Facilitating Validation Of Gas Adsorption Systems Using New Traceable Reference Materials
By Anthony Thornton, Director of Product Integrity and Performance, Micromeritics
Measuring the surface area of a material is an essential task, as the surface area of a solid determines how it interacts with its surroundings. For example, the surface area of a pharmaceutical oral dosage form, such as a tablet, determines how quickly the drug’s active pharmaceutical ingredient enters a patient’s bloodstream, which has a significant impact on its safety and efficacy. The ideal method for measuring surface area is gas adsorption analysis, which relies predominantly on relatively simple measurements of temperature, pressure, and volume.
To ensure a gas adsorption system is functioning properly and thereby delivering consistent, reproducible results, manufacturers are responsible for conducting periodic testing on their analytical instruments. Equipment that is not working properly could deliver out of specification (OOS) data later, leading to investigations that slow progress or even compromise a regulatory submission. For a commercialized product, it could mean a product recall. The investigation and implications of an OOS result are associated with high costs and, potentially, damage to a company’s reputation. Therefore, safeguarding the integrity of analytical data is paramount.
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