Module 7 Lesson 1 Flashcards
Is the science ,art amd technology of enclosing or protecting products or distribution, storage, sale, and use
packaging
Is the activities of designing and producing the container for a product
Packaging
It should not be reactive , additive or absorptive so as not to alter the safety, identity, strength, quality and purity of the product
Enumerate types of packaging materials (3)
Primary packaging components
Secondary packaging components
Tertiary packaging materials
Packaging materials which come n direct contact with the product itself
Primary packaging components
Packaging materials which do not come in direct contact with the product and serve as accessory to the primary packaging component
Secondary packaging
This packaging is used for bulk handling, warehouse storage and transport shipping
Tertiary packaging materials
Two types of special packaging
Unit-dose packaging
Device packaging
This packaging guarantees safer medication by reducing medication errors
Unit-dose packaging
May be useful in improving compliance with treatment
This type of packaging permits easier administration by means of devices such as prefilled syringes, dropper, transdermal delivery systems, pumps and aerosol sprays
Device packaging
Objectives of packging (7)
Physical protection
Barrier protection
Confinement or agglomeration
Marketing
Security
Convenience
Portion control
Objects enclosed in package may require protection
Physical protection
A barrier from oxygen, water vapor, dust is often required
barrier protection
Small objects are typically grouped together in one package
Containment or agglomeration
Packaging and labels can be used by marketers t encourage potential buyers to purchase the product
marketing
Packages can be made with improved tamper resistance to deter tampering and also can have tamper evident featured to help indicate tampering
Security
Packages can have features tha add convenience in distribution, handling, stacking, display, sale and reus
Convenience
To control usage
Portion control
Types of glass (4)
1 - highly resistant borosilicate glass
2 - treated soda lime glass
3 - soda lime glass
4 or NP (non parenteral) - soda lime glass
Glass that is suitable for all products and usually intended for parenteral admnistration
Highly resistant borosilicate glass
What is the chemical composition of highly resistant borosilicate glass
Silicon dioxide and boric dioxide
How to increase resistance of highly resistant borosilicate glass?
Treat with sulfur dioxide
This glass is usually for acidic or neutral solutions nonreactive with the glass
May also be used with alkaline if stability data demonstrate its suitability
Treated soda lime glass
How is treated soda lime treated
Under controlled temperature and humidity conditions
With sulfur dioxide or other dealkalizers - to neutralize the interior surface
Composition o soda lime glass
Silicon dioxide
Has higher proportion of sodium oxide and calcium oxide compared to type 2 (treated soda lime glass)
Soda lime glass
Type 4 or non parenteral
Soda lime glass not for parenterals
USP TEST FOR GLASS (3)
Powdered glass test
Water attack test
Powdered glass
What is the test for highly resistant borosilicate glass?
Powdered glass test
What glass is water attack test used
Treated soda lime glass
In soda lime glass, what test is used
Powdered glass
What are the 2 problems fo containers
Leaching and sorption
This test is to evaluate the chemical; resistance of glass formulations by measuring the amount of alkali released from glass powder
Powdered glass test
To differentiate type 1 from type 3
Performed on ground/powdered glass to expose internal surface
Powdered glass test
What is the method for powdered glass test
titration
Indicator and titrant for powdered glass test and water attack test
Methyl red
0.020 N sulfuric aciid
Exposure of the glass with sulfur dioxide at what degree
121C
How many ml of sulfuric acid used in highly resistant borosilicate glass
1.0
How many ml of sulfuric acid used in soda lime glass
8.5
This test evaluate the hydrolytic stability of the container under more severe condition.
