This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.

1. GLASS AS A PACKAGING MATERIAL IN
PHARMACEUTICAL PACKAGING
Prepared by: Shweta Sambhaji Shelke
M. Pharm (Q. A.)
1

2. INTRODUCTION
 The packaging can be defined as an economical means
of providing presentation, protection, identification
information, containment, convenience and compliance
for a product during storage, carriage, display and until
the product is consumed.
 Glass is an amorphous solid material which is usually
brittle and optically transparent.
 Glass is a uniform material of arguable phase ,
produced when the viscous molten material cools
rapidly to below its glass transition temperature, without
sufficient time for a regular crystal lattice to form.
2

3. COMPOSITION OF GLASS
 Glass is composed of sand, soda ash, cullet,
silicon, aluminum, boron, potassium, zinc etc.
 Most glasses contain about 70-72% by weight of
silicon dioxide (SiO2)
3

4. ADVANTAGES OF GLASSES
 They are transparent.
 They are available in various shapes and sizes.
 They can withstand the variation in temperature and pressure
during sterilization.
 They are economical and easily available.
 They can protect the photosensitive medicaments from light
during their storage.
 They are neutral after proper treatment.
 They are impermeable to atmospheric gases and moisture.
 They have good protection power.
 They do not deteriorate with age.
 They can be easily labelled.
 They can be sealed hermetically or by removable closures.
4

5. TYPES OF GLASSES
Type4
Type
3
Type2
Type
1 5

6. TYPE 1 : BOROSILICATE GLASS .
 COMPOSITION :
 Highly resistance glass, a substantial part of the
alkali and earth cations are replaced by boron
and/or aluminum and zinc.
 SiO-80%,Al2O3-95%,Na2O-7%,K2O-0.5%,B2O2-
12%,CaO-1%
 SUITABILITY:
 Parenteral usage ,Chemical glassware container
for alkali sensitive preparation.
6

7. PROPERTIES:
 Alkalinity is removed by using boric oxide to
neutralize the oxides of Potassium and sodium.
 The addition of about 6% boron to form borosilicate
glass reduces the leaching action, so that only 0.5
ppm is dissolved in a year.
 Borosillicte glass melt at a higher temperature than
ordinary Sillicate glass .
 It has very low thermal expansion coefficeint ,about
1/3 rd of ordinary glass.
7

8. PROPERTIES CONTINUE….
 This reduces material resistant to breaking .
 This glass begin to soften at 821ºc
 More resistant to thermal shock than other types of
glass, borosillicate glass can still crack or shatter
when subjected to the uneven temperature
variation.
8

9. TYPE 2- TREATED SODA LIME GLASS
 INTRODUCTION:
Type 2 is a soda glass which has a surface treatment by
sulphating or sulphuring forming a coating of sodium
sulfate, which is neutralize by excessive surface
alkalinity.
 COMPOSITION :
SiO-80%,Al2O3-95%,K2O-0.5%,B2O2-12%,CaO-1%
 SUITABILITY:
Parentral use, alkali sensitive preparations for blood,
plasma and infusion fluids. 9

10. PROPERTIES:
 Glasses are being given different treatments in
order to improve their surface lubricity, increasing
impact resistance and aesthetic appearance
 It has a very low coefficient of thermal expansion
 Softer than borosilicate
 Easy to mould
 Cheaper than Borosillicate
10

11. TYPE 3:SODA LIME GLASS
 INTRODUCTION:
Type 3 glass is a regular soda lime glass in which the
containers are untreated and have an average chemical
resistance
 COMPOSITION:
SiO-75%, Al2O3-2%, K2O-0.5%, B2O2-3%, CaO-12%
 SUITABILITY:
• Only for non aqueous preparation
• Not recommended for Parentral preparations until and
unless indicated
• Not for alkali sensitive preparation 11

12. PROPERTIES OF TYPE 3 GLASS
 It is an alkaline glass having high per cent of lime
and soda and no boric oxide as compare to Type 1
glass
 Moderate hydrolytic resistance ( Limited alkalinity)
 Easy alkali to water flakes separated out loss of
brilliance
 Cheapest glass
12

13. TYPE 4:NON PARENTRAL (N. P.) GLASS
Lead
free
glass
Coloured
glass
Silicone
treated
13

14. COLORED GLASS
 INTRODUCTION:
In addition to glass composition metal salts carbon
and sulphur or iron and mangnese for amber color
 SUITABILITY/USE:
• Used for light sensitive product
• Do not use for parentral unless specified
 PROPERTIES:
• It does not allow the UV rays to pass through it
14

