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ph@rm@ > Module 11 > Flashcards

Module 11 Flashcards

1
Q

The science, art and technology of enclosing or protecting products for distribution, storage, sale, and use.

A

Packaging

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2
Q

The wrapping material around a consumer item that serves to contain, identify, describe, protect, display, promote and otherwise make the product marketable and
keep it clean.

A

Packaging

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3
Q

The process of design, evaluation, and production of
packages with functions beneficial to the consumer
good.

A

Packaging process

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4
Q

The simple packaging design helped with the virality of The Ordinary.

A

Minimalist

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5
Q

The packaging greatly highlights
the product over the brand.

A

Authentic

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6
Q

The packaging enables users to know each product’s intended use and effects.

A

Transparent

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7
Q

The packaging does not
differentiate between genders.

A

Inclusive

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8
Q

The packaging’s marketability allowed production
costs to focus on formulation technologies.

A

Value

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9
Q

Timeline of packaging

A

1915 - Patent
1957 - Pure-Pak
1991 - Pure-Pak w. closure
2004 - Pure-Pak Curve
2006 - Pure-Pak Diamond Curve

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10
Q

Vital for protecting drugs from external factors such
as moisture, light, and contamination.

A

Pharmaceutical Packaging

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11
Q

Pharmaceutical Packaging provides essential information about the drug product, including (3)

A

dosage instructions, expiration dates, and potential hazards.

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12
Q

The immediate containment that is
in direct contact of drug products.

A

Primary Pharmaceutical Packaging

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13
Q

The outer packaging protecting the
individual primary units.

A

Secondary Pharmaceutical Packaging

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14
Q

Outermost layer of packaging mainly used in the supply chain of your drug product.

A

Tertiary Pharmaceutical Packaging

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15
Q

Primary packaging carries out the following functions (6)

A

❏ Contains, stores, and maintains the drug product in optimal conditions.
❏ Identify the product in line with current regulations (instructions for use, expiration date, etc.).
❏ Identify the brand and increase consumer appeal.
❏ Ensure the drug product remains in a stable position in its sale location.
❏ Guarantee that the contents are isolated.
❏ Protect the goods using the minimum possible material.

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16
Q

Secondary packaging is tasked with the following: (3)

A

❏ Be resistant to stacking (in the warehouse and at points of sale) and to handling during transportation so as to protect the product from damage.
❏ Contain a specific amount of product.
❏ Attract customers’ attention, especially for secondary packaging intended to be sold directly to the general public.

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17
Q

The functions and characteristics of tertiary packaging comprise of (3)

A

❏ Remain stable and enable loads to be stored compactly.
❏ Leverage the storage capacity of the installations and industrial vehicles.
❏ Be authorized for use and made of resistant materials.

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18
Q

➭ On occasion, tertiary packaging can also perform a significant role in relation to a brand’s image.
This is especially true for _____, where the box or packaging employed in transportation is tertiary and can include visual brand elements. (example: Amazon parcels)

A

e-commerce logistics

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19
Q

______: Consumption-unit packaging
______: Boxes and trays
______: Pallets

A

Primary; secondary; tertiary

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20
Q

Distribution format packaging (2)

A

Primary and secondary

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21
Q

Receipt format packaging (2)

A

Secondary and tertiary

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22
Q

The material used for primary packaging must be ______ to ensure it doesn’t interact with
the pharmaceutical product during its entire life.

A

inert

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23
Q

The most common material used for primary packaging includes non-reactive substances, such as ________ and _____.

A

aluminium; PVC

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24
Q

______ is used for liquid doses instead of glass. This ensures spills due to breakage won’t happen during transport of the drug product. The most common plastics used for _____ include polyethylene, polyvinyl chloride, nylon, polycarbonate, and polyethylene terephthalate.

A

High-quality plastic; tablets and pills

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25
Q

Primary packaging for medicines (7)

A

Vials
Bottles
Blister packs
Sachets
Syringes
Ampoules
Strip Foils

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26
Q

The most common packaging for solid dosages.

A

Blister Packs

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27
Q

Blister packs have a cavity made from ________. At its backside by a paperboard, plastic film,
or aluminum foil seal that can be easily punctured by hand.

A

thermoformed
plastic

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28
Q

It is a unit packing dosage and is specifically used to increase the dosage life as it protects the content individually.

A

Foil Strips

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29
Q

The most significant difference between blister and
strip packaging is that strip doesn’t have _________. Instead, the packaging is
formed around the tablet.

A

thermo-formed cavities

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30
Q

BLISTER PACKAGING FORM-FILL-SEAL METHOD Characteristics

A

❏ Higher packaging speed and typically no difficulties
during packaging.
❏ Two basic types of pharmaceutical blister packaging
exist: Thermoforming and Cold forming.

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31
Q

STRIP PACKAGING PROCESS

Characteristics:

A

❏ Slower packaging speed and typically no difficulties
during packaging.
❏ Wrinkling of the seal area or perforation of the pocket
periphery may occur.

