It's only natural for businesses to resist regulatory demands placed on them by government. What's remarkable is how many times during the process of becoming compliant, new technologies are introduced and productivity is improved. Resistance is forgotten, profitability embraced.
Uniform quality and distribution of blended bulk powders has numerous challenges, addressed over the past two decades by the FDA in pharmaceutical manufacturing. The infinite combination of product blends, production techniques, and various equipment styles makes for a nearly impossible set of circumstances to write a hard specification around. Nevertheless, like many other industries, the regulatory climate has driven both the research and development of blending practices and resulting quality.
In 1997, the International Association for Pharmaceutical Science and Technology (PDA) published Technical Report No. 25, “Blend Uniformity Analysis: Validation and In-Process Testing.” The purpose of the report was to identify and establish statistical models to develop criteria for eliminating sampling errors. The resulting guidance was given to establish a process of selecting product from various stages of manufacture for sampling. The focus was on operations in blending and filling that pose a higher risk of failure – and thief sampling product at those points.
Ultimately, using thief sampling of production runs can only result in marginal, yet by definition, acceptable quality assurance. There are test standards in place that use statistical modeling for pass/fail and marginally acceptable product. Searching for continued improvement, in-situ spectrometry was evaluated for it's potential. This evolution of quality evaluation now has led the pharmaceutical industry to depend on spectrometry as their source for reliable results in manufacturing bulk powders.
Spectrometry allows for in-situ and real-time quality data to be delivered for manufacturing control and quality assurance purposes. Placement of optical probes at critical junctures in the production process – such as drying and blending. The units reports moisture content data which can result in on-the-fly processing adjustments. These capabilities have significant practical benefits in terms of product flow, uniformity, granulation, and other key quality characteristics often problematic with powdered substances. The ability to manage and test product in real-time results in immediate cost savings stemming from potential product loss.
Further cost advantages come with deploying probes on clean-in-place systems for real-time cleanliness validation. Remarkably, this is an example of a technology intended for regulatory compliance becoming adopted primarily for the value proposition it represented. Four of every 5 major pharmaceutical manufacturer now deploys optical probes on their process lines as a result. At the end of the day, manufacturing issues within the pharmaceutical industry are typical of every blended bulk powder manufacturer and spectrometry may prove to be an avenue for significant process improvements with other products and other industries.
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