VALIDATION OF WATER PURIFICATION SYSTEM
Objective: Validation of water treatment systems is required to achieve water with all preferred quality attributes. This also delivers a circumstantialÂ to establish a total control over the process which screens efficacy, safety, and ultimately, the process outcomes. The goal of steering validation is toÂ establish that a process when operated within established limits, yields a product of reliable and definite quality with a high degree of assurance.
Methods: The current work is an effort to deliberate several aspects of validation comprising different approaches, machineries of water purificationÂ systems, equipment qualifications, performance testing phases, microbial and chemical analysis of water samples, documentation, and post-validation
monitoring. Mainly the validation is done for new water plants in pharmaceutical industry.
Results and Discussion: Sampling of water was carried out after each step in the purification process, and the results were found within limits.
Conclusion: Water purification systems must be operated in the interior regulatory guidelines as with pharmaceutical manufacture facilities.
Successful achievement of validation is confirmed by various testing phases. Usually, a three-phase testing approach is recommended over an extended
period to prove reliability and robustness of the system for producing water of specified quality with a high degree of assurance.
Keywords: Validation, Water purification systems, Quality attributes,Pharmaceutical manufacture facilities, Microbial and chemical analysis.
2. The United States Pharmacopoeia. USP XXII/The National Formulary NF XVII. Rockville: United States Pharmacopeial Convention; 1990.
3. Food and Drug Administration. Guideline on General Principles of Process Validation. Rockville, MD: FDA; 1984.
4. PMA Deionized Water Committee. Validation and control concepts for water treatment systems. Pharm Technol 1985;9(11):50-6.
5. Potdar MA. Pharmaceutical Quality Assurance. Geneva: World Health Organisation; 2007. p. 8.84-8.94.
6. McBride D, Mukhopadhyay D. Higher water recovery and solute rejection through a new RO process. Ultrapure Water 1997;14(5):24-9.
7. Paul DH. A review of membrane water treatment technologies. Ultrapure Water 1997;14(3):39-42.8. Debajit B, Yadav RN, Sangra A, Shahin L, Chaubey AK. Production, purification and characterization of nattokinase from bacillus subtilis, isolated from tea garden soil samples of Dibrugarh, Assam. Int J Pharm Pharm Sci 2012;5(3):124-5.
9. Singh R. A review of membrane technologies, reverse osmosis, nanofiltration and ultrafiltration. Ultrapure Water 1997;14(3):21-9.
10. Munson TE. FDA View on Water System Validation. Proceedings of the Pharmacy Technician Conference 10-12 September; 1985.
11. Nash RA. Validation of pharmaceutical processes. In: Swarbrick J, Boylan JC, editors. Encyclopedia of Pharmaceutical Technology. 2nd ed. New York: Marcel Dekker; 2002. p. 2917-31. Pahwa R, Khatri S, Rathour A, Lamba HS. Validation of moist heat sterilization cycles. J Sci Pharm 2004;5(4):125-30.
12. Carlrton FJ, Agalloco JP. Validation of Pharmaceutical Process. New York: Marcel Dekker; 1986.
13. Johnson WM. Validation of water systems for sterile and nonsterile products. In: Berry IR, Nash RA, editors. Pharmaceutical Process Validation. 2nd ed. New York: Marcel Dekker Inc., Revised and Expanded; 1993. p. 299-317.
14. Carleton FJ, Agalloco JP. Validation of Pharmaceutical Processes. 3rd ed. New York: CRC Press; 2007. p. 59-92.
15. Available from: http://www.authorstream.com.
16. Ferreira JA, Silva Z, Oliveira RC, Branquinho MR. Bacterial Contaminants in Water and Dialysate Used for Haemodialysis Therapy in Rio de Janeiro (1999-2001). XXI Congresso Brasileiro de Microbiologia (Brazilian Congress of Microbiology). 2001, IH 040. p. 148.
17. Palmieri MJ, Carito SL, Meyer RF. Comparison of rapid NFT and API 20E with conventional methods for identification of gram-negative nonfermentative bacilli from pharmaceuticals and cosmetics. Appl Environ Microbiol 1988;54:2838-41.
18. Ravichandran V, Shalini S, Sundram KM, Rajak H. Validation of analytical methods - Strategies & importance. Int J Pharm Pharm Sci 2010;2(3):18-22.
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