By Shane Hill

Confidence, reliability—ultimately peace of mind. In short, this is the takeaway following an analytical test method validation.

Do you work in pharmaceuticals, cosmetics, or the environmental realm? All of these fields, and more, benefit greatly from the method validation process. While initially only a mused measure proposed by minds at the US Food & Drug Administration to enhance the integrity of pharmaceutical drugs in the 1970s, it rapidly became a codified and collective effort to improve general processes in manufacturing. Supply chain elements such as product filling and equipment sterilization caught immediate attention and were subjected to a validation metric whereby consistency of execution was paramount. Soon after manufacturing yields were tightened and made more reliable, the eyes at FDA deemed the validation process applicable to the granular level of characteristic tests for sample analysis techniques such as particle size distribution.

Test validation began to incorporate elements from the engineering world, such as the concept of “gauge R&R,” or more broadly termed, a gauge repeatability and reproducibility systems approach. In equipment design, being able to repeat a blueprint within tight specification and moreover reproduce it at another manufacture site was crucial. This same concept was extended to sample material testing in a wide variety of applications.

By Michael Vinakos

The possibilities are endless when it comes to image analysis. Over the years, the experts at Particle Technology Labs have developed and validated countless particle characterization methods using microscopic image analysis, and the wealth of information from these tests is unmatched for characterizing particle systems..

Why Use Image Analysis?

By William Kopesky – Director of Analytical Services

Did you know Particle Technology Labs began as a testing service for companies needing to meet EPA environmental safety standards? While we are most known today for our testing for the pharmaceutical industry and our commitment to cGMP quality assurance regulations, some will be surprised to learn that the company’s early services were in testing environmental emission and water filtration samples. Now, almost 30 years later, we still assist companies in these industries including some of those first clients who are still with us today!

Testing for PM10 and PM2.5

The founder of Particle Technology Labs, Richard Karuhn Sr., started the company by providing analysis of stack emission samples for PM10 and PM2.5 in 1992. He not only tested them – he spent time collecting them as well!

What do PM10 and PM2.5 stand for? Glad you asked. PM is an abbreviation for “particulate matter.”  PM10 or PM2.5 is the particulate matter in an emission sample that is less than 10 or 2.5 micrometers respectively by mass. These sizes are of interest to the USA Environmental Protection Agency (EPA) as particles in this size range are not easily filtered out by the nasal passages nor impact the back of the throat for removal when we breathe. Particles less than 10 micrometers will enter the lungs and can cause both acute and chronic respiratory issues. Factories, power plants, and similar types of companies are required to monitor and control their emissions for these particles or risk expensive fines and/or production shutdowns.

Kelli Hubert, Particle Technology Labs’ Customer Service Manager, highly values her work and her colleagues

I can genuinely say that I am blessed to work at Particle Technology Labs and thankful for my coworkers. Without a doubt, I belong here. There are many “why’s” behind these feelings. However, I’d like to highlight three key reasons I’m especially proud of being part of the PTL Team.

1. I celebrated my 25-year work anniversary

September 2020 marked 25 years of working at PTL and being a part of this particle size and characterization world. It has been fun and enriching to work in such a niche industry over the years. It’s been gratifying to play a role in expanding PTL’s capabilities and ensuring results are on time, of a high quality, and deliver true business value to our customers. Over the past 25 years, I have worked alongside many dynamic staff members and communicated with a lot of fantastic clients that make the day-to-day simply a pleasure. I learn something new daily—which is great for me and for our clients. I am proud to bring 25 years of knowledge to those I serve.