Packaging Flashcards
Economical means of providing** presentation, protection, preservation, identification, information, containment, convenience**, & compliance for a drug product
Packaging
Device that holds a drug & is or may be in direct contact w/ the drug
Container
Direct interaction with the product
Primary / Immediate Container
Liners, Containers, Ampoules, Vials, Bottles
Primary / Immediate Container
No direct interaction with the product
Secondary container
Boxes, Cartons, Injection trays
Secondary Packaging
Exclusively used for bulk packaging purposes and must withstand transportation hurdles
Tertiary Packaging
Container Barrel
Tertiary Packaging
Protects the contents from extraneous solids & from loss of the article under ordinary conditions of handling, shipment, storage, & distribution
Well-closed Container
Protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, & from efflorence, deliquescence or evaporation under the ordinary or customary conditions of handling shipment, storage, & distribution & is capable of tight reclosure.
Tight Container
Impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, & distribution
Hermetic Container
Protects the contents from photochemical deterioration (290nm and 450nm)
Light Resistant Container
Difficult for most children under 5 years of age to open or gain access to the contents or obtain a harmful amount of the content
A young child is unlikely to coordinate two or more actions to achieve a successful opening
Child-Resistant Container
Indication or barrier to entry that is distinctive by design, or must employ an identifying characteristic which if breached or missing can reasonably be expected to provide visible evidence to consumers that tampering has occurred
Tamper-Resistant Container
One that holds a quantity of drug intended as a single dose & when opened, cannot be resealed w/ assurance that sterility has been maintained
Single Dose Container/ Unit Dose
Volume USP Limit of Single Dose Container
1000 mL
Single Dose Containers
Fusion-sealed ampules
Prefilled Syringes
Cartridges
Hermetic container that permits withdrawal of successive portions of the contents w/out changing the strength or endangering the quality or purity of the remaining portions
Multiple Dose Container
Volume USP Limit of Multiple dose Container
30 mL
Beyond use date of Multiple dose container
28 days
Main component of Glass
Silicon dioxide
Advantages of Glass Packaging
Gas & Moisture barrier properties
Allows easy inspection of contents
Strenght, Inertness, and Rigidity
Disadvantages of Glass Packaging
Fragility
Expensive and heavy
Release alkali into contents
Amber Glass
Carbon dioxide + Sulfur
Iron & Manganese dioxide
