In pharmaceutical manufacturing, determining a wide variety of compositional characteristics – such as the level of moisture, purity, or contaminants in raw inputs, in-process substances, and end products – can be essential to ensuring safety and compliance.
Although traditional laboratory and online based moisture measurement techniques are useful in the right settings, they have lacked the simplicity and flexibility required for frequent spot checks.
Additional primary tests have also been required to determine other necessary characteristics, such as the level of purity or contaminants in a pharmaceutical substance or product. Each of these tests usually requires separate tools, procedures, and sample preparation. This requires skilled personnel, extra time and labor for each measurement, and the additional use of expensive product.
In response, industry innovators have developed a simplified approach that allows less-trained personnel to take portable, desktop, or in-line, instant composition analysis readings of pharmaceutical industry feedstock, in-process formulations, or end products as needed.
The approach involves devices that utilize Near-Infrared (NIR) light, a highly accurate, non-contact, secondary measurement method that can deliver immediate, laboratory quality composition analysis readings.
“NIR composition analyzers allow very accurate, instant, simultaneous measurement of multiple organic components in solids and liquids without contact or sample preparation, so there is no product contamination when using handheld and inline/online models,”
says John Bogart, Managing Director of Kett US, a manufacturer of a full range of organic composition analyzers.
Since the NIR process is non-destructive, samples remain unaltered so they can be used for additional tests or put back into the product stream. Because no direct contact or sample alteration is required, particle size variation and unusual textures are not an issue. This is important when used with chemicals, formulations, or end products in different settings.
Because accurate measurement is achieved without pre-processing the samples or waiting for lab results, this dramatically reduces the test cycle, enabling pharmaceutical manufacturers to focus on improving product quality and not on sampling and prep work.
“The goal is for any staff member to successfully use a composition analyzer whenever and wherever needed with minimal required training,” says Bogart. “This allows the pharmaceutical industry to be certain that products are of the highest quality.”