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ALUALU+Packaging+Vs+ALUPVC+Blister+Packaging+Waste+to+Value++A+Comparative+Analysis

The research article compares ALU-ALU and ALU-PVC blister packaging in terms of their effectiveness in protecting oral solid medications from environmental hazards. ALU-ALU packaging, made entirely of aluminum, offers superior barrier properties and tamper resistance, making it ideal for sensitive products, while ALU-PVC incorporates a plastic layer for flexibility but provides less protection. The study emphasizes the importance of selecting appropriate packaging to ensure product stability, safety, and compliance with regulatory standards.

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0% found this document useful (0 votes)
19 views9 pages

ALUALU+Packaging+Vs+ALUPVC+Blister+Packaging+Waste+to+Value++A+Comparative+Analysis

The research article compares ALU-ALU and ALU-PVC blister packaging in terms of their effectiveness in protecting oral solid medications from environmental hazards. ALU-ALU packaging, made entirely of aluminum, offers superior barrier properties and tamper resistance, making it ideal for sensitive products, while ALU-PVC incorporates a plastic layer for flexibility but provides less protection. The study emphasizes the importance of selecting appropriate packaging to ensure product stability, safety, and compliance with regulatory standards.

Uploaded by

Rishabh Nagar
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Zuki Patel, Int. J. of Pharm. Sci.

, 2025, Vol 3, Issue 3, 2810-2818 | Research

INTERNATIONAL JOURNAL OF
PHARMACEUTICAL SCIENCES
[ISSN: 0975-4725; CODEN(USA): IJPS00]
Journal Homepage: https://www.ijpsjournal.com

Research Article

ALU-ALU Packaging Vs ALU-PVC Blister Packaging: Waste to Value -


A Comparative Analysis
Charmi Patel1, Hitesh Dani2, Maitreyi N. Zaveri3, Zuki Patel*4
1
B. Pharm, M. Pharm, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar.
2
Director, Saviour Pharmaceuticals, Ahmedabad.
3
M. Pharm, Ph.D., Professor & Head of Department of Regulatory Affairs, K.B. Institute of Pharmaceutical
Education and Research, Gandhinagar.
4
M. Pharm, Department of Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research,
Gandhinagar.

ARTICLE INFO ABSTRACT


Published: 28 Mar. 2025 To ensure the safety and effectiveness of oral solid medications, pharmaceutical
Keywords: packaging is crucial for shielding them from mechanical, chemical, and environmental
Packaging Materials, risks. The function of various packaging technologies, in particular ALU-ALU and
Aluminium Packaging, ALU-PVC blister packs, in preserving product stability is examined in this article.
Polyvinyl Chloride and While ALU-PVC adds a plastic layer for flexibility, ALU-ALU offers better protection
Polyvinyl Dichloride without plastic. The primary, secondary, and tertiary systems of packaging each have
Packaging Materials. specific functions in distributing and protecting the product. The study emphasizes how
DOI: crucial it is to select suitable packaging to satisfy legal requirements and encourage
10.5281/zenodo.15100484 patient adherence.

INTRODUCTION composition of different blister packaging types is


crucial for discerning their protective capabilities
Especially when referred to as ALU-ALU and appropriate application in the pharmaceutical
Packaging, typically does not contain plastic industry.
within the layers of aluminium used. However, in
other types of Blister Packaging, Such as Alu-PVC Introduction of Oral Solids
a layer of Plastic (Polyvinyl Chloride or PVC) is
used along with aluminium. Understanding the In the pharmaceutical sector, packaging plays a
critical role in preserving the quality of drug goods
*Corresponding Author: Zuki Patel
Address: M. Pharm, Department of Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research,
Gandhinagar.
Email : [email protected]
Relevant conflicts of interest/financial disclosures: The authors declare that the research was conducted in the absence of
any commercial or financial relationships that could be construed as a potential conflict of interest.

