Packaging used

in the industry
Pharmaceutical
Discipline: Physics and Unit Operations
Packaging
Definition
. Packaging is defined as all the material that
involves a product aimed at ensuring the preservation of its
characteristics during transportation, storage and
consumption.

The packaging of pharmaceutical products must follow the

determinations of the 'Good Manufacturing Practices'
aiming for Safety, Identification, Concentration, Purity
and Quality.

Your goal is to extend the lifespan of all products

pharmaceuticals.
(SALAY, 2006)
Packaging
Specifications
The packaging must meet four basic specifications.

Protection

Conditioning Communication

Utility

(GOMES; SOUZA, 2008)

Packaging
Classification
. Primary:
The primary packaging is the one that is in direct contact with the
product, providing an initial and usually greater barrier of
protection.
Glass, can, plastic

Secondary:
Protect the primary packaging.
cartridges, displays

Tertiary:
Combination of primary and secondary packaging, being the
wholesale sales measure
Cardboard boxes (SALAY, 2006)
Packaging
Classification
Quaternary:
Conditioning that facilitates movement and
storage.
pallet

Fifth level:
Special packaging for long-distance shipping

distance.

container

(SALAY, 2006)
Packaging
Function
Primary:
It must contain the medication, protect the product and provide

invulnerability, inform and identify the product, batch, date of

manufacturing and validity.

Secondary:

Provides inviolability, informs and identifies the medication,

facilitates use through mobility and adds values,
presenting the product and providing safety

(SALAY, 2006)
Packaging
Function

Tertiary and quaternary:

Protect in the handling and movement of the load, informs and

identifies the product, the quantity, the barcode, facilitates the

customer display and handling adds value.

(SALAY, 2006)
Packaging
Types of packaging

. AMPULE
It is a hermetically sealed container,
intended for the storage of liquids
esters for use by parenteral route and whose
the content is used in a single dose

(LIMA, 2010)
Packaging
Types of packaging

tube
It is a flexible, flat container or
sealed on one side, with an opening
removable from the other.

Used for conditioning of

semi-solid medications such as pastes
and creams.

(LIMA, 2010)
Packaging
Types of packaging
BLISTER
It is a container that consists of a
molded tray with cavities inside
which pharmaceutical forms are
stored. It has a covering of
laminated material sealing the part
mold that must be opened to access
the content.

(SALAY, 2006)
Packaging
Types of packaging
Advantages:

Transparencies favor the

recognition of the medication
by the consumer

They use a smaller amount of

materials, resulting in lower
space for storage and costs
of lower distribution.

(SALAY,2006)
Packaging
Types of packaging
BOTTLE
Container intended to accumulate
liquid.

. VIAL BOTTLE
Sealed bottle with a cork of
flexible material that must be
punctured for administration of
medication
(LIMA, 2010)
Packaging
Types of packaging
STRIP

Flexible material container

formed by two layers of the
same sealed material as
they separate and protect each dose of

medicine.

(SALAY, 2006)
Packaging
Types of packaging
. Advantages:
High air barrier, light vapors,
malleability, in addition to low weight

. Disadvantages:
Larger and non-packaging
allow the visualization of
medicine.
(SALAY, 2006)
Packaging
Packaging materials
glass

Used in bottle form by the industry

pharmaceutical since the beginning of its

activities in Brazil.

(GOMES; SOUZA, 2008)

Packaging
Packaging materials
ADVANTAGES:

Transparency, ease of cleaning, closure

effective, possibility of opening and closing
when necessary;
Service life of over one hundred years.

DISADVANTAGE:

Heavy and relatively more expensive and fragile

(GOMES; SOUZA, 2008)

Packaging
Packaging materials

PLASTIC

Represents 30% of the materials

used in packaging, replacing
widely the glass in the area
Pharmaceutical.

(LIMA, 2010)
Packaging
Packaging materials

ADVANTAGES:
weight reduction;
ease of molding;
reduction of accident risk by
breakage of the packaging;
high mechanical and chemical resistance;
relatively production cost
low.

(LIMA, 2010)
Packaging
Packaging materials
DISADVANTAGES:

Possible extraction;

Interaction;

Adsorption,

Passage of light

(LIMA, 2010)
Packaging
Packaging materials

. METAL
Wide use for container of
tablets, lozenges, and powders.

Advantages:

.Thermal resistance

.Barrier to light, gases, and humidity.

(LIMA, 2010)
Packaging
Packaging materials

. METAL
Disadvantage:

Very thin leaves present

micro holes that allow exchanges
gases between the interior and the exterior
from the packaging

(LIMA, 2010)
Packaging
Packaging materials

. PAPER

It is one of the most economical and versatile.

packaging materials.
Advantages:
Low cost, light weight, and ease of
processing.

