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SoM 2 sim > Packaging > Flashcards

Packaging 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?

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?

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?

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?

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?

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.

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
Q

What do typical plastic containers contain?

A
  • polymer
  • polymerisation residues
  • additives
    • plasticizers
    • fillers
    • lubricants
    • colouring agents
    • antioxidants
    • stabilisers
    • UV absorbers
  • processing aids
26
Q

What are advantages of plastic containers?

A
  • low cost
  • low particle release
  • light in weight
  • heat sealable
  • easily moulded
  • multipurpose
  • clear or opaque
  • mostly resistant to shocks
27
Q

What are disadvantages of plastics?

A
  • 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
Q

Describe PE.

A

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
Q

Describe PP.

A

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
Q

Describe PVC.

A

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
Q

Describe PVDC.

A

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
Q

Describe PCTFE.

A

poly(chlorotrifluoroethylene)

  • clear plastic
  • heat resistant
  • excellent barrier properties eg blister packs
33
Q

Describe PS.

A

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
Q

Describe PET.

A

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
Q

What are rubbers and what are they used for?

A

elastomers (elastic polymers) and additives

used in closures - soft and easy to mould (adopt shape of container to provide tight seal)

36
Q

What is the source, exampls and advantages of natural and synthetic elastomers?

A

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
Q

When are metals used in containers and closures?

A

containers

  • collapsible tubes
  • pMDI canisters
  • pouches, blister and strip packs

closures

  • rolled on closures
  • rolled on pilfer proof closures
  • foil caps
38
Q

What are advantages vs disadvantages of metals?

A

+

  • 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
Q

What are advantages vs disadvantages of paper and cardboard?

A

+

  • 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
Q

Why are closures used?

A
  • provide effective hermetic seal
    • protection against external contaminants
    • retain contents inside container
  • provide effective microbiological seal
  • provide suitable seal
41
Q

What should you consider when thinking about closures?

A
  • 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
Q

Desctibe the different types of closures.

A
  • 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
Q

What is the goal of anti-counterfeiting strategies?

A

prevent and/or detect counterfeiting

permit authentication of a product by

  • regulatory agencies
  • pharmaceutical industry
  • general public
44
Q

What different anti-countering strategies are there?

A
  • overt measures
  • covert measures
  • forensic markers
  • sterilisation and track and trace
45
Q

What are overt strategies, advantages, disadvantages and examples?

A

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
Q

What are covert strategies, advantages, disadvantages and examples?

A

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
Q

What are forensic markers, advantages, disadvantages and examples?

A

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 (21 decks)

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