Experiment No. 2
PM Inspection
Container is an integral part of the final product. No container is totally insoluble or does not in
some way affect the product it holds, particularly if it is aqueous. Two general type of container
is the glass and the plastic. Each has their desirable attributes and disadvantages.
Containers are subject to inspection to determine conformance to a given specification. Failure
to conform to specification refers to defects. Defects may be classified according to its
measurability, seriousness or nature. The term defect not only applies to packaging material but
to all the materials included in the process of manufacturing of a product.
Objectives:
1. To recognize the variety of designs for bottle finish.
2. To match the basic types of closures corresponding to the bottle finish
3. To familiarize the students with common bottle defects
4. To characterize the different type of defect
5. To determine the dimensions of the bottle
6. To evaluate conformity of sample containers using the water attack test
7. To understand the importance of vapor transmission test.
8. To demonstrate a simple stability study for a packaging component.
INSPECTION
1. Draw and identify the different bottle finishes and identify appropriate closure for each type
2. Using the same samples, inspect the units for presence of any defect.
3. Describe each defect and group them accordingly
DIMENSIONS
1. Using a vernier caliper, measure the length and width of the 10 samples.
2. Compute for the mean length and mean width.
3. Record the fill volume of the 10 samples. Get the mean volume.
4. Record the weight of the 10 samples. Get the mean weight.
WATER ATTACK TEST
1. Containers often take majority of the inspection process because of the consideration
that it is in direct contact with the product. Containers are classified in several ways. The
basis may include its ability to protect the content or its capacity, as well as the nature of
the material. Two common types include plastic and glass. Glass containers must meet
the requirements for Chemical Resistance test. Such test also identifies the type of
container.
2. Fill 10 container to 90% of its overflow capacity with distilled water
3. Place the containers in the autoclave set at 121° +/- 2.0 for 60 minutes
4. Empty the content measuring to 100mL in volume into a conical flask
5. Add 2 drops of Methyl red TS
6. Titrate, while warm, with 0.020 N sulfuric acid (Completing the titration within 60 minutes
after opening the autoclave). Record the volume
7. Perform blank test using 100 ml of distilled water.
8. Classify the type of container used and compare the results on the given specifications
MOISTURE PERMEATION
Containers may be classified according to their ability to protect their contents from external
conditions, which will affect the stability of a product. External conditions, particularly
atmospheric moisture alters the product consistency, as well as effectivity. The ability of the
container to protect t
1. Select 10 containers of uniform size and type, clean the sealing surface
2. Close and open each container 30 times. Apply the closure firmly and uniformly each time
the container is closed
3. Add desiccant to eight of the containers, designated as test containers, filling to within 13 mm
of the closure if the container volume is 20 ml or more, or filing each to two thirds of capacity
if the container volume is less than 20 ml.
4. Close each container immediately after adding the desiccant
5. To each of the two remaining containers, designated as controls, add sufficient glass beads
to attain a weight approximately equal to that of the test containers.
6. Record the weight of the prepared individual containers
7. Store in a container with relative humidity of 75± 3% relative humidity that is achieved by a
saturated system of 35 grams of sodium chloride with each 100 ml of water placed in the
bottom of a dessicator
8. After 14 days, record the weight of the individual containers in the same manner
9. Completely fill 5 containers of the same size and type as the containers under test with water
10. Transfer the contents of each in a graduated cylinder and determine the average container
volume, in mL
11. Calculate the rate of moisture permeability, in mg per day per liter, using the formula
(1000/ 14V) [(Tf – Ti) - (Cf - Ci)]
where: V is the mean volume of the containers in ml
Tf – Ti is the difference, in mg, of the final and initial weights of the test containers Cf – Ci is the
average of the differences, in mg, of the 2 controls
QUESTIONS:
1. Draw and label the parts of a bottle.

