SoM 2 sim > Packaging > Flashcards

Packaging Flashcards

(47 cards)

Study These Flashcards
1
Q

When would tertiary packaging be used?

A

multiple units eg deliveries

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2
Q

What are requirements of primary packaging?

A
  • be compatabile with content and protect
  • provide info - expiry date, batch no.
  • child resistant, but easy to open and reseal
  • tamper resistant or offer proof of tampering
  • fit for purpose
  • not leak or allow diffusion/permeation of product
  • be strong enough for handling
  • not be altered by formulation
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3
Q

What mechanical, chemical, biological and climatic hazards are there?

A

mechanical: shock, impact, abrasion, vibration, puncture
chemical: asdorption, loss of volatiles, alteration in organoleptic properties due to permetaion of volatile/odorous compounds
biological: micro-organism contamination, macroorganism infestation, pilferae, adulteration
climatic: temp, moisture, pressure, light, atmospheric gases, airborne particulates

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4
Q

What info is included on secondary packaging?

A
  • product name
  • type of product
  • quantity/strength/BN
  • ROA
  • date of manufacture
  • expiry
  • storage instructions
  • contarindications
  • MA/ML numbers
  • legal classification
  • manufacturers name/address
  • barcode
  • warnings
  • formulation details eg ingredients
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5
Q

What are properties of tablet and medicine bottles?

A

tablet

  • glass or plastic
  • amber coloured
  • child resistant cap

medicine

  • amber coloured
  • fluted amber bottle - child resistant cap
  • dropper bottle
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6
Q

What are examples of single dose containers?

A
  • glass ampoules
  • infusion bags
  • single dose syringes
  • nebuliser ampoules
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7
Q

What are examples of multi dose containers?

A
  • multi dose vials
  • multi dose glass/plastic bottle
  • pMDI
  • dry powder inhalers
  • cream/jar/bottle/tube
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8
Q

What wavelength to amber bottles protect against?

A

290nm-450nm

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9
Q

Why do containers need to be sealed?

A

protect againts air and moisture

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10
Q

What properties do blister packs have and what can they be sealed by?

A
  • hermetic seal
  • good barrier properties (metal excellent barrier, plastic coated PVC)
  • tamper evident
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11
Q

What is strip packaging?

A

tablets or capsules sealed between two same materials such as aluminium then heal sealed

protects against environment

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12
Q

Describe the properties of tubes.

A
  • either lacquered aluminium or LDPE/HDPE/PP (plastic)
  • sealed at both end - pierce layer of foil to use
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13
Q

Describe properties of ointment jars.

A
  • wide mouthed
  • semi-solid preparations
  • risk of contamination by patient
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14
Q

Why is patient pack dispensing preferred over repackaging?

A
  • patient can access info
  • less time consuming (dont need to make label and count units)
  • lower risk of errors or cross contamination
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15
Q

When may repackaging be required?

A

compliance aid/blister packs

eg for elderly or patients with loads of meds

helps with compliance

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16
Q

What is packaging selection based on?

A
  • dosage form
  • shelf life
  • dispensed or OTC
  • cost - production and transport
  • method of admin.
  • product
  • patient
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17
Q

What is glass made of and what can be added?

A
  • silica
  • limestone (calcium carbonate)
  • soda ash (sodium carbonate)
  • cullet - broken glass

additives for:

  • hardness
  • heat shock resistance
  • opacity/clarity
  • colour
    • amber colour: iron, carbon, manganese oxides and sulphur containing compounds
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18
Q

What are advantages of using glass for packaging?

A
  • relatively inert
  • impervious to air
  • impervious to moisture = good barrier properties
  • protects from loss of volatiles
  • easy inspection of content
  • can be tinted to block harmful light rays
  • easy to clean
  • easy to sterilise by heat
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19
Q

What are disadvantages of glass for packaging?

Study These Flashcards
A
  • brittleness
    • release of glass fragments = glass ampoules filteres
    • contamination through cracks
  • release of alkaline compounds
  • cost
  • weight
  • leaching of glass components
    • weatherisation (bloom)
20
Q

What is weatherisation (bloom) of glass and what can be done?

Study These Flashcards
A
  • appearance of white, opaque stains on glass
    • storage at high temp/humidity or under conditions where they fluctuate
  • migration of carbonate crystals on glass surface
    • more problematic for type II hlass (soda lime)
  • can be reduced by soaking in hot water or dilute acid solution
21
Q

What is type I glass, its properties and examples?

Study These Flashcards
A

borosilicate glass

  • most inert
    • lowest risk of leaching
  • low coefficient of thermal expansion
    • resistance to sudden temp changes - good for heat sterilisation
  • expensive

eg ampoules, injection vials (suitbale for packaging slightly acidic solutions)

22
Q

What is type II and III glass and its properties and uses?

Study These Flashcards
A

both soda lime glass

type II is treated (sulphur dioxides) = lower risk of leaching; used for aqueous solutions (slightly acidic/neutral)

type III is similar to food packaging (NP glass); used for non aqueous parenterals, powders for injection, large volume non parenteral

23
Q

When can plastic be used in packaging?

Study These Flashcards
A
  • packaging of tablets, capsules; rigid bottles
  • eye drops, nasal sprays; squeezable
  • as jars or flexible tubes
  • in blister or strip backs
  • infusion bags and for packaging of SVPs
  • closures for bottles
24
Q

Describe thermoplastics vs thermosetting plastics.

