Packaging Flashcards
(47 cards)
1
Q
When would tertiary packaging be used?
A
multiple units eg deliveries
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
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
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
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
6
Q
What are examples of single dose containers?
A
- glass ampoules
- infusion bags
- single dose syringes
- nebuliser ampoules
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
8
Q
What wavelength to amber bottles protect against?
A
290nm-450nm
9
Q
Why do containers need to be sealed?
A
protect againts air and moisture
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
11
Q
What is strip packaging?
A
tablets or capsules sealed between two same materials such as aluminium then heal sealed
protects against environment
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
13
Q
Describe properties of ointment jars.
A
- wide mouthed
- semi-solid preparations
- risk of contamination by patient
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
15
Q
When may repackaging be required?
A
compliance aid/blister packs
eg for elderly or patients with loads of meds
helps with compliance
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
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
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
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
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
