CLEANING VALIDATION: SAMPLING

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CLEANING VALIDATION: SAMPLING. By IZZUL ILHAM BIN JAMALUDIN (Protégé, Validation).

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SAMPLING. The process of collecting a portion of material selected as a representative of the locally remaining medium.

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DUOPHARMA MANUFACTURING (BANGI) SDN. BHD.. 3. When is the CV sampling will be carried out?.

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RINSE METHOD. Final Rinse (FR) samples: by rinsing all critical parts of the machine into a clean drum.

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RINSE METHOD (cont.). Visual Inspection. DUOPHARMA MANUFACTURING (BANGI) SDN. BHD..

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SWAB METHOD. Swab samples: by swabbing the surface of the critical parts of the machine (stainless steel).

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SWAB METHOD (cont.). DUOPHARMA MANUFACTURING (BANGI) SDN. BHD..

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SWAB METHOD (cont.). DUOPHARMA MANUFACTURING (BANGI) SDN. BHD..

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Flow of Sampling. DUOPHARMA MANUFACTURING (BANGI) SDN. BHD..

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ANALYSIS. Determination of chemical & detergent residue.

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Solid dark colored hexagon in the middle of image accent.