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Manufacturing > Packaging > Flashcards

Packaging Flashcards

1
Q

Economical means of providing** presentation, protection, preservation, identification, information, containment, convenience**, & compliance for a drug product

A

Packaging

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2
Q

Device that holds a drug & is or may be in direct contact w/ the drug

A

Container

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3
Q

Direct interaction with the product

A

Primary / Immediate Container

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4
Q

Liners, Containers, Ampoules, Vials, Bottles

A

Primary / Immediate Container

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5
Q

No direct interaction with the product

A

Secondary container

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6
Q

Boxes, Cartons, Injection trays

A

Secondary Packaging

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7
Q

Exclusively used for bulk packaging purposes and must withstand transportation hurdles

A

Tertiary Packaging

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8
Q

Container Barrel

A

Tertiary Packaging

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9
Q

Protects the contents from extraneous solids & from loss of the article under ordinary conditions of handling, shipment, storage, & distribution

A

Well-closed Container

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10
Q

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.

A

Tight Container

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11
Q

Impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, & distribution

A

Hermetic Container

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12
Q

Protects the contents from photochemical deterioration (290nm and 450nm)

A

Light Resistant Container

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13
Q

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

A

Child-Resistant Container

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14
Q

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

A

Tamper-Resistant Container

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15
Q

One that holds a quantity of drug intended as a single dose & when opened, cannot be resealed w/ assurance that sterility has been maintained

A

Single Dose Container/ Unit Dose

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16
Q

Volume USP Limit of Single Dose Container

A

1000 mL

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17
Q

Single Dose Containers

A

Fusion-sealed ampules
Prefilled Syringes
Cartridges

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18
Q

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

A

Multiple Dose Container

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19
Q

Volume USP Limit of Multiple dose Container

A

30 mL

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20
Q

Beyond use date of Multiple dose container

A

28 days

21
Q

Main component of Glass

A

Silicon dioxide

22
Q

Advantages of Glass Packaging

A

Gas & Moisture barrier properties
Allows easy inspection of contents
Strenght, Inertness, and Rigidity

23
Q

Disadvantages of Glass Packaging

A

Fragility
Expensive and heavy
Release alkali into contents

24
Q

Amber Glass

A

Carbon dioxide + Sulfur
Iron & Manganese dioxide

25
Q

Yellow Glass

A

Cadmium and sulphur compounds

26
Q

Blue Glass

A

Cobalt oxide or Cupric oxide

27
Q

Green Glass

A

Iron oxide, Manganese dioxide, Chromium dioxide

28
Q

Opal Glass

A

Fluorides or Phosphates

29
Q

Types of Glass

A

Highly resistant Borosilicate
Treat Soda Lime Glass
Soda Lime Glass
General Purpose Soda Lime

30
Q

Most resistant to heat, most unreactive, most inert glass

A

Highly Resistant Borosilicate Glass

Low leachability
Low thermal coefficient

31
Q

Components of Highly Borosilicate Glass

A

SiO2 + Boron trioxide

32
Q

Use of Type I Glass

A

Buffered and non-buffered aqueous solution

33
Q

Use of Treated Soda Lime Glass( Type II)

A

Buffered aqueous solution
Large Volume Parenteral
Eye Preparation and dropper bottles

34
Q

Use of Soda Lime Glass (Type III)

A

For Dry Powders and Oily Solutions
For ORAL and TOPICAL
NOT for Parenteral

35
Q

Use of General Purpose Soda Lime Glass

A

Topical and Oral Use
NOT for Parenteral

36
Q

QC Tests for Glass

A

Type I, III, NP - Powdered Glass Test
Type II - Water Attack Test

37
Q

Advantages of Plastics

A

Lightweight
Resistance to breakage
Disposabke after single use

38
Q

Disadvantages of Plastics

A

Permeation of molecules in etiher direction through the wall of container
Leaching
Sorption

39
Q

Classification of Plastics

A

Thermoplastics
Thermosetting plastics

40
Q

Plastic rigid at operating temperature, but can be remelted and reprocessed without decomposition

A

Thermoplastics

41
Q

Plastic with good dimensional and temperature stability

A

Thermosetting Plastics / Thermosets

Connot be remelted, only softens

42
Q

Autoclavable Plastics, heat resistant

A

Polypropylene (PP)

43
Q

Least resistant to moisture vapor permeation

A

Polyvinyl Chloride

Ex. Blister packs

44
Q

Oldest, most widely used plastics with poor gas barrier and solvent resistance

A

Polystyrene (PS)

Large Scale production of cans and bottles

45
Q

Softer, stretchable, flexible and permeable to essential oils and chloroform

A

Low Density Polyethylene (LDPE) / Branched Polyethylene

Squeeze bottle. soft bags, infusion bottles

46
Q

Stronger, Stiffer, widely used materual for pharmaceutical containers

A

High Density Polyethylene (LDPE) / Linear Polyethylene

Bottles for Solid Dosage Forms

47
Q

Low Cost, heat sealability, and decoration

A

Folis, Films, and Laminates

48
Q

Stoppers, plugs, bulb

A

Rubber

49
Q

Aluminum, Tin, Aerosol cans, collapsible tubes

A

Metal

Manufacturing (13 decks)

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