6 - Packaging and Storage of Drug Products

Proverbs 16:3

c. Packaging

An economic way of protecting, preparing, identifying, and containing the drug products, composed of container and closure
a. Storage
b. Labeling
c. Packaging
d. Sterilization

• Primary Packaging

• Secondary Packaging

Types of Packaging [2]

a. Primary Packaging

[Types of Packaging]

In direct contact with product

a. Primary Packaging

b. Secondary Packaging

a. Primary Packaging

[Types of Packaging]

Considered as immediate container, affects stability

a. Primary Packaging

b. Secondary Packaging

a. Primary Packaging

[Types of Packaging]

This may provide means of administration

a. Primary Packaging

b. Secondary Packaging

• Bottles

• Caps

• Liners

• Filler

• Desiccant

[Types of Packaging]

Examples of primary packaging
a. Carton box, sticker label, inserts
b. Bottles, caps, liners, filler, desiccant
c. Conjugated box
d. Shipping container

b. Secondary Packaging

[Types of Packaging]

Outer packaging (not always present)

a. Primary Packaging

b. Secondary Packaging

b. Secondary Packaging

[Types of Packaging]

Encloses primary packaging

a. Primary Packaging

b. Secondary Packaging

• Carton box

• Sticker label

• Inserts

• Conjugated box

[Types of Packaging]

Examples of secondary packaging
a. Bottles, caps, liners
b. Filler, desiccant
c. Carton box, sticker label, inserts, conjugated box
d. Ampoules, vials

f. Well-Closed Container

[Classification of Container According to Protection Ability]

Protects content from extraneous solids

a. Tamper-Resistant Container
b. Child-Resistant Container
c. Light-Resistant Container
d. Hermetic Container
e. Tight Container
f. Well-Closed Container

e. Tight Container

[Classification of Container According to Protection Ability]

Protects contents from extraneous solids, liquids, and vapors

a. Tamper-Resistant Container
b. Child-Resistant Container
c. Light-Resistant Container
d. Hermetic Container
e. Tight Container
f. Well-Closed Container

e. Tight Container

[Classification of Container According to Protection Ability]

Protects from deliquescence, efflorescence, evaporation

a. Tamper-Resistant Container
b. Child-Resistant Container
c. Light-Resistant Container
d. Hermetic Container
e. Tight Container
f. Well-Closed Container

d. Hermetic Container

[Classification of Container According to Protection Ability]

Impervious to air or any other gas

a. Tamper-Resistant Container
b. Child-Resistant Container
c. Light-Resistant Container
d. Hermetic Container
e. Tight Container
f. Well-Closed Container

c. Light-Resistant Container

[Classification of Container According to Protection Ability]

Protects from photochemical degradation

a. Tamper-Resistant Container
b. Child-Resistant Container
c. Light-Resistant Container
d. Hermetic Container
e. Tight Container
f. Well-Closed Container

a. Amber bottle

[Classification of Container According to Protection Ability]

Example of Light-Resistant Container
a. Amber bottle
b. Clear glass bottle
c. Plastic container
d. Metal container

b. Child-Resistant Container

[Classification of Container According to Protection Ability]

Difficult for children under 5 years of age to open:

• press down and turn

• squeeze and turn

• alight the ar

• latch top

a. Tamper-Resistant Container
b. Child-Resistant Container
c. Light-Resistant Container
d. Hermetic Container
e. Tight Container
f. Well-Closed Container

• press down and turn

• squeeze and turn

• alight the ar

• latch top

[Classification of Container According to Protection Ability]

Mechanisms used in child-resistant containers include _____ [4]

a. Tamper-Resistant Container

[Classification of Container According to Protection Ability]

Uses an indicator which if breached or missing can provide evidence that tampering has occurred:

• shrink seal/ wrap

• breakable caps

• tape seal

• bottle seal

• aerosol → only true tamper-resistant packaging

a. Tamper-Resistant Container
b. Child-Resistant Container
c. Light-Resistant Container
d. Hermetic Container
e. Tight Container
f. Well-Closed Container

