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Manuf > Packaging > Flashcards

Packaging Flashcards

1
Q

Economical means of providing presentation, protection, identification/information, containment, convenience and compliance for a product during storage, carriage, display and use until such time as the product is used or administered

A

Packaging

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2
Q

Packaging is the economical means of providing __________, _________, ________, _________, ________, and _______ for a product during storage, carriage, display and use until such time as the product is used or administered

A

presentation, protection, identification/information, containment, convenience and compliance

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3
Q

Packaging is the economical means of providing presentation, protection, identification/information, containment, convenience and compliance for a product during _________, ___________, ________ and _______ until such time as the product is used or administered

A

storage, carriage, display and use

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4
Q

Packaging is the __________ means of providing presentation, protection, identification/information, containment, convenience and compliance for a product during storage, carriage, display and use until such time as the product is used or administered

A

economical

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5
Q

Role of the Pack & Packaging

A

-needs emphasis
-must be economical
-must provide protection
-must provide acceptable presentation
-must contribute in terms of convenience and compliance

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6
Q

Packaging needs ____________ as the shelf life of all pharmaceutical products, irrespective of whether they are ethicals, semi-ethicals, or properietaries , is largely dependent on certain functions of the pack

A

emphasis

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7
Q

T/F: the shelf life of all pharmaceutical products, irrespective of whether they are ethicals, semi-ethicals, or properietaries , is largely dependent on certain functions of the pack

A

True

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8
Q

Packaging must be __________ and therefore contribute to overall profitability

A

economical

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9
Q

Packaging must provide protection against ______, __________, ______ and __________

A

climatic, biological, physical and chemical hazards

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10
Q

Packaging must provide an acceptable ____________ which will contribute to or enhance product confidence while at the same time maintaining adequate identification and information

A

presentation

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11
Q

Packaging must contribute in terms of convenience and __________

A

compliance

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12
Q

Shock or impact damage
Compression
Vibration
Abrasion
Puncture or piercing

A

Mechanical/Physical damages or hazards

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13
Q

Implies rough handling, where rapid deceleration occurs (drops, impacts

A

Shock/Impact damage

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14
Q

Shock can normally be reduced or overcome by various forms of ___________, _____________ more careful handling, etc

A

cushioning, restriction of movement,

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15
Q

_____________ can normally be reduced or overcome by various forms of cushioning, restriction of movement, more careful handling, etc

A

Shock

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16
Q

It should be noted that damage can occur to the pack or packaging material before it reaches the stage of a packed product

A

Shock/Impact damage

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17
Q

Top pressure or loading can distort and crush a pack and damage the product inside

A

Compression

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18
Q

Crushing of a carton can make a product unsealable even though no damage has occurred to the contents

A

Compression

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19
Q

Most likely to occur during stacking in the warehouse or in transit, where vibration adds a further hazard, compression of the pack can occur in other situation (i.e capping on a production line, when being carried home by the user, etc)

A

Compression

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20
Q

t/f: vibration adds a further hazard

A

true

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21
Q

Crushing of a carton can make a product _________ even though no damage has occurred to the contents

A

unsealable

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22
Q

components of product may separate, screw caps may loosen, labels or decoration may abrade, etc

A

Vibration

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23
Q

two variables of vibrations

A

frequency and amplitude

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24
Q

this results from both regular and irregular forms of vibration

A

Abrasion

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25
Q

Although Abrasion is from both regular and irregular vibration, it is listed separately because

A

visual appearance of the product or pack can be affected

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26
Q

rectangular bottle in a carton will move up and down and from side to side

A

Abrasion

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27
Q

A round bottle in the same circumstances will suffer from additional possibility of rotation

A

Abrasion

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28
Q

Many materials can suffer penetration from sharp objects

A

Puncture or Piercing

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29
Q

t/f: Puncture or Piercing can happen at any stage from basic material supply to the finished pack

A

T

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30
Q

reduce the risks of puncture or piercing

A

Adequate cushioning and/or resistance

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31
Q

Poor control of forklift trucks is a

A

puncture hazard

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32
Q

Moisture
Temperature
Pressure
Light
Atmospheric gases
Solid airborne contamination (particulates)

A

Climatic or environmental hazards

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33
Q

Liquid or water vapor may cause physical changes (eg dulling, softening, hardening, etc) or chemical change (hydrolysis, effervescence, et

