Exam 2 Packaging

Question 1

A _______ holds the article or may be in direct contact with the article. The _______ _____ is that which is in direct contact with the article at all times.

Answer 1

Container

Immediate container

Question 2

T or F: The closure is part of the container

Answer 2

True

Question 3

Special precautions and cleaning procedures may be necessary to ensure that each container is clean and that extraneous matter is not introduced into or onto the _____.

Answer 3

article

Question 4

T or F: No physical or chemical interactions between the container and the contents that might result in altering the strength, quality, or purity of the stored article beyond official requirements

Answer 4

True

Question 5

Tamper resistant packaging is used for what type of products?

Answer 5

Opthalmic, otic, or OTC

Question 6

Light resistant containers are used for compounds prone to ______. A container may be made light resistant by means of _____ coloring.

Answer 6

Oxidation

Opaque

Question 7

Well closed containers protect from extraneous ______ (solids, liquids, and/or gas) and from loss of the drug under the ordinary or customary conditions of handling, shipment, storage, and distribution

Answer 7

Solids

Question 8

Well closed containers are used for solid dosage forms not prone to ______ or _____

Answer 8

Oxidation or hydrolysis

Question 9

Tight container protect the contents form contamination by extraneous _____ (solids, liquids, and/or vapors) from loss of the article, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution

Answer 9

solids, liquids, and vapors

Question 10

T or F: Tight containers are not capable of tight re-closure

Answer 10

False: tight containers are capable of tight reclosure

Question 11

The loss of water of hydration in hydrates

Answer 11

Efflorescence

Question 12

The absorption of water vapor

Answer 12

Deliquescence

Question 13

Which containers are impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution

Answer 13

Hermetic

Question 14

T or F: Each single unit container shall be labeled to indicate the identity, quantity, and/or strength, name of the manufacturer, lot number, and expiration date of the article

Answer 14

True

Question 15

Packaging designed to hold a quantity of drug product intended for administration as a single dose or a single finished device intended for use promptly after the container is opened

Answer 15

Single-unit

Question 16

Single-dose containers are a single-unit container for articles intended for ______ administration, with no antimicrobial preservation required. The maximum volume is ___L

Answer 16

Parenteral administration

1 L

Question 17

A single-unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container

Answer 17

Unit-dose

Question 18

Multiple-dose includes multiple-unit containers for articles intended for ______ administration only. Antimicrobial preservation ____ (is / is not) required. The maximum volume is ____mL

Answer 18

30mL

Question 19

Container that contains a specific quantity of a drug product that is intended to be dispensed as such without further modification except for the addition of appropriate labeling

Answer 19

Unit-of-use containers

Question 20

T or F: The container must protect against adverse effects of the environments and must prevent loss of drug product components

Answer 20

True

Question 21

T or F: The materials selected for the container do not need to be FDA approved

Answer 21

False; they need to be FDA approved

Question 22

T or F: Glass is a liquid of a high degree of viscosity that it appears to exist as a solid

Answer 22

True

Question 23

In the composition of glass, a structural network is formed by ______ ______

Answer 23

Silicon oxide

Question 24

____ oxide can enter the structural network, but most other oxides cannot

Answer 24

Boric oxide

Question 25

Most common cations in pharmaceutical glassware include (8)

