Packaging_Blister_P.technology-lll .pdf

Packaging technology encompasses the methods and techniques used to create, design, and produce packages that protect, preserve, contain, and inform about a product. This field focuses on ensuring products are safely transported, stored, and presented to consumers while meeting legal and environmental requirements.

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Alu-Alu packaging
The alu-alu packaging refers to the packaging that both the bottom and lid
are made of aluminum-based film. It uses cold forming technology, where
the laminate is pressed into a mold without heating, using forming pins to
create the product cavity, and then the packaging is sealed with an
aluminum lid material.
--- Products using alu-alu packaging are generally effervescent tablets or
high-value, high-potency drugs.

PVC-packaging
The PVC packaging, also known as PVC-alu packaging, uses aluminum foil
material on one side and transparent materials such as PVC (PVC/PVDC,
PVC/PE/PVDC) on the other side to package different products. Most of the
tablets and capsules such as paracetamol tablets, amoxicillin capsules,
etc. are packed in this type of packaging.


Why alu-alu packaging solutions?
• Advanced product protection that tightly controls humidity,
oxygen and reactive impurities;
• Can be integrated into existing blister packaging production
lines;
• Eliminate residual solvents that may release gases and interact
with drug products.

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Why PVC packaging-solutions?
• Hot melt, adhesive-free and cost-effective;
• The process is simple and samples can be delivered quickly;
• The dose is visualized and the blister footprint is reduced by 40-60%;
• PVC packaging can adapt to tablets or capsules of any size and is
securely fixed to the lid using hot melt technology;
• Reduce packaging complexity. It enables controlled internal head-
space without the need for nitrogen flushing, secondary packaging or
refrigeration;

Tamper resistant packaging
••• A tamper resistant package is provided with an indicator or barrier before
entering the package, so that if this indicator or barrier is broken, the buyer
immediately gets the evidence that the product has been opened or
tampered.
‣ Especially over the counter products require tamper resistant packaging.

FDA Approved Tamper Resistant Packaging Systems:
• Film wrappers. • Tape seals
• Blister package. • Breakable caps
• Strip package. • Sealed tubes
• Bubble pack. • Aerosol containers
• Shrink seals and bands. • Sealed crotons
• Foils, paper or plastic pouches
• Bottle seals

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• Film wrappers: Transparent film with unique design, heat-shrunk around
the product; must be cut/torn.
--categories into 3types:
1. End-folded wrapper: Formed by passing the product into a sheet of
overwrapping film, which forms the film around the product in a "tuck
and fold" fashion. The longitudinal seal is heat-sealed by passing
heated bars.
2. Fin seal wrapper: Formed by crimping the film together and sealing
together the two inside surfaces of the film, producing a "fin seal."
3. Sprint wrapper: In vertical form-fill-seal packaging, the product is
packaged within a thermoplastic film that has been stretched and
sealed, forming a flexible structure that has the property of reverting
back to its unstretched dimensions once the molding structure is
removed.
• Blister package: Product in individual plastic cavities with a backing.
• Strip package: Product sealed in connected pouches.
• Bubble pack: Product in a plastic bubble on a card.
• Shrink seals and bands: Plastic that shrinks tightly around closures or
containers.
• Foils, paper or plastic pouches: Sealed and must be torn.
• Bottle seals: Seals inside bottle openings.
• Tape seals: Adhesive tape that breaks when opened.
• Breakable caps: Caps that fracture upon opening.
• Sealed tubes: Tubes with sealed openings.
• Aerosol containers: Inherently tamper-resistant.
• Sealed cartons: Cartons with glued flaps.