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Zuki Patel, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 3, 2810-2818 | Research
during distribution as well as ensuring their safety secondary packaging system, which includes
and effectiveness. The packaging serves as an plastic crates, cardboard, and show boxes,
essential barrier, shielding the medication from also known as cartons. This system provides
external influences and guaranteeing its stability additional protection during warehousing
from manufacturing to the final consumer, even and delivers detailed information about the
though the drug itself has a set shelf life. In product, such as leaflets. The two main
addition to providing protection, packaging is functions of these systems are to protect the
essential for increasing customer attractiveness. A flexible containers and to safeguard them
well-designed packaging with eye-catching from rough handling during transportation.
artwork and useful design can have a big impact III. Tertiary Packaging: The tertiary packaging
on customer loyalty and perception. For example, system is the outer package of the secondary
medications packaged in premium, laminated packaging which is supposed to prevent the
blisters or cartons protect the substance and products from damage. Common types of
encourage proper dose, both of which contribute to tertiary packaging in pharmaceutical
improved health results. To ensure the quality of industry are cardboard boxes, Pallets and
pharmaceutical items during storage, Shrink films. It needs to be robust enough to
transportation, delivery, sale, and usage, withstand the environmental challenges
pharmaceutical packaging is essential. To during transport. Packaging plays a critical
guarantee that the medications reach the patient role in preserving the purity and quality of
safely, the packaging is designed to encapsulate or pharmaceutical products, safeguarding them
protect the pharmaceutical items. The process of from spoilage, contamination, and
properly positioning pharmaceuticals to maintain manipulation. This ensures that a safe and
their therapeutic efficacy from the moment of effective dosage form is available to patients
packaging till consumption is known as up until the product’s expiration. In an
packaging. industry as highly regulated as healthcare, it
is imperative for healthcare organizations
“Packaging Is the Art and Science Which and pharmacies to utilize packaging that
Involves Preparing the Articles for Transport, complies with the stringent requirements set
Storage, Display and Use.” forth by regulatory authorities, such as the
U.S. Food and Drug Administration (FDA).
There are 3 types of packaging systems available
for pharmaceutical industries which are The ideal requirements for the container or
package should be such as:
I. Primary Packaging: The container that is
directly in contact with the medication 1. Protection from Environmental Hazards.
formulation. The primary objective of this 2. Protection from Mechanical Hazards.
packaging is to protect the product from 3. Prevention of Leaching.
environmental, chemical, mechanical, and 4. Appealing Appearance.
other hazards. The stability of the product 5. Ease of Access.
largely depends on the material used for the 6. Tamper-Resistant and Child-Resistant
packaging. Features.
II. Secondary Packaging: The package outside 7. Cost-Effectiveness and Sustainability
the primary container is referred to as the

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Aluminium As a Packaging Material in commonly used in the healthcare sector. Its
Medicinal Industry: distinct combination of chemical and physical
qualities has made it an appealing choice for pill,
The medical field is an important but sometimes capsule and medicine packaging. Its outstanding
dangerous one. The type of goods and services it durability and lightweight nature stand out among
offers patients is the cause. Aluminium is an its many benefits for pharmaceutical packaging,
incredibly flexible material that is used extensively making it convenient to handle and deal with.
in many different industries, but it is most

Figure 1. ALU-ALU Blister Packaging

Superior protection against environmental manufacturers keep every tablet well protected
elements that can jeopardize the stability or from the effects of the external environment and
potency of medications is offered by aluminum hence keep the effectiveness of all the tablets
foil. Additionally, these barrier qualities contribute intact.
to the product's longer shelf life, which is
important for pharmaceutical organizations that Types of Aluminium Foil Packaging:
need to handle their sensitive medications with 1. Blister Packs: These are the most common
precision. Nevertheless, there are worries about form of pharmaceutical packaging. They
the possible health hazards connected to the use of consist of a cavity or pocket made from a
aluminium in pharmaceutical packaging, despite formable material, usually plastic and a lidding
its many benefits. It is commonly known that material made from aluminium foil. Blister
certain drugs and aluminium might interact packs are used for tablets and capsules,
chemically, compromising the treatment's safety providing a secure environment and easy
and effectiveness. In severe cases, aluminium may access for patients.
even gradually infiltrate into the medication, 2. Strip Packs: In strip packs, tablets or capsules
causing an accumulation of aluminium in the are enclosed between two layers of aluminium
body. The aluminium foil is used to create a push- foil. This type of packaging offers excellent
through closure with lid film or blister film where protection but can be less convenient for
tablets and capsules are protected perfectly and patients to open compared to blister packs.
hygienically. These blister packs are compact and 3. Child-Resistant Foil: Safety is a key concern
easy to port and handle. The integration of in pharmaceutical packaging. Aluminium foil
aluminum foil has made aluminum blister foil can be designed to be child-resistant, ensuring

