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Process Analytics for Pharmaceuticals

Process Analyzers for the Pharmaceutical Industry Since 1984

Historically, pharmaceutical GMP’s assumed that if you validate a process and never change anything you will achieve the same quality product every time. Over the past 30 years we have learned that this isn’t an accurate assumption, which is why the FDA introduced in August 2002 the initiative Pharmaceutical cGMP’s for the 21st Century: A Risk Based Approach. Process Analytical Technology or PAT is a key component of that initiative with process analyzers, or process analytics, providing timely chemical information.

In general, a PAT program is designed to “enhance understanding and control the manufacturing process”. The major value of process analytics is different depending on what stage in the process development cycle it is being applied. The major value to the process development lab and the pilot plant is process understanding while, to manufacturing, the value is in attaining high precision, efficiency and safety. Of the tools amenable to process analytics, high performance liquid chromatography (HPLC) offers selectivity, sensitivity and robustness not achievable with other measurement tools.

Dionex has been working with pharmaceutical companies to develop and manufacture on-line LC-based process analyzers since 1984.