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Module 7 Lesson 1 Flashcards

1
Q

Is the science ,art amd technology of enclosing or protecting products or distribution, storage, sale, and use

A

packaging

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2
Q

Is the activities of designing and producing the container for a product

A

Packaging

It should not be reactive , additive or absorptive so as not to alter the safety, identity, strength, quality and purity of the product

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3
Q

Enumerate types of packaging materials (3)

A

Primary packaging components
Secondary packaging components
Tertiary packaging materials

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4
Q

Packaging materials which come n direct contact with the product itself

A

Primary packaging components

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5
Q

Packaging materials which do not come in direct contact with the product and serve as accessory to the primary packaging component

A

Secondary packaging

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6
Q

This packaging is used for bulk handling, warehouse storage and transport shipping

A

Tertiary packaging materials

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7
Q

Two types of special packaging

A

Unit-dose packaging
Device packaging

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8
Q

This packaging guarantees safer medication by reducing medication errors

A

Unit-dose packaging

May be useful in improving compliance with treatment

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9
Q

This type of packaging permits easier administration by means of devices such as prefilled syringes, dropper, transdermal delivery systems, pumps and aerosol sprays

A

Device packaging

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10
Q

Objectives of packging (7)

A

Physical protection
Barrier protection
Confinement or agglomeration
Marketing
Security
Convenience
Portion control

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11
Q

Objects enclosed in package may require protection

A

Physical protection

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12
Q

A barrier from oxygen, water vapor, dust is often required

A

barrier protection

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13
Q

Small objects are typically grouped together in one package

A

Containment or agglomeration

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14
Q

Packaging and labels can be used by marketers t encourage potential buyers to purchase the product

A

marketing

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15
Q

Packages can be made with improved tamper resistance to deter tampering and also can have tamper evident featured to help indicate tampering

A

Security

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16
Q

Packages can have features tha add convenience in distribution, handling, stacking, display, sale and reus

A

Convenience

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17
Q

To control usage

A

Portion control

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18
Q

Types of glass (4)

A

1 - highly resistant borosilicate glass
2 - treated soda lime glass
3 - soda lime glass
4 or NP (non parenteral) - soda lime glass

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19
Q

Glass that is suitable for all products and usually intended for parenteral admnistration

A

Highly resistant borosilicate glass

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20
Q

What is the chemical composition of highly resistant borosilicate glass

A

Silicon dioxide and boric dioxide

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21
Q

How to increase resistance of highly resistant borosilicate glass?