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that children cannot easily access the (polyvinyl chloride) and PVDC (polyvinylidene
medications, thereby preventing accidental chloride), although they can be hazardous to
ingestion. people and the environment. Pharmaceutical firms
are therefore searching for fresh substitutes.
PVC/PVDC As a Packaging Material in Although polypropylene is a good option,
Medicinal Industry: processing it can be challenging. This article offers
several coping mechanisms and performs a quick
Two blister packaging materials that are frequently
examination in this area.
used in the pharmaceutical business are PVC

Figure 2. PVC/PVDC Blisters Packaging

In medical blister packaging, PVC, either by itself transparency has a lower barrier, it is mostly
or in conjunction with polyvinylidene chloride utilized for medications that remain stable when
(PVDC), aluminum chlorotrifluoroethylene exposed to light and moisture. PVDC is used in
(CTFE), or oriented polyamide nylon (OPA), PVC Laminated or coated packaging, reducing the
accounts for nearly all of the market. PVC is an permeability of PVC to oxygen and moisture by 5-
inexpensive, transparent polymer that has a low 10 times. PVDC cannot be used as a sole material
permeability index to air humidity, good due to its relatively high cost and mechanical
thermoforming, physical, and chemical resistance, properties. For items like multivitamin pills or
and low permeability to oils, fats, and aromatic capsules that have a long shelf life and are not very
compounds. PVC is the most used material for sensitive to external conditions, PVDC combined
blister packing, yet it provides the least amount of with a PVC base coat yields the best results. PVC
protection of any material. The pharmaceutical has good chemical resistance and low permeability
industry typically uses PVDC film, which is 0.2 to oils, fats, and flavouring ingredients. When
mm to 0.8 mm thick and more rigid than PVC. combined with PVDC, gas and moisture
Because the greater the thickness, the less likely it permeability is reduced significantly compared to
is that light will travel through the film, thickness uncoated PVC. This coating is critical for
has a profound effect on light barrier qualities. maintaining the integrity and shelf life of
PVC and PVDC materials come in a variety of Pharmaceutical Products. Other Coatings like
colors, including blue, red, amber, white opaque, PVC/CTFE, Offer even lower water-Vapour
clear translucent, and more. Since clear permeability. For medications requiring the utmost