A

Moisture

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34
Q

Also act as carrier for other contaminants

A

Moisture

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35
Q

T/F: Certain materials (including all plastics) are to some degree permeable to moisture

A

True

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36
Q

T/F: even screw closures which appear to make a good seal are likely to permit some passage of moisture depending on the sealing medium , the torque, the evenness and shape of the sealing surface, the aperture size and circumferential area of the container

A

True

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37
Q

T/F: Must be emphasized that only moisture loss may be critical to some products

A

F: either moisture loss or moisture gain may be critical to some products

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38
Q

produce a shower effect if the temperature is lowered sufficiently to reach dew point

A

High temperature coupled with high RH

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39
Q

generally represent an acceleration effect occasions can be found where deterioration increases at lower temperatures

A

Higher temperatures

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40
Q

T/F: Extremes of temperature (hot) or cycling temperature can cause deterioration to product and/or pack

A

false - hot and cold

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41
Q

Contamination from liquid moisture can then encourage mould and bacterial growth

A

Temperature

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42
Q

Air pressure differentials are frequently seen as a danger for materials sent by air using ______________ aircraft

A

unpressurized

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43
Q

Pressurized aircraft are pressurized to the equivalent to about 3000 m above sea level, hence there is a ________ bar differential compared to take off

A

-0.25

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44
Q

T/F: Goods filled in factories at sea level and sent to mountainous areas, or vice versa, will suffer from similar patterns (of pressure change)

A

T

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45
Q

T/F: goods packed in johannesburg, south africa, at 2000 m and then sent to durban at sea level will be exposed both a positive pressure and probably to a temperature change

A

T

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46
Q

Consists of wavelength from the UV zone through the visible to infrared

A

Light

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47
Q

a potential source of photochemical change, such changes may not always be visible

A

UV

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48
Q

may reduce penetration or filter out selected wavelength.

A

tin plate, foil, etc opacity and/or color

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49
Q

may also restrict light rays entering the pack

A

Additional use of UV absorbers in plastics

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50
Q

Include oxygen, carbon dioxide, nitrogen and any other airborne gases

A

Atmospheric Gases

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51
Q

Oxygen leading to oxidation is the ________

A

more obvious hazard

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52
Q

can cause a pH shift and/or lead to precipitation of some products

A

Carbon dioxide

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53
Q

Permeation of the common gases through plastic is typically in the ratio of

A

1:4:20 (nitrogen, oxygen and carbon dioxide)

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54
Q

most permeable (gas)

A

carbon dioxide

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55
Q

T/F: Odorous gases or volatile ingredients associated with perfumes, flavors and product formulations may also pass into or out of a pack

A

T

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56
Q

If a volatile ingredient is lost from a flavor, an ___________ _________ or ______ may result

A

unpleasant odor or taste

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57
Q

Particulates
May be carried by or in the atmosphere

A

Solid Airborne Contamination

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58
Q

most plastic contamination may be ______________ (increased/decreased) by electrostatic attraction under dry conditions

A

increased

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59
Q

particulates are drawn from the atmosphere by ___________

A

electrical charges

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60
Q

In the case of most plastic contamination may be increased by ______________ under dry conditions whereby particulates are drawn from the atmosphere by __________

A

electrostatic attraction; electrical charges

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61
Q

Microbiological
Other forms of infestation
Pilferage and adulteration risks

A

Biological Hazards

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62
Q

Microbiological
Other forms of infestation
Pilferage and adulteration risks

A

Biological Hazards

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63
Q

Packaging materials must be reasonably clean initially, and when put together to form a finished pack, restrict any further contamination as much as possible

A

Microbiological

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64
Q

In the case of sterile products the pack and its closure must maintain a
_______________ effective seal against microbiological ingress (i.e bacteria, molds, yeasts

A

100%

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65
Q

Ingress of yeasts is critical with ____________ based products

A

sugar

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66
Q

Molds will grow on ________ based materials, i.e. paper and board, if these are kept under __________ conditions

A

cellulose; humid

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67
Q

T/F: , other sources of infestation that can contaminate pharmaceutical products include attack by insects, termites, vermin, rodents, or any other bird-or animal-contaminating source

A

T

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68
Q

More likely to happen under poorly controlled condition of hygiene and housekeeping

