Glass : An Overview
When
considered as a material, glass is a collective term for an unlimited`
number of materials of different compositions in a glassy state.
Glassy materials can also occur naturally. For example, obsidian,
often found in volcanic areas, has a composition comparable to man-made
glass. It consists of sand, and sodium and calcium compounds; and
it was fashioned into knives, arrowheads, spearheads, and other
weapons in ancient times. Natural glass in the form of obsidian
was in high demand in this region as an object of trade. The Aztecs
in Mexico were also familiar with obsidian and created religious
and household items from it.
Slowly
the usability of glasses increased and people started making them
for their specific need.
With the introduction of new elements of the periodic into its conventional
chemical composition glass acquired hither to unexpected features
which made possible its wider utilization ranging from optical fibers,
electrodes, pharmaceuticals, nuclear physics, space research etc.
Glass
is still unsurpassed as primary packaging material for pharmaceutical
applications. Ever since the end of World War II, man seems to labour
under the impression that he has conquered all his problems, particularly
those relating to Health and disease. Victory over infections, the
foremost killer before antibiotics, made him complacent until new
bugs reared their heads. These high tech and sensitive drugs are
formulated into finished dosage form by pharmaceutical industry.
Medicines
are therefore subject to the special standards of the pharmacist,
as well as National, International Standards and GMP(Good Manufacturing
Practice) regulations laid down in International law. A continual
quality control system means that manufacturers and their products
are also included in these standards. As primary containers are
in direct contact with the pharmaceutical compound, they are subjected
to strict testing, as described in both National and International
regulations.
Glass
has a number of qualities which make it particularly suitable for
use as primary packing for pharmaceutical products. GLASS has had
'specs' laid down bye the most respected of Pharmacopoeias, namely
the United States Pharmacopoeia, or USP.
Grades
of GLASS have been defined separately for containers for injectables
and for non-injected drugs. Needless to say the most stringent 'specs'
are for injectables.
Other
attributes giving distinct edge to glass as the safest container
compared to plastic are:
| CHARACTERISTIC |
GLASS |
PLASTIC |
| TRANSPARENCY |
HIGHLY
AUTOMATED LEVEL CONTROL AND PROBLEM - FREE PARTICLE EXAMINATION
|
MODERATE
AUTOMATED TEST DIFFICULT |
| UV-LIGHT
PROTECTION |
GUARANTEED
|
GUARANTEED
|
| STERILISABILITY
THROUGH |
-200
C TO +500 C LYOPHILISATION, HOT-AIR STERILIZATION, GAMMA RAY
IRRADIATION |
-20
C TO ? LYOPHILISATION POSSIBLE/CERTAIN CONDITIONS HOT AIR STERILIZATION
NOT POSSIBLE GAMMA-RAY IRRADIATION POSSIBLE UNDER CERTAIN CONDITIONS. |
| AGEING |
CANNOT
BE PROVED |
DEPENDING
ON STORAGE CONDITIONS(ENVIRONMENT, STERILISATION) |
COMPACTNESS
(PERMEATION) |
ABSOLUTELY
GAS-TIGHT |
PERMEABLE
FOR GASES |
INTERACTION
PACKING/CONTENTS
(MIGRATION) |
KNOWN
IF PRESENT, EASY TO REGULATE |
PRESENT
DIFFICULT EXAMINATION |
INTERACTION
CONTENTS/PACKING
(SORPTION) |
NEGLIGIBLE |
PRESENT
(CHANGE IN THE CONCENTRATION OF THE AGENT) |
| DISPOSAL
|
RECYCLING
POSSIBLE |
DOWN
CYCLING POSSIBLE |
| OUTER
PACKING/TRANSPORT MEASURE AGAINST BREAKAGE |
PROTECTION
AGAINST BREAKAGE NECESSARY |
PROTECTION
AGAINST SCRATCHES AND EMBRITTLEMENT NECESSARY |
| LETTERING/PRINTING/LABELLING |
SCREEN
PRINTING+LABELLING PROBLEM-FREE |
LABELLING+RELIEF-PRINTING
PROBLEM FREE. |
MECHANICAL
STABILITY
(SHORT-TERM COMPRESSIVE STRENGTH) |
GOOD |
PARTIAL
CRITICAL |
| EXPERIENCE
WITH THE MATERIAL |
VERY
HIGH |
LOW |
CONCLUSION:
AS COMPARED TO PLASTICS GLASS HAS DISTINCT ADVANTAGES IN
1)
TRANSPARENCY
2) AGEING
3) LEACHABILITY
4) PERMEABILITY
5) STERILISABILITY BY AUTOCLAVING AND DRY HEAT STERILIZATION.
|