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protection, a combination of OPA/ 13) Appreciable vacuum formation, toughness and
Aluminium/PVC is chosen. PVC is a non-toxic, durability.
inert substance. Its formulation for pharmaceutical
applications ensures the safety and effectiveness of Alu-Alu Blister Packaging:
drugs by not interacting with them. used in
1. Composition:
pharmaceutical packaging for many years. PVC
satisfies several international regulatory • ALU-ALU blister packaging consists entirely
requirements for medicine packaging and has a of Aluminium Layers that creates a robust
demonstrated safety profile. PVC is extremely barrier against moisture, Light and Oxygen. In
versatile for a variety of drug forms due to its ease this type, Both the base and lidding materials
of processing into diverse shapes. PVC is made are made from aluminium films. This structure
without plasticizers when it comes to blisters. The provides a very high level of protection
plastic is very flexible even without softening making it ideal for sensitive pharmaceutical
additives. To improve its barrier qualities or for products. ALU-ALU comes in a multiple
other practical purposes, PVC is easily laminated layered structure and used as aluminium based
or coated with various materials. For example, to materials for both the base and lidding of the
strengthen the barrier against gases and moisture, blister packs. Aluminium foil layers play a
a layer of PVDC can be applied. Unlike other vital role in protecting the content inside the
polymers, PVC is mainly composed of table salt- blister cavity. Additionally, it also serves as a
derived chlorine. As a result, PVC is more shield against moisture, air and UV rays and
economical than alternatives and uses less primary also enhance shelf life and tamper resistance.
energy derived from fossil fuels. Unlike other
polymers, PVC is mainly composed of table salt- 2. Manufacture:
derived chlorine. As a result, PVC is more
economical than alternatives and uses less primary • Typically, the ALU-ALU blister packs are
energy derived from fossil fuels. produced by the following steps:
A. Blister Formation: Due to the characteristics
Reasons for selecting PVC/PVDC: of the materials, ALU-ALU packaging is made
by cold forming. The aluminium foil is
1) Low Permeability: sandwiched between layers of plastic film
2) Increased Safety: during the process. The laminate is pressed
3) Excellent Thermo Formability: into a mold cavity using a stamp without
4) Compatibility with other materials: applying heat.
5) Cost-efficiency: B. Product Filling: The formed blister pack is
6) Enables radiation sterilization then transferred to the filling station, where the
7) Available in varied sizes and color shades cavities are filled with the required products.
8) Finest organoleptic properties so the taste and C. Sealing: After filling, another layer of
odor is neutral aluminum foil is applied on top of the filled
9) High dimension stability
blister cavities by sealing.
10) Remarkable heat-sealing Properties D. Perforation and Cutting: The sealed blisters
11) High dimension stability are then perforated if necessary and cut into
12) Gas transmission and moisture rates are low individual packs.

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Zuki Patel, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 3, 2810-2818 | Research
3. Advantages: • ALU-PVC integrates a layer of Plastic along
with aluminium specially, it uses a clear PVC
• Aluminium foil offers exceptional protection film as the base, which is coated with
for the medication from humidity, oxygen and aluminium foil. This combination allows for
UV radiation. These external elements could better visibility of the product but generally
degrade its quality or efficacy. offers less barrier protection compared to the
• The robust design of the ALU-ALU pack ALU-ALU packaging. The choice between
safeguards against physical damage or impact ALU-ALU and ALU-PVC packaging hinges
during handling, transportation, and storage. on the sensitivity of the products being
• Superior barrier properties of ALU-ALU packaged. ALU-ALU’s full aluminium
packaging contribute to an extended shelf life composition serves to protect hygroscopic
for pharmaceutical products. medications from environmental factors which
• ALU-ALU Packaging features tamper is critical for their stability and efficacy. ALU-
resistance. For example, blister perforation or PVC blister packaging incorporates a plastic
tear-off tabs can provide visible indications of layer along with aluminium, serving to provide
tampering. This ensures the integrity of the different levels of protection based on the
products inside. needs of the product being packaged.
• ALU-PVC is a combination of 2 materials
4. Disadvantages:
which utilizes a clear PVC film as its base
• ALU-ALU is generally more expensive than coated with a layer of Aluminium foil to create
other packaging solutions due to aluminum- the blister pack. It also offers a robust and
based materials. It can lead to increased flexible base for securely holding the
production costs. medication. Aluminium foil layer is sealed to
• Though the aluminum foil itself is recyclable the PVC film providing a protective barrier to
the blisters in ALU-ALU Packaging are not prevent moisture, oxygen and light from
made from this single material. degradation.
• Also, Aluminium foil is not biodegradable, so
2. Manufacture:
it has environmental implications to some
extent. • The ALU-PVC packaging process is quite
• The aluminum-based materials used in the similar to the ALU-ALU process. The major
packaging make it difficult to visually inspect difference lies in the blister forming step.
the contents of each blister cavity without A. Blister Formation: ALU-PVC packaging
opening the package. utilizes thermoforming. The plastic film is
• Aluminium foil is not that flexible compared heated to a specific temperature to be soft and
to plastic material. It can’t be simply molded pliable. It is then placed on a mold and
into any shape. subjected to vacuum or pressure to shape the
blister cavity.
Alu-Pvc Blister Packaging: B. Product Filling: After being formed, the
blister pack is taken to the filling station, where
1. Composition:
the products are placed into each cavity.

