Application notes: Cleaning validation is an essential process to ensure the quality and safety of pharmaceuticals.
In cleaning validation, it is important to select the appropriate analytical method according to the purpose. By choosing the optimal analytical method for each phase (design, validation, verification), the risk of product contamination can be minimized.
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**Specific Analytical Methods** Specific analytical methods focus on analyzing specific components. - **High-Performance Liquid Chromatography (HPLC)** Advantages: Detects specific residual compounds and provides information on cleaning failures. Challenges: Assumes that compounds do not decompose during the cleaning process. - **Enzyme-Linked Immunosorbent Assay (ELISA)** Advantages: Detects specific proteins. Challenges: Cannot detect if proteins are denatured. - **Ultraviolet/Visible Spectrophotometry (UV/Vis)** Advantages: A simple analytical method that does not require separation of the target from the matrix. Challenges: Not applicable to all compounds and may be interfered with by coexisting substances. **Non-Specific Analytical Methods** Non-specific analytical methods detect products with certain properties rather than specific components. - **Total Organic Carbon (TOC)** Advantages: Highly sensitive detection of all water-soluble organic compounds. Challenges: Additional analytical methods are needed to investigate causes when abnormal values are obtained. - **Conductivity** Advantages: Easy to automate and highly sensitive to ionic residues. Challenges: Can only be used with rinsing methods and is applicable to only certain compounds. For more details, please refer to the application notes.
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Cleaning validation of pharmaceuticals
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Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.