Abstract

CLEANING VALIDATION OF IBUPROFEN ORAL SUSPENSION

Bhusnure O.G.*, Ansari M.M.AW, Gholve S.B., Kazi P.A.

ABSTRACT

The cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients and cleaning agents so that the analytical monitoring may be reduced to a minimum in the routine phase. In addition one need to ensure there is no risk associated with cross contamination of active ingredients. Cleaning validation is intended to address special consideration and issues pertaining to validation cleaning procedures for equipment used in the manufactured of pharmaceutical products, radiopharmaceuticals, and biological drugs. Cross contamination is one of the major problems focused in manufacturing of drugs utilizing common facility which leads to inferior quality of final product and cause considerable loss to the company. Contamination of one batch product with significant levels of residual active ingredients from a previous batch and contamination by microorganisms are the real concern. The cleaning validation is a documented process that proves the effectiveness and consistency cleaning of pharmaceutical equipments to meet the regulatory requirements. Manufacturing of Ibuprofen oral suspension and utilizing common facility, where Ibuprofen could be a possible cross contaminant. Hence the present study was carried out to validate the cleaning activity from both regulatory and quality prospective. Visual inspection, Swab sampling for chemical residue and for microbiological analysis for two Mfg. batches were carried out to validate cleaning activity and results from all methods both batches were complying with acceptance criteria.

Keywords: Ibuprofen Oral Suspension; Cross Contamination; Cleaning Validation.