DeterminaÃÃo do teor Carbono OrgÃnico Total (TOC): Metodologia analÃtica e AplicaÃÃes na IndÃstria FarmacÃutica

AUTOR(ES)
DATA DE PUBLICAÇÃO

2006

RESUMO

The purified water is a component of mandatory use in pharmaceutical industries and scientific research organizations. One of the major difficulties for the users of this type of water is to know its quality. In compliance with the legal requirement of assuring the absence of contaminants in the water, a set of analysis was substituted by the use of the TOC monitor, English initials for Total Organic Carbon, which aims at identifying the water contarnination with the presence of organic impurities. Non specific method, rapid and effective technique, TOC analysis oxidates organic substances leads to the formation of C02 and the detection. This study have objective to apply the method of TOC to monitoring the water quality in the pharmacist industry. Since 1999, the US American pharmacopoeia (United States Pharmacopoeia), includes as one of the items of water analysis, the TOC quantification, presenting a maximum lirnit of 500 ppb or 0,5 ppm TOC. This is work also considered the use of TOC in the analysis for validation of equipment cleaning, used in whole the specific method, may be used to test residues of products previously manufactured, chemical detergents, solvents of the products, degradings and microbiological contaminants. Conceived as a part of the Good Medication Manufacturing Practices - BPF, the validation of equipment cleaning for the production of medications is demanded by Resolution 2 10 (Resolution of the Collegiate Board), of ANVISA (Brazilian National Sanitary Surveillance Agency)

ASSUNTO(S)

worst case pior-caso purified water Ãgua purificada farmacia carbono orgÃnico total validaÃÃo de limpeza cleaning validation total organic carbon

ACESSO AO ARTIGO

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