MODULE 7 Flashcards
The activities of designing and
producing the container for a product.
PACKAGING
Types of packaging materials.
Primary packaging materials
Secondary packaging materials
Tertiary packaging materials
Types of packaging materials which do
not come in direct contact with the product and serve as accessory to
the primary packaging component.
Secondary packaging materials
Types of packaging materials that is used for bulk handling, warehouse storage and transport shipping
Tertiary packaging materials
Types of packaging materials which come in
direct contact with the product itself.
Primary packaging materials
Two types of special packaging.
Unit-dose packaging
Device packaging
This type of packaging permits easier administration by means of devices
such as pre-filled syringes, droppers, transdermal delivery systems, pumps
and aerosol sprays.
Device packaging
This packaging guarantees safer medication by reducing medication errors.
Unit-dose packaging
This packaging materials may be very useful in improving compliance with treatment.
Unit-dose packaging
Objectives of Packaging
Physical protection
Barrier protection
Containment or Agglomeration
Marketing
Security
Convenience
Portion control
The science, art and technology of
enclosing or protecting products for distribution, storage, sale, and use.
PACKAGING
The packaging and labels can be used by
marketers to encourage potential buyers to purchase the product.
MARKETING
This packaging objectives used to control usage.
Portion Control
Packages can have
features that add convenience in
distribution, handling, stacking, display, sale, opening, reclosing, use, dispensing, and reuse.
CONVENIENCE
Packages can be made with improved tamper resistance to deter tampering and also can have tamper evident features to help indicate tampering
SECURITY
Small objects are typically grouped together in
one package.
Containment or Agglomeration
A barrier from oxygen, water vapor, dust, etc., is often required
Barrier Protection
The objects
enclosed in the package may
require protection from, among
other things, shock, vibration, compression, temperature etc.
Physical Protection
They are subject to inspection by an experienced proofreader for graphical errors, for compliance with specifications as to
type and grade of stock printing quality and dimensional
tolerance.
Printed Materials
Label includes all written, printed or graphic
materials accompanying a product.
Printed Materials
Objectives of Labeling
Brand Identification
Description
Promotion
This labeling helps in
the identification and principal place of business of the person by or for whom the prepackaged product was
manufactured, processed, produced or
packaged for resale
Brand Identification
Labels provide the information regarding the product
DESCRIPTION
These labels help in promoting the product.
PROMOTION
Production control issues a packaging form that
carries the name of the product; item number;
lot number; number of labels, inserts and
packaging materials to be used; operations to be performed, and the quantity to be packaged
Labelling Control
Minimum requirements for package insert.
- Product name
- Strength or quantity of the active substance contained
per unit dosage form - Description
- Action
- Indication
- Contraindications
- Warnings & Precautions
- Caution
- Side effect
- Dosage and administration
- Overdosage
- How supplied
- Manufacturer/packer/distributor
- Business address
Minimum criteria for acceptance of printed
materials consists of:
- Text
- Color
- Size
- Thickness
- Grain direction
- Sealability
- Cleanliness
- Surface finish
- Adequate paste
- Shape
The USP defines the container closure
system as the device that holds the drug and
is or maybe in direct contact with the drug.
CONTAINERS
Criteria for the physical inspections of
container:
- Shape
- Volume
- Finish
- Opening
- Diameter
- Height
- Thickness
- Color
- Clarity
- Leak
- Torque
- Peeling
- Cleanliness
- Light transmission
- Stress crack resistance
The physicochemical tests for the containers
include:
- Identification
- Infra-red properties
- Thermal analysis
- Extractable substance
- Non-volatile residue
- Water vapor permeation/transmission
- Moisture
- Resistance to water attack
The integrity of the seal between the
closure and container depends on the
geometry of the two, the materials
used in their construction, the
composition of the cap liner and the
tightness with which the cap has been
applied.
Container and closure control
Closure should fit the thread of the
container. It should sit on a container
without tilting, produce no leaks, should not
rotate continuously, be reasonably tight and
look elegant.
Container and closure control
Chest tightness also known as ____________.
TORQUE TESTER
The unit of force is in terms of ___________.
