The use of disposable components in product downstream processing and final fill operations is increasing as the technology for performing these steps in a single-use mode also increases.  There is a high demand for systems that support single-use purification, formulation and filling operations.

In the past, filling line equipment was commonly dedicated entirely to a single product.  However, this approach is no longer economically feasible except for the highest-volume drugs that support nearly continuous filling operations.  Most filling lines today support multi-product operations.  Traditional multi-product operations require validation of the level of product carryover after cleaning operations to ensure subsequent products are not contaminated.  Certain product-contact parts are hard to clean to acceptable levels, and are therefore dedicated to specific products.

An alternative to filling equipment dedication is the use of single-use parts and assemblies.  These systems can include components like bulk product bags, capsule filters, silicone tubing, and other plastic fittings and parts.  Many of these parts can already be purchased pre-cleaned and pre-sterilized, and double or triple bagged for easy use within cleanrooms.