Category Archives: Press

Particle Technology Labs’ Director of Analytical Services Gives Presentation in Amsterdam

Particle Technology Labs’ Executive Vice President and Director of Analytical Services William K. Kopesky just returned from the Netherlands where he was one of three presenters at The Center for Professional Advancement’s course entitled, Powders: Their Properties and Processing. The three-day event took place December 11th through December 13th, 2017, in Amsterdam.

The primary purpose of the course was to “review the various properties of powdered solids pertinent to the development and manufacture of the products of the pharmaceutical, cosmetic and allied industries.”  While the course was designed for those in product development, the event was attended by scientists, suppliers and technologists.

During the three day course, Mr. Kopesky presented on the following topics:

In his first session, Characterization of Powder Particle Size and Shape, Mr. Kopesky provided insight regarding particle size analysis, distributions and their presentation, and particle shape characterization.

In his second session, Characterization of Particle Surface and Pores, he covered surface area by BET and pore size distribution measurement by both gas physisorption and mercury porosimetry.

In his third and final session, Fine Particle Characterization, dynamic light scattering (photon correlation spectroscopy), zeta potential and flocculation/agglomeration were covered.

Joining PTL as a Particle Characterization Chemist in 2000, Mr. Kopesky became Laboratory Manager in 2002 before being named Managing Director in 2008 and Director of Analytical Services in 2012. His years at PTL have given him exposure to a tremendous variety of particle characterization topics, techniques, and projects spanning many industries including pharmaceutical, nutraceutical, environmental, industrial, and more. During his career with PTL, he has conducted presentations and training in the field of particle characterization, provided testimony for patent infringement cases, and has been involved with consulting services in addition to hands-on analytical work.

The Center for Professional Advancement – CfPA is the largest accredited technical training organization in the world offering technical training and continuing professional education courses to those in the Pharmaceutical, Biotechnology, Medical Device, Chemical Engineering and Cosmetics industries.

For further information about CfPA, click here

To learn more about Particle Technology Labs, click here

Evolution of Particle Characterization Instrumentation Advancing Test Methods for Upgraded Instrumentation

by Rebecca Wolfrom

Over time, advancements in technology have led to changes in many aspects of our lives. These advancements include improvements to tried-and-true scientific instruments, including those in the science of particle characterization.

Academic research continues to hone theories, and in turn the theories are built into software codes, hardware configurations, and even CFR Part 11 compliance programming. This means the instruments used while establishing a test method may be superseded by a newer model. In some fields, this may have a minimal effect on test results. But in particle characterization, it can mean significant differences in sensitivity, detection range, sample handling, or other factors. Any of these could mean a change in result relative to your specification – and no one likes surprises when it comes to meeting a specification.

This is where Particle Technology Labs comes in. At PTL, we’ve used particle characterization instrumentation all day, every day, for over 25 years. This translates to a high level of familiarity with the different techniques, theories, and upgraded equipment models. We stay up-to-date with the latest offerings from the manufacturers and are here to help with applying your method to the ever-evolving instrumentation.

Manufacturers can make a multitude of changes to their hardware in a single model upgrade. Such changes can include extended detection ranges, reconfigured flow paths, increased sensitivity, modified data capture rates, and automated sequences, to name just a few. While these features are often marketed as user-friendly benefits, they can present challenges when a body of work has already been established using a prior model. Some of the most interesting projects at PTL are those where the chemists investigate the effects of the new settings on the results and experiment until the puzzle is solved.

To meet the challenge presented by new instrument models, PTL first conducts internal studies to establish statistical equivalency between the legacy and new instrument model using reference materials. Each resulting report is available upon request to clients who are evaluating the need to make a move. Since the equivalency is demonstrated using model materials only, it is important to evaluate the results specific to the client’s own material. To do so, we first perform exploratory work to experimentally translate instrument settings from legacy to new model, and then we can add replicate testing to build confidence in the new method before it becomes routinely used. The scope of work is customizable to fit the client’s requirements.

PTL typically offers three levels of instrument model related method upgrades to choose from, at three different cost structures:

• A protocol-driven method transfer with repeat testing includes preliminary evaluation of the existing legacy method on the new instrument model, replicate analyses using the new method, statistical evaluation of the results with a comparison to historic method results if available, a copy of the new method, and a protocol and report both formally edited and approved by the client and PTL. The scope of the package is adjustable according to client need.