2. Give the significance of using appropriate closure and of having different designs for
bottle finish.

Closures are responsible for providing customers with easy-to-open packaging.
Proper closure is essential first and foremost to defend the product. There is not
much point in packaging that doesn't accomplish this. The closure is the last point
of entry for oxygen, moisture, and bacteria. Therefore, a good closure has to
create a proper barrier.
3. Describe a torque tester.
 A torque tester is a type of transducer, specifically a torque transducer that converts a
torque measurement (reaction, dynamic or rotary) into another physical variable, in this
case, into an electrical signal that can be measured, converted and standardized.
4. Attach the picture of each type of defect and differentiate by classifying these
according to severity
BIRD
- A filament or a surface of
glass connecting two sides
of container
MARK
- a wavy surface on
the inside of the
bottle
CHECK
- a small, shallow surface
crack, usually at the bore of
the container.
PINHOLE
- any opening causing
leakage. it occurs
most often in bottles
with pointed corners.
CHIPPED
POOR DISTRIBUTION
-
-
Chipped Finish defect is a
small fragment of glass
chipped off the finish
(scratched), sometimes not
completely detached.
thin shoulder, slug
neck, choke neck,
heavy bottom are
terms used to describe
the uneven found on or
near the sealing
surface.
CRACKS
-
Cracks defect is a
discontinuous, open surface
crack, dull in appearance,
caused by local changes in
temperature.
CRIZZLE
-
defect is small axial grooves
grouped around the baffle
line.
ROCKER BOTTOM
- A sunken center
portion at the base
of the bottle which
makes bottle
unstable when
placed on a flat
surface.
SPLIT
- an open crack
starting at the top
of the finish and
extending
downward.
DROPPED SHOULDER
-
STONE
Shoulder Check defect is a
crack that does not pass
through the entire thickness
of the glass (usually in a
straight line).
TEAR
FILAMENT
- A hair like string of glass
inside bottle.
-
similar to a check,
but opened up. a
tear will not break
when tapped, a
check will.
HEELTAP
WASHBOARD
- A manufacturing defect where excess glass has been - A wavy condition of
distributed into the heel.
horizontal lines in
the body of the
bottle.
5. Write down the USP specification for Water attack test.

The principle involved in the water attack test is to determine whether the alkali leached form
the surface of a container is within the specified limits or not. Since the inner surface is under
test entire container (ampoule) has to be used.
7. Aside from visual inspection discuss Give the advantages and disadvantages for each type of
container. (glass and plastic)

GLASS
o ADVANTAGES
- Glass is 100% recyclable and can be recycled endlessly without loss in quality
or purity.
- Legislation such as container deposit measures will further enhance the
benefits associated with glass packaging.
- 80% of the glass that is recovered is made into new glass products.
- A glass container can go from a recycling bin to a store shelf in as little as 30
days. An estimated 80% of recovered glass containers are made into new glass
bottles.
-
-
o

Glass is nonporous and impermeable, so there are no interactions between
glass packaging and products to affect the flavor of food and beverages. No
nasty after taste - ever.
Glass has an almost zero rate of chemical interactions, ensuring that the
products inside a glass bottle keep their strength, aroma, and flavor.
When consumers choose foods or beverages that are packaged in glass, they
avoid potential risks while enjoying a number of benefits.
DISADVANTAGES
- Transportation costs are higher than plastic. It's known that glass is much
heavier than plastic. ...
- Glass manufacturing is high energy-consuming. This is due to the high
temperature required for processing and manufacturing.
- Not highly impact resistant.
- Rigid and brittle.
PLASTIC
o ADVANTAGES
- Helps to protect and preserve goods:
- Reduced transportation weight
- Performance and energy-efficient
- Cheaper than glass
- Highly durable
o
DISADVANTAGES
- Poor Longevity- Plastic degrades over time
- Absorbs flavors and smells easily
- Large environmental and health impact
- At higher risk for high levels of BPA
8. Enumerate the different classes of containers.






Well-closed container
Single dose container
Multi-dose container
Air tight container
Aerosol container
Light resistant container
9. Between glass-type and plastic-type container, which has lower permeability? Explain the other
tests for containers?

Glass type offers lower permeability to O2 and CO2 than plastic, which means alcohol can
be stored longer. Glass has a non-porous surface that doesn't absorb like plastic and can be
safely washed at higher temperatures in your dishwasher without melting or warping—most
food storage containers made of glass are designed to withstand high heat without breaking.
Whereas Plastic type is more permeable than glass. That means the O2 and CO2 are more
likely to permeate a plastic container than a glass container.
10. What are the different storage conditions?

Room temperature – 20 to 25 oC temperature is considered room temperature in
pharmaceuticals. All controlled samples are also at this temperature.

Cool storage conditions – 8 to 15 oC temperature. Some drug substances in the warehouse,
those degrade at room temperature are stored at this temperature.

Cold storage conditions – are from 2 to 8 oC temperature. This temperature decreases the
rate of chemical reactions as well as the microbial growth. The highly degradable drugs,
vitamins and chemicals are stored in cold conditions.

Fridge storage – -4 to 2oC temperature storage conditions are known as the fridge