(LIMA, 2010)
 Packaging
Types of risk
Compression

Mechanics Pressure can distort or crush a package and

cause damage to the product;
Cream/Ointment

Humidity

Climatic or Both the loss and gain of moisture can be

environmental critics of some products;
Materials (including all plastics) are
permeable to moisture and even screw caps.

(AULTON, 2005)
 Packaging
Types of risk

Oxygen
.Oxidation reactions
.Oxygen absorbers
Climatic or
environmental
Temperature
.
.Extreme temperatures or temperature cycles can
cause degradation of the product and/or packaging

Light

(LIMA, 2010)
Packaging
Types of risk
The packaging and its sealing materials must maintain a seal.
100% effective against the entry of microorganisms (bacteria,
fungi).
Biological
. Break of stability
. Change of physical characteristics
. Inactivation of active ingredients

Chemicals Interaction and incompatibility between the product and packaging.

(LIMA, 2010)
Packaging
Development
It is important to understand the limitations.

Pre-formulation associated with any contact with the material of

packaging used to contain or keep under
test.

Certification that all contact materials

they are defined in the packaging and that
Formulation
all parameters of the conditioning action
are to be identified, controlled, and documented.

(LIMA, 2010)
Packaging
Development
It is important to have basic knowledge of
CONSIDERATIONS all packaging materials
ABOUT MATERIALS OF its properties, characteristics, processes
AIR CONDITIONING
involved in its manufacturing, such as the
components or processes used can
influence its properties.

A series of possible is employed.

TESTES OF
packaging at different temperatures and
FEASIBILITY OF
PACKAGING
moistures and it is defined from there which
packaging will be used.

(AULTON, 2005)
Packaging
Development
TESTES DE Formal stability tests, in which
STABILITY
OFFICIALS
the determination of life will be based
useful.

Repetition of the stability study in

FOLLOW-UP production batches, in order to confirm that
OF STABILITY the product's lifespan has not suffered
changes.

COMPLAINTS Monitoring and recording of reactions

adverse.
(AULTON, 2005)
Packaging
Development

Reasons that lead pharmaceutical industries to

have their products packaged by third parties:

Lack of adequate facilities;

Alcohol base - require explosion-proof installations;

When a new product is being launched in the company;

There is still no line for such service.

(LIMA, 2010)
Packaging
Selection
Factors that influence the choice of packaging

Product
Chemical and physical characteristics of the drug, method of
administration, type of patient (baby, child, adult);

Market
Points of sale (where, what environment the product will be)
used)

Distribution system
Wholesale market, or directly to distributors.

(GOMES; SOUZA, 2008)

 Legislation
Resolution RDC No. 17, of April 16, 2010
Provides for the Good Manufacturing Practices of Medicines

XXI - packaging: all operations, including filling and labeling, by which the
bulk product must go through in order to become a finished product. Normally, the
packaging of sterile products is not considered part of the packaging process, since
These in their primary packaging are considered bulk products;

XXV - master formula/standard formula: document or group of documents that

specify the raw materials and the packaging materials along with their respective
quantities, along with the description of the procedures and necessary precautions
for the production of a certain quantity of finished product. Furthermore, it provides
instructions on processing, including on process controls.

XXX - packaging material: any material, including printed material, used

in the packaging of a medication. This definition excludes any other packaging used
for transport or shipping. The packaging materials are classified as
primary or secondary, according to the degree of contact with the product;

Article 68. The person designated by Quality Assurance must have joint responsibility.
with other relevant departments to approve reliable suppliers of materials
raw materials and packaging materials that meet the established specifications.
 Final considerations

All products must have a shelf life and this is only achieved when the
products are properly packaged. Success is only achieved
when there is an efficient combination between product and packaging.

Remembering that the quality of the product is directly related

the conditioning and the packaging in which it is found,
showing that Good Pharmaceutical Practices, both in
pharmaceutical production regarding the packaging of the final product are
important to obtain a reliable final result.
Bibliographic References
AULTON, Michael E. Outline of pharmaceutical forms.- 2nd ed.- Porto Alegre. Artmed,
2005.
BRAZIL. Resolution of the Federal Pharmacy Council, April 17, 2010. Available at:
Accessed on August 30
2012

GOMES, Bernardo J. L SOUZA, Cristina G. de; Use of packaging materials in

pharmaceutical industry: exploratory study of the use of glass or PET in syrup bottles.
XXVI ENEGEP–Fortaleza. 2006.

LIMA, Bruna Rubia de. The importance of packaging development in the industry
pharmaceutical. São Paulo. 2010.

SALAY, Maria Cristina. Packaging Technology of Solids. Drugs & Medicines. RCN
Commercial and Publishing Ltd., v. 7, n. 41, p. 36-41. São Paulo. 2006.