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32
Q

BARRIER PROPERTIES: _______ shield against humidity, oxygen, and UV for foil strip against the blister pack’s _____ barrier against humidity and light

A

Exceptional; Good

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33
Q

HEAT RESISTANCE: ________-based materials with ______ heat resistance for foil strip against blister pack’s _______-based materials with ____ heat resistance

A

Aluminum; good; Plastic; limited

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34
Q

RECYCLABILITY: ________ recyclable due to a combination of materials for foil strip against ______ recyclable, separable PVC and aluminum in blister packs.

A

Less; More

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35
Q

SHELF LIFE: ________ shelf life due to excellent barrier properties for foil strip against ______ shelf life for blister packs.

A

Extended; Shorter

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36
Q

DESIGN: ______ flexible, occupies more space for foil strip against _______ flexible, design uses various blister shapes and sizes.

A

Less; More

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37
Q

TRANSPARENCY: _________ visibility for the contents inside for foil strips while ______ product visibility for blister packs.

A

No; Excellent

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38
Q

METHOD OF USE: Product is removed by _______ , difficult for some patients for foil strip against opens by simply _____ the material for blister packs.

A

tearing; pushing

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39
Q

CHILD RESISTANCE: ______ due to method of opening for foil strip against _______ for blister pack.

A

Child resistant; Not child resistant

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40
Q

PATIENT COMPLIANCE: ______ compliance for foil strip against _______ compliance for blister pack.

A

less; more

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41
Q

COST: More _______ production process but prone to problems for foil strip against _____ production costs due to use of special equipment for blister pack.

A

efficient; Higher

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42
Q

COST: Design uses _______ material than blister packs for foil strip against design uses _____ material than strips for blister pack.

A

more; less

43
Q

A unique way of packaging sterile, potent, and important medications that can be filled or pre-filled provides a highly efficient solution to pharmaceutical packing.

A

Syringes

44
Q

Syringes are mainly used for ______ drugs (and some for oral use).

A

intravenous

45
Q

The syringe is sterilized, pre-filled, and sealed, such that the risk of ______ is minimized greatly, making it safe for use.

A

contamination

46
Q

The syringe basically an ______ without the risk of contamination.

A

ampoule (or vial)

47
Q

Syringes provide the following benefits

A

✓ Convenience
✓ Affordability
✓ Accuracy
✓ Sterility
✓ Safety

48
Q

Sealed vials made by melting the top of the vial with a flame.

A

Ampoules

49
Q

Ampoules preserve potency and ________ of liquid/semi-liquid forms. As such, generally used as the
packaging choice for _____ liquid doses, particularly parenterals.

A

sterility; single-use

50
Q

Ampoules are generally made from _________, that is heat and temperature-resistant. Thus, considered more expensive compared to other liquid dose packages.

A

toughened high-quality glass

51
Q

Ampoules must be carefully cleaned to prevent contamination by foreign particles. The liquid solution must be clear and that the _______ does not show visible damage prior to use.

A

seal

52
Q

Breaking the ___ to open the ampoule for use may create ________ glass fragments that contaminate the injection solution.

A

tip; microscopic

53
Q

Air bubbles, cracks, breakage, etc. in the glass will negatively affect the quality of the _______ and its contained solution.

A

ampoule

54
Q

Vials are mainly used for storage of ________, such as injectable liquids or intravenous medicines.

A

liquid doses

55
Q

Vials are mainly made using ______, (for its non-reactive properties) but can also be made of _____ (for oral medications).

A

glass; plastic

56
Q

Vials with __________ packaging can be helpful in gauging any irregularities or impurities.

A

transparent

57
Q

Once a needle pierces the rubber stopper, pieces of the stopper may be_________and enter into the solution.

A

shaved off

58
Q

If a vial is ______ during manufacturing (i.e., foreign particles affixing to the bottle or rubber stopper), the quality and safety will be compromised.

A

contaminated

59
Q

Glass container ______ may affect the quality of the contained solution.

A

defects

60
Q

Most frequently used to carry liquid doses as well as solid doses like capsules, gels, and tablets
(with the use of desiccant packs).

A

Bottles

61
Q

Bottles can be of varied _________, depending on the dosage or product usage.

A

sizes

62
Q

Bottles can be found in both glass and plastic and can be stored
effectively even if opened, under ________ conditions.

A

prescribed

63
Q

On choice of material, _____ bottles are commonly used for _____doses while ______ bottles are used for ________.

A

glass; liquid; plastic; tablets and capsules

64
Q

On choice of color, ________ bottles (brown) protects from ________ while ______ bottles allows for ________.

A

amber; UV light; clear glass; transparency

65
Q

Whatdifferentiates between
a vial/bottle and an ampoule?

A

caps; point mark/cut line

66
Q

Caps play a crucial role in protecting drug products from
spills, contamination, and
evaporation. Ideally, they should form an ________ and be ______.

A

airtight seal; chemically inert

67
Q

________ caps form an excellent seal and mechanically hold the septum in place during piercing. No tools are required for assembly.

