There aren’t many industries that rely on the exact precision and attention to minute detail the way that the pharmaceutical industry does. Each aspect of the production process and every single product has to be created with impeccable accuracy. This, of course, is critical, as too much or too little of a particular substance can have major implications for the efficacy, strength, and safety of a drug.
Pharmaceutical science is incredibly exact, and concerns regarding things like an expired shelf life or trace impurities can have disastrous consequences for patients. As you develop, produce, package, transport, and store pharmaceuticals, they can develop impurities at any point, making them dangerous for use.
As a result, pharmaceuticals have to be screened at every stage to evaluate for impurities and changes in potency to ensure their continued safety and effectiveness. This can help pharmaceutical brands feel secure in knowing their products meet safety and compliance standards.
Here’s why having an online, near-infrared composition analyzer is so important for tracking the makeup of pharmaceuticals in real-time and searching for potentially life-threatening impurities—and how Kett’s suite of laboratory-quality instruments can help.
The Common Challenge of Composition Analysis During Development and Production
Frequent compositional analysis is essential to the viability and safety of pharmaceuticals. The problem? Conducting these tests during development, in production and manufacturing, or in the real world is often difficult. Operations have to cease—or, at the very least, slow down—to wait for testing. Often, a huge access barrier to conducting these tests is having the time to execute testing, not to mention having someone on hand with the expertise to perform these tests.
With outdated composition analysis instruments and testing procedures, testing requires a whole range of instruments to measure for things like moisture and for any of the compositional factors needed to test for impurities and substance levels at such trace amounts.
Especially when it comes to pharmaceutical production, traditional laboratory and online testing techniques don’t quite fit the bill. In this setting, they don’t provide the minute level of accuracy or the right testing cycle time needed to perform frequent spot checks.
For example, the Loss on Drying (LOD) technique, which only tests a subject for moisture, is not quite the right fit when testing a pharmaceutical’s composition. It measures the moisture levels of a sample by measuring the weight change of the test subject after drying. However, this requires having someone on hand with the expertise to prepare a sample for testing. What’s more, tests can take anywhere between 15 minutes to many hours—and the test is destructive, which means samples are destroyed. When it comes to pharmaceuticals that are expensive to produce or precious in number, this is not always a viable option.
Another common test, the Karl Fischer (KF) test, requires the use of chemical reagents to separate water from the rest of the sample to test the moisture content. Each test cycle must be performed on a relatively small sample, which means many test samples are required. Additionally, because KF testing relies on the precise use of chemical reagents, testing needs skilled hands to determine testing parameters and then calibrate and conduct the tests. Furthermore, once the tests have been performed, reagents and waste have to be properly disposed of, which requires time-consuming documentation and costly disposal management.
Why NIR Composition Analysis In Real-Time Is the Way to Go for Pharmaceuticals
Composition analyzers have been part of the pharmaceutical industry for quite some time. But not until the introduction of NIR composition analyzers has there been a way to evaluate every product—down to each individual capsule, if needed—for safety and effectiveness.
NIR composition analyzers can accurately assess the chemical composition of almost all liquids and solids in real time without needing to prepare a sample. Even better, the test is non-destructive and operates using near-infrared reflectance to evaluate for the presence and amount of substances like moisture, fats and oils, proteins, film thickness, coat weight, and carbon content, making them highly suitable for the pharmaceutical industry as well as most products that contain organic substances.
Not only does this support the needs of research and development teams throughout development and in and out of laboratory settings, but thanks to available online models—like Kett’s KJT700 Infrared Process Meter—these tests can also be conducted on the production line. Additionally, because there’s little to no sample preparation, any personnel at any skill level can conduct tests with very little training needed. This shortens the testing cycle time, cuts down on the cost of testing, and can even help improve the quality, efficacy, and safety of pharmaceuticals.
Once a Kett NIR composition analyzer has been calibrated to a pharmaceutical lab or production environment’s standards, these calibrations are valid for the entire life of the instrument, which can be tremendously helpful in evaluating samples anywhere along the process of development, production, and distribution. These instruments provide the ability to gather fast, accurate information to help verify the composition and worthiness of a pharmaceutical product.
Kett’s NIR Composition Analyzers: Get Laboratory-Quality Results for the Pharmaceutical Industry, Anywhere
At Kett, we believe that our instruments should only make your work easier and better. That’s why our online and desktop versions of our NIR composition analyzers are designed to take accurate measurements without pre-processing samples or stopping to wait for testing. The result? A much faster testing cycle that empowers pharmaceutical researchers, developers, and manufacturers to focus more of their efforts on improving product quality instead of on sampling, prepping, and waiting.
As John Bogart, Managing Director of Sales at Kett, stated, “The goal is for any staff member to be able to successfully use a composition analyzer whenever and wherever it is needed, with minimal required training,” continuing to say, “This allows the pharmaceutical industry to be certain that products are of the highest quality. The key is to be cost-effective and be able to conduct as much testing as required, with full confidence in the results, each and every time.”
This includes laboratory-quality instruments like these:
- The BSR1700 Online NIR Composition Analyzer, the KJT270F Infrared Process Meter, and the KJT700 Advanced Online NIR Composition Analyzer can take accurate readings on the production line in a moment to measure things like moisture, fat, protein, film thickness, coat weight, and carbon content to for monitoring and process control automation.
- The KB270 Desktop NIR Composition Analyzer is suitable for labs and development settings and measures samples easily and instantly.
Ready to learn more about these and our suite of composition analyzer instruments? Connect with our team of engineers today!