15. LEAD FREE GLASS
 USE:
• Used for liquid preparations
• Used when preparation meant for lead poisoning
e.g. Na E.D.T.A
 DISADVANTAGE:
• As lead monoxide is used in manufacturing of glass
cause lead poisoning
15

16. SILICONE TREATED GLASS
 Its surface is treated with dimethyl siloxone
 As it is hydrophobic in nature not welled so product
do not cling to surface
16

17. GENERAL TESTS
Critical dimensions
Capacity and height
Wall thickness
Thermal shock test
Limit of alkalinity
Verticality
Annealing test
Visual defects
Air bubble
Bottle thickness
Neck thin
17

18. QUALITY CONTROL TESTS AS PER U. S. P.
Powder
glass test
Water
attack test
Hydrolytic
resistance
test
18

19. POWDER GLASS TEST
 Preparation of specimen of powdered glass test.
Rinse 6 or more containers
Dry them
Divide 100gm of coarsely crushed
glass into 3 equal parts
Place 1 portion in mortar
Crush further by shrinking ¾ blows with
hammer
Nest the sieves
Empty the mortar into 20#sieve
Crush into fragments
19

20.  Continue preparation of specimen for powder glass
test
Shake the sieve & then remove the glass from 20 & 40#
Crush & sieve again as above
Transfer the retained portion on 50#, which should weigh
excess of 10gm
Spread the specimen on glazed paper & remove iron particle
with help of a magnet
Wash with six 30ml portions of acetone & decant acetone
Dry the contents for 20 min at 140ºC
Transfer to weighing bottle and cool in desiccators
Final specimen to be used in powdered glass test 20

21. POWDER GLASS TEST (AS PER U. S. P.)
Transfer 10.0g of prepared specimen in 250ml conical flask
digested previously with high purity water in bath at 90ºC
Add to conical flask containing 50ml of high purity water
Cap all the flask
Autoclave (continue heating for 10min )
Close vent cock
Adjust temp to121ºC
Hold the temp (121ºC ±221ºC for 30min) 21

22.  Powder glass test continue….
Reduce the heat & wait for autoclave to cool
Cool the flask in running water
Decant water
Wash the residual glass (4 times with 15ml high purity water)
Add the decanted washing to main portion
Add 5 drops of methyl red solution
Titrate immediately with 0.02N sulphuric acid
Record the volume of 0.02N sulphuric acid
Volume doesn’t exceed the limit
22

23. WATER ATTACK TEST AT 121ºC
 The water attack test at 121ºC is performed on
intact containers
 The containers are filled up to 90% of their overflow
capacity
 Containers are autoclaved for 60 min
 Then content of container are cooled & from
cooled content 100ml of the solution is titrate as in
case of powdered glass test
23

24. WATER ATTACK TEST…
Rinse 3 or more containers with high purity water
Fill each container to 90%of its overflow capacity
Cap all the flasks, autoclave for 60 min
Empty the contents & cool the contents in 250ml conical flask to a
volume of 100ml
Add five drops of methyl red solution
Record the volume consumed
Titrate with 0.02N Sulphuric acid while warm
Volume should not exceed limits
24

25. TYPES OF GLASS & THEIR LIMITS
Types of
glass
General description
of glass
Types of
test
Limits
size ml
Limits (ml
of 0.20N)
1 Highly resistant
borosilicate glass
Powdered
glass
All 1.0
2 Treated soda lime
glass
Water
attack
100 or
less
0.7
Over 100 0.2
3 Soda –lime glass Powdered
glass
All 8.5
4 General –purpose
soda lime glass
Powdered
glass
All 15.0
25

26. HYDROLYTIC RESISTANCE
 This test is done for detecting the type of glass
Type of container Test to be done
Type 1 & type 2 glass containers
to distinguish from type 3 glass
containers
Test 1 (surface test)
Type 1 & type 2 glass containers
where it is necessary to determine
whether the high hydrolytic
resistance is due to the chemical
composition or the surface
treatment
Test 1 & 2
26

27. HYDROLYTIC RESISTANCE TEST
Test 1 -Surface glass test
Wash containers with carbon dioxide free water
Fill the containers with CO2 free water (90%)
Close with aluminum foil
Autoclave at 100º-120ºC for 20 min
Maintain at 120ºC for 1 hr
At lower temp for 40 min
Remove containers & cool
27

