Product development M pharma 2nd send' dr harisingh gour sagar university

1. Stability
assessment of
containers and
closures

2. STABILTY ASSESMENT OF CONTAINERS AND CLOSURES
Assignment of
PRODUCT DEVELOPMENT
PHS CC 1202
Session 2023-2024
Department of Pharmaceutical Sciences
Dr. Harisingh Gour Vishwavidyalaya,Sagar, (M.P.)
(A Central University)
Supervisors:
PROF. VANDANASONI
PROF. SANJAYK. JAIN
DR. DHARMENDRA JAIN
Submitted by:
ARYA OJHA
Y23254025

3. ACKNOWLEGEMENT
Throughout my assignment, I truly appreciate the help and encouragement I received from my teachers
PROF. VANDANA SONI, PROF. S.K. JAIN and DR. DHARMENDRA JAIN .

4. INTRODUCTION :
• Pharmaceutical packaging can be defined as the economical means of providing presentation,
protection, identification , information, containment, convenience, compliance, integrity and stability of
the product.
• The selection of a package therefore begins with a determination of the product’s physical and
chemical characteristics, its protective needs, and its marketing requirements.
ROLE OF
PACKAGING:
Protection against
- light
- reactive gases
- moisture
- microbes
- physical damage
- adulteration
-
- Presentation
- Identification
- Information
- Compatible
- Convenience

5. The materials selected must have following characteristics:
They must protect the
preparation from
environmental
conditions.
They must not be
reactive with the
product.
They must not impart
to the product tastes
or odors.
Must be non-toxic.
They must be “FDA”
approved.
They must meet
applicable tamper
resistance
requirements.
They must be adaptable
to commonly employed
high-speed packaging
equipment.

6. Types of containers:
Well – closed containers A well-closed container protects the
contents from loss during
transportation, handling, storage or
sale.
Single dose containers : These containers are used to supply
only one of medicament and hold
generally parenteral products.
E.g. ampoules and vials
Multi dose containers: These containers allow the withdrawal
of dose at various intervals without
changing the strength, quality or purity
of remaining portion. These containers
hold more than one dose and are used
for injectables. E.g. vials

7. Light-resistant containers: These containers protect the
medicament from harmful effects of
light. These containers are used to
store those medicaments which are
photo-sensitive.
Air-tight containers: These are also called hermetic
containers. These containers have air-
tight sealing or closing. These
containers protect the products from
dust, moisture and air.
Aerosol containers: These containers are used to hold
aerosol products. These containers
have adequate mechanical strength in
order to bear the pressure of aerosol
packing.

8. Types of Packaging:
Primary Packaging :
- Glass bottle jars
- Plastic bottles
- Strip packs
-Pouches
-Ointment tubes
-Vials and Ampoules
Primary packaging is the
material that envelopes the
product and holds it. This usually
is the smallest unit of
distribution or use and is the
package which is in direct
contact with the contents.
Secondary Packaging : Is outside the primary packaging-
perhaps used to group primary
packages together.
Tertiary Packaging : Is used for bulk handling,
warehouse storage and transport
shipping. The most common form is
a palletized unit load that packs
tightly into the container.

9. Qualities of good container:
• The container must be neutral towards the material which is stored in it.
• The container must not interact physically or chemically with the substance which it holds.
• It should help in maintaining the stability of product against the environmental factors which causes its
deterioration.
• It should be made of materials which can withstand wear and tear during normal handling.
• It should be able to withstand changes in pressure and temperature.
• The materials used for making of the container must be non-toxic

10. Materials used for making of containers:
 GLASS-
e.g., Bottles, vials, ampules, syringes, i.v. containers, aerosol containers.
 PLASTIC-
e.g., Bottles, pouches, tapes, tubes, aerosol containers, laminates.