• A non-protocol-driven method change with repeat testing would include all of the above, but in place of the collaboratively reviewed protocol and report the client receives a PTL-generated standard report of analysis.

• A non-protocol-driven method change would include one analysis using the new instrument method based on PTL SOPs and scientific judgement and a PTL-generated standard report of analysis.

In all cases, the new method aims to maintain the same sample preparation procedures as employed in the legacy method (unless justified and approved by the client), but it adapts instrument settings as appropriate for the new hardware. If the legacy instrument is available at PTL, side-by-side analyses on both instrument models may be performed. Throughout the method change process, PTL standard operating procedures for both instrument operation and method revisions are upheld.

Do keep in mind that if a manufacturer has developed a new instrument model, it will only be a matter of time before the legacy model is removed from their maintenance and support plans. As such, PTL too will have to retire it. As a result, the original method cannot be sustained long-term. We make every effort to contact clients who are affected by these instrument retirements. We want to work with you to make the method change as smooth and scientifically supported as possible.

Contact Particle Technology Labs for more information.

Q & A with Shane Hill of PTL’s Method Services Department

The method services business has grown significantly in recent years. PTL is pleased to provide these services to form stronger relationships with our pharmaceutical clients and help them achieve their goals.

At the helm of PTL’s validation department is Shane Hill, Methods Compliance Assistant Manager. Shane took time from his schedule to answer a few questions about the method services available at PTL.

shane1. What are method developments, method validations, and method transfers, and what does each entail?

A method development is a process whereby an analytical procedure is created for a specified sample type. Clients will either submit a sample with no established test document or they will provide a nominal procedure that covers a given characterization technique (particle size, surface area, etc.), and PTL will tailor the method through detailed evaluations. A design of experiments (DOE) is then undertaken, during which several method parameters are investigated for their significance in affecting the results. The DOE data are processed via statistical software; the method is updated to incorporate the optimized settings and a proof of concept is executed to demonstrate precision of the new method.

A method validation is a process which is ideally initiated following varying degrees of method development. Validations are intended to demonstrate that an analytical procedure is suitable for a given sample type. For physical analyses, the testing typically consists of accuracy, precision, and robustness. Accuracy serves to illustrate the trueness of the data within the specified range of interest. Precision demonstrates repeatability of generated data; often validation studies at PTL examine precision across multiple days, chemists, and instruments for a comprehensive comparison. Robustness evaluates the impact of small method variations on the final results.  Data are compared against USP acceptance criteria and/or client-provided specifications, as well as processed via statistical software which reports means, equivalencies, and comparative variability.

A method transfer acts as a precision study between instruments, such as when an older generation instrument is retired and a test method requires transferring to a newer generation instrument, or between laboratories. PTL has extensive experience with both scenarios.  Typically, testing is conducted concurrently across instruments/laboratories, and the data are compared against acceptance criteria. Accuracy is often included as a measure of system suitability.

Across all our method services, PTL follows industry and regulatory guidances in the development and execution of the testing.

2.  How long, on average, does each service take to complete?

Method developments take about 3-4 weeks to complete, from initial evaluation to reporting. Method validations take about 4-6 weeks (depending on the inclusion of robustness and sample difficulty). Method transfers take about 3-4 weeks to complete, from protocol creation to reporting.

3. How does each service benefit the client?

Foremost, PTL’s method services help our clients comply with the FDA’s cGMP regulations.  A robust method development ensures that the analytical procedure provides optimized, linear data for the sample material. Method validations benefit our clients by allowing a test procedure to undergo several levels of precision testing to ensure correlation across several variables, such as days, chemists, and instruments. If robustness is evaluated, then there is the added benefit of demonstration of an optimized method. Method transfers allow a test method to seamlessly be updated to a newer, more efficient particle characterization instrument or to PTL if the transfer is from an outside laboratory.

4. Are there any related services that we offer?

In addition to developments, validations, and transfers, PTL also offers method verifications. Often clients will require a test procedure to be verified against a USP Chapter or Monograph; PTL will design a protocol that includes references to the USP guidelines and will perform the verification testing accordingly. Most often this testing includes a repeatability evaluation, but can include more elements depending on the USP Chapter or Monograph involved.

To read more about how PTL’s method services can benefit you, click here.

“We have been working with PTL’s Methods Service Department for many years and the client service has always been great in terms of technical knowledge, answering e-mails promptly, and quick turnaround of quotations and method transfer reports.”  – Rajat Gandhi of CPL, Ltd.

