Packaging: Basic Requirement

Question 1

Packaging material must be cleared by _____

Answer 1

FDA

Question 2

Packaging material must be __________ and able to __________ sterilization conditions.

Answer 2

1. compatible
2. withstand

Question 3

Packaging material must include __________ (3 words)

Answer 3

Information for use (IFU)

Question 4

Packaging material must allow for?

Answer 4

Adequate air removal, penetration of sterilant and evacuation

Question 5

What should packaging materials be a barrier to?

Answer 5

Microorganisms, dust, and vermin

Question 6

Packaging material must be strong enough to withstand _________ (2 words)

Answer 6

normal handling

Question 7

Packaging material must create a complete ___________ ( 2 words) that is __________

Answer 7

1. seal/closure
2. tamper-evident

Question 8

Packaging material must _________ its __________ until the time it is open

Answer 8

1. maintain
2. integrity

Question 9

Packaging material must allow for ____________ (2 words) of the sterilized medical device

Answer 9

aseptic removal

Question 10

Name 3 efficient characteristics of packaging material

Answer 10

1. Easy to use
2. Flexible
3. Conforms to the contents without excessive memory

Question 11

What does it mean for packaging to have “excessive memory”?

Answer 11

For packaging to spring back to its shape assumed when wrapped

Question 12

Packaging material must be capable of being adequately _________ and __________

Answer 12

1. sealed
2. labeled

Question 13

The seal of packaging material must be ___________ and able to seal only _____

Answer 13

1. tamper-proof
2. once

Question 14

Packaging material must be non-_______, non-________ and economical and available as needed

Answer 14

1. non-linting
2. non toxic