Inch pound
Packaging operation checklist. (PRODUCT)
- Product mixed with another product
- Wrong product or strength
- Homogeneity
- Appearance/color/odor
- Contamination with foreign matter
- Fill/weight/volume
- Heat marks on product
- Freedom from chips, cracks
Packaging operation checklist. (CONTAINERS)
- Freedom from cracks, chips
- Freedom from dents, distortions
- Contamination with foreign matter
- Leakage
- Fill/weight/volume
Packaging operation checklist.(Strips/Pouches)
- Product name/strength
- Control code
- Expiration date
- Rx symbol
- Leakers in vacuum test
- Weak seal
- Empty or wrong count
- Torn strip of pouch
- Freedom from dust or smears
- Correct cutting
- Powder in pouches and seals
- Perforations of tear notches non-functional
- Fill/weight/volume
Packaging operation checklist. (CLOSURES)
- Sealing lightness
- Freedom from dust/smears
- Crimping
- Correct design/colo
Packaging operation checklist. (LABELS)
- Product name/strength
- Control code
- Expiration date
- Rx symbol
- Registration number
- Incorrect
- Glueing
- Alignment
- Torn/soiled
- Freedom from dust/smears
- Missing
TYPES OF GLASS
TYPE 1 - Highly Resistant Borosilicate Glass
TYPE 2 - Treated Soda Lime Glass
TYPE 3 - SODA LIME
TYPE 4 - Sodalime Glass that is not suitable as container for Parenterals
USP TEST FOR GLASS
TYPE 1 - Highly Resistant Borosilicate Glass
TYPE 2 - Treated Sodalime Glass
TYPE 3 - Sodalime Glass
Types of Error in Experimental Data:
Random or Indeterminate Error
Systematic or Determinate Errors
Gross Errors
2 Problems with Container
Leaching
Sorption
- These are errors that affects the
precision of measurements. - An accidental and
more or less intangible errors, over
which the operator has little or any control.
Random or Indeterminate Error
These are errors that affects the
accuracy of the results.
○ A tangible one,
the magnitude of which can be
determined or approximated.
Systematic or Determinate Error
Sources of Systematic Errors
A. Instrumental Errors
B. Methodic Errors
C. Personal Errors
Errors leads to outliers (results that appear to
differ markedly from all other data in a set of replicate
measurements.
○ It is usually occasional.
○ It is often large and may cause a result to be either high or low.
GROSS ERROR
These result from
the carelessness,
inattention, or
personal limitations
of the analyst.
PERSONAL ERROR
• These are the most common and the most
troublesome.
● These arise from nonideal chemical or
physical behavior of analytical systems.
METHODIC ERROR
These errors are caused by
imperfections in measuring
devices and instabilities in
their power supplies
INSTRUMENTAL ERROR
It has a definite value, an
assignable cause, and are of the same magnitude for replicate measurements made in the same way.
○ They lead to bias measurement technique
ERROR
Systematic Errors may be either;
Constant or Proportional
Systematic errors that decrease or increase in
proportion to the size of the sample
Proportional Error
Systematic errors that are independent of the size of
the sample being analyze
Constant Error
Quality Control Test for Plastics
- Leakage Test
- Collapsibility Test
- Clarity Aqueous Extract
- Water Vapor Permeability Test
- Transparency Test
- Biological Test
Test is passed if no sign of leakage from container.
LEAKAGE TEST
o Applicable to containers which are squeezed for
removing the contents
COLLAPSIBILITY TEST
o Random selection of unlabeled, unmarked and non laminated
portions from suitable container
CLARITY AQUEOUS EXTRACT
Acceptance criteria of Water Vapor Permiability test
NMT 0.2%
2 test solutions used in TRANSPARENCY test
Hydrazine sulfate and Hexamine
Types of Biological Test
❑Systemic Injection
❑Intra-cutaneous Test
❑Eye Irritation Test
❑Resistance to Stress
Animals used in Systemic Injection test
ALBINO MICE
Animals used in Intra-cutaneous and Eye irritation test.
RABBIT
oAcceptance Criteria: No break, or deterioration should occur for the sample to pass the test.
Resistance to Stress
Quality variation which is not confined within a
specific range; tolerance or limit, will grow to
uncontrollable magnitude and will encourage the
proliferation of errors, thus producing a defective
product.
ERRORS AND DEFECTS
Tester used to check tightness of the container.
TORQUE TESTER