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□ Thermoforming Blister Machine: Thermoforming uses heat to
soften a plastic film, which is then vacuum-formed or pressure-formed into
cavities of a mold. These cavities hold the product, and a lidding material
(usually aluminum foil or a laminate) is then heat-sealed to the formed film.
Example: ALU-Tropical Machine
Operation Steps:
1. Heat the plastic.
2. Thermoforming it into blister cavities.
3. Loading the blister with the product.
4. Place lidding material over the blister,
5. Add heat sealing.
6. Installing the Al-foil
7. Cold forming it into a Pouch and seal it on the thermoformed blister to
give extra protection.
8. Then cutting it into individual blisters.

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Thermoforming:
Process: This method involves heating a plastic film (like PVC) to make it
pliable, then using heat and air pressure to form it into blister cavities using
a mold.
Materials: Commonly used materials include PVC, PET, and others.
Suitable for: Products that don’t require high protection from moisture,
oxygen, or light.
Advantages: Can be cost-effective and produce clear, visible blister packs.
Disadvantages: Not ideal for light-sensitive products.

Cold Forming:
Process: This method uses a series of punches or dies to press a sheet of
aluminum-based film into the desired shape, creating blister pockets
without using heat.
Materials: Typically uses aluminum-based films (like Alu-Alu or Alu-PVC).
Suitable for: Products that require protection from moisture, oxygen, and
light, such as pharmaceuticals.
Advantages: Provides a higher level of protection and can be used for
moisture and light-sensitive products.
Disadvantages: May have higher material and equipment costs.

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Thermo-Cold Complex: (Process)
This method combines both thermoforming and cold forming. 1
st
,
thermoforming is used to create the blister cavities, then a cold-formed Al-
foil pouch is placed over the blisters for added protection.

□ Technique of drug packaging for child and elderly person
:[NEW TECHNIQUE]
1. Child resistant packaging
2. Elder friendly
3. Temper proof packaging

Child-Resistant Packaging:
• The packaging the excludes entry of children < 5 years.
• Adults should be able to access contents.
• Legal standard: At least 80% of children (20-42 months) unable to
open the package in 10 minutes.

For Children:
• Multi-step opening: Requiring two or more distinct actions to open,
like pushing down and turning a cap, or squeezing and then opening.
• Blister packs with strong backing: Tablets or capsules are
individually sealed and require significant force to push through a
tough foil or plastic backing. Some require peeling a layer before
pushing.

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• Unit-dose packaging: Individually sealed doses reduce the risk of a
child accessing multiple pills at once.
• Tamper-evident features: Seals or mechanisms that show if the
packaging has been opened, deterring tampering.


Elder-Friendly Packaging:
• Square/rectangular bottles for easier opening.
• Resists rolling off countertops.
• Unit-dose packaging is helpful.
• Addresses poor vision (glow-in-dark inks).
• Missing dose is still a common problem for which special printed
strips are designed on which the day and time is printed on the drug
body.

For Elderly Persons:
Easy-grip caps: Larger caps with textured surfaces or extensions that are
easier to hold and turn, even with limited dexterity.
Large, clear labeling: Easy-to-read font sizes and colors for instructions
and warnings, crucial for those with vision impairments.
Simple opening mechanisms: Avoiding complex push-and-turn or squeeze
actions in favor of levers, tear notches (if designed for adults), or slide
mechanisms that require less strength.
Blister packs with easy-peel or push-through: Some CRSF blister packs
use thinner foils or specific designs that are easier for adults to open.
Calendar packs: Organizing medications by day and time can improve
adherence and reduce confusion.

Tamper-Proof Packaging
• Temper proof containers are those that resist the tamping of the product
before consuming the product.

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□ During selection of packaging materials why environmental
concern should be taken in?
Environmental concerns should be prioritized during packaging
material selection because packaging contributes significantly to
pollution, landfill waste, and resource depletion, impacting
ecosystems and wildlife. By choosing eco-friendly materials,
companies can reduce their environmental footprint, enhance
their brand image with consumers who prioritize sustainability,
and meet regulatory requirements.

