Packaging

Question 1

Why is the primary pack the most important?

Answer 1

because it has direct contact with the drug

Question 2

QC is only performed on the final pack-product combination. True or false?

Answer 2

false, on all packs used for intermediate products too

Question 3

Product-pack suitability is a “one time” test, usually performed at the stage of packaging development. True or false?

Answer 3

True

Question 4

The product packaging material should guarantee the physical protection and prevent mechanical damages to the medicine e.g. cracks. True or false?

Answer 4

True

Question 5

The pack material in contact with the formulation must be inert. True or false?

Answer 5

True

Question 6

Type I glass is the most inert glass and the best pharmaceutical grade. True or false?

Answer 6

True

Question 7

Plastic is impermeable to gas. True or false?

Answer 7

False, it’s a gas permeable material

Question 8

What are the main advantages of laminates combining aluminium and plastic?

Answer 8

mechanical strength, light protection, moisture protection

Question 9

What are the disadvantages of using paper in packaging?

Answer 9

poor transparency, highly hygroscopic so moisture sensitive, no barrier properties against moisture, gases and odours

Question 10

What is the primary pack defined as?

Answer 10

container of the product, is in direct contact and protects the product

Question 11

What does the secondary pack do?

Answer 11

provides additional physical protection, helps with transport, contains important information about medicine and is aesthetically pleasing

Question 12

What is the purpose of a tertiary pack?

Answer 12

used for bulk handling and shipping

Question 13

What characteristics should be considered when designing a pack?

Answer 13

containment, protection (against physical, chemical and environmental factors), presentation and information, identification and convenience

Question 14

What are the principal packaging materials and what are they commonly used for?

Answer 14

metal (tubes, tins, foil laminates, closures or sealings), glass (bottles), plastics (bottles, tubes, single dose container for liquids, blister packs, bottle closures), paper & laminates

Question 15

How can plastics be made to prevent photodegradation?

Answer 15

polymers prepared using dyes to give partial or total filtering to light

Question 16

What are the principal properties of metals?

Answer 16

not gas permeable, protect from light, aluminium, tin and tin coated lead are resistant to corrosion and oxidation

Question 17

What type of information should be on the pack?

Answer 17

hazards the product creates, end use of the product, directions for use, mandatory warning, regulatory requirements such as batch number, expiry date, storage conditions etc

Question 18

What are the characteristics of a closure?

Answer 18

to provide a totally hermetic seal, provide effective microbiological seal, be inert and compatible to product, protect from hazards

Question 19

How can a closure be designed to control moisture?

Answer 19

cardboard layer, foil seal, desiccant for humidity etc

Question 20

What other types of closure are available?

Answer 20

child resistant, compulsory for some drugs such as aspirin and paracetamol

Question 21

What is the difference between smart packaging, intelligent packaging and active?

Answer 21

smart serves a purpose other than containment and protection. Intelligent transmits or gathers data or information about the product and active actively improves the product or its potential use

Question 22

When using glass as a packing material, what are the 4 different classifications available

Answer 22

Type I: borosilicate neutral glass –best pharmaceutical grade and most inert glass;

Type II: soda lime glass, sulfur dioxide treated surfaces to reduce glass components leaching to the pharmaceutical product;

Type III: soda lime glass, produced to contain large volumes (reduce the surface-to-volume ratio = minimise leaching);

NP (Type IV): general purpose glass, less quality with impurity

Question 23

Why is it important to know that polymers are gas permeable?

Answer 23

Means that different polymers have different transmission rates of gases and oxygen in specific. This is important when designing a pack pharmaceutical product sensitive to oxygen, as some polymers may not provide the required level of protection against oxidative degradation. PET has a low o2 transmission rate whereas LDPE has a high one