the chemical can directly enter the bloodstream and when it happens, the small particles can camp in alveolar portion of the lungs.   When you find the properly operated and designed fume hoods, it will reduce the exposure to vapors, hazardous fumes from the chemicals, dust, and the gases.

The fume hood was designed to limit the hazardous airborne materials by just diluting with air, just drawing the fume through the exhausting system and then this will expel an air in the vents present in the roof of the building. The proper usage of the fume hoods can also help in shielding the workers from some form of uncontrolled reaction.

This equipment has mainly designed to work with the laboratory environment. The fume hoods have inspected and tested it on annual basis in order to assess the standard performance, but everything is up to the user. Once we start using the lab equipment, it is necessary to know how it works and what the perfect ways to use it. Here is the point to know the working of fume hoods.


Initially, fume hoods will draw an air out of the room when they installed in. there has to be an sufficient volume of air or the fume hood available on air, and this will not able to draw necessary volume of air to maintain its function and to make it work properly. When your working room is small, or you have an additional air supply for a wide ranges of fume hoods and Laminar Flow Hoods, you may need of normal room ventilation. Try to look at this term. The additional air that has mentioned earlier has known as makeup air. If you found the make-up, the air supply is not inadequate form or the air make-up air has switched off, the fume hoods may not able to achieve your required face velocity. This late can cause fume to escape into the laboratory. This can cause serious issues to the human around the laboratory. Therefore, it is always better to look for the fume hoods for your purpose, and he even helps in maintaining the sterile environment for the chemicals. 

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