Packaging Flashcards
Why is the primary pack the most important?
because it has direct contact with the drug
QC is only performed on the final pack-product combination. True or false?
false, on all packs used for intermediate products too
Product-pack suitability is a “one time” test, usually performed at the stage of packaging development. True or false?
True
The product packaging material should guarantee the physical protection and prevent mechanical damages to the medicine e.g. cracks. True or false?
True
The pack material in contact with the formulation must be inert. True or false?
True
Type I glass is the most inert glass and the best pharmaceutical grade. True or false?
True
Plastic is impermeable to gas. True or false?
False, it’s a gas permeable material
What are the main advantages of laminates combining aluminium and plastic?
mechanical strength, light protection, moisture protection
What are the disadvantages of using paper in packaging?
poor transparency, highly hygroscopic so moisture sensitive, no barrier properties against moisture, gases and odours
What is the primary pack defined as?
container of the product, is in direct contact and protects the product
What does the secondary pack do?
provides additional physical protection, helps with transport, contains important information about medicine and is aesthetically pleasing
What is the purpose of a tertiary pack?
used for bulk handling and shipping
What characteristics should be considered when designing a pack?
containment, protection (against physical, chemical and environmental factors), presentation and information, identification and convenience
What are the principal packaging materials and what are they commonly used for?
metal (tubes, tins, foil laminates, closures or sealings), glass (bottles), plastics (bottles, tubes, single dose container for liquids, blister packs, bottle closures), paper & laminates
How can plastics be made to prevent photodegradation?
polymers prepared using dyes to give partial or total filtering to light
What are the principal properties of metals?
not gas permeable, protect from light, aluminium, tin and tin coated lead are resistant to corrosion and oxidation
What type of information should be on the pack?
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
What are the characteristics of a closure?
to provide a totally hermetic seal, provide effective microbiological seal, be inert and compatible to product, protect from hazards
How can a closure be designed to control moisture?
cardboard layer, foil seal, desiccant for humidity etc
What other types of closure are available?
child resistant, compulsory for some drugs such as aspirin and paracetamol
What is the difference between smart packaging, intelligent packaging and active?
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
When using glass as a packing material, what are the 4 different classifications available
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
Why is it important to know that polymers are gas permeable?
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
