Transcript plastic - hcopgnt

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INTRODUCTION
GLASS
PLASTIC
CLOSURES
TAMPER RESISTANT PACKAGING
FDA REGULATIONS
Packaging materials are materials meant to enclose the
materials to be packed or to hold them together.
The materials selected must have the following properties.
 They must protect the preparation/formulation from
environmental conditions.
 They must not be reactive with the product.
 They must not impart any taste or odor to the product.
 They must be nontoxic.
 They must be FDA approved.
 They must meet applicable tamper resistant requirements.
Examples are Glass, Plastic, Aluminium, Copper, Cardboard.
Glass is commonly used in pharmaceutical packaging.
Composition of Glass
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Sand
Soda ash
Lime stone
Cullet
Common cations (Silicon, luminium,Boran,Sodium)
Anions (Oxygen)
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Borosilicate Glass(Type I)
Treated Soda lime Glass(Type II)
Regular Soda lime Glass(Type III)
General Purpose Soda lime Glass
Borosilicate Glass
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Highly resistant glass
In is type of glass with the main constituents are Silica
and Boron oxide.
It has strong hydrolytic resistance because of Boric oxide
Resist to thermal shock
It can able to withstand stress and not react with other
substances or parentral products
Mainly used to pack parentral products and Aerosols
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Used for oral dosage forms, aqueous, acid, neutral
solutions
It cannot be recycled
Not used for packing parentral products
It is not recommended for sulfur treatment.
Regular Soda lime Glass
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It has moderate and vulnerable hydrolytic resistance
Used for packing solid dosage forms or oily products or
oil dosage forms
Containers are untreated and made of commercial Soda
lime glass
General Purpose Soda lime Glass
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Containers supplied for non parentral products intended
for oral or topical use
Hydrolytic resistance Test
Fill the solution in glass tubes and place it in autoclave , increase
the temperature from 1000c to 1210c
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At 1210c keep it for 20 min
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Decrease the temperature from 1210c to 1000c for 40 min
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Then cool the container and the solution is collected in flask
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Add 0.15ml Methyl red and titrate against 0.01M Hydrochloric acid
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The end point is appearance of color
4% V/V of Hydrochloric acid is filled in the container
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Allow it to stand for 10 min
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After 10 min empty the container and wash it for 3 to 5
min
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After washing carry out Test 1
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Test 1 will give the result of Test 2 in 4% Hydrochloric
acid
10 ml of test solution + 10 ml of Nitric acid
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Keep it in water bath until it dry
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Dried residues are collected and further dried in oven at 1300c for 30 min and
cooled
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Then 10ml of Hydrazine – Moly Lead is added
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Keep it in Reflux condenser for 20min
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Note the absorbance at 840nm and compare with Hydrazine Moly Lead blank
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If Arsenic concentration exceeds 0.1 ml(10ppm) of Arsenic
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Arsenic Limit is allowed in glass
Wash the glass containers with purified water and crush
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3 parts of 100 gm each in the glass is taken
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The glass particles has to be passed through 10 mesh
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Using magnet remove Iron , Aluminium or other impurities
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Transfer this 100 ml into 250 ml conical flask
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Wash it with Acetone
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Dry it for 20 min at 1400c and cooled
Take 10gm from 250ml conical flask +50ml of purified water
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Take it into 250ml conical flask with Borosilicate beaker
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Place it in autoclave at 1210c
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Increase the temperature from 100 to 1210c for 19 t0 23 min
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1210c must be hold for 30 min
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It has to be reduced from 121 to 1000c in 38 to 42min ,cool
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Add 5 drops of Methyl red and titrate against 0.02N Sulfuric
acid
Water is taken into glass and autoclaved, watch it whether
it undergoes Weathering.
PLASTIC
Plastic is synthetic polymer or long chain of high molecular
polymers.
Constituents of Plastic
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Polymer
Residues associated with polymerisation process
Additives
• Impact Modifiers
• Lubricants
Processing aids
• Plasticizers
Antioxidants
• Stabilizers
Antistatic agents
Coloring agents
Thermoplastic - This type of plastic gets softened to viscous
fluid on heating and hardens again on cooling. The hardness
after cooling is influenced by the degree of cross linkage (or)
intramolecular attrition between the long chain molecules.
 Thermosetting – This type of plastic may become flexible but
does not become fluid on heating. They are generally hard
and brittle at room temperature because of a high degree of
cross linking.
 Polyethylene
 Polypropylene
 Polyvinylchloride
 Polystyrene
 Polymethylene
 Polycarbonate
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High density polyethylene is used in pharmaceutical industry.
It is good barrier against moisture, most solvents don’t attack on
polyethylene and is unaffected by strong acids and alkalies.
Polypropylene
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It does not stress, crack except for hot aromatic (or) halogenated
solvents which soften it.
It is resistant to all types of chemicals, strong acids, alkalies and
most of organic materials.
Excellent gas (or) vapour barrier.
Used for foil packages and for sterilizable products because it has
high melting point.
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It is crystal clear, stiff but has poor impact resistance at low
temperature.
PVC turns yellow when exposed to UV so add a stabilizer along
with resin supplies.