28. HYDROLYTIC RESISTANCE TEST (TEST 1)CONT…
Titrate it within 1 hour
Titrate with 0.01 M HCL (end point colourless)
Repeat with same volume of CO2 free water
28

29. VOLUME OF TEST SOLUTION TO BE USED
Sr. no. Nominal capacity
of container (ml)
No. of containers
to be used
Volume of test
solution to be
used (ml)
1 Up to 3 At least 20 25.0
2 5 or less At least 50.0
3 6 to 30 At least 50.0
4 More than 30 At least 100.0
29

30. VOLUME OF 0.01M HCL REQUIRED BY TEST SOLUTION
Capacity of container (corresponding
to 90% avg over flow volume ml)
Volume of 0.01M HCl for 100
ml of test solution
Type 1 or 2
glass (ml)
Type 3 glass
(ml)
Not more than 1 2.0 20.0
More than 1 but not more than 2 1.8 17.6
More than 2 but not more than 5 1.3 13.2
More than 5 but not more than 10 1.0 10.2
More than 10 but not more than 20 0.80 8.1
More than 20 but not more than 50 0.60 6.1
More than 50 but not more than 100 0.50 4.8
More than 100 but not more than 200 0.40 3.8
More than 200 but not more than 500 0.30 2.9
More than 500 0.20 2.2
30

31. HYDROLYTIC RESISTANCE TEST
 Test 2
Rinse container twice with water and with 4%volume solution of HF
Allow to stand for 10min
Empty the container
Rinse 5 times with water
Carry out test similar test 1
31

32. ARSENIC TEST
Inner & outer surfaces are washed 5 times with freshly
prepared distilled water
Prepare 50ml using adequate number of test solution
Pipette out 10 ml of test solution from combined content of
ampoule into flask
Add 10ml of HNO3
Evaporate to dryness on water-bath
Add the residue in an oven @ 130 C for 30 min
32

33. ARSENIC TEST CONTINUE…
Cool ,add to hydrazine molybdate reagent to dissolve
Heat under reflux on water bath for 20 min
Cool to room temperature
Determine the absorbance of resulting solution at
maximum of about 840 nm using hydrazine molybdate
reagent as a blank
Limit :0.1ml of arsenic std 33

34. DEFECTS
 Care should be taken to avoid unwanted defects in
packaging.
 It includes cracked /chipped bottle , fracture in
body, missing liner in closures ,stones or air
bubbles in glass bottle ,small dents or scratches
,etc.
 These are categories as follows:
 Class A –Critical defects
 Class B – Major defects
 Class C – Minor defects
34

35. DEFECTS IN GLASS CONTAINER
Sr.no. Critical defects Major defects Minor defects
1 These defects
which prevent
container or
package from
protecting the
contents are
referred as critical
defects .
These defects have
bottle like
dysfunction .it
reduces the identity
by virtue of graphic
defects .
These defects that
damage the
appearance but not
the function of
package are called
minor defects
2 Examples-
-Cracks &
penetrating checks
-Light side walls
broken /chip finish
contaminations with
insects
Examples-
- Nonfunctioning
stretching bead liner
in excess of 1/8
inch on each side
Examples-
-Stones & heavy
appearance followed
by rough molding
lines & uneven outer
surface
3 Acceptance criteria
is subjective matter.
Acceptance criteria
has demerits of 3
points
Acceptance criteria
has demerits of 2
points
35

36. CONCLUSION:
 A number of glass containers used in
pharmaceutical industry include ampoules, bottles,
vials, etc.
 Due to their advantages glass has served the
pharmaceutical industry as one of the good
packaging material for pharmaceutical
preparations.
36

37. REFERENCES:
 Phrmaceutical packaging handbook, Edward Baur
,page no 189-198
 USP 36,Physical tests /<663> containers Glass -1
 International Journal of Research in Pharmaceutical
and Biomedical Sciences ISSN: 2229-3701, Vol. 4
(4) Oct – Dec 2013
37

38. REFERENCES …
 Lachaman and Libermann, Theory and practice of
Industrial pharmacy, Verghese pub.723-731
 Lockhart H and Paine FA. Packaging of pharmaceuticals
and healthcare Products, Blackie Academic and
Professional pub. P-1, 98-99
 “Selection and Evaluation of Pharmaceutical Packaging
Materials, Containers and Closures”
by Hemant Rathod, Natasha Sharma. 38

39. THANK YOU
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