Dr. Jose G.

Tamayo Medical University

TYPES OF
CONTAINERS
Final Coverage
PhCh1 Lecture
UNIVERSITY OF PERPETUAL HELP – DR. JOSE G. TAMAYO MEDICAL UNIVERSITY

Learning Objectives:
1. Discuss the importance of pharmaceutical aids and necessities
in the preparation of pharmaceutical products.
2. To know the different types of containers and closures, their
applications/uses in the preparation of pharmaceutical products.

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Light resistant
containers

requires the glass to

provide protection against
290-450 nm of light. Only
amber glass and red glass
are effective in protecting
the contents of a bottle
from the effects of sunlight
by screening out harm
ultraviolet rays. Amber
color meets these above
specifications but iron
oxide added to produce
this color, leach in to the C O L L E G E O F P H A R M A C Y
1 oz Red Shaded Glass Boston
Round Bottle
The red color is from light to dark
and lends an artistic look to the
bottle. It looks great with a dropper
or lid and the collared neck works
well with a shrink band to create a
tamper evident seal.
16 oz Amber Glass Boston Round
Bottle
Characteristic of the boston round
is the rounded shoulders and base.
The amber color gives the item a
medicinal, pharmaceutical flair as
well as provides a limited
protection to light sensitive
products
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Well-closed
Container

it protects the contents

from extraneous solids and
from loss under ordinary
conditions of handling,
shipment, storage, and
distribution.

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Tight Containers
protects the contents from
contamination by
extraneous liquids, solids,
or vapors, from loss of the
article, and from
efflorescence,
deliquescence, or
evaporation under the White PP/PS Double Wall Round Base Jar
1/2 oz

ordinary or customary This is a durable container that can accommodate

conditions of handling, up to 1/2 oz of product and is perfect for
shipment, storage, and cosmetic applications, lip balms, lotions, travel
distribution and is capable containers, and product samples.
of tight re-closure.
Ex: Acyclovir,
Benzocaine, Lidocaine

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Hermetic Container
is impervious to air or
any other gas under
the ordinary or
customary conditions
of handling, shipment,
storage, and
distribution.

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Single-unit container
is designed to hold a
quantity of drug
intended for
administration as a
single dose promptly
after the container is
opened.

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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 ampules and prefilled Cartridge – is a type of prefilled syringes that is is
syringes and cartridges a single syringe and needle unit which is to be
Ex. Sterile water, Heparin, placed in a special holder before use. Once the
Bacteriostatic Water, syringe and needle unit is used, they are discarded
Concentrated Sodium
Chloride but the holder is used again with a new unit.
Ampule - sealed glass containers with an elongated
neck that must be broken off. Most ampules are
weakened around the neck for easy breaking.
Vial - made of glass or plastic and are sealed with a rubber
stopper.
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needle
A C Yis used to add contents to or withdraw
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Unit dose container

a.k.a as unit dose package;
designed that the contents
are administered to
the patient as a single dose,
direct from the container.
Each unit dose container mu
st bear a separate label, be
labeled with the name and
strength of the medication,
the name of the
manufacturer or distributor,
an identifying lot number and,
if applicable, the expiration
date of the medication.
Ex. Salbutamol Nebule
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Multiple-unit
container
contain more than a single
unit or dose of the
medication; single-unit
package is termed a unit-
dose package.

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Multiple Dose
Container
is a hermetic container that
permits withdrawal of
successive portions of the
contents without changing
the strength or
endangering the quality or
purity of the remaining
portion. Self-contained multiple-
Multiple-dose vaccine vial Multiple-dose drop
dose syringe
dispenser

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Prescription bottles
and cups
glass containers for
dispensing liquid and
semisolid dosage forms are
available in a variety of
sizes, shapes, and colors.
Most containers used today
are of clear green or amber
light-resistant glass. Plastic
closures are used on most
Rx bottles and jars since
they are durable and less
reactive than metal.
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Standard Rx Bottles
containers that contain medicine
prescribed by physicians, come in
several different colors, the most
common of which being orange or
light brown due to its ability to
prevent ultraviolet light from
degrading the potentially
photosensitive con tents
through photochemical reactions,
while still letting enough visible light
through for the contents to be easily
visible. Other common colors
include: Clear (for compounds that
don't degrade in light), blue, dark
brown, green, and various opaque
hues.,
Ex: Prednisone 20 mg Amoxicillin
500 mg

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Ointment jars
are used to dispense
ointment, creams or
extremely viscous
suspensions or emulsions.

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Wide-Mouthed
Powder Jars

is usually cylindrical, m
ade of glass or earthen
ware, and without
handles
3 oz. Clear Round Wide-Mouth Jars

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Capsule vials
are used for dispensing
capsules, tablets, or small
quantities of bulk powders.

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Dropper Bottles
a glass tube with a hollow
rubber bulb at one end and
a small opening at the
other, for drawing in a
liquid and expelling it in
drops
Ex. Contact lense cleanser

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Applicator bottles
have a small glass or
plastic rod attached to
the closure. These are
useful for applying
medication to a wound
or skin surface, as in
the case of antiseptic
solutions.

