Ophthalmic products are specialized dosage forms designed for administration to or around the eye. Common types include eye drops, ointments, gels and contact lens solutions. Plastic bottles made of materials like LDPE are widely used for packaging as they are easy to use and reduce spillage compared to older glass bottles. Parenteral products must be exceptionally pure and free from contamination due to direct injection. Common containers include glass vials, syringes and plastic bags or bottles. Rubber stoppers and seals are often used for closures. Proper packaging and container selection is important to prevent issues like permeation, leaching or sorption which could impact drug stability or purity. A variety of tests exist to check package

2. Name Reg. no.

3. Name Reg. no.

4. Joyanta kundu
08103074

5. Ophthalmic
preparations are
specialized dosage
forms designed to be
instilled onto the
external surface of
the eye, administered
inside or adjacent to
the eye or used in
conjunction with an
ophthalmic device.

6. Ophthalmic products are used:
 For the treatment of eye diseases.
 For the relief of symptoms associated with
eye diseases.
 For diagnosis purposes.
 As adjuncts ophthalmic surgical procedures.

7. Ophthalmic products have several types. Such
as – eye drops, eye lotions, eye ointments,
eye creams, eye gels, contact lens solutions,
parenteral products, ophthalmic inserts and
powders.

8.  Currently almost all commercially available
ophthalmic products are packaged in plastic
containers. Obvious advantages-ease of use, less
spillage, little breakage- have led to universal
acceptance of these plastic packaging
components, consisting of bottles, fitment and
closures. Alcon was the first company to
introduce these packaging components, identified
as a “Drop-Tainer” for ophthalmic products, in
the late 1940s and saw them adopted by the
industry as the standard for packaging topical
ophthalmic products.

9.  The plastic bottles for packaging of
ophthalmic products are generally made of
Low Density Polyethylene(LDPE), either with
or without any colorants or with opacifying
agents. Polypropylene(PP) or high density
polyethylene(HDPE) are also used to meet
specific product requirements.

10. Eye
drops(Single-
dose containers):
Plastic
bottles(LDPE) are
widely used.

11. Eye drops(Multiple-
dose containers):
Traditionally, glass
bottles with rubber
teat dropper were
widely used. Now-
a-days, plastic
bottles(LDPE) are
widely used.

12. Eye ointments:
Flexible plastic
or collapsible
metal tubes are
used.

13.  Caps or closures
are generally
made from
Polypropylene(PP)
and basically seal
the container to
prevent
contamination or
leakage of the
product.

14. Color Pharmaceutical Class
Yellow or Blue Beta-Blockers
Grey Non-Steroids
Pink Steroids
Brown or Tan Anti-Infectives
Orange Carbonic anhydrase inhibitors
Turquoise Prostaglandins
Red Mydriatics
Green Miotics

15.  Plastic containers have sorption and permeability
characteristics. Volatile ingredients such as the
chlorobutanol and phenylethyl alcohol can
migrate into the plastic and eventually permeate
through the walls of the container. The sorption
and permeation can be detected by stability
studies if they are significant. To overcome
permeation problems employ a secondary
package, such as a peel-apart blister or pouch
composed of nonpermeable materials (e.g.,
aluminum foil or vinyl).

17.  Neutral,Boro-silicate type glass(Type 1 glass)
were widely used as a container for
ophthalmic preparations, but glass containers
are not widely used now which has been
replaced by plastic containers(more
commonly known as Drop-Tainers).

19.  Parenteral dosage forms differ from all other dosage
forms because they are injected directly into body tissue
through the primary protective system of the human
body, the skin and the mucous membranes. They must
be exceptionally pure and free from physical, chemical
and biological contaminants. These requirements place a
heavy responsibility on the pharmaceutical industry to
practice current good manufacturing practices(cGMPs) in
the manufacture and packaging of parenteral dosage
forms and upon pharmacists and other health care
professionals to practice good aceptic practices(GAPs) in
dispensing them for administration to patients.

20.  Injectable formulations are
packaged into containers
made of glass or plastic.
Container systems include
ampoules, vials, syringes,
cartridges, bottles and bags.
Ampoules are all glass while
bags are all plastic. The
other containers can be
composed of either glass or
plastic and must include
rubber materials such as
rubber stoppers for vials
and bottles, rubber plungers
and rubber seals for
syringes and cartridges.