Particle Technology Labs Announces 25 Year Anniversary

 

Partners at Particle Technology Labs

Our Partners – Richard J Karuhn (President), Lisa Jandacek (Executive Vice President & Director of Operations), Richard F Karuhn (President Emeritus), William Kopesky (Executive Vice President & Director of Analytical Services)

Particle Technology Labs, the particle technology and research advisory company of choice for the world’s leading pharmaceutical, industrial, public sector and scientific organizations is celebrating their 25th anniversary this year.

Since the beginning, PTL’s philosophy has been anchored to the premise that for every particle characterization need, there is an optimal scientific solution that they can provide. As they celebrate their 25th year, they take great pride in continuing to progress in their industry, staying on top of the most current technologies and instrumentation while continuing to grow as a company.

In a statement, President Richard J. Karuhn said, “2017 marked another exciting year of incredible growth across virtually all of our business segments. We continued to expand our sales and customer base at double-digit rates, and invest in our laboratory infrastructure and staffing in order to support this sustained growth. At PTL, we are committed to positioning our laboratory as offering a comprehensive array of advanced analyses for particle characterization. To us, this means continuously delivering business value to our clients by providing comprehensive and innovative solutions, excellent customer service, expert knowledge in the field of particle technology, and a commitment to analytical integrity. We greatly appreciate your continued business and trust in Particle Technology Labs and look forward to fulfilling your particle characterization needs for many more years to come.”

Particle Technology Labs’ contract facility is FDA-registered, and is a proven cGMP (current Good Manufacturing Practices) compliant laboratory, in accordance with 21 CFR, Part 210 and 211. They are DEA licensed and approved to handle Schedule II through V Controlled Substances and hold an ATF permit for analysing pyrotechnics. Their trained chemists perform routine and advanced material characterization testing and analysis services, conduct method development, validation and transfer protocols, and solve complex problems for clients from a variety of industries. Services include particle size distribution analyses, gas adsorption & porosimetry analyses, microscopy services, nanotechnology services, powder flowability, thermal analyses and zeta potential analysis.

PTL can be visited online at www.ParticleTechLabs.com.

25-ptl_anniversarylogo_1

PTL and JAXA Space Water Nanoparticle Tracking Analysis

Spacewater from JAXA is analyzed at PTL using Nanoparticle Tracking Analysis

Spacewater from JAXA is analyzed at PTL using Nanoparticle Tracking Analysis

Over the past twenty-five years, Particle Technology Labs has received tens of thousands of different sample types from all kinds of industries. From pharmaceuticals, to food, to municipalities, it would be a tough challenge to find a product or industry PTL has not touched in some way. However, once in a great while, a request to analyze something very unusual will come in, and a palatable wave of excitement can be felt throughout the laboratory.

It may seem rather surprising that the excitement all started with a request to analyze water. Something so intrinsic that we see and use every day suddenly became extraordinary when correspondence regarding this request started arriving in our in-boxes. Phrases such as, “launched by rocket,” “transported from ISS” (International Space Station), and “for purpose of human space exploration” seemed more like a work of science fiction than an actual request for analysis.

The water samples belong to the Japan Aerospace Exploration Agency, or JAXA, Japan’s national aerospace agency similar to our NASA here in the United States. This water is part of a research project developed by JAXA studying how water can be treated and recycled on-board spacecraft that will be suitable for human consumption during future long-term space travel missions.

On April 17, 2017, we had the pleasure of hosting Tomoka Nagase, Engineer and Human Spaceflight Technology Directorate, and Naoko Iwata, Engineer and Human Spaceflight Technology Directorate at JAXA. Dr. Nagase and Dr. Iwata visited PTL to observe the analysis of their space water in our laboratory.

The water, which is waste water gathered from human waste and condensation, was treated with nanobubbles as a biocide, and then recycled back into potable water.

Presently, water is being recycled in space. However, there are some issues with the current processes.

JAXA’s study of nanobubbles is showing promise as an improved method to recycle water. So far, their findings have shown it is harmless to humans, and has been proven to be effective against E. coli and other bacteria. There is no need to filter the water before drinking, and the process may be able to maintain a longer period of disinfecting performance.

In December of 2016, several samples of JAXA’s treated water were launched and stowed on the ISS. The first of these samples arrived back to Earth in April and was shipped to PTL where we analyzed the water for concentration and distribution of nanobubbles using Nanoparticle Tracking Analysis. The water also underwent other testing by JAXA outside of PTL’s laboratory. Over the next two years, remaining samples will be returned from space on a scheduled basis and tested for antimicrobial effectiveness and performance over time.

