glass and its importance in pharmacy containing evaluation test types of glass uses of glass etc.

1. GLASS
AND IT’S IMPORTANCE IN
PHARMACY
BY
AVISHEK SANYAL
3RD YEAR SEM-6TH ROLL-20801914026
BHARAT TECHNOLOGY

2. INTRODUCTION:
 Glass (a non-crystalline amorphous solid,
hard, brittle substance, typically transparent or
translucent, made by fusing sand with soda
and lime and cooling rapidly) was discovered
since 4500 BC plays an important role in our
daily lives, right from cookery, light sources to
high end technologies including
Pharmaceutical industries. It is usually
produced when the viscous molten material
cools very rapidly to below its glass transition
temperature.
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3. COMPOSITION OF GLASS:
Most glasses contain about 70-72% by weight of Silicon
dioxide (SiO2). The most common form of glass is Soda-lime
glass which contains nearly 30% sodium and calcium oxides
or carbonates. Pyrex is borosilicate glass containing about
10% boric oxide. Lead crystals is a form of lead glass that
contains a minimum of 24% of lead oxide.
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4. TYPES OF GLASS:
General Description Properties Suitability
Type I
Highly resistant,
Borosilicate glass
Alkanity is removed by
using Boric Oxide to
neutrilize the oxides of
Potassium and Sodium
Preparations for
parenteral administration.
Type II
Treated soda-lime Glass
Obtained by treating the
hot surface type III glass by
Sluphur Dioxide /
Ammonium Sulphate /
Ammonium Chloride
Preparation for parenteral
administration.
Type III
Soda-lime glass
It is an alkaline glass
having high.
Percentage of lime and
soda and no boric oxide as
compare to Type I glass
Not generally used for
parenteral preparationns
until and unless
indicated.
Type IV/ Type NP
General purpose
Soda-lime glass
It has similar compositions
to that of Type-III glass but
there is guarantee of
similar properties
Not for parenteral use.
Only for tablets, oral
solutions, external liquids
& ointments.
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5.  Highly resistance glass, a substantial part of
the alkali and earth cataions are replaced by
boron and/or aluminum and zinc.
 The addition of about 6% boron to form
borosilicate glass reduces the leaching
action, so that only 0.5 ppm is dissolved.
 Suitable for parenteral usage.
Type I Glass: Borosilicate Glass
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6. Type II Glass: Treated Soda-lime Glass
 This type of glass is formed by removal of
surface alkali by treatment with Silica.
 Sulfur di-oxide, ammonium sulfate or
ammonium chloride is used to prevent
“weathering” or “blooming”.
 The glass is treated with the above said
chemicals at an elevated temperature.
 This makes the surface resistant and the
alkali removed appears on surface as
blooms.
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7. Type III Glass: Soda-lime Glass
Containers are made of untreated
commercial soda-lime glass.
Chemical resistance is average or
better then average.
Suitable for storage of anhydrous
parenteral products.
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8. Type IV Glass/Type NP: General Purpose
Soda-lime Glass
 It is made up of plain soda-lime.
 Glass is not used for parenterals.
 Used only for products intended to
be used orally or topically.
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9.  Coloured glass is used to screen out
Ultraviolet rays and is thus effective
for protecting contents from light.
 Amber coloured glass and red
coloured glass is used for this
purpose.
Miscellaneous:
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10. EVALUATION PARAMETERS:-
A. Crushed Glass Test:
I. It is an official U.S.P test.
II. The container is crushed and sieved to produce
uniform particles of which a definite weight of taken.
III.The control of the particle size and weight of powder
ensures that a constant surface area is exposed to the
solution.
IV.The technique is tedious and is not applicable to
surface treated containers (sulphured or siliconed).
V. 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.
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11. B. Whole-Container test:
I. This test is official in European, British and International
Pharmacopoeias.
II. It is used in the USP for treated soda-lime containers only.
III. The containers are simply filled with the test solution and exposed to the
test conditions.
IV. Glassware may pass the whole container test more easily because the
surface layer of a container is smooth and less reactive.
V. 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.
Container
Surface area which supplies alkali
to each milliliter of the solution.
Ampoule (1 ml.) 5.9 cm2
Ampoule (10 ml.) 2.9 cm2
Bottle (1000 ml) 0.5 cm2
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12. C. Chemical resistance of test:
I. USP and IP provide two tests to determine
the chemical resistance of glass containers.
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
Table shows limits of alkalinity for glass containers
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13. D. Powerdered Glass Test:
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.
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14. E. Water Attack Test:
I. This test is used only with containers that have been
exposed to sulphur dioxide fumes under controlled
humidity conditions.
II. Such a treatment neutralizes the surface alkali.
III.It makes the glass chemically more resistant.
IV.The water attack test determines whether the alkali
leached form the surface of a container is within the
specified limits or not.
V. 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.
VI.Methyl red indicator is used to determine the end point.
VII.The basic is acid-base titration.
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15. W.H.O GUIDELINES
FOR QUALITY CONTROL OF PACKAGING MATERIALS
(GLASS):
 All the containers and closures intended for use shall comply with the
Pharmacopoeial and other specified requirements.
 Suitable sample sizes, specifications, test methods, cleansing procedures and
sterilization procedures shall be to suitability of packaging materials.
 All the containers and closure shall be rinsed prior to sterilization with water for
injection according to written procedure.
 The design of the closures, containers and stoppers shall be as such as to
make an airtight seal when fitted to the bottles.
 Individual containers of parenteral preparations, ophthalmic preparations shall
be examined against black or white background fitted with diffused light after
so as to ensure freedom from foreign matters.
 While using glass bottles, the written schedule of cleansing shall be laid down
and followed.
 It shall be ensured that containers and closures chosen for a particular
product do not affect the product adversely.
 Glass Bottles-
a) Shape and design of the glass bottle shall be rational and standardized.
b) Glass bottles made of USP Type-I and USP Type-II glass shall only be
ussed.
c) USP Type-III glass containers may be used for non-parenteral sterile
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16. ADVANTAGES OF GLASS:
 Economical.
 Readily available container of variety of sizes
and shapes.
 It has less Impermeability.
 It is useful due to Translucency.
 Strength and rigidity.
 It has FDA clearance.
 It does not deteriorate with age.
 Easy to clean.
 Effective closure and resolves are applicable.
 Coloured glass, especially amber, can give
protection against light when it is required.
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17. DISADVANTAGES OF GLASS:
 It’s main disadvantage is Fragility.
 It’s heavy weight is one of its disadvantage.
 Compatibility with the other ingredients is less
than others.
 High cost associated with glass re-cycling.
 Not all glasses can be re-cycled.
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18. REFERENCE:
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1. Nasa P. (2014). A Review on Pharmaceutical Packaging
Material. World Journal of Pharmaceutical Research, 3(5): 344-368.
Pillai S. A., ChobisA D., Urimi D. and Ravindra N. (2016).
2. Pharmaceutical Glass Interactions: A Review of
Possibilities. Journal of Pharmaceutical Sciences and Research, 8(2),
103-111.
3. Shivsharan U. S., Raut E.S. and Shaikh Z. M. (2014). Packaging of
Cosmetics: A Review. Journal of Pharmaceutical and Scientific
Innovation, 3(4), 286-293.
4. Donald C. Liebe, Packaging of Pharmaceutical Dosage Form,
Modern Pharmaceutics by G.S.Banker, Marcel Dekker, p 681-725.
5. C.P.Croce, A.Fischer & R.L.Thomas, Packaging material Science,
The theory & Practice of Industrial Pharmacy by Leon Lachman,
Third edition, p 711-732

19. A.S.026
Thank You