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Collapsible tubes
cylinder of metal or
plastic sealed at one
end and having a
capped opening at the
other from which paint,
toothpaste, or some
other semifluid
substance may be
squeezed.
Ex. Colgate,
Betamethasone
Valerate

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CLOSURES
TYPES OF CLOSURES AND ITS QUALITY
CONTROL CONSIDERATIONS

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CLOSURE
• Closures are devices and techniques used to close or seal
a bottle, jug, jar, tube, can, etc
• Closures can be a cap, cover, lid, plug, etc

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• The closure is normally the most vulnerable and

critical component of a container
• An effective closure must prevent the contents from
escaping and allow no substance to enter the
container

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FUNCTION OF A CLOSURE
• Provide a totally hermetic seal
• Provide an effective seal which is acceptable to the
products
• Provide an effective microbiological seal

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CHARACTERISTICS OF CLOSURE
• It should be resistant and compatible with the product
• If closure is of re closable type, it should be readily operable
and should be re-sealed effectively
• It should be capable of high speed application
• It should be decorative and of a shape that blends with the main
containers

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TYPES OF CLOSURES

• Closures are available in five basic designs

1. Screw-on, threaded, or lug
2. Crimp-on (crowns)
3. Press-on (snap)
4. Roll-on
5. Friction.

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• Many variations of these basic

types exist, including

Tamperproof
Child resistant
Dispenser applicators

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THREADED SCREW CAP

• 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.

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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
• Unlike the threaded closure, it requires only a quarter turn
• The cap is widely used in the food industry

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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

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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
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PILFER PROOF CLOSURES

• The pilfer proof closure is similar to the standard roll-
on closure except that it has a greater skirt length
• When the pilfer proof closure is removed, the
bridges break, and the bank remains in place on the
neck of the container
• The torque is necessary to remove the cap.

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SNAP ON
• Some closures snap on. For opening, the top is
designed to pry off or, break off, or have a built in
dispenser.

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FRICTION FIT

Some containers have a

loose lid for a closure. A
friction fit requires some
force to close and open,
providing additional
security. Paint cans often
have a friction fit plug.

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TAMPER RESISTANT
Resistance to tampering is required for some
types of products.

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DISPENSING
• A wide variety of convenience dispensing features
can be built in to closures. Spray bottles and cans
with aerosol spray have special closure
requirements.

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CHILD-RESISTANT
• Child-resistant packaging or C-R packaging has
special closures designed to reduce the risk of
children ingesting dangerous items Tamper-evident

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CLOSURE LINER
• A liner may be defined as any material that is inserted in a cap
to effect a seal between the closure and the container.
• Liners are usually made of a resilient backing and a facing
material. The backing material must be soft enough to take up
any irregularities in the sealing surface and elastic enough to
recover some of its original shape when removed and replaced.

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FACTORS IN SELECTING A LINER

• The most important consideration is that the liner
should be chemically inert with its product.

• Gas and vapor transmission rates are usually

relative and depend chiefly on the shelf life required
for the product.

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• Homogenous Liner:
These one piece liners are available as a disk
or as a ring of rubber and plastic.
• Expensive
• Complicated to apply
• Widely used in pharmaceuticals
• Uniform properties
• Can withstand high-temperature sterilization

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• Heterogenous liner or composite

liner:
They are composed of layers of different
materials.
• It consists of two parts
• A facing and a backing

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Torque testing
• Controlling cap tightness on a
packaging line with a torque
tester can prevent:
• Evaporation
• Leakage of the product
• Breakage of a plastic molded
closure
• Owens-illinnois torque tester
are commonly used.

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COMPOSITION OF CLOSURE
• Closures are made of
Rubber
plastics
Glass
Metal
Cork

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PLASTIC CLOSURES
• The two basic types of
plastic generally used for
closures are
Thermosetting
Thermoplastic resins
Urea
phenols

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RUBBER CLOSURES
• Rubber is used in the pharmaceutical industry to make
closures, cap liners and bulbs for dropper assemblies.
• The rubber stopper is used primarily for multiple dose vials
and disposable syringes.
• Rubber closures for containers for aqueous parenteral
• Preparations for powders and for freeze-dried powders

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GLASS CLOSURE

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METAL CLOSURE

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CORK

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Quality Control of Container-

Closures
• A number of quality control checks are required for the
manufacture and release of container-closures. These
include:
a) After the material has been mixed
b) Post-compression and molding
c) Washing process
d) Post-washing and post-siliconization
e) Packaging After packaging
f) Sterilization

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a) After the material has been

mixed
Specific gravity
Color
Dispersion in relation to particle size
Hardness

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b) Post-compression and molding

Here the material is checked for rubber thickness

c) Washing process
During the loading of stoppers into a washer, the quality
of the water should be checked for bioburden and
endotoxin (using compendial methods).

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d) Post-washing and post-siliconization

After the stoppers have been washed, a number of
quality control checks should be performed. These
include:
• Mechanical and Material Tests
Compression set
Hardness
Fragmentation
Penetrability (what happens when a needle passes through the
stopper?
Assessment of dimensions and flexibility

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• PHYSICAL TESTS
Resistance to sterilization
Particle testing

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CHEMICAL TESTING

• Tests for extractables and leachables:

Extractables are chemical substances that are
obtained by exposing the packaging to a variety
of solvents under exaggerated incubation
conditions of time and temperature.
Leachables differ from extractables in that they
are chemical substances that migrate under
normal conditions of use from the stopper into a
drug product
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• Silicone oil determination:

The effect of subvisible silicone particles should be
assessed, for these can cause aggregation with
proteins, and the new complex can potentially
trigger an immunochemical reaction within the body
of the patient receiving the drug.

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BIOLOGICAL TESTS
Cytological testing
Bioburden assessment
Some manufacturers undertake an examination for
mesophilic counts whilst others focus on examining
for thermophilic bacteria.
Bacterial endotoxin testing
The testing of container-closures for endotoxin, using the
Limulus amebocyte lysate (LAL) method

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e) Packaging After packaging

A selection of bags should be examined for tears as
a part of quality control assessment
f) Sterilization
Container-closures are typically sterilized by one of
two methods: steam sterilization (using autoclaves)
and gamma irradiation

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