Particle Technology Labs is very proud to have been included as a small part in JAXA’s mission which may change the way water is processed and recycled in space.

To learn more about JAXA, please visit http://global.jaxa.jp.

Dynamic Vapor Sorption System (DVS)

DVS Intrinsic - Dynamic Vapor Sorption System

Particle Technology Labs DVS Intrinsic – Dynamic Vapor Sorption System

PTL’s newest instrument, the Surface Measurement Systems DVS Intrinsic is a highly sensitive, accurate means for determining the moisture sorption properties of a material. This can provide critical information on the stability, processing, performance, and storage of materials. The analysis is applicable to  pharmaceuticals, food products, packaging, personal care products, fibers, building materials and agricultural materials.

Dynamic vapor sorption (DVS) is a gravimetric technique that measures the quantity, and how quickly water vapor is adsorbed and/or absorbed by a material, such as cement, or an active pharmaceutical ingredient. The DVS system works by flowing precisely controlled concentrations of water vapors in dry air over a sample at a known flow rate and temperature. The sample rests on a digital microbalance which detects the sorption/desorption of water vapor through the increase or decrease in mass of the material as the relative humidity (RH) varies.

Accurate measurements are achieved by controlling the temperature and humidity electronically, allowing excellent instrument baseline stability as well as accurate control of the generated relative humidity. The DVS instrument provides a relatively quick way of obtaining the water sorption and desorption isotherm of the sample (typically in a few days) compared to traditional methods (typically weeks to months).  The DVS can also perform isoactivity measurements in which materials are kept under constant RH conditions while linearly or stepwise varying the temperature.

Our DVS accommodates a wide variety of sample geometries and allows sorption behavior to be accurately determined on very small sample sizes (typically 50-100 mg). Sample masses up to around 3 grams and with dimensions as large as 15mm can also be analyzed.  The relative humidity levels can be varied between 0-95%, while the operational temperature ranges from 20-40°C.

plotSample DVS Intrinsic Data Plot – Milk powder, two cycles, showing amorphous recrystallization.

 

DVS Intrinsic Applications
Studying hygroscopicity of powders, fibers and solids
Kinetics of water sorption and desorption
Water induced morphology changes
Food shelf-life prediction studies
Effects of moisture on texture of materials
Accelerated stability studies of active pharmaceutical ingredients (APIs)

Materials Studied
Pharmaceuticals: powders, tablets, APIs and excipient materials
Food: powders, processed food, biscuits
Natural Materials: grains/seeds, wood
Building Materials: aggregates, cement, ceramics
Personal Care Products: cosmetics, hair care, contact lenses
Packaging Materials: paper, plastics

To find out more about DVS or other particle characterization services available at Particle Technology Labs, please contact us at 1-630-969-2703.

Scanning Electron Microscopy (SEM)

Particle Technology Labs offers an encompassing array of particle size and characterization services, providing key information for research, formulation and manufacturing purposes across many different industry segments.

When it comes to imaging sample materials, Scanning Electron Microscopy (SEM) is one of the most widely used analytical tools providing profound depth of field and detail in images of microscopic materials.

Particle Characterization Chemist Michael Vinakos on PTL's system, the JEOL NeoScope II JCM-6000 Benchtop SEM

Particle Characterization Chemist Michael Vinakos on PTL’s system, the JEOL NeoScope II JCM-6000 Benchtop SEM

PTL’s system, the JEOL NeoScope II JCM-6000 Benchtop SEM, produces magnifications of 10 – 60,000x for secondary electron images, and 10 – 30,000x for backscattered electron images. This allows a high definition view of pharmaceuticals, fibers, abrasives, and other microscopic materials for many industries including pharmaceutical, environmental, aerospace, chemical, and others.

Vivid images of the topography of a material’s surface provide very important information including process characterization, compositional differences, morphology and weathering processes. These are just a few of many applications available with the use of SEM imaging.

Information from SEM can stand alone as a powerful tool in the research and development of your material, or complement the data obtained through other physical characterization analyses such as particle size, porosity, BET surface area and other analysis offered at PTL. “We have found that using SEM analysis helps provide further insight for our clients as it can provide a visual representation of a particle’s characteristics and an orthogonal analytical survey technique to other commonly used particle sizing equipment. For our clients, a picture can truly be worth a thousand words when attempting to describe the size and shape of particles.” says Bill Kopesky, Director of Analytical Services.

sem1 sem2

Example of images generated using SEM analysis. A focused beam of electrons scans the surface of the sample, which in turn produces secondary and backscattered electrons. The instrument's detector(s) collect these emitted electrons and translate the signal into a high-resolution, multi-dimensional image of the sample's surface.