• shrink seal/ wrap

• breakable caps

• tape seal

• bottle seal

• aerosol

Mechanisms used in tamper-resistant containers include _____ [5]

c. Aerosol

[Classification of Container According to Protection Ability]

Only true tamper-resistant packaging
a. Shrink seal/wrap
b. Bottle seal
c. Aerosol
d. Breakable caps

a. Single Unit Container

[Classification of Container According to Quantity Held]

Contains a single dose only and packaged in nonresealable containers

a. Single Unit Container

b. Multiple Unit Container

a. Single Unit Container

[Classification of Container According to Quantity Held]

No antimicrobial agent added

a. Single Unit Container

b. Multiple Unit Container

b. WFI or SWFI

[Classification of Container According to Quantity Held]

Type of water used in single unit containers

a. BWFI
b. WFI or SWFI
c. Distilled water
d. Deionized water

b. 1000 mL

[Classification of Container According to Quantity Held]

USP limit for single unit containers
a. 30 mL
b. 1000 mL
c. 500 mL
d. 100 mL

• Ampoules

• Prefilled syringes

[Classification of Container According to Quantity Held]

Examples of single unit containers
a. Vials
b. Ampoules, prefilled syringes
c. Bottles
d. Multi-dose vials

• Low cost

• Not Breakable

• Light weight

• Chemically inert

Advantages of Single Unit Container [4]

• Permeable

• Low heat resistance

• Not as clear as glass

• Poor physical stability

Disadvantages of Single Unit Container [4]

b. Multiple Unit Container

[Classification of Container According to Quantity Held]

Contains multiple doses and packaged in resealable containers

a. Single Unit Container

b. Multiple Unit Container

b. Multiple Unit Container

[Classification of Container According to Quantity Held]

With antimicrobial agent added

a. Single Unit Container

b. Multiple Unit Container

b. BWFI

[Classification of Container According to Quantity Held]

Type of water used in multiple unit containers
a. WFI or SWFI
b. BWFI
c. Distilled water
d. Purified water

c. 30 mL

[Classification of Container According to Quantity Held]

USP limit for multiple unit containers
a. 1000 mL
b. 500 mL
c. 30 mL
d. 100 mL

c. Vials

[Classification of Container According to Quantity Held]

Example of multiple unit container
a. Ampoules
b. Prefilled syringes
c. Vials
d. Single-dose syringes

b. Glass

[Classification of Container According to Material Used]

• This is the most widely used container material

• This is made up of inorganic compounds (major component: SiO₂)

a. Plastic
b. Glass
c. Rubber
d. Metal

• Rigid and transparent

• Impermeable

• Chemically resistant

• Can be easily sterilized

[Classification of Container According to Material Used]

Advantage of Glass as Container material [4]

• High cost

• Fragile

• Relatively heavy

• Prone to leaching

[Classification of Container According to Material Used]

Disadvantage of Glass as Container material [4]

a. Silica (SiO₂)

[Classification of Container According to Material Used]

Major component of glass
a. Silica (SiO₂)
b. Soda (Na₂O)
c. Lime (CaO)
d. Alumina (Al₂O₃)

c. Type I

[Type of Glass]

Highly Resistant Borosilicate Glass
a. Type II
b. Type III
c. Type I
d. Type IV/NP

b. Boron

[Type of Glass]

Component of glass that decreases coefficient of expansion
a. Silica
b. Boron
c. Sodium
d. Calcium

• Pyrex

• Borosil

[Type of Glass]

Brand names of Highly Resistant Borosilicate glass
a. Soda Lime Glass
b. Pyrex, Borosil
c. General Soda Lime Glass
d. Treated Soda Lime Glass

c. Type II

[Type of Glass]

Treated Soda Lime Glass
a. Type I
b. Type III
c. Type II
d. Type IV/NP

c. Type III

[Type of Glass]

