dose and dosage form packaging technology slideshare introduction container type of container quality control

1. Presented by: suneel Kumar kurmi
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2.  Container and closure
 Quality control of container
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3.  PACKAGING
 Packaging is the science ,art and technology of enclosing or protecting
products for distribution , storage , sale and use
 Pharmaceutical packaging can be defined as the economical means of
providing presentation , protection ,identification , information ,
convenience , compliance , integrity and stability of the product
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4.  CONTAINER : A container masy be defined as a device in which the
drug is enclosed and is in direct contact with the drug
 CLOSURES:A closure is a device which seals the container to exclude
oxygen, carbon dioxide , moisture , micro-organisms and prevent the
loss of volatile substances
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5.  The containers can be classified into the following types.
 1. Well closed containers: A well closed containers is used to protect
the preparation from contamination by extraneous solids to prevent
the loss of potency of active constituents and to prevent the loss of
contents during transport, storage and handling.
 2. Air-tight containers: Air-tight containers are used to protect the
containers from atmospheric contamination of liquids, solids or
vapors. They prevent the drugs due to efflorescence, deliquescence or
evaporation.
 3. Hermetically-Sealed containers: Hermetically sealed container is
that which does not allow the air or other gases to pass through it.
They are generally used for injectables.
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6.  4. Light-resistant containers: Light resistant containers are used to protect
the drugs which undergo decomposition in the presence of light. For e.g
.Amber colored glass or opaque glass.
 5. Single dose containers: They are used to supply only one dose of the
medicament. They are sealed in such a way that the contents cannot be
removed without removing the seal; the contents so removed are
consumed immediately. e,g. ampoules.
 6. Multi dose containers: A multi dose container should hold a number of
doses. It is sealed in such a way that success doses can be withdrawn easily
without changing the strength, quality or purity of the remaining contents
e.g multi dose vials.
 7. Aerosol containers: Containers for aerosols must be strong enough to
withstand the pressure evolved inside the container at the time of use of
preparation.
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7.  1. Glass/Polyethene bottles
• Wide mouthed bottles are used for containing solid dosage forms like powder,
capsules, and tablets. To absorb the moisture sometimes silica-gel bags are given
inside the bottle.
• For low viscosity liquids e.g. gargles, mouth washes, mixtures, elixirs narrow
mouthed bottle is used. For high viscosity liquids or for suspensions wide-
mouthed bottles are used.
• Liquid preparations for external uses like lotion, liniments, paints etc. are supplied
in coloured fluted bottles in order to distinguish them from preparations meant for
internal use.
 2. Dropper bottles or drop containers: Eye drops, ear drops, nasal drops etc. should
be dispensed in amber colour glass bottles fitted with a dropper. Now- a-days
manufacturers prefer plastic drop containers. It is a single piece of squeezable
container having an in built dropper.
 3. Collapsible tubes: Ointments, pastes, gels are packed in plastic or metal
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8.  4. Ampoules: Ampoules are made of special type of neutral glass
having low m.p. so that it can be heat sealed at low temperature.
 5.Vials: Used for storing multi dose indictable preparation. The
needle is passed through the rubber closure, the drug is drawn
out. The rubber plug automatically seals the hole. Thus
contamination of bacteria is checked.
 6. Polyethene packets for infusion fluid: These flexible bags or
packets are made of PVC, polyethylene or polypropylene.
 7. Glass bottles for i.v. fluids: Previously glass bottles with big
rubber stoppers were used.
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10.  Metals are used for construction of containers. The metals commonly used
for this purpose are Aluminium, tin plated steel, stainless steel, tin and lead.
Advantages
1. They are sturdy.
2. They are impermeable to light, moisture and gases.
3. They can be made into rigid unbreakable containers by impact extrusion.
4. They are light in weight as compared to glass containers.
Disadvantages
1. They are expensive.
2. 2. They react with certain chemicals
3. 3. They may shed metal particles into the pharmaceutical product.
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11.  The collapsible metal tube is an attractive container that permits controlled amounts to be
dispensed easily, with good enclosure, and adequate protection of the product. It is light in
weight and unbreakable and lends itself to high speed automatic filling operations. Most
commonly used are tin, aluminium and lead.
TIN
 Advantages:
I. This metal is very resistant to chemical attack.
II. Readily coats a number of the metals e.g. tin-coated lead tubes combine the softness of lead
with the inertness of tin and for this reason it was formerly used for packaging fluoride
toothpaste.
