the validation of packaging by the method water vapour transmission rate

Abstract

The role of packaging is to preserve and protect a drug from contamination and degradation, so the drug retains its therapeutic efficacy. All manufacturers do their best to provide protective packaging for moisture-sensitive medications, but sometimes the drug may not reach its intended life. This is the case of the product Clavodex CONTINENTAL PHARM laboratory (CLP), for which an alteration of the tablets and powder was found on finished product in its packaging. This thesis presents the approach taken by CLP to verify the quality and integrity of packaging using the WVTR method, to achieve it, we have established procedures for the adjustment of packaging machines and a procedure for the preparation of samples for testing, thus checking the conditions of their preparation. At the end we prepared the samples in accordance with the established procedures and good manufacturing practices, to control them and then send them for the WVRT test.