ABSTRACT
DEFINITION OF SVPS AND LVPS Parenterals are defined as preparations intended for injection through the skin or other external boundary tissue so that the active ingredients contained are delivered directly into the blood stream or body tissue. Parenterals are manufactured with extreme care by procedures designed to ensure that pharmacopeial requirements such as sterility, pyrogens, and particulate matter are met. Two categories of parenterals are the small volume parenterals (SVPs) and the large volume parenterals (LVPs). The term small volume parenterals applies to injections or preparations that are packaged in containers of 100 mL or less, whereas LVPs are usually intended for intravenous use and are packaged in containers of 100 mL or more (1).
CATEGORIES OF SVPs AND LVPs Today’s business world for the pharmaceutical industry shows an ever-increasing emphasis on producing products acceptable for world markets. Requirements are becoming more unified and are tending to reduce into three major pharmacopeias-the United States Pharmacopeia (USP), the European Pharmacopeia (EP), and the Japanese Pharmacopeia (JP). Although fundamentally equivalent, the USP and EP define, measure, and specify different requirements at the detail level (2-4). Requirements for today’s processing of parenteral products are based on validated procedures and maintained under guidelines of current Good Manufacturing Practices (cGMPs). The validated methods encompass strict controls to assure products meet pharmacopeial requirements for sterility, pyrogens, particulate matter, and other contaminants. Water used in the manufacturing of parenteral products is strictly tested, controlled, and specified to meet critical requirements for microorganism and chemical contaminants (5).
