Packaging of medicines

Question 1

Why should packaging provide a suitable degree of protection?

Answer 1

To minimise loss of contents, not interact chemically or physically with the contents

Question 2

Container attributes

Answer 2

Cost, provide protection, acceptable presentation, adequate identification information, patient compliance and convenience

Question 3

Mechanical hazards

Environmental hazards

Answer 3

Shock/ impact, compression, vibration, abrasion, puncture

Moisture, temperature, pressure, light, atmospheric gases, particulate airborne contamination

Question 4

Climatic testing conditions for long term stability

Answer 4

ICH accelerated storage testing, 6 months at 40c and 75% RH

Question 5

Light

Light protection

Answer 5

The shorter the wavelength the greater the energy, test coloured glass containers at 290-450nm
Use dyes/pigments in capsule shell or tablet film coat that absorb strongly at wavelength of light causing problem, pack dosage form in an opaque primary and secondary container

Question 6

Plastic containers performance requirements

Answer 6

Ingredients in contact are not absorbed or adsorbed and do not migrate into or through the plastic, material does not release enough substances to affect stability or risk toxicity

Question 7

Bags or bottles requirements

Answer 7

Impermeable to microorganisms, transparent, flexible, site for secure connection, withstand tension, sterilization and accidental freezing

Question 8

Parenteral containers

Answer 8

Resistance to centrifugation, stretching, leakage and vapour permeability, must also empty under pressure, fill in 8 minutes, resistance to temperature variations, transparency, extractable matter, blow fill seal packs used for ear, eye and nose liquids, low volume sterile liquids and high volume parenteral liquids

Question 9

Glass

Answer 9

Transparent, easy to clean, easy to make good closures, needs to be kept clean before filling, bulky, heavy, fragile

Question 10

Paper based products

Answer 10

Low costs, easy to print on, good secondary container, not suitable as a Viagra container

Question 11

Hydrolytic resistance test for glass

Answer 11

Rinse and fill with water (90% of volume), autoclave following heating holding and cooling cycle, titrate with 0.01M HCl vs methyl red solution as indicator, limits given by capacity of container and type of glass

Question 12

Test for powdered glass

Answer 12

Pestle and mortar, rinse and dry container, smash and sieve, retain particles 250-425 micrometres,
Remove metal particles with magnet, wash 6 times with acetone and dry
Conical mask with 100mL carbon dioxide free water, autoclave 30 mins at 121c, titrate as before
Limits not more than: type 1 2mL, type 2 or 3 17mL, type 4 30mL

Question 13

Resistance to thermal shock for blood and components

Answer 13

Place empty in autoclave, raise temperature to 140c in 30 minutes then leave for 30 minutes, place empty in an oven and raise temperature to 250c in 30 minutes and leave for one hour,
Fill to 70% capacity with 0.9% sodium chloride solution, cool to -20c, keep for 24 hours, then fill with tap water and place in two water baths with a temperature difference of 40c
Glass does not crack, break or split

Question 14

Resistance to centrifugation

Answer 14

Use containers that have been cooled and now at room temperature, fill with water to maximum marked volume, centrifuge, accelerate to at least 200g for at least one minute, must resist for 30 minutes

Question 15

Rubber closure tests

Answer 15

Penetrability- force required for hypodermic needle not greater than 10N
Fragmentation- 12 vials, pierce seal with needle, empty liquid and filter, no more than 5 particles
Self sealing- 10 filled vials, pierce seal with needle, immerse in methylene blue solution, reduce pressure by 27 kPa for 10 minutes, restore to atmospheric after 30 minutes, no vials with coloured contents