21. • Glass
Glass is employed as the container material
of choice for most SVIs. It is composed
principally of silicon dioxide, with varying
amounts of other oxides such as sodium,
potassium, calcium, magnesium, aluminum,
boron and iron. Boric oxide will enter into the
basic structure of glass formed by silicone oxide
and persist as loosely bound, so thereby
relatively free to migrate. These migratory oxides
may be leached into a solution in contact with
the glass.

22. • According to USP there are four types of glass used as containers. They are-
Type 1, neutral, a borosilicate glass
Type 2, treated soda lime glass
Type 3, regular soda lime glass or soda lime glass of limited alkalinity.
Type 4, a soda lime glass not suitable for containers for parenterals.
Type 1 glass is suitable for all products as it has the highest resistance to
leachables, permeation and adsorption. It also has a low thermal co-efficient of
expansion. Sometimes sulfur dioxide treatment is used for even greater resistance
to leachables. Schott has developed a technology called Plasma Impulse Chemical
Vapour Deposition(PICVD) that coats the inner surface of of type 1 glass vials with
an ultrathin film of silicon dioxide. This film forms a highly efficient diffusion
barrier that practically eliminates glass leachables.
Type 2 glass may be suitable for, for example, for a solution that is buffered, has a
pH below 7, or it is not reactive with the glass.
Type 3 glass will be suitable principally for anhydrous liquids or dry substances.
The glass types are determined by two USP tests. (1)powdered glass test (2)water
attack test .
Type 4 is not used for parenteral purpose.

23. Glass Leaching Potential Permeati Potential Adsorpti
Type Extent Leachabl on Agents on
es Extent (selectiv
e) Extent
Type 1 1 Alkaline 0 N/A 2
earth and
heavy
metal
oxides
Type 2 5 Alkaline 0 N/A 2
earth and
heavy
metal
oxides

24.  Thermoplastic polymers have been established as
packaging materials for sterile preparations such as
large-volume parenterals, ophthalmic solutions and
increasingly, small-volume parenterals. For such use
to be acceptable , a thorough understanding of the
characteristics, potential problems and advantages for
use must be developed. Three principal problem areas
exist in using these materials:
1. Permeation of vapours and other molecules in
either direction through the wall of the plastic
container.
2. Leaching of constituents from the container to the
product.
3. Sorption(absorption and/or adsorption) of drug
molecules or ions on the plastic materials.

25.  Permeation, the most extensive problem, may be
troublesome by permitting volatile constituents, water or
specific drug molecules to migrate through the wall of the
container to the outside. This problem have been resolved,
for example, by the use of an overwrap in the packaging of
IV solutions in PVC bags to prevent the loss of water during
storage. Leaching may be a problem when certain
constituent in the plastic formulation , such as plasticizers
or antioxidants migrate into the product. Sorption may be a
problem in selective basis, that is, sorption of a few drug
molecules occurs on specific polymers, for example,
sorption of insulin and other protien, Vitamin A acetate etc
has been shown to occur on PVC bags when these drugs
were present as additives in IV admixtures.
 A brief summary of some of these compatibility
relationships is given below:

26. Plastic Leaching Potential Permeati Potential Adsorpti
Polymers extent leachabl on agents on(select
es extent ive)
LDPE 2 Plasticizer 5 Gases, extent
2
s, water
antioxidan vapors.
ts
HDPE 1 antioxidan 3 Gases, 2
ts water
vapors.
PVC 4 HCl, 5 Gases, 2
specially water
plasticizer vapors.
s.
Polyolefins 2 Antioxida 2 Gases, 2
nts water
vapors.
Polypropyl 2 Lubricants 4 Gases, 1
ene water
vapors.

27. PVC large volume IV PVC small volume IV
infusion bag infusion bag

28.  Ampoules
A parenteral product container made
entirely of glass and intended for
single use.
The ampoules can be broken at the
neck restriction either by scoring
or by having a ceramic point (ring
or spot) baked on during the
manufacture thus causing a weak
point. However breaking on the
ceramic point can cause colored
particles to fall into the
product.this led to an alternative
where the the ampoule is scored
and then has a colored ring above
or below the score to indicate the
break point( one point cut/open
point cut method).

29.  A glass or plastic
container closed with
a rubber stopper and
sealed with an
aluminum crimp.
Vials are available for
single
dosing or for multiple
dosing. Injection vials
can be obtained in
either neutral or soda
glass and occasionally
in treated soda glass.

