packaging lecture 17 Flashcards Preview

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Flashcards in packaging lecture 17 Deck (22):
1

define packaging :

different compartments which surround the pharmaceutical product from the time of production to its use

2

what are the 5 functions of a pack?

- containment
- identification
- protection
- presentation and info
- convenience

3

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

4

which 4 hazards should a pack protect against?

- climate
- biological
- chemical
- physical

5

why is glass better than plastic?

glass is inert

6

what should all closures do?

- have an airtight seal
- seal against bacteria
- be inert and compatible to the product
- protect from hazards

7

what are the different layers in a lid/closure?

cardboard layer, foil, desiccant, opening

8

what is the difference between QC and QA?

QC - tests during manufacturing
QA - provides documents and records

9

what 7 things should a pack contain as info?

- storage instructions
- barcode
- dosing instructions
- ingredients
- safety info
- manufacturer
- content

10

in what 3 ways can a product be fake?

1. duplication
2. substitution
3. tampering

11

what are the 3 regulatory bodies involved in packaging?

FDA
MHRA
EMA

12

which drugs need child resistant packaging?

aspirin, paracetamol

13

define suitability?

one time test performed at the stage of packaging development to test:
materials compatibility
safety
protection
performance

14

what 2 main roles should a pack be?

inert and protective

15

How is glass made?

by heating silica, sodium carbonate and calcium carbonate
(other things can be added to make more hard/heat resistant etc)

16

what are the 4 types of glass according to the BP?

1. borosilicate neutral glass - most inert
2. soda lime glass - with SO2 to reduce leaching
3. soda lime glass - for large volumes
4. general purpose glass - poor quality, has impurities

17

what are the advantages of blow fill seal technology?

sterile, cheap, high quality

18

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

19

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

20

What special requirements do ferrous sulphate packs need and why?

White PVC (to protect from light)
desiccant (to protect from moisture)

21

What are the disadvantages of paper as packaging?

- no barrier properties
- moisture sensitive
- poor transparency

22

What are the advantages of pre-filled syringes

- accurate doses
- sterile
- low injection costs
- no need for preservatives