Analytical Techniques In The Courtroom

Interview conducted by G.P. ThomasJul 16 2013

Founder of Avomeen Analytical Services, Shri Thanedar, discusses how a variety of analytical techniques can be used to help develop new products as well as settle patent disputes.

Could you please provide a brief introduction to Avomeen and the sector that it works within?

Sure. Avomeen is a chemical analysis and testing lab. We have four segments of our business - one is failure analysis of any kind of manufacturing problems.

So where there's discoloration or breakage within a material and any time a product failure occurs we will investigate it. Avomeen is staffed by scientists of all levels: bachelors, masters, and PhDs. Many of them have expertise in material science, pharmaceutical science and with formulation development.

Looking at the deformulation services that you provide, I was wondering if you could give a typical overview of what products you get asked to look at?

Sure, we use the deformulation service to provide a competitive product analysis and also for failure analysis or batch-to-batch variations in products. We can also use it for contamination identification.

The deformulation process is simply separating and identifying the various components of a complex mixture.

For example, we had a situation recently where a plastic fence manufacturer had purchased raw materials and one batch of the raw materials that they purchased to make the plastic fences out of started chalking, powdering and cracking.

This particular case happened to be a litigation related matter. Often, clients come to us when there is a legal dispute and they want us to investigate the matter. In this particular case, we found that the manufacturer had not incorporated a UV stabilizer in the product. And the lack of that protection was causing discoloration and a breaking down of the polymeric materials.

At the same time, a ballpoint pen company came to us and said that a Japanese made ballpoint pen had shinier ink which also dried faster than theirs. They wanted to know what we could tell them about the competing products technology and how it was different for theirs at a chemical level.

They can use your services to understand where they can improve, I suppose?

Exactly. We were able to analyze the ink from the ballpoint pen and found a metallic catalyst that catalyzed the drying process and made the curing much faster.

Very interesting! So could you elaborate on how your services can help in developing new products?

Sure. Clients come to us and they want to develop a new kind of product which has certain properties. For example, a lady who has a boutique business that caters for dogs recently came to us with an idea for developing a lotion that people could put on the paws of their dogs. She wanted to insure that when the dogs walk on snow their paws won't get hurt!

There was a product similar to that on the market but it included a lot of synthetic materials, some of which were toxic. The woman that came to us wanted to make a product from all naturally available materials. So not only did she want a better product, she also wanted a greener product. We were able to develop a product for her that she was very happy with and she was able to then manufacture it for her clients.

Brilliant. So we have covered a few case studies there - just briefly, what other kind of products do people come to you with?

Well, we have had aircraft parts that have failed and our job was to investigate the cause of failure.

We have techniques such as scanning electron microscopy (SEM), energy dispersive x-ray analysis, Infrared, magnetic resonance and mass Spectrometry.

So, we used a variety of analytical instrumentation to solve some of the toughest problems. We would analyze circuit boards when they have corrosion and people want to know what went wrong. We do investigative analysis services of that nature.

We also have a division that does pharmaceutical testing. Recently, we had a large patent infringement case where one of our clients has a medical device and they found other similar products in the marketplace and they may have been in violation of patents that they maintain on the technology.

Our task was to acquire samples and materials from various competitors and look for key ingredients that would have classed as patent infringement.

On the Avomeen site it mentions that several of your chemists are chemical expert witnesses. Could explain this in a bit more detail, and when their knowledge is required?

Yes. For example, one of our clients made a new pharmaceutical supplement, and two key ingredients are patented, and they need to be of certain proteins of certain molecule rates, and certain orientation and structure. They suspected that there was competition that had used their technology without licensing it from them, so we would go analyze it and do some detailed studies.

Most scientists understand the scientific aspects of it in research, but when you are involved in a litigation situation, it's a different ball game.

In the legal community, you need to have definitive answers. And so it takes a special kind of scientist that can not only perform high quality scientific research, but also be able to communicate that to the key members of the jury or the judge.

Exactly. Being able to explain in layman’s terms what they have found.

Yes. And it's really important that any statements that we make are fully supported and can be defended. The attorneys on the other side are looking to find holes in your analysis.

That must be quite tough.

A lot of scientists find it very stressful, and a lot of labs like ours do not get involved in the litigation work. However, we have done this for years and I particularly enjoy it because you are able to provide a very valuable service to the legal community.