A

Other Forms of Infestation

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69
Q

widely used for pharmaceutical products as a means of increasing and maintaining user confidence in the product and pack

A

Security seals

70
Q

used to indicate whether any product had been removed or replaced, rather than as a means of protecting against deliberate adulteration

A

Various seal

71
Q

T/F: Pilferage being a human failing is broadly another biological hazard

A

T

72
Q

Organoleptic changes
Increase in toxicity/irritancy
Degradation
Loss or gain of microbial effectiveness
Precipitation
Haze
Turbidity
Color changes
pH shifts

A

Chemical Hazards

73
Q

Stages in the Development of a Pack-Product Combination

A

Preformulation
Product formulation
Consideration of container materials
Pack feasibility tests
Formal stability tests
Ongoing stability
complaints

74
Q

Stage where a product is tested in a range of possible packs, usually over a range of conditions from -20 C to 45 C, together with some cycling conditions covering a temperature-humidity range

A

Pack Feasibility Tests

75
Q

are mandatory for plastics used for injectables and ophthalmic products

A

Extractive tests

76
Q

Feasibility tests usually extend over 1-12 months, with ________ months normally being the minimum before a decision to proceed with a certain pack is taken

A

3-6

77
Q

Once sufficient confidence has been generated in the pack-product combination,________________, on which the shelf life will be based, can proceed

A

formal stability tests

78
Q

Test conditions have been specified by the ________________- and adopted by the major regulatory bodies in Europe, USA, Japan and Asia

A

International Conference on Harmonization

79
Q

for long term stability

A

25C and 60%

80
Q

for accelerated stability

A

40 C and 75% RH

81
Q

3 large scale batches of product in each pack variant are stored at 25C and 60% RH for long term stability purposes and at 40 C and 75% RH for accelerated stability, and sampled over a period of _______ years

A

5

82
Q

Data generated are sent to the _______

A

regulatory authorities

83
Q

This consists of repeated stability on random batches from production in order to confirm that the shelf life does not change

A

Ongoing stability

84
Q

Final means of monitoring the success of the product and pack

A

Complaints

85
Q

T/F: Complaints are somewhat similar to the monitoring and recording of adverse reactions in that it is a safeguard to both the company producing the drug and the person receiving it

A

T

86
Q

Factors Influencing Choice of Pack

A

Product
The market
The distribution system
Manufacturing facilities

87
Q

Disadvantages of glass

A

friability and heavy weights

88
Q

surface treated soda glass

A

neutral (type 1

89
Q

soda or alkali glass

A

(types III and IV).

90
Q

equipment used to shape glass cane

A

tubular container

91
Q

glasses can be converted by

A

pressing, blowing into a mold, or the shaping of glass cane

92
Q

Silica composition

A

Type 1 - 66-74
Type 2 - 66-75

93
Q

Lime composition

A

(I) 1-5
(II) 6-12

94
Q

Soda compostiion

A

(I) 7-10
(II) 12.5-19

95
Q

Alumina composition

A

(I) 4-10
(II) 1-7

96
Q

Boric oxide composition

A

(I) 9-11

97
Q

In what type of glass is the alkaline element is largely eliminated by the use of boric acid oxide to neutralize the oxides of potassium and sodium

A

type I

98
Q

t/f: Neutral glass has a higher melt temperature (around 1750 C) and narrower working temperature range

A

True

99
Q

T/F: Neutral glass has a higher melt temperature (around 1750 C) and narrower working temperature range, which, together with higher cost of boric oxide and lesser likelihood of imperfections, usually a cost of 2-3x that of soda glass for containers ma. de by blow molding process

A

F: greater likelihood of imperfections

100
Q

made by treating the hot surface of type III glass with sulfur dioxide, ammonium sulfate or, in some countries, ammonium chloride

A

Surface treated glass

101
Q

Surface treated glass type

A

Type II

102
Q

invariably leaves a hazy surface bloom and so washing is essential prior to use

A

sulfurating or sulphating

103
Q

neutralizes some of the surface alkali radicals, producing a more surface

A

sulfurating or sulphating,

104
Q

Most widely used material where extraction of alkali metal ions is not critical to the product; Soda Glass

A

Type III

105
Q

Has the same composition to type III, but it cannot be guaranteed to have the same quality

