packaging lecture 17

Question 1

define packaging :

Answer 1

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

Question 2

what are the 5 functions of a pack?

Answer 2

• containment
• identification
• protection
• presentation and info
• convenience

Question 3

what is the difference between primary, secondary and tertiary packs?

Answer 3

primary - in contact with drug
secondary - additional protection, for transport, contains info,
tertiary - for bulk handling and shipping

Question 4

which 4 hazards should a pack protect against?

Answer 4

• climate
• biological
• chemical
• physical

Question 5

why is glass better than plastic?

Answer 5

glass is inert

Question 6

what should all closures do?

Answer 6

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

Question 7

what are the different layers in a lid/closure?

Answer 7

cardboard layer, foil, desiccant, opening

Question 8

what is the difference between QC and QA?

Answer 8

QC - tests during manufacturing

QA - provides documents and records

Question 9

what 7 things should a pack contain as info?

Answer 9

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

Question 10

in what 3 ways can a product be fake?

Answer 10

1. duplication
2. substitution
3. tampering

Question 11

what are the 3 regulatory bodies involved in packaging?

Answer 11

FDA
MHRA
EMA

Question 12

which drugs need child resistant packaging?

Answer 12

aspirin, paracetamol

Question 13

define suitability?

Answer 13

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

Question 14

what 2 main roles should a pack be?

Answer 14

inert and protective

Question 15

How is glass made?

Answer 15

by heating silica, sodium carbonate and calcium carbonate

other things can be added to make more hard/heat resistant etc

Question 16

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

Answer 16

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

Question 17

what are the advantages of blow fill seal technology?

Answer 17

sterile, cheap, high quality

Question 18

which types of metals are used for which packs?

Answer 18

aluminium for tubes and tin for tins (lead also used)

only these 3 metals as they are inert and resistant to oxidation and corrosion

Question 19

Define laminate:

Answer 19

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

Question 20

What special requirements do ferrous sulphate packs need and why?

Answer 20

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

Question 21

What are the disadvantages of paper as packaging?

Answer 21

• no barrier properties
• moisture sensitive
• poor transparency

Question 22

What are the advantages of pre-filled syringes

Answer 22

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