2.  Defn :-
Art & science of enclosing protecting
products for distn, storage, sale & use.
 Package label- Written, electronic or graphic
on packaging or separate but associated label
 Recognition of product
 Packaging drug regulations

3.  Physical protection eg. Shock, vibration
 Barrier protection eg. O2, light
 Containment eg. 10*10 packs
 Information trasmission eg. Direction
 Marketing potential
 Security eg. Antithept seal,
 Convenience eg. Distribution, handling, sale
 Portion control eg. Single dosage pack

4.  Packaging material that is in intimate
contact with product
 First envelopes & holds product
 Smallest unit of distribution
eg. Aerosol can, wrappers, bottle, envelope
 It should be inert (no leaching, absorption or
adsorption, etc.)
 Should withstand mfg. condition eg. Freezing

5.  Packaging material outside the primary
packaging
 Perhaps used to group primary packaging
eg. Boxes, cartons, shrink-wrap, etc.
 Should protect from excessive
moisture, light, reactive
gases, microbes, etc.
 Protection to flexible container
 Ease in handling

6.  Used for bulk handling and shipping eg.
Barrel, crate, Slip sheet, etc.

7.  Container: refers to storage media in which
product is placed or enclosed. Glass, Plastic
 Closure: tightly packs container to exclude
O2, CO2, moisture and micro-organisms &
prevent loss of water and volatile substances
from product. Rubber, aluminum

8.  Carton: Outer covering which gives sec.
protection against mech. & environmental
hazards also display written information
Cardboard, molded wood pulp, expanded polystyrene
 Box: Prim. defence against ext. hazards
provide containment, absorbs shocks.
Cardboard, wood

9. Container Closure Carton

10.  Prevents contents from escaping and allow no
substance to enter the container
 Resiliency of liner, flatness of sealing surface &
tightness of seal
 Closure designs:
 Threaded screw cap- Engage threads in corresponding
threads molded on neck of bottle
 Crimp on (crown)- Used for beverage bottles
 Press on(snap)- Cap pressed to seal
 Roll on- Seals securely, opened
easily, specific, available as reselable, nonresealable
& pliferproof
 Friction design

11.  Material inserted  Selection factors
in a cap to effect  Compatibility
a seal between  Appearance
closure &container  Gas Transmission
usually made of  Heat resistance
resilient backing &  Shelf life
facing material  Economic
(soft & elastic)
 Types
 Homogenous
 Heterogeneous

12.  Well closed Container:
Protects from extraneous solids & loss of
article under ordinary or customary
conditions of handling, shipment, storage &
distribution
 Tight Container:
Protects from contamination by
extraneous material, prevents loss of by
vaporization, efflorescence, deliquescence
under ordinary or customary conditions of
handling, shipment, storage & distribution
and capable of tight re-closure.

13.  Hermetic Container:
Impervious to air or any other gas under
ordinary…
 Light Resistant Containers…

14.  Package having indicator or barrier to entry
which if breached or missing provides
evidence of tampering.
 It may involve immediate container/closure
system or Sec. container/carton system
 It was introduced to avoid adulteration of
product
 Eg. Film wrappers, Blister packages, Strip
Package, Bubble packs, Shrink Seal, Aerosol
container

15.  Wrapper Strip
 Aerosol
Blister

16.  Film Wrapper
 End folded wrapper-
Cellophane,PVDC, nitrocellulose
 Fin seal- Crimping
 Shrink Seal- PE, PP, PVC
 Blister Package
 Heat softened sheet of thermoplastic resin &
vacuum drawing of sheet in contoured moulds-
PVC, PVC/PE, PP, polystyrene,
 Push through backing- Heat seal coated Al-foil
 Peelable backing-polyester or paper

17.  Strip Package
 Formed by feeding 2 webs of heat sealable
flexible film thr’ heated crimping roller &
product is dropped into pocket formed prior to
forming final seal.
 Cellophane, PE, PVC, etc.
 Shrink Banding
 Heat shrinkable polymer slightly larger in
diameter than cap and neck ring of bottle
 Bottle is moved thr’ a heat tunnel which shrinks
tubing material tightly to engage cap & neck

18.  Aerosol
 HC propellant in its cooled liquid phase added to
drawn Al-container along with product and spray
nozzle contained in gasketted metal ferrule
crimmped over opening of container
 Other Temper Resistant Packagings
 Bubble pack
 Breakable caps
 Sealed Tubes
 Sealed Cartons

19.  Pilferproof packaging has a closure with
greater skirt length which extends below
threaded portion to form a bank.
 It has several narrow metal “bridges”
 When pilferproof closure is removed bridges
break and bank remains in place on the neck
of container
 User can reseal closure but detached band
indicates package has been opened
 Torque required to break bridge is nominal

21.  To avoid cases of poisoning
 Reduce risk of accidental
ingestion medication
 Safety cap provided for
prescription drug, OTC
medicine, pesticide, etc.

