Packaging Flashcards
When would tertiary packaging be used?
multiple units eg deliveries
What are requirements of primary packaging?
- 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
What mechanical, chemical, biological and climatic hazards are there?
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
What info is included on secondary packaging?
- 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
What are properties of tablet and medicine bottles?
tablet
- glass or plastic
- amber coloured
- child resistant cap
medicine
- amber coloured
- fluted amber bottle - child resistant cap
- dropper bottle
What are examples of single dose containers?
- glass ampoules
- infusion bags
- single dose syringes
- nebuliser ampoules
What are examples of multi dose containers?
- multi dose vials
- multi dose glass/plastic bottle
- pMDI
- dry powder inhalers
- cream/jar/bottle/tube
What wavelength to amber bottles protect against?
290nm-450nm
Why do containers need to be sealed?
protect againts air and moisture
What properties do blister packs have and what can they be sealed by?
- hermetic seal
- good barrier properties (metal excellent barrier, plastic coated PVC)
- tamper evident
What is strip packaging?
tablets or capsules sealed between two same materials such as aluminium then heal sealed
protects against environment
Describe the properties of tubes.
- either lacquered aluminium or LDPE/HDPE/PP (plastic)
- sealed at both end - pierce layer of foil to use
Describe properties of ointment jars.
- wide mouthed
- semi-solid preparations
- risk of contamination by patient
Why is patient pack dispensing preferred over repackaging?
- patient can access info
- less time consuming (dont need to make label and count units)
- lower risk of errors or cross contamination
When may repackaging be required?
compliance aid/blister packs
eg for elderly or patients with loads of meds
helps with compliance
What is packaging selection based on?
- dosage form
- shelf life
- dispensed or OTC
- cost - production and transport
- method of admin.
- product
- patient
What is glass made of and what can be added?
- 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
What are advantages of using glass for packaging?
- 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
What are disadvantages of glass for packaging?
- brittleness
- release of glass fragments = glass ampoules filteres
- contamination through cracks
- release of alkaline compounds
- cost
- weight
- leaching of glass components
- weatherisation (bloom)
What is weatherisation (bloom) of glass and what can be done?
- 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
What is type I glass, its properties and examples?
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)
What is type II and III glass and its properties and uses?
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
When can plastic be used in packaging?
- 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
Describe thermoplastics vs thermosetting plastics.
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
What do typical plastic containers contain?
- polymer
- polymerisation residues
- additives
- plasticizers
- fillers
- lubricants
- colouring agents
- antioxidants
- stabilisers
- UV absorbers
- processing aids
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
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
- stress cracking
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
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
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
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
Describe PCTFE.
poly(chlorotrifluoroethylene)
- clear plastic
- heat resistant
- excellent barrier properties eg blister packs
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
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
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)
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
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
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
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
Why are closures used?
- provide effective hermetic seal
- protection against external contaminants
- retain contents inside container
- provide effective microbiological seal
- provide suitable seal
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
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)
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
What different anti-countering strategies are there?
- overt measures
- covert measures
- forensic markers
- sterilisation and track and trace
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
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
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
