Table I.

Examples of Points to Consider When Introducing Single-Use Components

Examples of lists to be assessed	Examples of issues to be assessed
Structure design	Shape, layered structure for preventing leachables, compatibility with other components, structure for preventing misuse, strength
Raw materials control	Monomers, polymerization initiators, metal catalysts, additives (antioxidants, lubricants, anti-adhesives, antistatics), adhesives, printing inks, solvents, and biological ingredients
Manufacturing environment control	Air cleanliness, airborne microorganisms
Manufacturing process control	Inspections upon receipt of materials and components, shape-forming, film-forming, bag-making, assembly, integrity test
Sterilization process control	Radiation dosage (gamma- and beta-rays), level of ethylene oxide gas
Quality control	Reliability of test procedure and analytical methods for extractables, test procedure and acceptance criteria for insoluble particulate matter
Release test	Appearance, integrity test, consistency with the drawings, endotoxin test, inspection of foreign matters, sterility assurance
Packaging and delivery control	Primary packaging, wrapping, transport