Packaging

Nanang Yunarto
 PACKAGING OF
PHARMACEUTICALS
The quality of the packaging of pharmaceutical products plays a
very important role in the quality of such products. It must:
protect against all adverse external influences that can alter
the properties of the product, e.g. moisture, light, oxygen and
temperature variations;
protect against biological contamination;
protect against physical damage;
Carry the correct information and identification of the
product.
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PHARMACEUTICALS
• A distinction must be made between primary and secondary packaging
components. The primary packaging components (e.g. bottles, vials,
closures, blisters) are in direct physical contact with the product, whereas
the secondary components are not (e.g. aluminium caps, cardboard boxes).
• The choice of primary and/or secondary packaging materials will depend
on the degree of protection required, compatibility with the contents, the
filling method and cost, but also the presentation for over-the-counter
(OTC) drugs and the convenience of the packaging for the user (e.g. size,
weight, method of opening/reclosing (if appropriate), legibility of printing).
• Containers may be referred to as primary or secondary, depending on
whether they are for immediate use after production of the finished product
or not. Both single-dose and multi-dose containers exist.
• Containers may be well-closed, tightly closed, hermetically closed or light-
resistant, airtight.
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PHARMACEUTICALS
Functions of packaging:
Containment:
• The containment of the product is the most fundamental function of
packaging for medicinal products. The design of high-quality
packaging must take into account both the needs of the product and
of the manufacturing and distribution system.
This requires the packaging:
• • Not to leak, nor allow diffusion and permeation of the product;
• • To be strong enough to hold the contents when subjected to normal
handling.
• • Not to be altered by the ingredients of the formulation in its final
dosage form.
• • Protection
 PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Containment:
• The packaging must protect the product against all adverse
external influences that may affect its quality or potency, such
as:
• light
• moisture
• oxygen
• biological contamination
• Mechanical damage
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PHARMACEUTICALS
Functions of packaging:
Stability:
• Information on stability is given in the guidelines for stability
testing of pharmaceutical products containing well established
drug substances in conventional dosage forms.
• For primary packaging, it is necessary to know the possible
interactions between the container and the contents.
• Normally, product/component stability and compatibility are
confirmed during the primary research and development stage.
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PHARMACEUTICALS
Functions of packaging:

Stability:
• There are numerous possibilities of interactions between (primary) packaging
materials and pharmaceutical products, such as:
- The release of chemicals from components of the packaging materials;
- The release of visible and/or sub visible particles;
- The absorption or adsorption of pharmaceutical components by the packaging
materials;
- Chemical reactions between the pharmaceutical product and the packaging
materials;
- The degradation of packaging components in contact with the pharmaceutical
products;
- The influence of the manufacturing process (e.g. sterilization) on the container.
 PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Labels:
Throughout manufacturing, a succession of specific outer labels is applied to the container
of the medicinal product.
The level of processing is indicated by the following words:
• Quarantine
• Storage
• Distribution.
• Specifications for labels for finished drug products are defined in the WHO guidelines
on GMP for pharmaceutical products .
- Written labels on the packaging:
• Permit the identification of each active ingredient by means of its INN, and also give
the dosage form and the trade name/trademark. All information concerning the medicinal
product, as required by national legislation, must be stated on the packaging.
• Preserve the stability of the medicinal product by giving advice on its storage
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PHARMACEUTICALS
Functions of packaging:
Labels:
After the stability of the product has been evaluated, one of the following
recommendations as to storage conditions can be prominently indicated on the label:
• • Store under normal storage conditions;
• • Store between 2 and 8 °C (under refrigeration, no
• freezing);
• • Store below 8 °C (under refrigeration);
• • Store between -5 and -20 °C (in a freezer);
• • Store below -18 °C (in a deep freezer).
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PHARMACEUTICALS
Functions of packaging:
Protection of patients:
• Packaging must not only increase compliance
through its design, but must also protect the
patient and indicate the integrity of the product
.
• Packaging equipped with a tamperevident
device protects against incidental and
accidental poisoning. To protect children,
several child-resistant closures have been
 PACKAGING OF
PHARMACEUTICALS
Packaging materials and closures
Glass:
• For a large number of pharmaceuticals, including medicinal products for oral and
local administration, glass containers are usually the first choice (e.g. bottles for
tablets, injection syringes for unit- or multi dose administration.
• Classifications of types of glass are given in the European and United States
pharmacopoeias, whereas no such classification exists in the Japanese
pharmacopoeia.
• Glass can be tested for light transmission and hydrolytic resistance. In the Japanese
pharmacopoeia, such tests are described only for glass containers for injection,
whereas in the European and United States pharmacopoeias they are given for all
types of glass containers.
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PHARMACEUTICALS
Packaging materials and closures
Plastics:
• Some containers are now being made of plastics;
• the main use is for bags for parenteral solutions.
• Plastic containers have several advantages compared with glass containers
unbreakable, collapsible, light resistant.
Metal:
• Metal containers are used solely for medicinal products for non parenteral
administration. They include tubes, packs made from foil or blisters, cans, and
aerosol and gas cylinders.
• Aluminum and stainless steel are the metals of choice for both primary and
secondary packaging for medicinal products. They have certain advantages and
provide excellent tamper-evident containers. Metal is strong, impermeable to gases
and shatter proof, it is the ideal packaging material for pressurized containers.
 PACKAGING OF
PHARMACEUTICALS
Packaging materials and closures
• Closures used for the purpose of covering drug containers after the filling process should be
as inert as possible. They should not give rise to undesired interactions between the contents
and the outside environment, and should provide a complete seal.
• Besides their protective function, closures must also allow the easy and safe administration of
the drug.
• Depending on the application, closures may have to be pierced with a needle for intravenous
sets. Such closures are made from elastomeric materials (rubbers), while those that cannot be
pierced are generally made from plastics such as polyethylene or polypropylene.
• Depending on the type of container, closures may have different shapes and sizes, e.g.
stoppers for infusion or injection bottles or plungers for prefilled syringes. A special design of
stopper may also be required for some pharmaceutical production processes such as
lyophilization.
• Closures, as primary packaging components, are of critical importance and must be carefully
selected.
 PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Solid dosage forms:
Tamper resistant packaging:
• The requirement for tamper resistant packaging is now one of the major consideration in the development
of packaging for pharmaceutical products. Tamper evident containers are closed containers fitted with a
device that irreversibly indicates if the container has been opened.
• The following package configuration have been identified by the FDA as examples of packaging systems
that are capable of meeting the requirements of tamper resistant packaging as defined by FDA regulation
• Film wrappers
• Blister package
• Strip package
• Bubble pack
• Shrink seal and bands
• Foil paper or plastic pouches
• Bottle seals
• Tape seals
• Breakable caps
• Sealed tubes
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PHARMACEUTICALS
Packaging material for different formulations
Solid dosage forms:
Strip packages:

• A strip package is a form of unit dose packaging that is commonly used for the packaging of tablets and
capsules. A strip package is formed by feeding two webs of a heatsealable flexible film through either a
heated crimping roller or a heated reciprocating plate. The product is dropped into the pocket formed prior
to forming the final set of seals. A continuous strip of packets is formed, generally several packets wide
depending on the packaging machine's limitations. The strip of packets is cut to the desired number of
packets in length.
• The strips formed are usually collated and packaged into a folding carton. The product sealed between the
two sheets of film usually has a seal around each tablet, with perforations usually separating adjacent
packets. The seals can be in a simple rectangular or "picture-frame" format or can be contoured to the shape
of the product .Different packaging materials are used for strip packaging based on their properties for high-
barrier applications a paper/polyethylene/foil/polyethylene lamination is commonly used.
 PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Solid dosage forms:
Blister packages
• When one thinks of unit dose in pharmaceutical packaging, the package that invariably comes to mind is
the blister package. This packaging mode has been used extensively for pharmaceutical packaging for
several good reasons. It is a packaging configuration capable of providing excellent environmental
protection, coupled with an esthetically pleasing and efficacious appearance. It also provides user
functionality in terms of convenience, child resistance, and no, tamperresistance.
• The blister package is formed by heat-softening a sheet of thermoplastic resin and vacuum-drawing the
softened sheet of plastic into a contoured mold. After cooling, the sheet is released from the mold and
proceeds to the filling station of the packaging machine.
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PHARMACEUTICALS
Packaging material for different formulations
Containers for liquids Parentrals
Injectable formulations are packaged in to containers made of plastic or glass. Container system includes
ampoules, syringes, vials, bottles, cartridges, bags ampoules are all glass, and plastic are all bags.
Rubber materials for rubber stoppers for vials and bottles, rubber plungers and rubber seals for syringes,
cartridges.
Irrigation solutions are packaged in glass bottles with aluminum screwcaps.
A single-dose container is one that holds a quantity of drug intended as a single dose and when opened cannot
be resealed with assurance that sterility has been maintained.
These containers include fusion-sealed ampoules and prefilled syringes and cartridges
 PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Closures
The closure is normally the most vulnerable and critical component of a container in so far as stability and
compatibility with the product are concerned. An effective closure must prevent the contents from escaping
and allow no substance to enter the container.
Function of a closure:
Provide a totally hermetic seal.
Provide an effective seal which is acceptable to the products.
Provide an effective microbiological seal.
Types of closures
Closures are available in five basic designs
Threaded screw cap
Lug cap
Crimp-on (crowns)
pilfer proof closure
Roll-on
Many variations of these basic types exist, including vacuum, tamperproof, safety, child resistant, and liner less
types, and dispenser applicators.
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PHARMACEUTICALS
Packaging material for different formulations
Closures
1. Threaded Screw Cap:
The screw cap when applied overcome the sealing surface irregularities and provides physical and chemical
protection to content being sealed. The screw cap is commonly made of metal or plastics. The metal is usually
tinplate or aluminum, and in plastics, both thermoplastic and thermosetting materials are used.

1. Threaded Screw Cap 2. Lug cap

2. Lug Cap:
The lug cap is similar to the threaded screw cap and operates on the same principle. It is simply an interrupted
thread on the glass finish, instead of a continuous thread. It is used to engage a lug on the cap sidewall and
draw the cap down to the sealing surface of the container. Unlike the threaded closure, it requires only a
quarter turn. The lug cap is used for both normal atmospheric-pressure and vacuum pressure closing.
 PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Closures

3. Crown Caps:
This style of cap is commonly used as a crimped closure for beverage bottles and has remained essentially
unchanged for more than 50 years.

4. Roll-On Closures:
The aluminum roll-on cap can be sealed securely, opened easily, and resealed effectively. It finds wide
application in the packaging of food, beverages, chemicals, and pharmaceuticals. The roll-on closure requires a
material that is easy to form, such as aluminum or other light-gauge metal. Re sealable, non re sealable, and
pilfer proof types of the roll-on closure are available for use on glass or plastic bottles and jars.
 PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Closures

5. Pilfer proof Closures

The pilfer proof closure is similar to the standard roll-on closure except that it has a greater skirt length. This
additional length extends below the threaded portion to form a bank, which is fastened to the basic cap by a
series of narrow metal "bridges." When the pilfer proof closure is removed, the bridges break, and the bank
remains in place on the neck of the container. The closure can be re sealed easily and the detached band
indicates that the package has been opened. The torque is necessary to remove the cap.
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PHARMACEUTICALS
Packaging material for different formulations
Packaging for liposomes
1. Hermetically sealed borosilicate glass ampoules
Provide a secure environment for lipids sensitive to oxidation. The ampules are shipped in cardboard liners for
protection and storage convenience. Ampules are pre-scored for easier opening. Once the seal is broken,
sample may be transferred to a Screw Cap Storage Vial.

2. Narrow-mouth borosilicate glass bottles

Convenient for shipping and storage of larger volumes of lipids. The closure system is composed of a
closed-top screw cap with a teflon liner fused to a silicone rubber backing. The liner is sonically welded to the
cap, therefore no glue can come in contact with the organic solution.
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PHARMACEUTICALS
Packaging material for different formulations
Packaging for liposomes
3. Wide-mouth borosilicate glass bottles
Convenient for shipping and storage of dry powder lipids. Larger openings provide easier access to lipid
samples. The closure system is composed of a closed-top screw cap with a teflon liner.

4. The Screw Cap Storage Vial

Designed as a storage option for materials shipped in glass ampules or bottles. The closure system contains an
open-top screw cap with a teflon liner fused to a silicone rubber septum.