container and closures

1. By
Trisha Das (18HMPA05)
Pharmaceutical manufacturing technology
Pharmaceutical analysis and Quality assurance
Himalayan Pharmacy Institute

2.  Container is defined as a
object that can be used to
hold or transport something.
 Pharmaceutical container is a
device that hold the
pharmaceutical product and it
may or may not be in direct
contact with it.

3.  Well closed container  Single dose container

4.  Light resistant container Multi dose container

5.  Aerosol container Air tight container

6.  Closures are devices and
techniques used to close or
seal container such as
a bottle, jug, jar, tube, can
etc.
 Closures can be
a cap, cover, lid, plug, etc.

7. Screw top
 A screw closure is a mechanical
device which is screwed on and
off of a threaded "finish" on a
container.
 Either continuous threads or lugs
are used.
 Metal caps can be either
preformed or in some instances,
rolled on after application.
 Plastic caps may use several types
of molded polymer.

8. Crown cap
 Beverage bottles are
frequently closed with
crown beverage caps.
 These are shallow metal
caps that are crimped into
locking position around
the head of the bottle.

9. Snap on
Some closures snap on.
For opening, the top is
designed to pry off or,
break off, or have a built
in dispenser.
Spray bottle
 A spray bottle is a bottle that
can dispense, squirt, spray or
mist fluids.
 A common use for spray bottles
is dispensing cool cleaners,
cosmetics, and chemical
specialties.

10. Child-resistant
 Child-resistant packaging
has special closures
designed to reduce the risk
of children ingesting
dangerous items.
 This is often accomplished
by the use of a special
safety cap.
 It is required by regulation
for prescription drugs, over-
the-counter medications,
pesticides, and household
chemicals.
Friction fit
 Some containers have a
loose lid for a closure.
 Laboratory glassware often
has ground glass joints that
allow the pieces to be fitted
together easily.
 An Interference fit or
friction fit requires some
force to close and open,
providing additional
security.
 Paint cans often have a
friction fit plug.

11.  Tamper-evident
Resistance to tampering is required for some types
of products. Container closures can be one of
several layers of packaging to deter tampering and
to provide evidence of attempts at tampering.
Sometimes tamper resistance is obtained by or
integral with the closure.

12. There are various evaluation tests for assuring the
quality of glass:
 Crushed glass test
 Whole container test
 Chemical resistant test
 Powdered glass test
 Water attack test

13.  The container is crushed and sieved to produce uniform particles of which a
definite weight of taken.
 The control of the particle size and weight of powder ensures that a constant
surface area is exposed to the solution. Because all of the glass (not just the
surface layer) is examined and extraction is enhanced by the rough surfaces of
the particles, this is a severe test, and, if a glass passes, it is unlikely that
containers made from it will give trouble while in use.
 Nevertheless, the technique is tedious and is not applicable to surface treated
containers because crushing would expose the alkaline glass below the surface.
 This test can be used for determining the nature of a glass or for distinguish
between two types of glasses, such as neutral or surface – treated.

14.  The containers are filled with the test solution and
exposed to the test conditions. Glassware may
pass the whole container test more easily because
the surface layer of a container is smooth and less
reactive.
 In this test, surface area does not increase as
much as volume with the increase in container
size, consequently, the small sized containers are
more attacked by the leaching of the alkali from
the surface.

15. Container Surface area which supplies
alkali to each mili liter of the
solution.
Ampoule (1 ml.) 5.9 cm2
Ampoule (10 ml.) 2.9 cm2
Bottle (1000 ml) 0.5 cm2

16. Tests Containers
Limits ml of 0.02 N
H2so4
1. Powdered Glass Test
Type I
Type III
Type NP
1.0
8.5
15.0
2. Water Attack Test
type II (100ml of less)
type II (over 100ml)
0.7
0.2
USP and IP provide two tests to determine the chemical resistance of glass
containers.
Table shows limits of alkalinity for glass containers:-

17.  From the glass containers, alkaline constituents (oxides of sodium,
potassium, calcium, aluminium, etc.) are leached into purified water under
conditions of elevated temperatures.
 When the glass is powdered the leaching of alkali can be enhanced in the
powdered is critical.
 The principle involved in the powdered glass test in estimate the amount of
alkali leached form the glass powder.
 The amount of acid that is necessary to neutralize the released alkali (a
specified limit) is specified in the pharmacopoeia.
 The basic analysis is acid-base titration using methyl red indicator.

18.  This test is used only with containers that have been exposed to sulphur dioxide
fumes under controlled humidity conditions. Such a treatment neutralizes the
surface alkali. Now the glass becomes chemically more resistant.
 The principle involved in the water attack test is to determine whether the alkali
leached form the surface of a container is within the specified limits or not. Since
the inner surface is under test entire container (ampoule) has to be used.
 The amount of acid that is necessary to neutralize the released alkali from the
surface is estimated, the leaching of alkali is accelerated using elevated
temperature for a specified time. Methyl red indicator is used to determine the
end point. The basic is acid-base titration.

19. 1. Container and closure, INDIAN PHARMACOPOEIA 1996, Volume-I
(A-O), Page no. 130, Published by the controller of publications,
Delhi.
2. https://en.wikipedia.org/wiki/Closure_(container)
3. https://www.slideshare.net/rohillarajat/containers-closures
4. https://www.slideshare.net/PrincyAgarwal6/pharmaceutical-
containers-and-closures-an-overview
5. https://hmc.usp.org/sites/default/files/documents/HMC/GCs-
Pdfs/c671.pdf
6. https://www.pharmatutor.org/articles/quality-control-testing-
packaging-materials?page=1%2C4