Example of images generated using SEM analysis. A focused beam of electrons scans the surface of the sample, which in turn produces secondary and backscattered electrons. The instrument’s detector(s) collect these emitted electrons and translate the signal into a high-resolution, multi-dimensional image of the sample’s surface.

Features of our SEM instrument, the JEOL NeoScope II JCM-6000 Benchtop SEM, include:

Magnifications of 10 – 60,000x for secondary electron images and 10 – 30,000x for backscattered electron images (sample dependent).

Dual frame imaging which allows for a comparison between two images.

A motorized tilt/rotation specimen holder allowing for focused and optimized sampleorientation thus highlighting features of interest.

Accommodation of sample sizes up to 70 mm in diameter and 50 mm in height.

Contact PTL today for more information about Scanning Electron Microscopy and how it can be a valuable tool in the research, development or manufacturing of your material.

Particle Technology Labs & Engineers Without Borders USA Provide Water to Villagers in Sabhung, Nepal

nepal-engineers-without-borders

Particle Technology Labs is very proud to announce a recent contribution to an Engineers Without Borders USA project. Engineers Without Borders USA is an organization which works with developing communities around the world to empower them to sustainably meet their basic human needs. This is achieved through several projects including building water supply facilities, civil works, sanitation, agriculture, energy and other municipal facilities.

The Project

The Hartford Professional Chapter of Engineers Without Borders USA was tasked to design and implement a potable water system for a community in Sabhung, Nepal. They planned to accomplish this by constructing the system with the aid of village residents. Once the water system was functional, the engineers would educate and train citizens to be self-sufficient in maintaining the newly constructed system.

Prior to having this water system, women and children in Sabhung had to collect and physically carry water on their backs from several difficult sources, which included traveling very long distances over treacherous terrain on foot. The journey took hours to complete, resulting in a significant impact to their daily life.

Particle Technology Labs Involvement

Engineers Without Borders USA contacted Particle Technology Labs to help with the important issue of water quality. Once the new water system was put into place, a problem arose. During monsoon season, the water became more turbid than normal. Standard sedimentation methods were not successful due to the broad particle size range and composition of the particles. Particle characterization testing was needed to determine the particle size and concentration, as well as the density of the particles suspended in the water. PTL used their years of experience in the field to perform this testing on the organization’s behalf. Information gained from this testing was then used in the design and creation of a filtration system to effectively clean the water as it is pumped to a central location within Sabhung.

Chemist Jakub Strycharz performing particle size and concentration analysis on PTL's Particle Sizing System's Accusizer 780/780AD Instrumentation

Chemist Jakub Strycharz performing particle size and concentration analysis on PTL’s Particle Sizing System’s Accusizer 780/780AD Instrumentation

“It’s very gratifying to lend our analytical services to an organization whose main objective is to improve the quality of life for people in developing countries,” states William Kopesky, Director of Analytical Services at PTL.   “It is easy to take for granted something as basic as clean water in our everyday lives. It is a tremendous opportunity for us to see directly how our results can impact a community in such a positive way.”

engineers-without-bordersSince successful completion of the project, villagers have enjoyed their new and dramatically more convenient water supply. Through this improvement, they have used the reclaimed time for new purposes. Children can now spend more time in school acquiring a better education, which will enhance the future of their entire community. Sewing and weaving centers have been built where women are now able to earn an income by selling their crafts instead of spending hours to obtain water. The outcome has been truly dynamic both socially and economically for the community.

Particle Technology Labs is very pleased to have been able to help bring clean water to Sabhung, Nepal. This project also met the Engineers Without Borders USA’s continuing mission to improve the lives of those who had previously lacked basic human needs. PTL is honored to have been a part of a project that has given so much to an entire community.

Video

A short film about this project and the people of Sabhung can be viewed at the following link.

https://www.youtube.com/watch?v=97pLYIyJa9c

Websites

To learn more about this project and the Engineers Without Borders organization, visit the following websites.

