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Qualified Person Training > Microbiology > Flashcards

Microbiology Flashcards

1
Q

What organism is used to validate Dry Heat Sterilisation?

A

Bacillus Atrophaeus

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2
Q

What is a D Value?

A

The exposure time required for a 1 log reduction in microorganisms

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3
Q

What is the definition of F0 and FH?

A

F0 is the time equivalent to the time at 121’C that an object is exposed to the desired temperature (Moist Heat Sterilisation)

FHs the time equivalent to the time at 170’C that an object is exposed to the desired temperature (Dry Heat Sterilisation)

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4
Q

What organisms are used to validate the following:-
a) Autoclaves (Steam)
b) Filters
c) Oven (Dry Heat)
d) Irradiation

A

a) Geobacillius Stearothermophilius
b) Brevundimonas Diminuta
c) B.Subtilius or Bacilius Astrophaeus
d) Bacillius Pumilus

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5
Q

Where can you find information on Water for Pharmaceutical use?

A

WHO, EMA and Pharmacopeia’s

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6
Q

Name some objectionable organisms

A

Morexella, Staphlacocus, Ecoli, Salmonella

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7
Q

What is PET and what organisms are used?

A

Preservative Efficacy Testing - stimulates contamination through a series of inoculations of challenge microorganisms over a period of time and assess the ability of the preservatives in your product to reduce or eradicate the organism.

  • 3 Bacteria - Staph aureus, ecoli and pseud aeruginosa
  • 2 fungi - candida albicans and aspergillus brasliensis
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8
Q

What efficiency do we expect for H14 and H13 filters?

A

H14 - 99.995%
H14 - 99.95

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9
Q

What are the micro specifications for:-
Grade A
Grade B
Grade C
Grade D

A

A - all plates 0cfu,
in operation 0.5- 3520 and 5-20

B - AS- 10cfu/m3, Settle- 5cfu, Contact - 5cfu, Finger- 5cfu,
in operation 0.5- 352000, 5- 2930

C - AS- 100cfu/m3, Settle- 50cfy, Contact- 25cfu, No Finger,
In operation 0.5- 3520000, 5- 29300

D - AS- 200cfu/m3, Settle- 100cfu, Contact 50cfu, No Finger
In operation- Not Defined

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10
Q

What are the test we do on steam quality?

What guidance do we have?

A

Super Heat, Condensable Gases and Steam Dryness

EN285

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11
Q

What are the micro specifications for:-
Tablets
Liquids
MDI’s
Sterile

A

Tab - TYMC 100cfu/ml TAMC 1000cfu/ml, no Ecoli

Liquid- TYMC 10cfu/ml TAMC 100cfu/ml - no Ecoli

MDI - TYMC 10cfu/ml TAMC 100cfu/ml - no Pseudo or Bile tolerant gram

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12
Q

What are the different methods for FIT?

A

Bubble Point
Diffusive Flow
Pressure Hold
Forward Flow

Or

Hydrophobic Filters- water intrusion

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13
Q

What test do we perform on a HEPA?

A

DOP testing - Dry Oil Particulate Testing

Oil is dispersed as an aresol into the upstream flow of the filter and the number of particles downstream is measured using a calibrated photometer leak is >0.01% of upstream challenge

Face velocity - 0.45m/s

Efficiency of seal and housing

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14
Q

What are the different types of microorganisms?

A

Bacteria,
Mycoplasmas
Fungi- Moulds and Yeasts
Viruses
Prions

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15
Q

What causes Endotoxins?

A

Gram Negative Bacteria

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16
Q

Which Bacteria can form Spores?

A

Gram +’ve

17
Q

What temperature suits the following organisms:-
A) mould
B) Gram +’ve
C) Gram -‘ve

A

A) 15-35 degrees Celsius
B) 22-40 degrees Celsius
C) 15-39 degrees Celsius

18
Q

How is a biofilm formed?

A

Formed by Gram-‘ve bacteria

5 stage process
- Initial attachment
- Maturation I
- Maturation II
- Dispersion

19
Q

Process for identification of microorganisms?

A

Gram Stain followed by morphological and biochemical tests using different growth media.

20
Q

Micro Specifications:-
- Non-aqueous for oral use
- Aqueous for oral use
- Nasal Use
- Inhalation

A
  • TAMC 10^3 TYMC 10^2 absence Ecoli
  • TAMC 10^2 TYMC 10^1 absence Ecoli
  • TAMC 10^2 TYMC 10^1 absence Staph aureus, Pseudo Aeruginosa
  • TAMC 10^2 TYMC 10^1 absence Staph aureus, Pseudo Aeruginosa and bile tolerant gram -‘ve bacteria
21
Q

Where should sterility samples be taken from in the batch?

A
  • Aseptically prepared products - beginning and end of batch and additional samples after critical interventions
  • Terminal - worst case locations (coolest or slowest to heat part of load)
  • Lyophilised products from different lyophilised loads
22
Q

What are the different types of Air Samplers?

A

Slit Agar - air drawn through slit under vacuum on to a revolving air sample plate.
Sieve Sampler - air drawn in and accelerated through holes in a sieve plate on to underlying agar at constant sampling rate, air velocity and impact speed.
Gelatin Pad - air is drawn through a gelatin filter pad which can be dissolved in sterile silent for plating out. Or pad can be transferred on to agar where it eventually dissolves into surface.
Centrifugal Sampler - air drawn into open cylinder housing and impacts on to rotating impeller blades. Following impact air is forced rapidly outward on to a plastic strip coated with agar.

23
Q

What Agar is used for micro testing of water?

A

R2A

Qualified Person Training (11 decks)

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