Abstract: An apparatus for making a sterile emulsion, comprising a fluid pathway, a pumping bore, a reciprocable (reciprocal) member, and a valve body. The pumping bore being in fluid communication with the fluid pathway and having a reciprocable member reciprocably disposed in the pumping bore. The reciprocable member having first portion disposed in fluid communication with the fluid pathway and a second portion isolated from the fluid pathway, said second portion having a sterilant passage adjacent thereto. The fluid pathway, reciprocable member first portion and reciprocable member second portion may be sterilized and one or more emulsion constituents may be directed into the fluid pathway defined by the piston apparatus after sterilization. The valve body defines a valve bore in communication with the fluid pathway and a valve plunger disposed therein. The valve body may also be configured to maintain emulsion sterility.

Abstract: An apparatus for adding a quantity of a sterile liquid to a processing system. The apparatus includes an additive reservoir constructed to retain a liquid therein and a first flow channel having a first end portion fluidly connected to the additive reservoir and having a second end portion constructed for fluid connection to a processing system. The apparatus further includes a container constructed to retain a liquid therein and a second flow channel having a first end portion fluidly connected to the container and having a second end portion in fluid communication with the additive reservoir. A filter constructed to sterilize a liquid flowing through the second flow channel is provided. A first valve constructed to control flow through said second flow channel also is included in the apparatus.