In pharmaceutical manufacturing, cleaning validation is essential for demonstrating the reliability and efficiency of cleaning methods for production equipment. This documented process ensures that cleaning practices effectively and consistently prevent cross-contamination and adulteration of drug, chemical, or biological products. This thesis aims to develop a cleaning validation model specifically for a tablet production line, focusing on four key machines: the double cone blender, fluidized bed dryer, compression machine, and high-shear mixer. Cleaning Standard Operating Procedures (SOP) were developed and implemented for each equipment. Paracetamol was selected as the worst-case API for testing residue levels among all other active ingredients due to its poor solubility and toxicity. To evaluate the efficiency of the cleaning procedure, we collected swab and rinse samples from crucial parts of the apparatus. The residues were analyzed using a UV analytical method, supported by a standard calibration curve with a correlation coefficient R2 of 0.9975 and a maximum absorbance of 243 nm. This guarantees the excellent accuracy of the UV analytical method. The Maximum Allowable Carryover (MACO) was calculated to determine acceptable residue thresholds. The efficacy of the cleaning techniques was confirmed by the fact that every result of the swab and rinse samples was below the calculated limits. The results confirmed that the cleanliness of all equipment was safe before beginning the next production batch and that the cleaning procedures were validated. Furthermore, it ensures the production of safe and effective pharmaceutical products.
| Published in | Pharmaceutical Science and Technology (Volume 9, Issue 1) |
| DOI | 10.11648/j.pst.20250901.14 |
| Page(s) | 27-36 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2025. Published by Science Publishing Group |
Cleaning Validation, Pharmaceutical Manufacturing, Paracetamol, Swab, Rinse, UV Spectrophotometry, MACO
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APA Style
Elsamman, S., Abdelkader, N., Mansour, S. (2025). Cleaning Validation Model for Tablet Production Line. Pharmaceutical Science and Technology, 9(1), 27-36. https://doi.org/10.11648/j.pst.20250901.14
ACS Style
Elsamman, S.; Abdelkader, N.; Mansour, S. Cleaning Validation Model for Tablet Production Line. Pharm. Sci. Technol. 2025, 9(1), 27-36. doi: 10.11648/j.pst.20250901.14
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Download@article{10.11648/j.pst.20250901.14,
author = {Sama Elsamman and Nouran Abdelkader and Samar Mansour},
title = {Cleaning Validation Model for Tablet Production Line
},
journal = {Pharmaceutical Science and Technology},
volume = {9},
number = {1},
pages = {27-36},
doi = {10.11648/j.pst.20250901.14},
url = {https://doi.org/10.11648/j.pst.20250901.14},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.pst.20250901.14},
abstract = {In pharmaceutical manufacturing, cleaning validation is essential for demonstrating the reliability and efficiency of cleaning methods for production equipment. This documented process ensures that cleaning practices effectively and consistently prevent cross-contamination and adulteration of drug, chemical, or biological products. This thesis aims to develop a cleaning validation model specifically for a tablet production line, focusing on four key machines: the double cone blender, fluidized bed dryer, compression machine, and high-shear mixer. Cleaning Standard Operating Procedures (SOP) were developed and implemented for each equipment. Paracetamol was selected as the worst-case API for testing residue levels among all other active ingredients due to its poor solubility and toxicity. To evaluate the efficiency of the cleaning procedure, we collected swab and rinse samples from crucial parts of the apparatus. The residues were analyzed using a UV analytical method, supported by a standard calibration curve with a correlation coefficient R2 of 0.9975 and a maximum absorbance of 243 nm. This guarantees the excellent accuracy of the UV analytical method. The Maximum Allowable Carryover (MACO) was calculated to determine acceptable residue thresholds. The efficacy of the cleaning techniques was confirmed by the fact that every result of the swab and rinse samples was below the calculated limits. The results confirmed that the cleanliness of all equipment was safe before beginning the next production batch and that the cleaning procedures were validated. Furthermore, it ensures the production of safe and effective pharmaceutical products.
},
year = {2025}
}
TY - JOUR T1 - Cleaning Validation Model for Tablet Production Line AU - Sama Elsamman AU - Nouran Abdelkader AU - Samar Mansour Y1 - 2025/06/13 PY - 2025 N1 - https://doi.org/10.11648/j.pst.20250901.14 DO - 10.11648/j.pst.20250901.14 T2 - Pharmaceutical Science and Technology JF - Pharmaceutical Science and Technology JO - Pharmaceutical Science and Technology SP - 27 EP - 36 PB - Science Publishing Group SN - 2640-4540 UR - https://doi.org/10.11648/j.pst.20250901.14 AB - In pharmaceutical manufacturing, cleaning validation is essential for demonstrating the reliability and efficiency of cleaning methods for production equipment. This documented process ensures that cleaning practices effectively and consistently prevent cross-contamination and adulteration of drug, chemical, or biological products. This thesis aims to develop a cleaning validation model specifically for a tablet production line, focusing on four key machines: the double cone blender, fluidized bed dryer, compression machine, and high-shear mixer. Cleaning Standard Operating Procedures (SOP) were developed and implemented for each equipment. Paracetamol was selected as the worst-case API for testing residue levels among all other active ingredients due to its poor solubility and toxicity. To evaluate the efficiency of the cleaning procedure, we collected swab and rinse samples from crucial parts of the apparatus. The residues were analyzed using a UV analytical method, supported by a standard calibration curve with a correlation coefficient R2 of 0.9975 and a maximum absorbance of 243 nm. This guarantees the excellent accuracy of the UV analytical method. The Maximum Allowable Carryover (MACO) was calculated to determine acceptable residue thresholds. The efficacy of the cleaning techniques was confirmed by the fact that every result of the swab and rinse samples was below the calculated limits. The results confirmed that the cleanliness of all equipment was safe before beginning the next production batch and that the cleaning procedures were validated. Furthermore, it ensures the production of safe and effective pharmaceutical products. VL - 9 IS - 1 ER -
Faculty of Pharmaceutical Engineering and Technology, German International University-GIU, Cairo, Egypt
Faculty of Pharmaceutical Engineering and Technology, German International University-GIU, Cairo, Egypt
