Introduction

Pharmaceutical parenteral preparations are, by standard requirements, sterile and very often devoid of particulate contaminants. Included are ophthalmic preparations, surgical lavages, total parenteral nutrition formulations, APD formulations, dialysis formulations, cell culture formulations, and various fluids used for patients with autoimmune diseases. The production of these compounds and formulations to produce a sterile product requires environmental and personnel control, as well as direct manipulation of the solution. To accomplish these techniques, established regimens for the use of containment of the manufacturing area; incoming raw material monitoring; gowning; container cleaning and sterilization; the use of ultraviolet, gamma; and explicit standard operating procedures are usually advised. These processes generally involve working with cold sterilization, and work has proceeded in this area to examine the impact of proper gowning to prevent accidental microbial contamination of the working environment. Filter sterility testing became more consistent with procedures developed by Frances Bowman of the US Food and Drug Administration and Charles Schaufus of Millipore Corp.