Page 107 - Assurance of Sterility for Sensitive Combination Products and Materials

Package/container closures 91

Fig. 5.4 Inhaler device. iStock.com/csheezio

Table 5.3 Categories of packaging systems and examples.
Bulk Unit-dose/non-reclosable Multi-dose
Bottle (Plastic Pre-filled syringe Vial
and Glass)
Sacks/Bags Blister packs Bottles (Plastic and Glass)
Drums/Kegs Blow-fill-Seal (BFS) Tubes
Ampules Aerosols
Vials Ophthalmic/Otic solution or
suspension Delivery Systems
Injection/Infusion Systems Metered Dose Inhalers
Sachets

5.2.5 Considerations for plastic selection-pharmaceutical and
medical device packaging
Table 5.4 illustrates the correlation between the degree of concern re-
garding the route of administration with the likelihood of packaging
component-dosage form interactions for different classes of drug products.
To appropriately select plastic materials for a terminally sterilized package,