11.  RUBBER-
e.g., Closures, caps,vialswrapers,plungers.
 METALS-
e.g., Collapsible tubes, foils, needles, aerosol containers

12. Closures: A closure is the part of the package which prevent the contents from escaping and allow no
substance to enter the container.
Made up of :
 Rubber
 Plastics
 Metals
Materials used for secondary packaging:
 Papers
 Cardboards

13. 1. Chemical resistance test
a)Powdered attack test
b)Water attack test
2. Hydrolytic resistance test
3. Arsenic test
4. Thermal shock test
5. Internal bursting pressure test
Stability test of glasses:

14. • Powdered glass test:
It is done to estimate the amount of alkali leached from the powdered glass, which happens at
elevated temperatures.
The decanted liquid is titrated with 0.02N H2SO4 using methyl red as
indicator.
It is autoclaved at 121°C for 30 min and cooled and decanted.
10 gm of the sample is washed with acetone and dried. 50 ml of purified
water is added to the dried sample .
The containers are grinded in a mortar to a fine powder and passed through
sieve no. 20 & 50.
Sample containers are rinsed with purified water and dried.
LIMITS:
TEST CONTAINER VOL OF 0.02N
H2SO4 (ML)
Powdered glass
test
 Type I
(borosilicate
glass)
 Type II (soda-
lime glass)
 Type N.P
(general
purpose soda-
lime glass)
1.0
8.5
15.0

15. • Water attack test:
This test is for type II glass. The principle involved in this is whether the alkali leaches from surface of
container.
The volume of H2SO4 consumed is recorded and compared with limits.
Then it is cooled, and liquid is decanted.
Decanted liquid is titrated with 0.02N H2SO4 using methyl red as an indicator
It is then autoclaved at 121°C for 30 min.
It is then filled with water upto 90% of its capacity
The container is rinsed thoroughly with high purity water. .
LIMITS:
TEST CONTAINER VOL OF 0.02N
H2SO4 (ML)
Water attack test Type II (soda-lime
glass)
 100 ml
 Less than 100
ml
 0.7
 0.2

16. • Hydrolytic resistant test:
This test is directly related to the stability of pharmaceuticals packed in it.
 Test 1: Type I and Type II glass containers to distinguish from Type III glass containers.
 Test 2: Type I and Type II glass containers where it is necessary to determine whether the high hydrolytic
resistance is due to the chemical composition or the surface treatment.
LIMITS:
NOMINAL CAPACITY OF
CONTAINER (ml)
NO. OF CONTAINERS THAT CAN
BE USED
VOL OF TEST SOLUTION FOR
TITRATION
Upto 3 At least 20 25.0
5 or less At least 10 50.0
6 to 30 At least 5 50.0
More than 30 At least 3 100.0

17. • Test 1:
A blank titration is performed with water and the difference between the titration represents the volume of HCl consumed by the test solution.
This test solution is titrated with 0.01M HCl using methyl red as an indicator (methyl red is red in alkaline pH and pink in acidic).
The container are removed from autoclave, cooled and the liquids are combined in a conical flask and the volume is measured.
The temp. is lowered from 121°C to 100°C over 40 min.
The temp. is maintained at 121°C to 122°C for 60 mins.
The temp. is risen from 100°C to 121°C over 20 mins.
Vials and bottles are covered and autoclaved at 100°C for 10 mins and the steam is allowed to displace from the vent cork.
Each container is rinsed at least three times with CO2 free water and filled with the same to their filling volume.
• Test 2:
Rest procedure are same as in test 1.
Empty containers and rinse 5 times with water.
Rinse the container twice with water and fill completely with 4% v/v solution of Hydrofluoric acid and allow to stand at room temperature for 10 mins.

18. • Arsenic test:
Limits:- The absorbance of the test solution should be less than the absorbance obtained using 0.1 ml of arsenic standard solution (10
ppm
It is cooled and absorbance is measured at 840nm. A Blank test is performed with 10 ml hydrogen molybdate.
10 ml of hydrogen molybdate is added and refluxed for 25 mins
To it 10 ml of HNO3 is added and dried in an oven at 130°C.
10 ml from the final combined volume is pipetted out.
The containers are cooled, and the liquids are combined, and volume measured.
The temp. is risen from 100°C to 121°C over 20 mins. The temp. is maintained at 121°C to 122°C for 60 mins.
Containers are covered and autoclaved at 100°C for 10 mins.
The inner and outer surface of container is washed with fresh distilled water for 5 min.
This test is for glass containers intended for aqueous parenteral.