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PA30304 > Contamination control > Flashcards

Contamination control Flashcards

1
Q

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

A 
People
Workspace
Starting materials & consumables
Storage
Aseptic process
Administration of product
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2
Q

How many skin particles are shed per minute while walking?

A

5,000,000

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3
Q

Name 3 non spore forming bacteria which can affect air quality

A

Staphylococcus
Streptococcus
Micrococcus

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4
Q

Name 2 types of bacterial spores

A

Bacillus spp

Clostridium spp

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5
Q

Name one type of fungal spore

A

Penicillium

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6
Q

Name 7 sources of contamination during aseptic processes

A 
Operator
Staffing
Supervision
Transfer disinfection
Storage of opened ampoules
No. sterile manipulations performed
Work flow
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7
Q

What 4 aspects make up a pharmaceutical management system?

A

QA
GMP
QC
Risk management

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8
Q

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

A

Clothing
Behaviour
Comfort
Competency

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9
Q

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

A

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

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10
Q

Cleaning always precedes what?

A

Disinfection

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11
Q

Aseptic facility must be cleaned in line with what?

A

SOP

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12
Q

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

A

Sterile

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13
Q

What are the 3 optimum cleaning techniques?

A

Ensure thorough wetting
Consider contact time and drying
Wiping essential

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14
Q

How should an isolator be cleaned?

A

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

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15
Q

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

A

air lock

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16
Q

How long does sterility testing take?

A

14 days

17
Q

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

A

4 hours

18
Q

How long should settle plates be incubated for bacteria?

A

5 days at 30-35 deg

19
Q

How long should settle plates be incubated for fungi?

A

7 days at 20-25degs

20
Q

When should swabs be used for surface monitoring?

A

For non flat surfaces

21
Q

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

A

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

22
Q

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

A

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

23
Q

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

A

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

24
Q

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

A

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

PA30304 (13 decks)

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