packaging lecture 17 Flashcards
define packaging :
different compartments which surround the pharmaceutical product from the time of production to its use
what are the 5 functions of a pack?
- containment
- identification
- protection
- presentation and info
- convenience
what is the difference between primary, secondary and tertiary packs?
primary - in contact with drug
secondary - additional protection, for transport, contains info,
tertiary - for bulk handling and shipping
which 4 hazards should a pack protect against?
- climate
- biological
- chemical
- physical
why is glass better than plastic?
glass is inert
what should all closures do?
- have an airtight seal
- seal against bacteria
- be inert and compatible to the product
- protect from hazards
what are the different layers in a lid/closure?
cardboard layer, foil, desiccant, opening
what is the difference between QC and QA?
QC - tests during manufacturing
QA - provides documents and records
what 7 things should a pack contain as info?
- storage instructions
- barcode
- dosing instructions
- ingredients
- safety info
- manufacturer
- content
in what 3 ways can a product be fake?
- duplication
- substitution
- tampering
what are the 3 regulatory bodies involved in packaging?
FDA
MHRA
EMA
which drugs need child resistant packaging?
aspirin, paracetamol
define suitability?
one time test performed at the stage of packaging development to test: materials compatibility safety protection performance
what 2 main roles should a pack be?
inert and protective
How is glass made?
by heating silica, sodium carbonate and calcium carbonate
other things can be added to make more hard/heat resistant etc
what are the 4 types of glass according to the BP?
- borosilicate neutral glass - most inert
- soda lime glass - with SO2 to reduce leaching
- soda lime glass - for large volumes
- general purpose glass - poor quality, has impurities
what are the advantages of blow fill seal technology?
sterile, cheap, high quality
which types of metals are used for which packs?
aluminium for tubes and tin for tins (lead also used)
only these 3 metals as they are inert and resistant to oxidation and corrosion
Define laminate:
bonding of 2 materials together e.g. plastic and metal
- aluminium and plastic is v good as it’s light, protects from moisture, mechanically strong
What special requirements do ferrous sulphate packs need and why?
White PVC (to protect from light) desiccant (to protect from moisture)
What are the disadvantages of paper as packaging?
- no barrier properties
- moisture sensitive
- poor transparency
What are the advantages of pre-filled syringes
- accurate doses
- sterile
- low injection costs
- no need for preservatives
