Contamination control

Question 1

What are the 6 sources of microbial contamination in an aseptic suite?

Answer 1

People
Workspace
Starting materials & consumables
Storage
Aseptic process
Administration of product

Question 2

How many skin particles are shed per minute while walking?

Answer 2

5,000,000

Question 3

Name 3 non spore forming bacteria which can affect air quality

Answer 3

Staphylococcus
Streptococcus
Micrococcus

Question 4

Name 2 types of bacterial spores

Answer 4

Bacillus spp

Clostridium spp

Question 5

Name one type of fungal spore

Answer 5

Penicillium

Question 6

Name 7 sources of contamination during aseptic processes

Answer 6

Operator
Staffing
Supervision
Transfer disinfection
Storage of opened ampoules
No. sterile manipulations performed
Work flow

Question 7

What 4 aspects make up a pharmaceutical management system?

Answer 7

QA
GMP
QC
Risk management

Question 8

What are 4 ways of minimising risk of contamination by people?

Answer 8

Clothing
Behaviour
Comfort
Competency

Question 9

What are 4 ways of minimising contamination in the work space?

Answer 9

Filter air through HEPA filter
Maintain +ve pressure
Biological safety cabinet or laminar flow cabinet in Grade A or B area
Work area cleaned and disinfected

Question 10

Cleaning always precedes what?

Answer 10

Disinfection

Question 11

Aseptic facility must be cleaned in line with what?

Answer 11

SOP

Question 12

What disinfectants should be used in Grade A & B areas?

Answer 12

Sterile

Question 13

What are the 3 optimum cleaning techniques?

Answer 13

Ensure thorough wetting
Consider contact time and drying
Wiping essential

Question 14

How should an isolator be cleaned?

Answer 14

Sterile neutral detergent at start and end of each session + alcohol + weekly bleach

Question 15

What should products be transferred into Grad A and B environments using?

Answer 15

air lock

Question 16

How long does sterility testing take?

Answer 16

14 days

Question 17

what is the maximum time an agar plate should be exposed for?

Answer 17

4 hours

Question 18

How long should settle plates be incubated for bacteria?

Answer 18

5 days at 30-35 deg

Question 19

How long should settle plates be incubated for fungi?

Answer 19

7 days at 20-25degs

Question 20

When should swabs be used for surface monitoring?

Answer 20

For non flat surfaces

Question 21

What is the recommended limit for microbial contamination in Grade A environment?

Answer 21

Air sample:<1
Settle plate:<1
Contact plate:<1
Glove print:<1

Question 22

What is the recommended limit for microbial contamination in Grade B environment?

Answer 22

Air sample:10
Settle plate:5
Contact plate:5
Glove print:5

Question 23

What is the recommended limit for microbial contamination in Grade C environment?

Answer 23

Air sample:100
Settle plate:50
Contact plate:25
Glove print:-

Question 24

What is the recommended limit for microbial contamination in Grade D environment?

Answer 24

Air sample:200
Settle plate:100
Contact plate:50
Glove print:-