Regulatory pathway for labeling combination products as sterile

Sterility Assurance Across-Sectors—New Paradigms and Tools

“…They have a history for many decades of being sterilized at greater SALs than 10 −6 (e.g., 10 −3 ) and still being labeled as "STERILE." However, these same products sold in many other countries around the world are not categorized as medical devices and in some cases are not deemed to require a "STERILE" label claim (13).…”

“…An intuitive definition was recently used in an ISO guidance document 13 and does not restrict usage of the term to product after a sterilization process,…”

“…In the United States, some products used in healthcare practices that do not contact compromised tissue have been designated as medical devices (for example gowns and drapes). They have a history for many decades of being sterilized at greater SALs than 10 −6 (e.g., 10 −3 ) and still being labeled as “STERILE.” However, these same products sold in many other countries around the world are not categorized as medical devices and in some cases are not deemed to require a “STERILE” label claim ( 13 ).…”

“…The definition comes from TR 1:2007, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification, and Ongoing Control. Note: The mission of the PDA is advance pharmaceutical/biopharmaceutical manufacturing science and regulation so members can better serve patients 13. ISO/TS 19930 clause 4.5.…”