Water attack test
Limit of water attack test for treated sodlaime glass and corresponding mL
100 or less - 0.7
Over 100 - 0.2
Enumerate 6 quality control test for plastics
Leakage test
Collapsibility test
Clarity aqueous extract
Water vapor permeability test
Transparency test
Biologcal test
This test is filling the container with water and wit with intended closure and keeping it inverted at room temperature for 24 hrs
Leakage test
Acceptance criteria for leakage test
The test is passed if no sigh of leakage from the container
This test is applicable to containers which are squeezed for removing the contents
Collapsibility test
How is Collapsibility test conducted
By collapsing inward during use, yield at least 90% of its normal content at the required rate at flow at ambient temperature
What is the acceptance criteria for clarity aqueous extract
Extract should be colorless and free from turbidity
What is the measure of strips in clarity aqueous extrac
20 sq cm
After cutting the strips and placing it in a flask what is the next step in clarity aqueous exttract
Add 250 ml of distillers water and autoclave for 121 C for 30 mins
Water vapor permeability test acceptance criteria
Loss in weight of each container is NMT 0.2%
How many days in water vapor permeability test is the container allowed to stand and at what temprature
14 days at relative humidity of 60+_ 5% and temp of 20-25 C
What is the test solution for transparency test
Hydrazine sulfate and hexamin solution
In transparency test absorbance is measure at
640 nm and range within 0.73 to 0.43
4 biological test
Systemic injection
Intracutaneous test
Eye irritation test
Resistance to stress
What animal is used in systemic injection test
Albino mice
What should be observed in systemic injection test
Abnormal behavior convulsion, prostrations, loss in body weight
What animal is used in intra-cutaneous test
rabbits
what is observer for biological test
observe for erythema, edema neurosis for 24 48 72 hrs
any irritations in eyes due to sample is studied as compared to blank
eye irritation test
in resistance to stress water is acidified with
2M HCl
sample is accepted in resistance to stress test if
no break, or deterioration should occur for the sample to pass the test
may be due to chance assignable causes such as materials, machines, methods and men
errors
3 types of error in experimental data
random or indeterminate errors
systematic or determinate errors
gross errors
these are errors that affects the precision of measurements
random or indeterminate error
footnote
random errors are accidental and more or less intangible errors over which the operator has little if any control
What are common contributors for random errors
Fluctuation in temperature
Imperfections
fatigue of the observer
these are errors that affects the accuracy of the results
systematic or determinate error
It is a tangible one, the magnitude which can be determined or approximated
most common and most troublesome
Methodic errors
These arise from nonideal chemical or physical behavior of analytical systems
3 sources of systematic errors
Instrumental errors
Methodic Errors
Personal errors
caused by imperfection in measuring devices
Instrumental errors
these results from the careless ness inattention or personal limitaition of the analyst
personal errors
they can arise from the tendency of the analyst consistently to overtitrate or to undertitrate a solution because of the inablity to distinguish shades of color
personal errors
Systematic errors may be either____ or ___
Constant or proportional
are independent of the size of the sample being analyze
Constant errors
decrease or increase in proportion to the size of the sample
proprotional errors
errors leads to outliers
Gross errors
footnote
Outliers - results that appear differ markedly from all other data in a set of replicate measurements
this error is usually occasional
gross error
it is often large and may cause a result to be either high or low
gross error
an undesireable characteristic of a product
defect
defined as a failure to conform to specification
defecta
a unit of a product that contains one or more defects is called ___
defective
3 classification of defects
according to:
- measurability
- seriousness or gravity
- nature
2 defect according to measurability
variable defect
attributive defect
a defect which can be measured directly by instruments giving dimensions of length, wight
variable defect
a defect which cannot be measured directly by instruments
attributive/attribute defect
defects according to seriousness or gravity (3)
critical defect
major defect
minor defect
defect which may endager life or property and may render the product nonfucntional
critical defect
a defect which may affect the function of the object. may render the product useless
major defect
a defect which does not endanger life nor it will affecy the function but nevertheless remains a defect since it is outside the prescribe limits
minor defect
3 defects according to nature
ocular defect
internal defect
performance defect
a defect that is visible
ocular defect
a defect that is not seen although present
internal defect
a defect in function
performance defect
Bottle defects can also be categorized in 3 defects
critical defect
major defect
minor defect
critical defects of bottle defects (10)
bird swings and spikes
overpress
filament
split
check
freaks
poor distribution
soft blister
cracks
pinhole
a long thin strands inside bottle that would break off
bird swings and spikes
run extending from inside edge of the finish and sometimes sharp
overpress
hair like string inside the bottle
filament
an open crack from the top of the finish extending downward
split
shallow small surface crack
check
group of checks are called
crizzled finish
odd shapes and conditions that render the container completely unusable
freaks
uneven thickness of glass
poor distribution
thin blister in or near the sealing surface or anywhere on the bottle
soft blister
partial fractures on the heel area or shoulder
cracks
opening that causes leakage
pinhole
Major defects in bottle (5)
chipped finish
stone
mismatch
fin
out-of-round finish
pieces broken out of the op edge in the manufacturing process
chipped finish
small inclusion center portion of the bottom
stone
1/2 of the finish may be sifted to the side or upward of the other half
mismatch
seam on the top surface or down the side of the parting line
fin
pinched, flattened or oval finish
out of round finish
minor defects in bottle
(10)
sunken or dropped shoulder
tear
washboard
hard blister
heel top
mark
stuck
long neck
seeds
not fully blown
sunken or dropped shoulder
similar to check but opened up
tear
a wavy horizontal line in the body of the bottle
washboardde
deeply imbedded blister not easily broken
hard blister
heavy glass on one side of the bottom
heel top
a brush mark of fine vertical taps
mark
rough spot left after putting apart bottles that touch while still soft aND STICKY
stuck
sketched out neck resulting from bottles too hot when picked up
long neck