A

Treat with sulfur dioxide

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22
Q

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

A

Treated soda lime glass

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23
Q

How is treated soda lime treated

A

Under controlled temperature and humidity conditions

With sulfur dioxide or other dealkalizers - to neutralize the interior surface

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24
Q

Composition o soda lime glass

A

Silicon dioxide

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25
Has higher proportion of sodium oxide and calcium oxide compared to type 2 (treated soda lime glass)
Soda lime glass
26
Type 4 or non parenteral
Soda lime glass not for parenterals
27
USP TEST FOR GLASS (3)
Powdered glass test Water attack test Powdered glass
28
What is the test for highly resistant borosilicate glass?
Powdered glass test
29
What glass is water attack test used
Treated soda lime glass
30
In soda lime glass, what test is used
Powdered glass
31
What are the 2 problems fo containers
Leaching and sorption
32
This test is to evaluate the chemical; resistance of glass formulations by measuring the amount of alkali released from glass powder
Powdered glass test ## footnote To differentiate type 1 from type 3
33
Performed on ground/powdered glass to expose internal surface
Powdered glass test
34
What is the method for powdered glass test
titration
35
Indicator and titrant for powdered glass test and water attack test
Methyl red 0.020 N sulfuric aciid
36
Exposure of the glass with sulfur dioxide at what degree
121C
37
How many ml of sulfuric acid used in highly resistant borosilicate glass
1.0
38
How many ml of sulfuric acid used in soda lime glass
8.5
39
This test evaluate the hydrolytic stability of the container under more severe condition.
Water attack test
40
Limit of water attack test for treated sodlaime glass and corresponding mL
100 or less - 0.7 Over 100 - 0.2
41
Enumerate 6 quality control test for plastics
Leakage test Collapsibility test Clarity aqueous extract Water vapor permeability test Transparency test Biologcal test
42
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
43
Acceptance criteria for leakage test
The test is passed if no sigh of leakage from the container
44
This test is applicable to containers which are squeezed for removing the contents
Collapsibility test
45
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
46
What is the acceptance criteria for clarity aqueous extract
Extract should be colorless and free from turbidity
47
What is the measure of strips in clarity aqueous extrac
20 sq cm
48
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
49
Water vapor permeability test acceptance criteria
Loss in weight of each container is NMT 0.2%
50
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
51
What is the test solution for transparency test
Hydrazine sulfate and hexamin solution
52
In transparency test absorbance is measure at
640 nm and range within 0.73 to 0.43
53
4 biological test
Systemic injection Intracutaneous test Eye irritation test Resistance to stress
54
What animal is used in systemic injection test
Albino mice
55
What should be observed in systemic injection test
Abnormal behavior convulsion, prostrations, loss in body weight
56
What animal is used in intra-cutaneous test
rabbits
57
what is observer for biological test
observe for erythema, edema neurosis for 24 48 72 hrs
58
any irritations in eyes due to sample is studied as compared to blank
eye irritation test
59
in resistance to stress water is acidified with
2M HCl
60
sample is accepted in resistance to stress test if
no break, or deterioration should occur for the sample to pass the test
61
may be due to chance assignable causes such as materials, machines, methods and men
errors
62
3 types of error in experimental data
random or indeterminate errors systematic or determinate errors gross errors
63
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
64
What are common contributors for random errors
Fluctuation in temperature Imperfections fatigue of the observer
65
these are errors that affects the accuracy of the results
systematic or determinate error ## Footnote It is a tangible one, the magnitude which can be determined or approximated
66
most common and most troublesome
Methodic errors ## footnote These arise from nonideal chemical or physical behavior of analytical systems
67
3 sources of systematic errors
Instrumental errors Methodic Errors Personal errors
68
caused by imperfection in measuring devices
Instrumental errors
69
these results from the careless ness inattention or personal limitaition of the analyst
personal errors
70
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
71
Systematic errors may be either____ or ___
Constant or proportional
72
are independent of the size of the sample being analyze
Constant errors
73
decrease or increase in proportion to the size of the sample
proprotional errors
74
errors leads to outliers
Gross errors footnote Outliers - results that appear differ markedly from all other data in a set of replicate measurements
75
this error is usually occasional
gross error
76
it is often large and may cause a result to be either high or low
gross error
77
an undesireable characteristic of a product
defect
78
defined as a failure to conform to specification
defecta
79
a unit of a product that contains one or more defects is called ___
defective
80
3 classification of defects
according to: 1. measurability 2. seriousness or gravity 3. nature
80
2 defect according to measurability
variable defect attributive defect
81
a defect which can be measured directly by instruments giving dimensions of length, wight
variable defect
82
a defect which cannot be measured directly by instruments
attributive/attribute defect
83
defects according to seriousness or gravity (3)
critical defect major defect minor defect
84
defect which may endager life or property and may render the product nonfucntional
critical defect
85
a defect which may affect the function of the object. may render the product useless
major defect
86
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
87
3 defects according to nature
ocular defect internal defect performance defect
88
a defect that is visible
ocular defect
89
a defect that is not seen although present
internal defect
90
a defect in function
performance defect
91
Bottle defects can also be categorized in 3 defects
critical defect major defect minor defect
92
critical defects of bottle defects (10)
bird swings and spikes overpress filament split check freaks poor distribution soft blister cracks pinhole
93
a long thin strands inside bottle that would break off
bird swings and spikes
94
run extending from inside edge of the finish and sometimes sharp
overpress
95
hair like string inside the bottle
filament
96
an open crack from the top of the finish extending downward
split
97
shallow small surface crack
check
98
group of checks are called
crizzled finish
99
odd shapes and conditions that render the container completely unusable
freaks
100
uneven thickness of glass
poor distribution
101
thin blister in or near the sealing surface or anywhere on the bottle
soft blister
102
partial fractures on the heel area or shoulder
cracks
103
opening that causes leakage
pinhole
104
Major defects in bottle (5)
chipped finish stone mismatch fin out-of-round finish
105
pieces broken out of the op edge in the manufacturing process
chipped finish
106
small inclusion center portion of the bottom
stone
107
1/2 of the finish may be sifted to the side or upward of the other half
mismatch
108
seam on the top surface or down the side of the parting line
fin
109
pinched, flattened or oval finish
out of round finish
110
minor defects in bottle (10)
sunken or dropped shoulder tear washboard hard blister heel top mark stuck long neck seeds
111
not fully blown
sunken or dropped shoulder
112
similar to check but opened up
tear
113
a wavy horizontal line in the body of the bottle
washboardde
114
deeply imbedded blister not easily broken
hard blister
115
heavy glass on one side of the bottom
heel top
116
a brush mark of fine vertical taps
mark
117
rough spot left after putting apart bottles that touch while still soft aND STICKY
stuck
118
sketched out neck resulting from bottles too hot when picked up
long neck
119

analysis (7 decks)

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