A

Type IV

106
Q

_________ mainly used in metal containers

A

tin plate or aluminum

107
Q

widely used for collapsible tubes

A

Light, flexible gauges of metal (aluminum, tin and tin coated lead)

108
Q

widely used as foil in combination with other support or heat sealing polymer films

A

Thin gauges of aluminum

109
Q

The production of collapsible tubes made by a process known as

A

impact extrusions

110
Q

Tubes with elongated nozzles and a controlled orifice size are used for

A

eye ointments

111
Q

T/:F Nearly all caps on metal tubes are wadless, being plastic and moulded in polyethylene and polypropylene

A

True

112
Q

Plastics now used are related mainly to the

A

thermoplastic resins

113
Q

Most economic four are

A

polyethylene
polyvinyl chloride
polypropylene
polystyrene

114
Q

Disadvantages of Using Plastics

A
  • Possilbe extraction, interaction, adsorption, absorption, lightness and poor physical stability
  • All are permeable to some degree to moisture, oxygen, carbon dioxide etc
  • Most exhibit electrostatic attraction, allow penetration of light rays unless pigmentted black etc
  • stress cracking, panelling or cravitations, crazing, poor key print and poor impact resistance
115
Q

Phenomenon related to low density polythene and wetting agents, detergents and some volatile oils

A

Stress Cracking

116
Q

Whereby a container shows inward distortion or partial collapse owing to absorption of gases from the headspace, absorption causing swelling of the plastic, or dimpling following a steam autoclaving operations

A

Panelling or Cavitation

117
Q

Surface reticulation which can occur particularly with polystyrene and certain chemical substances

A

Crazing

118
Q

first causes crazing, which ultimately reaches a state of total embrittlement and disintegration

A

isopropyl myristate

119
Q

Certain plastic, such as the polyolefins, need penetrating before ink will key

A

Poor Key of Print

120
Q

have poor impact resistance

A

polystyrene and PVC

121
Q

how to improve plastic’s impact resistance

A

the inclusion of impact modifiers; rubebr for polysterine and methyl methacrylate butadiene for pvc

122
Q

Materials that found in a plastic materials fall into 4 categories :

A
  • polymer
  • residues associated with the polymerization process
  • additives (those constituents added to modify the plastic in a specific way) - any processing aids (which are used to assist any part of the process)
123
Q

Injection moulding, injection and extrusion blow moulding, injection stretch and extrusion stretch blow moulding, thermoforming, scrapless forming process, reaction injection molding and solid phase pressure forming, all of which relate mainly to thermoplastic resins

A

Fabrication of Plastics

124
Q

Covers labels, cartons, bags, outer, trays for shrink wraps, layer boards on pallets etc

A

Paper & Board

125
Q

are used for high % of pharmaceutical products

A

Cartons

126
Q

increasing display area, providing better stacking for display of stock items, coating of leaflets, physical protection.

A

Cartons

127
Q

used as an overwrapping material either for individual cartons or to collate a number of cartons

A

Regenerated cellulose film (Cellophane and Rayophane)

128
Q

t/f: paper, even when waxed, has relatively poor protective properties against moistures, both paper and board

A

t

129
Q

Supportive, barrier, heat seal and decorative

A

Films, Foils and Laminates

130
Q

Sachets, diaphragm seals for bottles, strip packs, blister packs, liners for boxes, either attached or loose bag in box systems and bags

A

Films, Foils and Laminates

131
Q

appear to offer reasonable degree of child resistance, particularly if the materials are opaque

A

Both blister and strip packs

132
Q

T/F: rubbers are made from either natural or synthetic sources

A

t

133
Q

T/F: Majority of rubber usage is related to the closure of sterile products

A

T

134
Q

offers advantages in terms of resealing, fragmentation and coring ), but is poorer in respect to ageing, multiple autoclaving, extractives, moisture and gas permeation and the absorption of preservative systems.