23.  Supercooled liquid of viscosity greater than
1013 poise which is composed of SiO2 (65-75%)
tetrahedron modified with oxides of metal
cations
 Monovalent cations- M.P. of glass but also
reduce strength eg. Na, K, B
 Divalent Cations- gives mech. strength and
chem. resistance eg. CaO, MgO
 Trivalent Cations- chem. durability &
mech. Strength eg. B2O3, Al2O3

24.  Advantages  Disadvantages
 Impermeable  Leaching
 Inert  Fragility
 Transparent  Flaking
 Inexpensive  Heavy wt.
 Withstand high  Light trasmission
temp-pressure
 Easy to clean
 No absorption of
active

25.  Glass
Type Description Use
I Highly resistant For aqueous solution
borosilicate (neutral glass)
II Surface treated soda lime For Aq. Soln, dry
glass powders, oily solutions
III Sodalime glass For dry powders, oily
(Regular) solutions
IV Nonparenteral glass (NP) NP use
 Flint glass- Colorless glass
 Amber colored glass/Nonactinic- Iron & MnO2
 Siliconized glass- avoids sticking of oily formulation

26.  Powdered Glass Test (Crushed Glass Test)
 Digest borosilicate flask 121C for 60 min
 Crush 6 Containers Sieving 10gm powder
40/50# + 50ml high
121 C
Decant & titrate 30 min purity water
solution with 0.02N H2SO4
Indicator Methyl red
Similarly blank
 Limits:
 Type I = 1.0ml, Type III = 8.5ml, NP= 15.0ml

27.  Water Attack Test for Type II glass
 3 containers filled 90% of overflow capacity
High
Purity
Water
 Autoclaving at 121 C for 30 min
 100 ml of combined extract titrated with
0.02N H2SO4
 Capacity 100ml or less = 0.7 ml H2SO4
 Capacity over 100ml = 0.2 ml H2SO4

28.  Plastics are made of polymer and additives
like plasticizer, antioxidant, antistat
agent, fillers, lubricant, etc.
 Additives are not chemically bound hence
can migrate into product
Material Use
PE, PP IV infusion container
HDPE, PP, PS Disposible syringes
Polypropylene IPP) Dialysis fluid &
irrigation solution
container

29.  Advantages
 Light Weight, Inexpensive, Nonbreakable
 Disadvantages
 Leaching of plastic additives
 Sorption of API
 Permeation of water vapours or gas
 Loss of volatile components
 Softening of plastic material during autoclaving
 Chemical reactivity

30.  Physicochemical Tests
 Aq. Extract tested for nonvoalatile
residue, residue on ignition, heavy
metals, buffering capacity
 Biological Reactivity Tests
 In vitro Test- Extract placed in contact with
mammalian cells to check to toxicity
 In Vivo Test-
 Systemic Injection Test- Mice
 Intracutaneous Inj. Test- Rabbit
 Implantation Test & Eye Irritaion Test- Rabbit

31.  Rubber is generally used as elastomeric
closure for vial infusion bottles & cartridges
 Soft & elastic nature permits needle
insertion
 Resilient- Seal integrity maintained
 Autoclavable

32.  Composed of
 Polymer (elastomer)-
 Vulcanising Agent- cross linking eg.sulphur
 Accelerator- reduce sulphur requirement & time
for vulcanization eg. MBT
 Activator- Activity of accelerator
 Filler- carbon black, talc
 Antioxidant- Prevents oxidatn of elastomer
 Lubricant- Mould release eg.Talc
 Softner- Plasticity eg. Mineral oil

33.  Types of Rubber
 Natural- Haevea brazilensis high preservative
uptake
 Grey butyl-Polyisobutyl-Low permeability & low
preservative uptake
 Nitrile- Butadiene acrylonitrile Oil resistant
 Silicone Rubber- Heat resistant & high uptake

34.  Advantages  Disadvantages
 Softness allows  Permeation
needle insertion  Leaching
 Resilence maintains  Sorption
sterility  Loss of volatile
 Elasticity allows component
perfect fit

35.  Physico Chemical Testing
 Extract of Rubber is prepared and tested for
total extractable, heavy metals, pH
change, turbidity, reducing agents
 Biological Testing
 In Vitro Test: on mammalian cells direect contact
test
 In Vivo Test:
Systemic Injection Test- Mice
Intracutaneous Inj. Test- Rabbits

36.  Apperance
 Closures must be free from
dust, fibres, pigments, oily pathces, etc.
 Tackiness
 Closures washed several times with
detergent and autoclaved at 121C in dist.
Water for 30 min. It should not become
tacky

37.  Penetrability
 Closure fixed to vial and force required to
penetrate it measured. It should not exceed in
house limits.
 Self Sealability
 Half filled vial with methylene blue, then 25
needle punctures made in 5mm circle
diameter
 Vials then inverted in water there should not
be leakage of coloured solution

38.  Fragmentation
 20 closures selected randomly, 5 times
needle penetrated in specific area
 Needle washed with water to collect
fragments
 Fragments NMT 3 per closure
 Permeability to water vapours
 Anhydrous CaCl2 placed in vial, kept it in
high humidity conditions, measure wt. gain

39.  Metals used as packaging material for
creams, aerosols, beverages, etc.
 Metals can be moulded as collapsible
tubes, beverage cans, aerosol
containers, etc.
 The mechanical strength provided by metal
containers is advantageous.
 Leaching of metals into products may cause
catalytic oxidation of product
 Its chemical reactivity may form
pharmacologically inert, less active or toxic
cpmpounds

40. Material Use
Tin Foods, pharmaceuticals,
Aerosol
Aluminium Collapsible tubes, foil packing,
Aerosol
Lead Non food products like inks
paints, lubricants
Stainless Aerosol containers
steel

41.  Gen. Properties  Disadvantages
 Strong(Nonbrekabl)  Leaching (Attcked
 Opaque by acids & alkalis)
 Mouldable to any  Sorption
shape  Corrosion
 Withstand high
temp-pressure
 Impermeable to
moisture, microbes,
gases, light, etc.

42.  Cans, pails, boxes.
 Closures
 Aluminium foil, laminate, labels
 Barrels, kegs, drums
 Crates
 Metal bandings

43.  Cellulose from gettable fibres (Pulp)
 Lignin, cerin removed by chemical process
 Fillers, coloring agents, etc. added
 Properties
 Low cost, nontoxic, renewable
 Strength depends on moisture content
 Readily printable
 Poor transperancy & gloss comparative to plastic
 Can’t be sealed unless coated