Module 11 Flashcards by Jose Gabriel H. Escorial

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

Packaging

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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.

Packaging

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

Packaging process

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

Minimalist

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The packaging greatly highlights
the product over the brand.

Authentic

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

Transparent

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The packaging does not
differentiate between genders.

Inclusive

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

Value

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Timeline of packaging

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

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

Pharmaceutical Packaging

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

dosage instructions, expiration dates, and potential hazards.

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

Primary Pharmaceutical Packaging

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The outer packaging protecting the
individual primary units.

Secondary Pharmaceutical Packaging

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

Tertiary Pharmaceutical Packaging

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Primary packaging carries out the following functions (6)

❏ 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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Secondary packaging is tasked with the following: (3)

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

❏ 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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➭ 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)

e-commerce logistics

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

Primary; secondary; tertiary

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Distribution format packaging (2)

Primary and secondary

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Receipt format packaging (2)

Secondary and tertiary

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

inert

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

aluminium; PVC

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______ 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.

High-quality plastic; tablets and pills

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Primary packaging for medicines (7)

Vials Bottles Blister packs Sachets Syringes Ampoules Strip Foils

The most common packaging for solid dosages.

Blister Packs

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.

thermoformed plastic

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

Foil Strips

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

thermo-formed cavities

BLISTER PACKAGING FORM-FILL-SEAL METHOD Characteristics

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

STRIP PACKAGING PROCESS Characteristics:

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

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

Exceptional; Good

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

Aluminum; good; Plastic; limited

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

Less; More

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

Extended; Shorter

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

Less; More

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

No; Excellent

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

tearing; pushing

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

Child resistant; Not child resistant

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

less; more

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

efficient; Higher

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

more; less

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.

Syringes

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

intravenous

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

contamination

The syringe basically an ______ without the risk of contamination.

ampoule (or vial)

Syringes provide the following benefits

✓ Convenience ✓ Affordability ✓ Accuracy ✓ Sterility ✓ Safety

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

Ampoules

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

sterility; single-use

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

toughened high-quality glass

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.

seal

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

tip; microscopic

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

ampoule

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

liquid doses

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

glass; plastic

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

transparent

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

shaved off

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

contaminated

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

defects

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

Bottles

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

sizes

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

prescribed

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

glass; liquid; plastic; tablets and capsules

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

amber; UV light; clear glass; transparency

Whatdifferentiates between a vial/bottle and an ampoule?

caps; point mark/cut line

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

airtight seal; chemically inert

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

Screw

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

septum; glass rim

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

over-tighten

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

dislodging

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

Crimp

Crimp caps require the use of manual or automatic ______.

crimping tools

Crimp caps often consist of an ________ and _________.

aluminum cap; PTFE/silicone septum

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

snap cap; hand

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

cracking

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

dislodging

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

cartons or boxes

Protects both the product and packaging during transportation.

Tertiary Packaging

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.

tightly and compact

Optimised tertiary packaging helps to

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

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

Primary

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

Secondary

________ packaging is important for shipping and transportation purposes.

Tertiary

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

safe storage; administration

Other function of product packaging.

PRODUCT IDENTIFICATION

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

PRODUCT IDENTIFICATION.

US FDA Guideline

US FDA: CONTAINER LABELING GUIDELINE

Philippine FDA Circular No.2022-005

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

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

Distribution Environment Contamination

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.

easy to open

There is _______ associated with product use or administration.

convenience

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

preservatives; cross-infection

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 _________.

reclose

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 _________.

tampering

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.

promotion

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

promotional; aesthetic and functional

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

packaging

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

packaging type; material

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

❏ 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)

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

Compliance with Product Regulations

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

Business Process to Support Packaging

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.

Automation of Packaging and Labelling

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

Optimization of Pharmaceutical Product Packaging

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

Sustainable Packaging

Module 11 Flashcards

(104 cards)