A

natural rubber

135
Q

descriptions for the means by which particles are created when a needle is passed through a rubber

A

coring

136
Q

improve reseability, fragmentation and coring

A

natural rubber

137
Q

contains vulcanizing agents (many of which are sulfur based), accelerators, fillers, activators, pigments, anti-oxidants, lubricants, softeners or waxes

A

rubber formulations

138
Q

Main types of rubber

A

natural rubber, neoprene, nitrile, butyl-, chlorobutyl-, bromobutyl and silicone

139
Q

most expensive and inert, is readily permeable to moisture, gases and absorbent to certain preservatives

A

Silicone

140
Q

are likely contain more additives than plastics, therefore tested by basically similar extractives and product contact procedures before they are used for injectable or IV products

A

Rubber

141
Q

are also found in aerosols and metered dose pump system

A

Rubber gaskets

142
Q

Providing a seal frequently depends on the marriage of a hard material with a softer, more resilient one, so that the former makes a physical impression on the latter

A

Closures

143
Q

To provide a totally hermetic seal
To provide an effective microbiological seal
To provide an effective seal which is acceptable to the product

A

Functions of a closure

144
Q

General consideration for closure

A

-must be resistant and compatible with the product
-readily openable and resealed if of a reclosable
-be capable of high speed application
-decoarative
-offer additional functitons
-prevent limit exchange with outside temp

145
Q

Physical compression systems

A

Screw caps
Plug in
Push over

146
Q

– inmetal or plastic; prethreated or rolled on, with or without a wadding system

A

Screw caps

147
Q

friction push in fit

A

Plug in

148
Q

where a flanged or raised ring portion is pressed over a bead or lip

A

Push over

149
Q

Placing a dessicant in a pack stored under high RH and detecting any moisture gain

A

Determination of closure efficiency

150
Q

Putting liquid inside the pack, storing at high temperature and low RH, and then detecting any moisture loss as a reduction in weight

A

Determination of closure efficiency

151
Q

Holding the empty pack under water, applying a vacuum and observing for leakage or liquid ingress. Adding a dye and wetting agent to the water may assist the defection of leaks

A

Determination of closure efficiency

152
Q

Putting liquid in the pack, inverting and applying a vacuum. A poor seal is detected by liquid seeping or leaking out

A

Determination of closure efficiency

153
Q

Checking that cap-removal torque is satisfactory

A

Determination of closure efficiency

154
Q

Checking on compression ring seal in cap liner when the system contains a liner or lining compound

A

Determination of closure efficiency

155
Q

the length of time that temperature and pressure are applied

A

dwell

156
Q

T/F: in heat seals, Factors (temp. pressure, dwell, cooling) have to be controlled

A

T

157
Q

Main heat sealants include

A

polyethylene, wax coating, PVdC, Surlyn ionomer, selected vinyl based products and certain types of modified polypropylene

158
Q

Other Sealing Methods

A

Ultrasonics, high fequency welding, hot air welding and by other heat sources (flame, infrared, induction, etc)

159
Q

products packed on production lines include such items as unit and multidose packs, closable and non-reclosable packs, sterile products produced aseptically or by terminal sterilization, or non-sterile products with or without degree of microbiological control, preformed containers which have to be filled and sealed

A

Filling

160
Q

T/F: filling may be fauirly conventional and involve unscrambling, cleaning, filling, closuring, labeling, cartoning, outerization and finally palletization, or be selective to a specialist operation

A

t

161
Q

printing, batch coding, expiry dating and incorporation of administration aids

A

aditional operations for filling

162
Q

labor, planned maintenance, staff training, online quality control, facilities for batch coding and expiry dating where relevant, constant delivery of an adequate supply of materials to the agreed specification on to the line, and removal of the finished product from the line

A

Organization of packaging lines

163
Q

Defined procedures for cleaning, start up and close down of the line, plus full documentation on both procedures and materials to be handled and environmental control, which all form part of CGMP

A

Organization of packaging lines

164
Q

tablets, capsules, are counted by

A

resolving disc, slat counter, breaking a beam of light

165
Q

volume using an auger or filling cup, or by weight using a bulk feed plus trickle top up

A

Powder or granular products

166
Q

filled volumetrically either by a piston type filler or gravity feed

A

Cream and ointment type products

167
Q

filled by piston filler, volume cup method using a pressure or gravity feed

A

Liquid products

168
Q

used variety of materials (metal, glass coated glass or plastic as containers and combinations of metal, plastic, and rubber for the valve). Comes into existence once it has been filled with a product and pressurized with a propellant

A

Aerosols

169
Q

Aerosols are pressurized with a

A

propellant

170
Q

divided into small volume, large volume injections and dialysis solution. Glass, plastic, rubber

A

Parenterals

Manuf (12 decks)

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