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 1a 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/m3.
The following analogy illustrates how potentially dangerous these substances are considered to be: if one were to take the volume of air in the Empire State Building, only one twentieth of a teaspoon of a toxic material would be allowed in the building to remain within the OEB 5 limits. Often there is only one possibility – to work inside an isolator. Most isolators are made from rigid stainless steel, which can be an expensive and not very flexible material to handle. The use of rigid stainless steel structures for API production gives rise to issues such as the need to clean the isolator, especially in multi-purpose facilities, which is usually a task for the quality management teams.
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