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Research Journal of Science and Technology
Year : 2019, Volume : 11, Issue : 4
First page : ( 268) Last page : ( 274)
Print ISSN : 0975-4393. Online ISSN : 2349-2988.
Article DOI : 10.5958/2349-2988.2019.00038.X

Simultaneous Analytical Methods Development and Validation of for Cleaning Samples Analysis using Total Organic Carbon Analyzer (TOC)

Singh Ashish, Sharma Pushpendra

University Teaching Department, Sri Satya Sai University of Technology & Medical Sciences, Pachama, Sehore-466001, India

Online published on 31 December, 2019.

Abstract

Pharmaceuticals produced in a multi-product manufacturing facility can be contaminated by potentially harmful and toxic substances. In such facilities, the equipment is commonly used for manufacturing several different products of varying potencies. Improper equipment cleaning procedures can lead to possible contamination of the products with different types of residues. Although it is theoretically possible to clean equipment to such an extent that it is free from residues of the previous product, this situation is neither practical nor a business-friendly option in today's competitive environment. The time and cost involved in such cleaning would make it practically impossible to run an economically viable manufacturing unit. The study also included validation of manufacturing unit's cleaning procedures to demonstrate that the procedures are capable of reducing active ingredient concentrations on equipment surface to levels below the calculated acceptance criteria.

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Keywords

Cleaning Validation, Pharmaceutical Industry, MACO (Maximum Allowable Carry over), Method Validation.

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