A

Screw

68
Q

Screwing the cap applies a mechanical force that squeezes the ________ between the _______ and the cap.

A

septum; glass rim

69
Q

The septum begins to cup
or indent when you begin
to _______.

A

over-tighten

70
Q

Over-tightening the cap
can compromise the seal
and lead to _______.

A

dislodging

71
Q

This type of cap tightly squeezes the septum between the vial and the cap, forming a superior seal and reducing evaporation.

A

Crimp

72
Q

Crimp caps require the use of manual or automatic ______.

A

crimping tools

73
Q

Crimp caps often consist of an ________ and _________.

A

aluminum cap; PTFE/silicone septum

74
Q

A _______ provides a moderate seal and doesn’t require special tools because they can be snapped onto a vial and removed by _______.

A

snap cap; hand

75
Q

If the fit of the snap cap is very tight, they are hard to apply and may be subject to ___________.

A

cracking

76
Q

If the fit of the snap cap is too loose, the seal is not very good, and the septa may be subject to _______.

A

dislodging

77
Q

Secondary packaging is typically
found in the form of _________ that are customisable, help with brand awareness, offers good protection, and is recyclable.

A

cartons or boxes

78
Q

Protects both the product and packaging during transportation.

A

Tertiary Packaging

79
Q

An optimised tertiary packaging should be able to combine products as _____ as possible, while using minimal materials and without causing strain or damage to products.

A

tightly and compact

80
Q

Optimised tertiary packaging helps to

A

✓ Increase pallet stability
✓ Decrease CO2 emissions
✓ Lower transport costs
✓ Save on material waste
✓ Protect the product

81
Q

_________ packaging is critical for branding and protection
on the shelves.

A

Primary

82
Q

________ packaging is critical for protection and branding during transit between points of sale.

A

Secondary

83
Q

________ packaging is important for shipping and transportation purposes.

A

Tertiary

84
Q

Packaging plays an important role in the _______ and ________
of pharmaceutical products.

A

safe storage; administration

85
Q

Other function of product packaging.

A

PRODUCT IDENTIFICATION

86
Q

You may be required to include certain information on the label of your product
when it is distributed in specific ways.

A

PRODUCT IDENTIFICATION.

87
Q

US FDA Guideline

A

US FDA: CONTAINER LABELING GUIDELINE

88
Q

Philippine FDA Circular No.2022-005

A

Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP)

89
Q

Packaging plays an instrumental role in preserving the quality and extending the shelf life of many products through helping with:

A

Distribution
Environment
Contamination

90
Q

Packaging should be convenient to open, handle, and use for the consumers.
The product needs to be _______ - may sound simple but can often be a major frustration for customers.

A

easy to open

91
Q

There is _______ associated with product use or administration.

A

convenience

92
Q

A unit dose, single-use, eye drop eliminates the need for ___________
and reduces risks associated with ___________.

A

preservatives; cross-infection

93
Q

If your product is one that will be distributed in such a way that customers will want
to–and should be able to–sample or examine it before buying, your packaging will have to be easy to open and to _________.

A

reclose

94
Q

If your product should not be opened by anyone other than the purchaser–an over-the-counter medication, for instance–then the packaging will have to be
designed to resist and reveal _________.

A

tampering

95
Q

Packaging can play a huge role in the _________ of both a company and its goods as more consumers choose to create their own experiences and educate themselves on their purchasing decisions instead of being persuaded by an ad.

A

promotion

96
Q

Packaging is also used for _______ and attracting the attention of the people while purchasing. Packaging must be ___________.

A

promotional; aesthetic and functional

97
Q

The ___________ alone gives
information on which product is
safe for pediatric use.

A

packaging

98
Q

Selecting the _________ and
_________ for packaging of a
pharmaceutical product depends
on a multitude of factors.

A

packaging type; material

99
Q

The type of packaging that is selected will depend on factors such as:

A

❏ Drug product characteristics
❏ The degree of protection needed for the product
❏ The dosage (this will affect the size)
❏ Convenience and ease of use for the customer
❏ The method of filling
❏ The sterilisation technique that is used
❏ Points of sale
❏ Environmental impact
❏ The cost (material, process, handling, storage, losses)

100
Q

It is compulsory to follow regulations which can change whenever necessary.

A

Compliance with Product Regulations

101
Q

Business processes must be evaluated to ensure there are no gaps or inconsistencies in the labelling and packaging of
products.

A

Business Process to Support Packaging

102
Q

There is a need to embrace ________ technology to decrease the time. and also reduces the chances of error
due to minimal human interference. Automation also allows for real time monitoring of products in the market.

A

Automation of Packaging and Labelling

103
Q

Test the sturdiness of the package design and check if it will be able to protect the drug product

A

Optimization of Pharmaceutical Product Packaging

104
Q

_____________ is becoming a higher priority for both brands and consumers - as such it is now considered a
necessity for brand and product satisfaction.

A

Sustainable Packaging

ph@rm@ (11 decks)

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