Excellent barrier for oil, both volatile and fixed alcohols and
petroleum solvents.
Causes liver cancer in persons exposed to vinyl chloride polymers.
Polystyrene
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Rigid , crystal clear plastic.
It has high water vapor transmission and high oxygen
permeability
Resistant to acids except strong oxidizing acids and alkalies.
Used to pack dry products only because it is cracked by many
chemicals
Permeation
 Permeation of water through plastic wall into drug creates
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problem to dosage form if it is sensitive to hydrolysis and
oxidation.
Temperature, humidity influence permeability of oxygen
and water through plastic
Leaching
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This problem arises in colored plastics. Coloring agents
migrate into ophthalmic (or) parentral solution cause toxic
effect cause drug contamination.
Sorption
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This process is removal of constituents from the drug
product by the packaging material.
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This effects the therapeutic efficacy of the preparation.
Sorption of low concentration preservatives causes
microbial growth .
Chemical Reactivity
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Certain ingredients in plastic formulation react with drug
components chemically. At times ingredients in
formulation react with plastic. This alter the appearance of
plastic (or) drug product.
Modification
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The physical and chemical alteration of packaging material
by drug product is modification.
Closures
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A closure must prevent the contents from escaping and
allow no substance to enter the container.
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Screw –on, threaded (or) lug closure
Crimp –on (Crowns)
Press –on (Snap)
Roll –on
Friction
Screw Cap
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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 performed (or) in
some instances, rolled on after application.
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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.
Snap On
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Some closures snap on. For opening,
the top is designed to pry off (or) break off
(or) have a built in dispenser.
Roll on Closures
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It has aluminum (or) light gauge metal.
Resealable, non resealable and pilferproof types of roll on closures
are used for both glass and plastic.
• This extends below the threaded
portion to form a bank fastened to
basic cap by a series of narrow metal
bridges.
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.
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FDA defined Tamper resistant package is one having an
indicator (or) barrier to entry which if breached (or) missing,
can reasonably be expected to provide visible evidence to
consumers that tampering has occurred.
Film Wrapper
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It is for products requiring package integrity (or)
environmental protection.
End Folded Wrapper
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Formed by pushing the product the
into sheet of overlapping film which
forms the film around the product
and folds the edges in a gift wrap
fashion.
• The seals are formed by crimping the
film together and sealing together, the
two inside surfaces of film producing a
“fin” seal.
Shrink Wrapper
• In this shrink film is used in roll form
with centre fold the sheet into which
product is inserted.
• An L-Shaped sealer seals the overwrap
and trims extra film.
Blister Package
• It is formed by heat softening a sheet of
thermoplastic resin and vacuum drawing
the softened sheet of plastic into a
contoured mold.
• It is formed by feeding two cubes
of heat sealable flexible film
through either a heated crimping
roller (or) a heated reciprocating
plate.
Bubble Pack
• Formed by sand witching the
product between a thermo
formable, extensible (or) heat
shrinkable plastic film and a rigid
backing material.
• If heat shrinkable material is used
pass through heated tunnel this
shrinks the film into bubble (or)
skin over the product.
• It uses heat shrinking polymer like
pvc. It is manufactured as oriented
tube with larger cap and neck ring of
the bottle is to be sealed.
Foil, paper (or) Plastic Pouches
• In VERTICAL OPERATION a web
of film is drawn over a metal collar
and around a vertical filling tube
through which product is dropped
into formed package.
Horizontal System
• It is for small volume products in
this web of film is folded upon itself
rather than tube.
• The inner seal is inserted in the bottle
cap and held in over the permanent cap
lines by friction fit into the cap (or) a
application of wax, this temporarily
adheres the seal to cap liner.
Tape Seals
• Involves the application of glue (or)
Pressure sensitive tape (or) label over
Closure package. The paper used must be
high density light weight paper.
Breakable Caps
• The cap blank is held on the bottle
Under pressure while rollers crimp and
Contour the bottle thread into cap blank.
The bottom portion of cap is
rolled around.
• Tubes are made of
polypropylene (or) polyethylene.
For high barrier packaging metal
(or) laminated tubes are used.
Aerosol Containers
• A hydrocarbon propellant in its
cooled liquid phase is added to
container along with product and
a spray nozzle contained in a
gasketed
Metal ferrule is crimped over the
opening of aerosol container.
Sealed Cartons
• The closure of folding cartons is
accomplished by many ways by
use of “tuck end” design.
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It evaluates that specific drug preserve drug’s efficacy as
well as it’s purity, identity, strength and quality for its
entire life.
Under Federal Food, Drug and Cosmetic Act it is
responsible of manufacturer to get approval of packaging
material safety before using it.
A list of substances “Generally Recognized As Safe “
(GRAS) has been published by the FDA.
The drug manufacturer must include data on container
and package components in contact with pharmaceutical
product in its “New Drug Application “ (NDA).
If FDA determine drug is safe and effective then that
package is suitable it approves drug and package.
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The Theory and Practice of Industrial Pharmacy –
LACHMAN
Pharmaceutical Dosage Forms – AULTON
Packaging materials - Wikipedia