• Pollution & Waste: Reduces landfill burden and prevents harmful
chemical leaching from non-biodegradable materials.
• Resource Depletion: Conserves finite resources by favoring
renewable or recycled options.
• Climate Change: Lowers greenhouse gas emissions associated
with production, transport, and disposal.
• Wildlife Impacts: Minimizes harm to animals and ecosystems
caused by plastic pollution.
• Consumer Preference: Meets growing demand for sustainable
packaging, enhancing brand image.
• Regulatory Compliance: Ensures adherence to environmental
regulations and standards.
• Reduced Costs: Optimizing material use can lower packaging
and transportation expenses.


Ques. >> Why do container packaging is more Preference
instead of blister and strip packaging ?
•••• While both container and blister/strip packaging serve crucial roles in
pharmaceutical product protection and dispensing, container packaging
(like bottles and vials) often holds preference due to a combination of
factors:

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1. Wider dosage form use
o Liquids and suspensions: Blister and strip packs are generally
not suitable for these.
o Powders: While some powders can be filled into blister packs,
containers offer more flexibility in volume and dispensing
methods (e.g., with scoops).
o Larger tablets or capsules: Containers can accommodate
various sizes and shapes more easily.
o Multi-dose formulations: Bottles and vials are ideal for
products where multiple doses are required over time.

2. Cost-Effective (Larger Quantities): Cheaper for bulk dispensing.
3. Patient Familiarity: Many patients are used to bottles and find
them easy to use.
4. More Label Space: Allows for detailed instructions and warnings.
5. Better Stability (Certain Drugs): Specific container materials
enhance shelf life for some medications.
6. Easier Dispensing (Specific Products): Best for creams,
ointments, etc.


--- However, it's important to note that blister and strip packaging have
their own significant advantages, which make them preferred in specific
situations:-

• Unit-dose accuracy: They ensure each dose is precisely measured
and separated, reducing the risk of errors.
3

• Tamper evidence: Individual seals clearly indicate if a dose has been
accessed.
• Child resistance: Blister packs can be designed with features that
make them difficult for children to open.
4

• Portability and convenience for single doses: They are easy to
carry and use when a patient is on the go.
• Improved patient compliance: Calendar blister packs can help
patients track their medication intake.
5

• Enhanced protection for individual doses: They offer excellent
protection against moisture, oxygen, and contamination for each
tablet or capsule until it's used.

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Blister packaging is a form of unit-dose packaging in which a semi-rigid blister/
cavity previously formed is filled with product and lidded with a heat-sealable
backing material. Here, blister/ cavity/pocket is formed either a thermoforming
or cold forming process.



Strip packaging is an alternative form of unit dose packaging in which a
pharmaceutical product is enclosed between two webs of heat-sealable flexible
film through either a heated reciprocating platen or a heated crimp roller.

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Feature Alu Alu Blister Packaging Alu PVC Blister Packaging
Material
(Base)
Aluminum-based laminate
(OPA/Alu/PVC)
Plastic (PVC, PVC/PVDC,
PVC/PE/PVDC)
Material (Lid) Aluminum foil Aluminum foil
Formation Cold forming Thermoforming
Protection Superior Moderate
Visibility Opaque Typically transparent
Cost Higher Lower
Stability Excellent Good
Formability Less flexible, larger cavities often More flexible, various shapes/sizes
Applications Sensitive drugs Most tablets/capsules

Feature Blister Packaging Strip Packaging
Cavities Pre-formed, rigid Formed around the product during
sealing, no pre-form
Protection Generally higher, especially against
mechanical damage
Good, especially against moisture
and light
Visibility Typically transparent Typically opaque
Tamper
Evidence
Good Good
Child
Resistance
Can be high Can be higher
Ease of Use Pushing through or peeling backing Tearing the strip
Cost Generally higher Generally lower
Flexibility Less flexible for unique shapes More flexible for various shapes
Speed Higher speed Lower speed
Materials Plastic (PVC, PET, etc.), Aluminum foil
backing
Aluminum foil, plastic films,
laminates