ABSTRACT
The majority of sterilizing grade filters, as well as pre-filtration devices, are supplied into
the highly regulated biopharmaceutical industry by outside vendors. This means that
quality standards pertinent to the processes of the biopharmaceutical industry have to be
applied to the vendors’ processes. These standards start with the qualification of the
production equipment during the development phase, and extend through the validation
of the production process in its entirety, definitions of in-process controls and
documentation during the production process, release criteria, specifications and
tolerance settings, and complete traceability of the finalized product and product
components. Standard operating procedures and training matrices are as manifold within
the vendors systems as with the equipment end-user.