One of our clients purchased a pesticide from an overseas company in China, which was supposed to be 98.5% pure. They would then take this pesticide and put it in their formulation to make a consumer product.

However, it so happened that the quality of the pesticide that came from China was inconsistent, which affected the formulation. We were able to go analyze the set of metrics, analyze the purity, and were able to do a deposition explaining to the other side what we found.

Based on our testimony and our work, the case was settled on very beneficial terms to our client.

Could you explain a little bit more about your contamination analysis? What kinds of industries typically need such accurate analyses?

Primarily these processes benefit the pharmaceutical industry, whether it's contamination or drug degradation. Drug molecules degrade over time and create other molecules which may or may not have therapeutic value. Also, some of the degraded molecules may actually be toxic to human beings. We have the ability to analyze for trace levels of these parts per million, parts per billion, sometimes even parts per trillion levels of contamination. The pharmaceutical industry looks for that very often.

There's a lot of medication that's coming from overseas and sometimes it does not either contain what was supposed to be in there, or it has a lot of other chemicals, toxic and otherwise that should not be there. So we use our techniques to analyze for those types of contamination.

Do you work with the food industry at all?

Yes, we do some work with people in the food sector. We are a FDA registered lab and we operate under the good manufacturing practices (GMP) to assure a certain level of quality to our customers.

What are the main analytical techniques that you use for your deformulation and failure analysis?

There are about 15 different techniques we use.

The major ones include infra-red spectroscopy, specifically Fourier Transform Infrared Spectroscopy (FTIR).

We also use a number of separation techniques like gas chromatography and liquid chromatography, which is then sometimes coupled with mass spectrometry. Through this we are able to then identify the components of a sample.

We have a nuclear magnetic resonance spectrograph (NMR) that we use very often and we also use X-ray diffraction, SEM and various other microscopy techniques.

For metal analysis, for example when you have a metallic part and you are uncertain about its composition, we would use a technique called inductively coupled plasma, ICP. ICPMS allows us to analyze, identify and quantitate the metallic content. And this technique is sensitive to parts per million, parts per billion levels. So, we are also able to look for any kind of trace contamination elements that shouldn't be in a product.

How do you believe analytical techniques in general have progressed in the last few years, and how has that benefitted Avomeen?

Well, the sensitivity of the instruments has increased by several orders of magnitude. The instruments have become easier to operate, they have a smaller floor space. The separation techniques have improved because there are newer types of columns and color coatings that have made it easier to separate similar components.

We can do that now at a much faster rate, so solving problems which used to take weeks, we can do it in a matter of hours now because we have access to highly sophisticated, highly sensitive instrumentation.

So a product could have a bad odor and the chemical causing that could be present at parts per trillion levels. We have techniques and sensitive instruments now that we did not have access to when I graduated with my PhD back in 1982.

It has probably progressed even since I was at university! It does move very quickly.

It moves very quickly, and there is a continuous innovation in the technology, in the separation science, in identification, and so that really has benefitted us in solving problems for the manufacturing industry and also in developing new products.

About Shri Thanedar

Shri Thanedar arrived from India to pursue his Ph.D. in Chemistry at the University of Akron, Ohio.  He also received an MBA from Fontbone College, St. Louis Missouri.

After school and frustrated with his job in a large bureaucratic company where opportunities for advancement were few and limitations for innovation were plenty, Shri began his entrepreneurial journey. With a bank loan of $50,000 along with $3,000 from his credit card, Shri purchased Chemir Analytical Services.  The testing lab had annual revenues of $150,000 before Shri grew it to revenues of $14 million and sold it for over $25 million. He also grew a pharmaceutical services company with 350 employees and an enterprise value of $130 million before it folded under the 2008 recession.

Being a serial entrepreneur, never to be discouraged Shri founded Avomeen Analytical Services in Ann Arbor Michigan which is growing three times the speed of his previous company.  Avomeen is a customized analytical services lab specializing in material characterization, failure analysis, deformulation and new product formulation development.  The company’s rapid growth has been attributed to its ability to help its clients solve complex manufacturing problems.  Additional growth has been seen due to its support of both large companies and budding entrepreneurs alike with their product research & development services.