Hartford Professional Chapter
Engineers Without Borders USA
http://www.blog.ewb-hpc.org/

Engineers Without Borders USA
http://www.ewb-usa.org/

To read more about how PTL’s particle characterization services can benefit you, please contact us at 630.969.2703.

 

Surface Area and Porosity Analyses Available at PTL

The value of knowing the surface area and porosity of a material cannot be underestimated. Surface area affects the dissolution rate in powders, including pharmaceuticals, as well as the adsorption rate of filtration and purifying materials such as activated carbon. Surface area and porosity also govern the performance of catalysts and catalytic supports such as zeolites, porous silica, and alumina. The porosity of materials such as tricalcium phosphate granules and bone graft strips is also vital in the biomedical field.

PTL has several different methods available for determining surface area and porosity.

BET Specific Surface Area

The BET (Brunauer, Emmett and Teller) theory is commonly used to evaluate gas adsorption data and generate a specific surface area result expressed in units of area per mass of sample ( m 2 /g). Prior to analysis, the sample must be preconditioned to

Micromeritics Tristar II 3020. remove physically bonded impurities from the surface of the material in a process called degassing or outgassing.

Chorthip “Chip” Peeraphatdit and our Micromeritics Tristar II 3020.
remove physically bonded impurities from the surface of the material in a process called degassing or outgassing.

The specific surface area of a material is then determined by the physical adsorption of a gas (typically nitrogen, krypton, or argon) onto the surface of the sample at cryogenic temperatures. Once the amount of adsorbate gas has been measured, calculations which assume a monomolecular layer of the known gas are applied.

Mesopore Micropore Measurement

Mesopores are pores of internal width between 2 and 50 nm, while micropores are defined as pores with internal diameters of less than 2 nm. Characterization of both mesopores and micropores involves the use of physisorptive gases that can penetrate into the pores under investigation. Gases used include nitrogen and argon, which are physically bound at the solid surface in a process referred to as physisorption. Micropores are filled at very low relative pressure, while pores of larger sizes are filled at higher relative pressure ranges. The appropriate calculations are then applied in order to obtain the physisorption isotherm.

Mercury Intrusion Porosimetry

Mercury intrusion porosimetry (MIP) is a technique utilized for the evaluation of porosity, pore size distribution, and pore volume, among other properties.  The instrument, known as a porosimeter, employs a pressurized chamber that forces mercury to intrude into the voids within a porous substrate.  As pressure is applied, mercury fills the larger pores first.  As pressure increases, the filling proceeds to smaller and smaller pores.  Both the inter-particle pores (between the individual particles) and the intra-particle pores (within the particle itself) can be characterized using this technique.

The gas adsorption process. The gas adsorption process.

To read more about how surface area and porosity analyses can benefit you, contact PTL at 630.969.2703.

PTL’s NanoSight LM10-HSB Instrument is cGMP Compliant

Particle Technology Labs is pleased to announce that our NanoSight LM10-HSB instrument is cGMP compliant as of June 4, 2013 and is thereby the first cGMP NanoSight unit in the United States. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). NanoSight’s Nanoparticle Tracking Analysis technology, NTA, has been adopted for both research-based projects and as a quality control tool for regulated industries. With cGMP compliance established, NTA via PTL is now fully available to the pharmaceutical industry.

William Kopesky, PTL’s Director of Analytical Services, has driven the process to be the first US laboratory with a cGMP compliant NTA. “We are excited to have this new technology in our laboratory. As a cGMP qualified instrument, the NanoSight LM10-HSB expands our capabilities to our regulated clients, providing them with an accurate particle concentration and size device in the submicron range.”

Continuing, Kopesky added, “NTA has significantly better resolution than DLS, as we have verified here at PTL. Its ability to count particles in the submicron range constitutes a paradigm shift. Access to NTA technology is a benefit for several applications. One example is California Proposition 65, which requires companies to test their products and materials for the existence of nano-sized particles. Thanks to the sensitivity of NTA technology, PTL can now detect an even lower level of submicron particles.”

Says Jeremy Warren, CEO of NanoSight, “We are delighted that PTL has achieved cGMP accreditation for their NTA instrumentation; this is a first. While many would see this accreditation as a necessary burden to working within the Pharmaceutical Industry, PTL has embraced the discipline of methodology, training and record keeping to drive robustness in the results they get. In protein aggregation studies, samples naturally exhibit variations in aggregation kinetics and in end-points; standardizing the method allows users to minimize, quantify and factor out the instrument issues and concentrate on this inherent complexity.”
www.nanosight.com.