THE ADVANTAGES OF SINGLE-USE SYSTEMS IN PHARMACEUTICAL PRODUCTION

摘要

The biotechnical industry has been a pioneer in the use of single-use equipment and has shown that it works well in an industrial setting and, more importantly, that cost savings of up to 40% are possible in some cases. In the US, some companies are looking at using more disposable facilities because it offers the opportunity to reduce production and cleaning costs and the issues of production residues and cross contamination no longer come into play (see cost comparisons in Figures la and 1b). At many pharmaceutical manufacturing sites the active pharmaceutical ingredients (APIs) used today are more potent than in the past and thus more dangerous. Many of these substances are categorised as being in the Occupational Exposure Band (OEB) 5. This means that the operators must be effectively protected against exposure to the APIs and the contamination level must not exceed 1μg/m~3.