 Disadvantage:
1. Tin is the most expensive metal among tin, lead, aluminium and iron.
 Uses:
1. Tin containers are preferred for foods, like milk powder containers are coated with tin.
2. Currently, some eye ointment still packaged in pure tin ointment tubes..
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12.  Advantages:
1. Aluminium is a light metal-hence the shipment cost of the product is less.
2. They provide attractiveness of tin at somewhat lower cost.
3. The surface of aluminium reacts with atmospheric oxygen to form a thin, tough, coherent,
transparent coating of oxide, of atomic thickness, which protects the metal from further
oxidation.
 Disadvantages:
1. Any substance that reacts with the oxide coating can cause corrosion e.g. products with the
oxide coating can cause corrosion e.g. products of high or low pH, some complexing agents
etc.
2. As a result of corrosion process H₂ may evolve.
 Uses:
 1. Aluminium ointment tubes.
 2. Screw caps
 3. Aluminium strips for strip-packaging of tablet, capsules etc. Sometimes internally lacquered
aluminium containers are used to stop the reaction with the content.
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13. Plastics may be defined as any group of substances, of natural or
synthetic origins, consisting chiefly of polymers of high molecular
weight that can be moulded into a shape or form by heat and
pressure.
 Advantages
1. They are light in weight than glass and can be handled easily.
2. They are poor conductor of heat.
3. They have sufficient mechanical strength.
4. They can be transported easily.
5. Extremely resistant to breakage.
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14.  Disadvantages
1. All are permeable to some degree to moisture, oxygen, carbon
dioxide etc.
2. Most exhibit electrostatic attraction.
3. Allow penetration of light rays unless pigmented black etc.
4. Poor printing, thermostatic charge.
5. They cannot withstand heat without softening distorting.
6. They may interact with certain chemical to cause softening or
distortion.
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15. Closures are the devices by means of which containers can be opened and closed.
Proper closing of the container is necessary because
-It prevents loss of material by spilling or volatilization.
- It avoids contamination of the product from dirt, microorganisms or insects.
- It prevents deterioration of the product from the effect of the environment such as
moisture, oxygen or carbon dioxide.
Material used for closures
The closures for containers meant for storage of pharmaceutical products are generally
made from the following basic materials.
✓ Cork
✓ Glass
✓ Plastic
✓ Metal
✓ Rubber
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16.  Cork: Cork is essentially a wood obtained from the bark of oak tree. It
is used for the manufacture of stoppers for narrow mouth bottles.
 Glass: As compared to cork glass is an ideal material for stoppers but
they do not provide leak proof closure as well as can easily slip out of
the neck of the closure during transport and handling.
 Plastic: As compared to cork, glass, rubber and metal Plastic closures
are becoming popular day by day as they are unbreakable, light in
weight and can be easily molded into various shapes and sizes.
 Metal: Tin plate and aluminum are mostly commonly used for the
manufacture of closures but aluminum is mostly used for this purpose.
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17. RUBBERS (Elastomers):
Excellent material for forming seals, used to form closures such as bungs
for vials or in similar applications such as gaskets in aerosol cans.
Categories of Rubbers:
Natural rubbers: Suitable for multiple use closures for injectable products
as rubber reseals after multiple insertion of needle.
Synthetic rubber: Have fewer additives and thus fewer extractable and
tends to experience less sorption of product ingredients.
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18.  Glass container
 Plastic container
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19.  1) CHEMICAL RESISTANT OF GLASS CONTAINERS
 A) POWDERED GLASS TEST:
 It is done to estimate the amount of alkali leached from the powdered
glass
 Procedure:
 10gm sample is added with 50ml of high purity water in a 250ml flask
 Place it in an autoclave at 121°C+2°C for 30min.
 Titrate immediately with 0.02N sulphuric acid using methyl red as an
indicator and record the volume.
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20.  This is only for treated soda lime glass containers .Principle involved is
whether the alkali leached or not from the surface of the container.
 Procedure:
 Fill each container to 90% of its overflow capacity with water and is
autoclaved at 121°C for 30min
 which is titrated with 0.02N sulphuric acid using methyl red as an
indicator.
 The volume of sulfuric acid consumed is the measure of the amount of
alkaline oxides present in the glass containers.
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21.  2) THERMAL SHOCK TEST:
 Place the samples in upright position in a tray.
 Immerse the tray into a hot water for a given time and transfers to cold
water bath, temp of both are closely controlled.
 Examine cracks or breaks before and after the test. •Small bottles withstand
a temp differential of 60 to 80°C and 1 pint bottle 30 to 40°C.A typical test
uses 45C temp difference between hot and cold water.
3)LEAKAGE TEST:
Drug filled container is placed in a container filled with coloured solution (due
to the addition of dye)which is at high pressure so that the coloured solution
enters the container if any cracks or any breakage is present.
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