Table 3.

Factors for selecting vials and closures for lyophilized drug product.

Component	Factor
Vial	Material compatibility with formulation Heat transfer properties (material, bottom geometry, wall thickness, size) Extractable and leachable profile Susceptibility to breakage Machinability Oxygen permeability Fill volume Color/light protection Other functions (such as inner coating to improve cake appearance)
Closure	Material compatibility with formulation, surface interaction Moisture permeability/absorption Water vapor flow (venting design) Extractable and leachable profile Fitting with vial neck design to provide good sealing Machinability and surface stickiness Coring potential (e.g. needle, spike) Resealable property Balanced hardness permitting stopper insertion and needle penetration