Answer 25

``` Silicon Boron Aluminum Sodium Potassium Calcium Magnesium Barium ```

Question 26

T or F: In glass, many useful properties are affected by the kind of elements presents, such as lead in small traces can give clarity and brilliance

Answer 26

True

Question 27

T or F: The USP provides chemical resistance tests for glass containers, which are designed to determine the resistance of new glass containers to water attack

Answer 27

True

Question 28

T or F: The degree of attack in chemical resistance testing is determined by the amount of acid released from the glass under the influence of the attacking medium under specific conditions

Answer 28

False; alkali released

Question 29

T or F: The volume of 0.02 N sulfuric acid required to neutralize the alkalinity leached from the test material should not exceed certain value specified for each type of glass

Answer 29

True

Question 30

Type I glass

Answer 30

Borosilicate (6% boron)

Question 31

Type I glass is ____ (highly/ not highly) resistant, with ____ (high or low) leachability. A substantial part of the alkali and earth cations are replaced by boron and/or aluminum and zinc

Answer 31

Highly | Low leachability

Question 32

The level of the non-network forming oxides is known as

Answer 32

Leachability

Question 33

T or F: Type I glass is suitable for all products, but because of cost, one of the other less expensive types may be acceptable

Answer 33

True

Question 34

Type II glass

Answer 34

Treated soda-lime glass

Question 35

Type II glass undergoes _____ treatment with _____ _____, which neutralizes the alkali oxides on the interior surface of the container, making the glass more resistant and prevents "weathering"

Answer 35

Sulfur treatment with sulfur dioxide

Question 36

T or F: Type II may be suitable for a solution that is buffered, has a pH above 7, or is not reactive with the glass

Answer 36

False; has a pH below 7

Question 37

T or F: Type II usually has a lower concentration of migratory oxides than Type III

Answer 37

True

Question 38

Type III glass

Answer 38

Soda-lime glass

Question 39

T or F: Type III soda lime glass will be suitable principally for anhydrous liquids or dry powders

Answer 39

True

Question 40

T or F: NP Soda-lime glass is also suitable for containers for parenterals

Answer 40

False; not suitable for parenterals

Question 41

Which types of glass undergo a powdered glass test?

Answer 41

Types I, III, and NP

Question 42

What type of glass undergoes a water attack test?

Answer 42

Treated soda-lime glass

Question 43

What is the limit in mL of 0.020 N Acid for Type I glass?

Answer 43

1.0

Question 44

What is the limit in mL of 0.02 N Acid for Type II glass that is 100mL or less?

Answer 44

0.7

Question 45

What is the limit in mL of 0.02 N Acid for Type II glass that is over 100mL?

Answer 45

0.2

Question 46

What is the limit in mL of 0.02 N Acid for Type III glass?

Answer 46

8.5

Question 47

What is the limit in mL of 0.02 N Acid for NP glass?

Answer 47

15

Question 48

Advantage of glass include ______, _______, and _____.

Answer 48

Inertness, visibility, and stability

Question 49

T or F: Any other material proposed by a manufacturer is tested agains glass as the standard before use for drug packaging

Answer 49

True

Question 50

A material that contains as an essential ingredient one or more polymeric organic substances of large molecular weight

Answer 50

Plastic

Question 51

T or F: There are over 100 different polymers available for use in packaging

Answer 51

True

Question 52

Material that assists in processing of plastic during the molding or extrusion operation. A commonly used substance for polyethylene is zinc stearate

Answer 52

Lubricant

Question 53

Material that retards or prevents degradation of the polymer by heat and light, during manufacturing, as well as improves its aging characteristics

Answer 53

Stabilizers

Question 54

Classes of common stabilizers (2)

Answer 54

Fatty acids, inorganic oxides

Question 55

Common lubricant for PE

Answer 55

Zinc oxide

Question 56

Material that achieves softness and flexibility and are used commonly in vinyls and cellulosics

Answer 56

Plasticizers

Question 57

Material that assists in retarding oxidation

Answer 57

Antioxidants

Question 58

Material that prevents the buildup of static charges on the plastic surface

Answer 58

Antistatic agents

Question 59

Material added primarily to polyolefins (polyethylene and polypropylene) to reduce the coefficient of friction of the material

Answer 59

Slip agents

Question 60

Material added to impart color

Answer 60

Dyes and pigments

Question 61

Most widely used plastic that is a good barrier against water, but relatively poor against oxygen

Answer 61

Polyethylene

Question 62

What are the two types of polyethylene?

Answer 62

Low density or branched: LDPE | High density or linear: HDPE

Question 63

_____ (LDPE/HDPE) is more crystalline, better moisture barrier, more heat-resistant, and stiffer than _____ (LDPE/HDPE)

Answer 63

HDPE; LDPE

Question 64

T or F: Polyethylenes have a high resistance to most solvents and chemicals, are unaffected by strong acids and alkalis, and are tasteless and odorless.

Answer 64

True

Question 65

T or F: Polyethylenes lack clarity and have a relatively low rate of permeation of essential odor, flavor, and oxygen

Answer 65

False; have a relatively high rate of permeation

Question 66

_____ (LDPE/HDPE) is used widely where rigidity and barrier properties are preferred, such as in bottles of solid dosage formes

Answer 66

HDPE

Question 67

_____ (LDPE/HDPE) is used where flexibility is required, such as in squeeze bottles of sprays and drops

Answer 67

LDPE

Question 68

T or F: HDPE can be sterilized with ethylene oxide only, while LDPE can be sterilized with steam and ethylene oxide

Answer 68

False: HDPE sterilized with steam and ethylene oxide | LDPE sterilized with only ethylene oxide

Question 69

