ABSTRACT
Sterile products may be in liquid or powder form as drug products and may be presented in formats including ampoules, vials, presterilized vials, cartridges, prefilled syringes, presterilized bottles, and blow-fill-seal containers. Product form and presentation influence processing conditions, equipment selection, and therefore facility design. Sterile chemical bulk drug substances are derived from chemical reactions. Facilities producing sterile Active Pharmaceutical Ingredient (API) will be required to provide protection of the product during synthesis, isolation, and bulk filling. An adjuvant produced by precipitation is an example of a sterile API. Potent compounds are classified as those chemical drug substances that are considered to be toxic to humans when exposure limits are exceeded, and may cause allergic reactions, birth defects, cancer, or other conditions. For this reason, it is required to ensure protection of operators working with potent compounds, ensure containment of all operations, and prevent release of products into the environment.
