Darshan A. Salade, Kishor S. Arote, P. H. Patil, Pankaj S. Patil, Amol R. Pawar
Darshan A. Salade*, Kishor S. Arote*, P. H. Patil, Pankaj S. Patil, Amol R. Pawar:
Department of Quality Assurance, Kisan Vidya Prasarak Sanstha's, Institute of Pharmaceutical Education, Boradi 425405.
Volume - 12,
Issue - 3,
Year - 2022
The goal of this review is to establish the significance of cleaning validation in the pharmaceutical industry. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques.
Cite this article:
Darshan A. Salade, Kishor S. Arote, P. H. Patil, Pankaj S. Patil, Amol R. Pawar. A Review on Pharmaceutical Cleaning Validation. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):197-2. doi: 10.52711/2231-5675.2022.00033
Darshan A. Salade, Kishor S. Arote, P. H. Patil, Pankaj S. Patil, Amol R. Pawar. A Review on Pharmaceutical Cleaning Validation. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):197-2. doi: 10.52711/2231-5675.2022.00033 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-3-7
1. Ahir KB, Singh KD, Yadav SP, Patel HS, Poyahari CB. Overview of Validation and Basic Concepts of Process Validation. Scholars Academic Journal of Pharmacy 2014;3(2):178–190.
2. Maurya S, Goyal D, Verma C. Cleaning validation in pharmaceutical industry- An overview. Pharmatutor. 2016;4(9):14-20.
3. Asgharian R, Hamedani M, Heydari A. Step by Step How to Do Cleaning Validation. International Journal of Pharmacy and Life Sciences 2014;5(3):3345–3366.
4. Debaje PD, Chhabra GS, Gujarathi N, Jadhav A. Regulatory Aspects of Cleaning and Cleaning Validation in Active Pharmaceutical Ingredients. Asian Journal of Pharmaceutical Research and Development. 2018;6(3):69–74.
5. Chandani Y, Rajat V, Anju G. Aspects of Pharmaceutical Process Validation: A Review. International Journal of pharmacy and Pharmaceutical Research. 2018;14(1):55–66.
6. Sharma S, Khurana G, Gupta R. A Review on Pharmaceutical Validation and Its Implications. International journal of Pharmaceutical and Biological Research. 2013;1(3):100–104.
7. Jindal D, Kaur H, Patil RK, Patil HC. Validation – In pharmaceutical industry: Equipment validation: A brief review. Adesh University Journal of Medical Sciences and Research. 2020;2(2):94–98.
8. Kumar V., Sanjeev T, Sharma PK. Overview of cleaning validation in pharmaceutical manufacturing unit Kumar. International Journal of Advanced Research in Pharmaceutical and Bio Sciences. 2012;2(2):154–164.
9. Lodhi B, Padamwar P, Patel A. Cleaning Validation for the Pharmaceuticals, Biopharmaceuticals, Cosmetic and Neutraceuticals Industries. Journal of Innovations in Pharmaceuticals and Biological Sciences. 2014;1(1):27–38.
10. Gawai A, Lokhande S, Magar S, Biyani K. A Review On Cleaning Validation In Pharmaceutical Industry. International Journal of Pharmacy and Engineering. 2013;1(2):133–144.
11. Active pharmaceutical ingredient committee. Guide lines to cleaning validation in active pharmaceutical ingredient manufacturing plan.1999. Available from: - URL http:/apic.cefic.org/pub/4cleaning val9909.pdf.
12. Raj A. Cleaning Validation in Pharmaceutical Industries. Journal of Atoms and Molecules 2014;4(4):779–783.
13. Narayana Murthy D, Chitra K. A Review Article On Cleaning Validation. International Journal of Pharmaceutical Sciences and Research. 2013; 4(9):3317–3327.
14. Manu C, Gupta V. Review on cleaning validation in pharmaceutical industry. International Journal of PharmTech Research. 2016;9(3):415–421.
15. Khan F, Khan AS, Rao N. Cleaning Validation in Pharmaceutical Industries. International Journal of Research in Pharmacy and Chemistry. 2020;10(2):205–214.
16. Robert A Nash and Alfred HW. A Text Book of Pharmaceutical Process Validation. 3rd ed. New York: Marcel Dekker. 2003;793-820.
17. Tomar P, Khothiyal P. A Review on Cleaning Validation for Pharmaceutical Industry. Indian Research Journal of Pharmacy and Science. 2017; 4(2):950–962.
18. Rosen M J, Dispersion and aggregation of solids in liquid media in Surfactants and Interfacial Phenomena, New York, John Wiley and Sons Inc, 1978, pp. 251-271.
19. Rosen M J, Emulsification by surfactants in surfactants and interfacial phenomena, New York, John Wiley and Sons Inc, 1978, pp. 123-148.
20. Morgan JJ and Stumm W, Water in Encyclopedia of Chemical Technology, 4th Edition, Volume 25, New York, John Wiley and Sons, 1998, pp. 383-388.
21. Rosen M J, Solubilization by solutions of surfactants: Micelles catalysis in Surfactants and Interfacial Phenomena, New York, John Wiley and Sons Inc, 1978, pp. 224-250.
22. Tau K D, V Elango and J A McDonough, Organic in Encyclopedia of Chemical Technology. 4th Edition, Volume 9, New York, John Wiley and Sons, 1994, pp.783-786.
23. Kumar S, A review on concept of cleaning validation in pharmaceutical Industry, International Research Journal of Pharmaceutical Sciences. 3(7), 2012, pp. 17-19.
24. Agallaco J. Frederick Carelton J: A Text Book of Validation of Pharmaceutical Process. Spring Publisher, 3 rd Edition 2008: 525-565.
25. Waghmare PV, Chinchole AS, Poul BN, Bhusnure OG. A Brief Review on Cleaning Validation and Its Significance In Pharmaceutical Industry. An International Journal of Pharmaceutical Sciences. 2013;4(4):165–192.
26. Pawar HA, Banerjee ND, Pawar S, Pawar P: Current Perspectives on Cleaning Validation in Pharmaceutical Industry: A Scientific and Risk Based Approach. International Journal of Pharmaceutical and Phytopharmacological Research. 2011, 1(1): 8-16.
27. Kakad SB, Kolhe MH, Dukre TP. A review on pharmaceutical validation. International Journal of Pharmaceutical Quality Assurance. 2020;11(3):338–342.
28. Cleaning Validation Guidelines (GUIDE0028), Health Canada. pdf.
29. Dhole A, Fuloria N. An Overview on Cleaning Validation of API Manufacturing Plants. Journal of Current Pharma Research. 2013;4(1):1097–1104.
30. Karthick C, Kathiresan K. Pharmaceutical Process Validation: A Review. Journal of Drug Delivery and Therapeutics. 2022;12(1-s):164–170.
31. Mishra MK, Kumari P. A Review on Pharmaceutical Validation. The Pharma Innovation. 2020; 8(6):950–958.