______ is lighter than PE but much stiffer and more heat resistant. It _____ (has / lacks) clarity, is a _______ (poor/excellent) moisture barrier, and is ________ (susceptible/resistant) to solvents

Answer 69

Polypropylene Lacks clarity Excellent moisture barrier Resistant to solvents

Question 70

Polypropylene is used widely for ____ (solid/liquid) dosage products and can be sterilized with (steam and/or ethylene oxide)

Answer 70

Solid dosage products | Steam and ethylene oxide

Question 71

Plastic that has glass-like clarity, and is used in the manufacture of blood bags, examination gloves, IV solution containers and pump tubing

Answer 71

Polyvinyl chloride (PVC)

Question 72

What is the most commonly used plasticizer in PVC to add flexibility

Answer 72

DEHP

Question 73

T or F: DEHP is toxic

Answer 73

True

Question 74

Widely used for fabrication of containers and syringes, but lacks impact strength i.e. used for solid dosage forms and not liquid products

Answer 74

Polystyrene (PS)

Question 75

T or F: PS is rigid and non-transparent

Answer 75

False; PS is rigid and transparent

Question 76

Nylon is a ______ with a ______ (high/low) water transmission rate, and a (high/low) oxygen transmission

Answer 76

Polyamide High water transmission Low oxygen transmission

Question 77

T or F: Laminates of PE and nylon are resistant to both water and oxygen

Answer 77

True

Question 78

Class of plastics that includes polymethacrtylates, polyacrylates, and copolymers of acrylonitrile

Answer 78

Acrylics

Question 79

Acrylics have a ____ (high/low) water transmission rate and are used in adapters of IV solution administration sets and blood collection sets

Answer 79

Low water transmission rate

Question 80

Cellulose alcohol groups are esterified with which three types of acids?

Answer 80

Acetic, butyric and/or propionic acid

Question 81

T or F: Cellulosics are used in articles such as tubing and membranes in dialyzers for sterile filtration

Answer 81

True

Question 82

The transmission of gases, vapors, or liquids through the plastic material that can adversely affect the stability of a drug

Answer 82

Permeation

Question 83

Permeation rate is influenced by both _____ and relative ______

Answer 83

Temperature and relative humidity

Question 84

T or F: Molecules do not permeate through crystalline zones

Answer 84

True

Question 85

T or F: Nylon is hydrophobic while Polyethylene is hydrophilic

Answer 85

False: Nylon = hydrophilic | PE = hydrophobic

Question 86

When plasticizers, colorants, and other additives are removed by contents and can have a toxic effect in parenterals

Answer 86

Leaching

Question 87

The removal of constituents from contents by the container that can result in adverse effects such as a decrease in potent drugs and preservative concentration which can cause low doses or no protection

Answer 87

Sorption

Question 88

When chemical reactions between plastic and drug in contact result in changes in color, viscosity, or potency, as well as haze or precipitate

Answer 88

Chemical attack

Question 89

Increasing temperature and humidity (increases/decreases) the rate of chemical attack

Answer 89

Increases

Question 90

The physical and chemical alteration of the container by the drug product, in which permeation, leaching, and sorption are also factors.

Answer 90

Modification

Question 91

T or F: PE containers are deformed due to permeation of gases and vapors or loss of contents through the walls i.e. oils soften PE

Answer 91

True

Question 92

T or F: Flexibility of a container can be affected by extraction of plasticizers

Answer 92

True

Question 93

Biological tests for plastics are designed to test the suitability of plastic material intended for use in fabricating containers and accessories for use in ______ preparations and for use in _____ devices, implants, and other systems

Answer 93

Parenteral preparations and medical devices and implants

Question 94

Biological tests the reaction of living animal tissue and animals to the presence of the _____ or extracts of it is determined

Answer 94

plastics or extracts

Question 95

Biological reactivity test to evaluate systemic response; tested in albino mice

Answer 95

Systemic injection test

Question 96

Biological reactivity test to evaluate local response; tested in albino mice

Answer 96

Intracutaneous test

Question 97

Biological reactivity test in direct contact with living tissue where strips of plastic are implanted into rabbits

Answer 97

Implantation

Question 98

Four types of physiochemical tests (4)

Answer 98

1. Nonvolatile residue 2. Residue on ignition 3. Heavy metals 4. Buffering capacity

Question 99

Determines the moisture permeability when packaging and storage in a tight container or a well-closed container is specified

Answer 99

Moisture permeation test

Question 100

Classification of a tight moisture permeation test

Answer 100

Exceeds 100mg/day/liter in not more than 1 of the 10 test containers. Exceeds 200 mg/day/liter in none of them

Question 101

Classification of a well-closed permeation test

Answer 101

Exceeds 2000 mg/day/liter in not more than 1 of the 10 test containers, and exceeds 3000mg/day/liter in none of them

Question 102

In a light transmission test for plastic containers, the products intended for oral or topical administration does not exceed 10% at any wave length in the range of ____ to ____ nm

Answer 102

290-450 nm

Question 103

Category one of recycling plastics

Answer 103

PETE

Question 104

Category two of recycling plastics

Answer 104

HDPE

Question 105

Category three of recycling plastics

Answer 105

V

Question 106

Category four of recycling plastics

Answer 106

LDPE

Question 107

Category five of recycling plastics

Answer 107

PP

Question 108

Category six of recycling plastics

Answer 108

PS

Question 109

_____ can leach bisphenol A, a potential hormone disruptor, into liquids, which is controversial in baby bottles

Answer 109

Polycarbonate