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Quality Control > Introduction > Flashcards

Introduction Flashcards

1
Q

What are micro organisms used for ?

A

As cell factories to make medicines

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2
Q

What is microbiology used for ?

A

Used in lab testing to check medicines

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3
Q

Factors to be considered when designing a microbial QC programme

A

Sample to be analysed
Choice of tests
Frequency of testing
Methods for their validation

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4
Q

Samples to be analysed

A

Raw materials , in line samples , end products , water , air , surfaces , personnel

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5
Q

Types of general counts

A

Total viable counts
Total anaerobes
Spores

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6
Q

Total viable counts

A

Also known as standard plate count

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7
Q

Example of test method

A

European Pharmacopoeia

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8
Q

Total cell count

A

Living and dead cell enumeration

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9
Q

Indicator organism

A

Used for analysis for faecal contamination

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10
Q

Total coliforms

A

35-37 degrees for 48 hours
Indicators of general level of sanitation

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11
Q

Selective media for coliforms

A

MacConkey Agar
Violet Bile Agar

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12
Q

Examples of Micro organism contamination of medicinal products

A

Eye care products
Powders
Water
Mouthwashes

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13
Q

Main sources of microbial contamination

A

Raw materials
Water
Personnel
Packaging components
Air
Post processing contamination
In use contamination

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14
Q

Stages of microbial growth curve

A

Lag phase
Log phase
Stationary phase
Death phase

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15
Q

Lag phase

A

Period of no growth / slow growth

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16
Q

Log phase

A

Cell division begins
Number of cells increases exponentially

17
Q

Stationary phase

A

No overall growth due to nutrient depletion / lack of space

18
Q

Death phase

A

Cell death spores can survive

19
Q

Viable cell counts

A

Living cells only

20
Q

Viable cell counts

A

Pour Plate technique
Spread Plate technique
Membrane filtration method
Dip slides
Millipore samples
Sim Plates
Colliert kits

21
Q

Colony forming units

A

C.f.u

22
Q

Diluents used

A

Ringers Solution

23
Q

Pour plate method

A

Most suitable when small numbers of bacteria are expected.
48-50 degrees

24
Q

Pour plate technique

A

Day 1: Serial dilution and set up samples in agar
Day 2: count plates

25
Q

Spread Plate technique

A

30-35 degrees for 72 hours

26
Q

Reading results

A

For all TVC all types of colonies are counted
Only use 25-250
C.f.u ml / g

27
Q

Validation and controls

A

Negative controls on sterility of medium used .
Growth promotion test as validation test .

28
Q

Colilert

A

Uses DST

29
Q

DST

A

Defined substrate technology

30
Q

Applications of Colilert

A

Analysis of water for faecal indicators

31
Q

DST is

A

A method of isolating and identifying bacteria through the effect of the enzymes on chromogenically labelled specific substrates

Quality Control (1 decks)

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