Soda Lime Glass

a. Type I
b. Type II
c. Type III
d. Type IV/NP

c. Type III

[Type of Glass]

Type of glass used for Dry Powder Packaging

a. Type I
b. Type II
c. Type III
d. Type IV/NP

d. Type IV/NP

[Type of Glass]

General Soda Lime Glass
a. Type I
b. Type II
c. Type III
d. Type IV/NP

b. Plastic

[Classification of Container According to Material Used]

Container material composed of organic polymers of HMW
a. Glass
b. Plastic
c. Rubber
d. Metal

b. Thermoplastic

[Types of Plastic]

• Soft when heated and hard when cooled

• Flexible and squeezable

a. Thermoset
b. Thermoplastic

b. Thermoplastic

[Types of Plastic]

• Permanently hard

• Rigid

a. Thermoset
b. Thermoplastic

e. Polyethylene Terephthalate

[Types of Polymers for Plastic]

For beverages

a. Polypropylene (PP)

b. Low-density Polyethylene (LDPE)

c. Polyvinyl Chloride (PVC)

d. High-density Polyethylene (HDPE)

e. Polyethylene Terephthalate (PET)

d. High-density Polyethylene

[Types of Polymers for Plastic]

Used as hard thermoset for solid dosage forms

a. Polypropylene (PP)

b. Low-density Polyethylene (LDPE)

c. Polyvinyl Chloride (PVC)

d. High-density Polyethylene (HDPE)

e. Polyethylene Terephthalate (PET)

c. Polyvinyl Chloride (PVC)

[Types of Polymers for Plastic]

Used for blister packs

a. Polypropylene (PP)

b. Low-density Polyethylene (LDPE)

c. Polyvinyl Chloride (PVC)

d. High-density Polyethylene (HDPE)

e. Polyethylene Terephthalate (PET)

b. Low-density Polyethylene (LDPE)

[Types of Polymers for Plastic]

Used as thermoplastic for squeeze bottles and medicine droppersa. a. Polypropylene (PP)

b. Low-density Polyethylene (LDPE)

c. Polyvinyl Chloride (PVC)

d. High-density Polyethylene (HDPE)

e. Polyethylene Terephthalate (PET)

a. Polypropylene (PP)

[Types of Polymers for Plastic]

Used for autoclave containers

a. Polypropylene (PP)

b. Low-density Polyethylene (LDPE)

c. Polyvinyl Chloride (PVC)

d. High-density Polyethylene (HDPE)

e. Polyethylene Terephthalate (PET)

b. Metal

[Classification of Container According to Material Used]

Container material used in aerosol cans and collapsible tubes
a. Rubber
b. Metal
c. Paper
d. Foils

c. Foils, Films and Laminates

[Classification of Container According to Material Used]

Container material used in blister packs and strip packs
a. Rubber
b. Metal
c. Foils, Films and Laminates
d. Paper

b. Rubber

[Classification of Container According to Material Used]

Container material used in vial stoppers and syringe plugs
a. Metal
b. Rubber
c. Foils
d. Paper

d. Paper

[Classification of Container According to Material Used]

Container material used for divided powders
a. Rubber
b. Metal
c. Foils
d. Paper

e. Cold

[Storage Conditions]

NMT 2 to 8°C

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature

f. Refrigerator

[Storage Conditions]

2 to 8°C

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature

g. Freezer

[Storage Conditions]

-20 to -10°C

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature

d. Cool

[Storage Conditions]

8 to 15°C

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature

h. Room Temperature

[Storage Conditions]

Temperature prevailing in the area

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature

c. Controlled Room Temperature

[Storage Conditions]

20 to 25°C

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature

b. Warm

[Storage Conditions]

30 to 40°C

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature

a. Excessive Heat

[Storage Conditions]

>40°C

a. Excessive Heat

b. Warm

c. Controlled Room Temperature

d. Cool

e. Cold

f. Refrigerator

g. Freezer

h. Room Temperature