Terminal Sterilizer

Terminal sterilization is the process of sterilizing products in their final container. With respect to pharmaceutical manufacturing, traditional liquid sterile drug products are filled into clean and sterile primary containers such as vials, bottles, syringes, cartridges, or bags. Terminal sterilization is less complex, less costly, and more easily reproducible than aseptic processing.

It is the preferred method for sterilizing drug products because sterilization takes place after formulation, and once the product has been filled into the primary packaging. Steam sterilization is generally carried out at temperatures between 121°C (250°F) and 134°C (273°F), under 15–30 psi (1.0–2.0 bar) pressure, between 10 and 60 min, depending upon the material and the type of organism to be inactivated.

Terminal sterilization is the preferred method for drug products because sterilization takes place after the product has been filled into the primary packaging, thus severely limiting further opportunities for contamination due to human intervention. The process is reliable, repeatable, and delivers an excellent quality product. Terminal sterilization is also less complex, less costly, and more easily reproducible than aseptic processing. When conducted by well-trained, knowledgeable experts, sterilization conditions can be adapted to ensure they are appropriate to the drug product in question, and deliver the robust, thorough sterility results expected from this type of process. In our Grade C suites we develop injectable drug products and topical ophthalmic preparations that can be terminally sterilized after manufacture. All such drug processing is conducted in our Grade C, cGMP facility, which has been inspected by both the FDA and the European Union Quality Personnel. STERILE HEALTHCARE’ team of experts will guide you in the selection, method development and validation, and final delivery of fully sterilized product. We have decades of experience in the field, and will ensure the efficient, effective implementation of the most appropriate sterilization method for your drug product.