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C. Sealing: A layer of aluminium foil is heat- • While Alu-PVC packaging provides
sealed to the preformed PVC blister pack. All reasonable protection, it may not offer the
cavities are securely covered and sealed. same barrier performance level as Alu-Alu
D. Perforation and cutting: This step is the same packaging.
as the one during the ALU-ALU packaging • The plastic material makes Alu-PVC blister
process. cavities more susceptible to impact damage
during handling, transportation, or storage.
3. Advantage:
• PVC material has poor thermal stability. It's
• ALU-PVC blister packs are made of plastic crucial to carefully control the temperature
based materials. This results in lower during the blister formation and heat-sealing
production costs, making it a more cost- stages.
effective option for pharmaceutical packaging. • The transparency of the PVC material is a two-
• It allows for easy visibility of medications edged sword. While it allows for excellent
inside the blister cavities. This enables end product visibility, it may not be suitable for
consumers to check the product integrity and light-sensitive medications.
verify the dosage before consumption. • PVC is not readily biodegradable. Improper
• Packaging is more flexible and versatile in disposal of PVC blister packs can cause
customization. The PVC blister cavities can be environmental concerns.
easily molded to accommodate different
Summary
product shapes and sizes.

4. Disadvantage:

Table 1. Material Comparison between ALU-ALU and ALU-PVC


ALU-ALU Packaging ALU-PVC Packaging
Composition Aluminium Foil Layer sandwiched Aluminum foil layer with a layer of
between plastic film layers. polyvinyl chloride (PVC)
Barrier Properties Exceptional shield against Good barrier against moisture and
humidity, oxygen, and UV rays. light.
Visibility No visibility for the contents inside Transparent PVC film for excellent
the blister cavities. product visibility.
Tamper Resistance Enhanced tamper resistance with Can be made tamper-resistant with
features like blister perforations or appropriate blister designs.
tear lines.
Flexibility Less flexible, suitable for standard- More flexible, and suitable for
sized blisters. various blister shapes and sizes.
Cost Generally, more expensive Generally, more economical
Heat Resistance Aluminum-based materials with Plastic-based materials with limited
good resistance to temperature heat resistance.
changes.
Recyclability Less recyclable due to a More recyclable with separate PVC
combination of materials. and aluminium recycling.
Shelf Life Extended shelf life due to excellent Good protection but slightly inferior
barrier properties. barrier properties.

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Table 2. Material Comparison between PVC and PVDC
PVC PVDC
Composition Polyvinyl Chloride is created Polyvinylidene Chloride is a synthetic
through the polymerization of the thermoplastic produced by the
vinyl chloride monomer and is polymerization of vinylidene chloride,
known for its strength and
resistance to environmental factors.
Barrier Properties Offers moderate barrier protection Provides superior barrier properties
against moisture and gases. This compared to PVC. It is highly effective
makes it suitable for general in protecting products from moisture,
consumer goods and non-sensitive oxygen, and other gases, making it
pharmaceutical products ideal for moisture-sensitive and
perishable products.
Mechanical Has good mechanical strength and While also strong, the primary focus of
Properties is resistant to abrasion and impact. PVDC is on barrier properties rather
This makes it a durable choice for a than mechanical strength.
wide range of products.
Cost consideration Generally, less expensive than More expensive due to its enhanced
PVDC, making it a cost-effective barrier properties. The cost is justified
option for many applications. for products that require extended shelf
life or are highly sensitive to moisture
and gases.
Flexibility and High Flexible and easy to form into While it can be formed into blisters, it
Formability different shapes. is typically less flexible than PVC and
is often used as a coating over PVC to
enhance barrier properties.
Applications Used in non-sensitive Ideal for packaging moisture-sensitive
pharmaceutical packaging and pharmaceuticals, food products and
preferred for products that do not perishable items. Often used in
require high barrier protection combination with PVC, where PVDC
against moisture and gases . acts as a coating to enhance barrier
properties.
Regulatory and Concerned about the release of Generally considered safe for food and
Health Aspects harmful substances from PVC, pharmaceutical packaging, but its use
especially when it contains certain is regulated to ensure that no harmful
plasticizers. substances leach into the packaged
products.