30. Type 1 Glass Vial for multi
HDPE Plastic Vials
dosing purpose

31. Syringes are devices for injecting,
withdrawing or instilling fluids.
Syringes consists of a glass or
plastic barrel with a tight fitting
plunger at one end, a small opening
at the other end ac-comodates the
head of a needle. Needle Gauge is
the outside diameter of the needle
shaft; the larger the number, the
smaller the diameter. Gauges in
common use range from 13 (largest
diameter) to 27. Subcutaneous
injections usually require a 24-
gauge or 25-gauge needle.
Intramuscular injections require a
needle with a gauge between 19
and 22. Needles between 18 gauge
and 20 gauge are commonly used
for compounding parenterals.

32. Disposable plastic syringe Disposable glass syringe

33.  Prefilled Syringe: is a ready-to-use prefilled
medication syringe with a needle attached, as
with Insulin syringes, Interferon and some
emergency drugs. As the pharmaceutical
industry continues to seek out drug delivery
methods that improve safety and efficiency
while reducing costs, the traditional multidose
or single-dose vial format for vaccines and
injectables is starting to show its age.
Developed markets are increasingly turning to
packaging vaccines in prefilled, single-use
syringes, with more and more companies
recognising the benefits that come from this
area's innovations. Prefilled syringes have been
used to delivery drug categories like vaccines,
therapeutic proteins, blood stimulants,
erythroproteins and more.
 "Syringes made from plastic-based cyclopoly
olefin (COP) resin are becoming more common."
 Advantages:
 contamination prevention
 ease of use and dosages

34.  Cartridges are an ideal packaging
for insulin and other drugs. They are
used with pen or pump systems,
auto injectors and needle free
injectors.
 The magnetic plungerless injection
system is a hand held apparatus
with a magnetically driven piston
capable of displacing, moving and
transferring liquid or gas through a
cartridge chamber and into a sterile
needle for injections. This apparatus
works on the that a magnetic field
penetrates glass and plastic walls of
the cartridge. A magnet located
outside of the cartridge walls and a
Ferrous piston positioned inside of
the cartridge create strong coupling
with the piston repeating the
movements of the magnet.
Movement of the piston in one
direction generates insertion of
liquids and movement in the other
direction generates extraction.

35.  Rubber based closures are
effective in sealing provided
there is adequate
compression of the rubber.
Over compression, disc type
seals and relatively shallow
stoppers may cause the
materials to distort, ruck at
the flunge, etc. and thereby
causing loss of closure
efficiency.
 Rubber stoppers are used as
closures in IV
solutions(ampoules, vials,
large volume parenteral
containers), cartridge tubes
and prefilled syringes.

36.  There are a number of
rubbers that may be used
in pharmaceutical
packing. Butyl rubber and
chlorobutyl rubbers have
the majority share of
parenteral closure market.
These materials offer the
best resistance to
permeation by oxygen
and water vapor. Silicone
rubbers have limited
applications in
pharmaceuticals as they
are prone to tearing.

37. Test Basic Principle Advantages Disadvantages
Acoustic Ultrasonic Visualize Expensive,
Imaging energy focused delamination Requires
onto sample experts, not for
submerged in porous
water . Echo materials.
patterns
produce images.
Bubble test Submerge Simple, Relatively
package in inexpensive, insensitive.
liquid, location of leaks
pressurize and/ can be
or temperature observed.
cycling to
accelerate
leakage.

38. Test Basic Principle Advantages Disadvantages
Helium mass Helium is placed Inert gas, Expensive,
spectometry either inside or extremely expert
outside of the sensitive test personnel is
container and required.
migration of
helium is
detected by
mass
spectometry.
High Voltage High voltage is 100% automatic Requires liquid
Leak applied to inspection, non fill products.
Detection(HVLD) sealed container destructive.Used
, increase in for ampoules,
conductivity vials, syringes,
correlated to blow/fill/seal
presence of containers.
liquid along the
seal.

39. Tests Basic Principle Advantages Disadvantages
Residual Gas High voltage Used for Inconsistencies
Ionization Test field is applied Lyophilized in result.
to vials sealed products.
under vaccum.
The field causes
residual gas to
glow.
Liquid Tracer Packaged Operator Destructive,
Tests immersed in independent, Large sample
solution of inexpensive numbers need.
tracer chemical
or dye.
Pressure/vaccu
m or temp.
cycling used to
improve
sensitivity.
Leakage
detected visually
or mechanically

40. 1.Remington, The Science and Practice of
Pharmacy, 21st Edition, Volume 1, Chapter 41,
Page 802-836.
2.MANAGEMENT SCİENCE AND
ENGİNEERİNG
Vol. 4, No. 3, 2010, pp.
138-143,www.cscanada.org