PACKAGING MATERIAL INSPECTION AND : PM Inspection: Closures, Bottle Finish and Bottle Defects Flashcards
the packaging system sum of packaging
components and materials that together
contain and protect the article
PACKAGING SYSTEM
any single part of the Package or Container– closure system
PACKAGING COMPONENT
a packaging component that is in direct
contact with or may come into direct
contact with the article
PRIMARY PACKAGING
a packaging component that is in direct
contact with a primary packaging
component and may provide additional
protection for the article.
SECONDARY PACKAGING
a packaging component that is in direct
contact with a Secondary packaging
component and may provide additional
protection for the article during
transportation and/or storage.
TERTIARY PACKAGING
receptacle that holds an intermediate
compound, API, excipient, or dosage form, and is in direct contact with the article.
CONTAINER
a material that seals an otherwise open
space of a Container and provides
protection for the contents. It also provides
access to the contents of the container.
CLOSURE
Highly resistant borosilicate glass
Type I
Treated Soda lime glass
Type II
Soda lime glass
Type III
General purpose soda lime glass
Type IV
- Draw and identify the different bottle
finishes and identify appropriate closure
for each type - Using the same samples, inspect the
units for presence of any defect. - Describe each defect and group them
accordingly
INSPECTION
- using a vernier caliper, measure the
length and width of the 10 samples. - Compute for the mean length and mean
width. - Record the fill volume of the 10 samples. Get the mean volume.
- Record the weight of the 10 samples. Get the mean weight.
DIMENSION
1.Fill 10 container to 90% of its overflow
capacity with distilled water
2.Place the containers in the autoclave set
at 121° +/- 2.0 for 60 minutes
3.Empty the content measuring to 100mL
in volume into a conical flask
- Add 2 drops of Methyl red TS
- Titrate, while warm, with 0.020 N
sulfuric acid (Completing the titration
within 60 minutes after opening the
autoclave). Record the volume - Perform blank test using 100 ml of
distilled water. - Classify the type of container used and
compare the results on the given
specifications
WATER ATTACK TEST
- Select 10 containers of uniform size and type, clean the sealing surface.
- Close and open each container 30 times. Apply the closure firmly and uniformly each time the container is closed.
- 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.
- Close each container immediately after
adding the desiccant - 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. - Record the weight of the prepared
individual containers - 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
- After 14 days, record the weight of the
individual containers in the same manner - Completely fill 5 containers of the same size and type as the containers under test with water
MOISTURE PERMEATION
______are an integral part of the
formulation of a product.
Containers
Two types pf containers
- Glass containers
- Plastic containers
This is the very top section of bottle
and it is made to seal with a cap.
Finish
This is the section from the ring seam
down to where the form curve makes a wide
bend at the base of neck.
Neck
Section that widens out up to the
straight form of the body
Shoulder
The largest part. Section were the
contents go in. Product label should be placed in this part.
Body
The flat section that enable it to
stand upright
Bottom
The curve part down from the
bottom plate seam to where the flat bottom
starts is specially named _______.
Heel
There are many factors to consider when
selecting a closure for container:
- How the product should be dispensed
- Packaging requires extra protection
- Overall style