ABSTRACT
Disposable devices from filter housings to the lining of bioreactors make extensive use of plastic materials or elastomer systems. Today, perhaps the most significant impediment in the wider acceptance of disposable systems is the controversy surrounding the possibility of contaminating the product from the chemicals in the plastic film. Plastic and rubber are also disposable, so issues associated with cleaning and validation can be avoided. Despite the risk in the use of additives added to polymers, the utility of polymers in disposable bioprocess equipment (and in all medical or pharmaceutical applications) far outweighs the risks associated with their use. In general, a product stream or formulation that has higher levels of organics, particularly high or low pH, or solubilizing agents such as surfactants (detergents), will increase the regulatory and safety concern for potential leachables. Neutral buffers lower concern about potential leachables.