Study These Flashcards
A

thermoplastics:

  • can be remoulded and heated more than once
  • melt when heated, harden when cooled
  • free polymer chains eg PE, PS, PPE, PET, PVC, nylon, acrylic

thermosetting:

  • can be heated and moulded once
  • cross linked polymer chains eg epoxides, polyester resin, urea formaldehyde
25
What do typical plastic containers contain?
* polymer * polymerisation residues * additives * plasticizers * fillers * lubricants * colouring agents * antioxidants * stabilisers * UV absorbers * processing aids
26
What are advantages of plastic containers?
* low cost * low particle release * light in weight * heat sealable * easily moulded * multipurpose * clear or opaque * mostly resistant to shocks
27
What are disadvantages of plastics?
* not as inert as type I glass * stability issues * stress cracking * wetting agents, oils, organic solvents (LDPE) * distortion * eg dimpling during autoclaving * sensitivity to heat * soften under heat sterilisation * electrostatic charge * leaching of additives * adsorption - loss of preservative * poor barrier properties to sun and gas
28
Describe PE.
poly(ethylene) * good compatability with drugs but can sorb preservatives * poor odour barrier, permeable to ocygen * LDPE: clear and flexible * HDPE: strong, rigid, translucent, lower permeability, heat resistant, can be pigmented
29
Describe PP.
poly(propylene) * clear, strong, rigid * heat resistant and excellent barrier to moisture * lower risk of adsorption and less additives than PE * better barrier to odours than PP * good resistance to crackign when bent
30
Describe PVC.
poly(vinyl chloride) * variable rigidity, clear and glossy * plasticizers added to improve flexibility eg iv bags * heat sensitive * poor impact resistant - imporved by additives * resistant to oils, fats, flavouring
31
Describe PVDC.
poly(vinylidene chloride) * best barrier to moisture, gases, flavours and odours * mixed with other plastics to imporve barrier properties * heat resistant, clear, flexible * excellent barrier properties * eg blister packs
32
Describe PCTFE.
poly(chlorotrifluoroethylene) * clear plastic * heat resistant * excellent barrier properties eg blister packs
33
Describe PS.
poly(styrene) * crystal: clear, strong, rigid but brittle * PS foam: cushion, insulation * poor impact resistance, improved by additives * poor barrier to moisture, gases = poor chemical resistance * insufficient heat resistance to resist autoclaving * good for general purpose use - bottles for tablets/capsules
34
Describe PET.
poly(ethylene terephthalate) [polyester] * clear and strong * good resistance to high temps * sterilisation possible * good barrier to moisture, gases, oils, chemicals * popular for cough syrup bottles
35
What are rubbers and what are they used for?
elastomers (elastic polymers) and additives used in closures - soft and easy to mould (adopt shape of container to provide tight seal)
36
What is the source, exampls and advantages of natural and synthetic elastomers?
natural * source: rubber trees * example: latex * better resealing properties, better resistance to fragmentation synthetic * source: petrochemicals * example: neoprene, nitrile, butyl, silicone (inert, poor barrier) * better barrier to moisture, gases, better resistance to ageing and autoclaving, lower risk of preservative adsorption
37
When are metals used in containers and closures?
containers * collapsible tubes * pMDI canisters * pouches, blister and strip packs closures * rolled on closures * rolled on pilfer proof closures * foil caps
38
What are advantages vs disadvantages of metals?
+ * impermable to light, moisture and gases * rigid and shock resistant * light weight vs glass * heat resistant * opaque * imprinted labels on foil - * cheaper than glass * chemical reactivity * opacity
39
What are advantages vs disadvantages of paper and cardboard?
+ * low cost * tailored for application * easy to recycle, non toxic * easy to cut and fold * rigid and strong (cardboard) - * poor barrier properties * moisture sensitive * requires additives to be sealed * poor transparency
40
Why are closures used?
* provide effective hermetic seal * protection against external contaminants * retain contents inside container * provide effective microbiological seal * provide suitable seal
41
What should you consider when thinking about closures?
* compatability * with product and product/air space * barrier properties * ease of use * resistance to processing * maintains integrity even when process at high speed * appearance * additional functionalities * may help measure dose * child resistance and evidence of tampering
42
Desctibe the different types of closures.
* screw caps (plastic/metal) - seal (tin plated or Al) produced by liner inside * lug caps (vacuum pressure closing - idea of tampering) * crown caps - crimped closure (glass beverages) * roll on (hermetic seal, easily removed and resealed) * roll on plifer proof closures (temper evident - band broken) * child resistant caps (push and turn) * tamper evident (band removed before opening)
43
What is the goal of anti-counterfeiting strategies?
prevent and/or detect counterfeiting permit authentication of a product by * regulatory agencies * pharmaceutical industry * general public
44
What different anti-countering strategies are there?
* overt measures * covert measures * forensic markers * sterilisation and track and trace
45
What are overt strategies, advantages, disadvantages and examples?
target: end user eg holograms, colour shifting inks/films, sequential product numbering, on product marking + * product verified by user * can be decorative and a deterrent - * use must be educated * easy to mimic * increase production cost * false assurance
46
What are covert strategies, advantages, disadvantages and examples?
hidden; target: brand owner eg: invisible ink, embedded images, digital watermarks, odour + * simple and low cost * easy to add and modify * no approval required * can be in house or supplied - * easy to copy * risk of being compromised * higher cost if more secure measure
47
What are forensic markers, advantages, disadvantages and examples?
target: brand owner eg taggants, isotope ratio + * highly secure * allows authentication * not detectable under nroaml condiitons - * cost * proprietary techniques * increased risk of compromise with wider use * requires access to specific equipment * availability may be limited
SoM 2 sim
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