Potent oral solid dosage APIs: containment fundamentals

Published: 17-Nov-2016

The last 20 years have seen a significant increase in the need for contained handling and processing in the pharmaceutical industry, driven by the development of more potent APIs and a stronger focus on health and safety by the regulatory authorities

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Containment issues have become a vitally important aspect of solid dosage form production. Active pharmaceutical ingredients (APIs) are becoming increasingly effective, with more than 50% of all new chemical entities (NCEs) being classified as potent (OEL <10µg/m3); at the same time, the health and protection of operators, all over the world, is being put under an ever more intense spotlight.

Containment is the separation of the product from the people — and from the environment — by a barrier. Containment is used to prevent any negative impacts (contamination) being transferred from one area to another, and vice versa. Why is the pharmaceutical industry interested in containment? For two reasons: operator exposure and the prevention or elimination of cross-contamination. In the event of exposure or cross-contamination, an operator could become sick, deformed or worse, making the employer liable to fines, FDA intervention, legal procedures and possibly even prison.

But how much containment is required? Navigating the maze of available hardware components and the huge variety of containment solutions has made it more and more difficult to select the most appropriate equipment for the specified task: suppliers of various hardware components have developed a wide range of containment solutions, making it difficult, even for experienced people, to decide on the optimal solution.

"A key point," says David Johnson, Sales Manager, Containment Technology, GEA, "is that the required level of equipment and containment performance is not simply a matter of measuring the Occupational Exposure Limit (OEL) of the product. This is a common misconception and, as a result, there is a tendency within the industry to over specify."

He explains: "Selecting an overly complicated solution means that the system is more difficult to operate, difficult to clean and maintain and, of course, more expensive to buy. It can be problematic to show that a particular solution is ‘good enough,’ but it can be done. By understanding containment and looking at the product, the operator and the equipment, we can create well engineered and better value solutions."

GEA has a long history of expertise in the field of containment. The company not only offers a comprehensive range of robust and compliant containment products, it also boasts unrivalled experience in identifying the most appropriate solution and a thorough understanding of containment risk analysis.

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