Lecture 13

Question 1

what are the four aspects included in quality control?

Answer 1

analysis of:
- geometry
- surface roughness and texture
- internal defects
- chemical composition

Question 2

how can you analyse the geometry?

Answer 2

optical scanning -> surface deviations from the CAD

Question 3

how can you analyse internal defects (2 ways). WHat is the rule of thumb for titanium?

Answer 3

• x-ray
• CT

Factor 1000 rule -> for a 50 mm wide sample, you can achieve 50 microns resolution

Question 4

what are the three main sterilisation method groups?

Answer 4

heat
chemicals
radiation

Question 5

list some requirements for packaging

Answer 5

• sterility maintenance until use
• barrier to microbial penetration
• resistance to physical damage
• provide for aseptic opening
• compatibility with sterilisation process
• ease of use by healthcare providers
• ease of manufacture
• regulatory compliance