CONCLUSION: transparency for visual inspection. The choice of


packaging should be based on the drug's stability
The comparison between ALU-ALU and ALU- needs, environmental conditions, and cost
PVC blister packaging reveals distinct advantages considerations. As environmental concerns rise,
and limitations for each material. ALU-ALU there is a growing need for sustainable packaging
offers superior protection against environmental alternatives that balance protection with ecological
factors like moisture, light, and oxygen, making it impact.
ideal for sensitive drugs, though it is costlier and
less flexible in design. ALU-PVC, while providing
slightly lower barrier protection, is more cost-
effective and versatile, with the added benefit of

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Zuki Patel, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 3, 2810-2818 | Research
ACKNOWLEDGMENT REFERENCES

I would like to take this opportunity to extend my 1. [email protected]. Development


heartfelt thanks to everyone who has supported of the Pharmaceutical Packaging Industry
and guided me throughout my research project, [Internet]. Medical Packaging Inc., LLC. 2022.
“ALU-ALU Packaging Vs ALU-PVC Blister Available from:
Packaging: Waste to Value - A Comparative https://medpak.com/pharmaceutical-
Analysis.” First and foremost, I would like to packaging-development/
express my sincere appreciation to my academic 2. admin. Why Do Pharmaceuticals Need
mentor, Mrs. Zuki Patel, Assistant Professor of Aluminium Packaging? - Accupack [Internet].
Regulatory Affairs, for her invaluable guidance, Accupack. 2022. Available from:
unwavering support, and insightful https://www.accupackengineering.com/post/w
recommendations during this project. Her hy-do-pharmaceuticals-need-aluminium-
expertise and constant assistance have been packaging/
instrumental in shaping the direction of my work. 3. Aluminum Foil Manufacturer, Supplier &
I am also deeply grateful to my industrial mentors, Exporter in India [Internet]. Ravirajfoils.com.
Mr. Hitesh Dani, Director of Saviour 2015. Available from:
Pharmaceuticals, their professional insights and https://www.ravirajfoils.com/blog/aluminum-
guidance on the regulatory landscape have foil%E2%80%93for-pharmaceutical-
significantly enhanced my understanding of the packaging
subject. I would also like to thank my colleagues 4. Pharmaceutical Packaging - European
and the entire faculty of the Department of Aluminium Foil Association [Internet].
Regulatory Affairs at K.B.I.P.E.R. for their www.alufoil.org. Available from:
continuous support and constructive feedback. https://www.alufoil.org/pharmaceutical-
Their encouragement has been essential in the packaging
successful completion of this work. I am especially 5. Uniworth Enterprises LL – Uniworth
thankful to my family for their unwavering Enterprises LL [Internet]. Uniworthllp.com.
support, patience, and belief in me, which has been 2016. Available from:
my greatest strength throughout this journey. https://www.uniworthllp.com/
Lastly, I wish to express my deep gratitude to
HOW TO CITE: Charmi Patel, Hitesh Dani, Maitreyi N.
everyone who has contributed to the completion of Zaveri, Zuki Patel*, ALU-ALU Packaging Vs ALU-
my thesis, whether directly or indirectly. PVC Blister Packaging: Waste to Value - A Comparative
Analysis, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 3,
Conflict of Interest Statement 2810-2818 https://doi.org/10.5281/zenodo.15100484

The authors declare no conflicts of interest related


to this study, “ALU-ALU Packaging Vs ALU-
PVC Blister Packaging: Waste to Value - A
Comparative Analysis.” The research was
conducted independently, and there are no
financial, personal, or professional relationships
that could have influenced the study's outcomes.

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