INTRODUCTION

Steam sterilization of aqueous liquids (including both suspensions and emulsions with mixing), also known as sterilization of nonporous loads, is the method of choice for aqueous parenteral products, in-process aqueous liquids, laboratory media, and biological waste materials. This type of sterilization is accomplished primarily in closed containers. During steam sterilization by direct contact (also called steam sterilization of parts, hard goods, or porous items) the steam in the chamber directly contacts the surface of load items to effect sterilization (see Steam Sterilization by Direct Contact 〈1229.1〉). In contrast, sterilization of liquids in containers is accomplished by application of heat to the container, heating of the container wall, and ultimately heating of the internal liquid volume. This can be accomplished using steam, superheated water, and air in various combinations. Some aqueous liquids are susceptible to over-processing that could render them unfit for their intended use. Manufacturers should consider the influence of these differences when they establish a suitable process.