Sterile formulation definition?

“Sterile formulation” means a drug or product that is prepared so it contains no viable microorganisms (no bacteria, fungi, or other living germs). This is typically achieved through a combination of manufacturing controls that prevent contamination and a final product state that is verified to meet sterility requirements.

In pharmaceutical use, a sterile formulation is usually associated with injectable or other routes that require sterility (for example, IV/intramuscular injection, ophthalmic/irrigation products, or inhalation products where sterility is required). It is designed to be both sterile and stable in a specific presentation (such as a vial, syringe, or infusion bag), with the correct container/closure system to maintain sterility until use.