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PHA6114 > [PHA6114 lab] Experiment 11 > Flashcards

[PHA6114 lab] Experiment 11 Flashcards

1
Q

Program the evaluates the cleanliness of the manufacturing or process environment

A

Environmental Monitoring

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2
Q

Effectiveness of cleaning and disinfection programs and the operational performance of environmental controls

A

Environmental Monitoring

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3
Q

Environmental Monitoring is divided into two, what are those?

A

Viable monitoring and Non-viable monitoring

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4
Q

Type of monitoring for air-borne particles

A

Non-viable monitoring

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5
Q

What range of sizes are read in non-viable monitoring?

A

0.5 to 5.0 μm

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6
Q

Device use for non-viable monitoring

A

Optical particle counter

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7
Q

These are used to determine the air quality by counting and sizing the number of particles in the air

A

Particle counters

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8
Q

Type of monitoring for detection of levels of bacteria and fungi present in defined locations/areas during a particular stage in the activity of processing and filling a product

A

Viable monitoring

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9
Q

What type of microorganisms are detected in viable monitoring?

A

Mesophilic microorganisms because they are more common in room temp or body temp

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10
Q

T or F: Some manufactures may have other requirements to examine for other types of microorganisms

A

True

Ex. anaerobes if nitrogen lines are used

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11
Q

When is viable monitoring normally performed?

A

“in operation” - meaning, during the manufacturing process as this represents a more realistic assessment of the challenge to the manufacturing process

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12
Q

It involves the collection of data relating to the numbers of microorganisms present in a clean room or clean zone

A

Microbiological environmental monitoring

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13
Q

Microorganisms in MEM are recovered from the following:

A

surface, air, people

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14
Q

A physical test which functions has often resided with the microbiology department to perform and due to the theoretical relationship between high numbers of nonviable particles and viable counts

A

Nonviable particle counting

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15
Q

What is the main aim of MEM?

A

Assess the monitoring of trends over time and the detection of an upward or downward movement within clean areas

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16
Q

Enumerating the numbers of microorganisms present in a clean room by collecting results using sample types

A

Viable count aspect of Environmental Monitoring

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17
Q

Different types of Collection for Viable Count aspect of Environmental Monitoring

A

Passive air-sampling: settle plates (SDA)
Active air-sampling: volumetric air-sampler
Surface samples: contact plates, swabs
Finger plates
Plates of sleeves/gowns

18
Q

Types of Monitoring Methods

A
  1. General purpose medium
  2. 2 Different culture media used at two different temperatures
19
Q

What is the general purpose medium?

A

Tryptone Soya Agar (TSA) at a dual incubation of 20-25 and 30-35 degrees

20
Q

T or F: Choice of culture media, incubation times, and temperatures do not require validating

A

False, it requires validating

21
Q

T or F: Emphasis should always be upon environmental control rather than environmental monitoring

A

True

22
Q

T or F: Where a risk is identified, the risk should be minimized as a part of strategy of bringing the clean area into tighter control

A

True

23
Q

What should you do if a risk cannot be minimized but continues to exist

A

Carefully targeted monitoring should be undertaken and the data reviewed, and examined for trends by a registered and professional microbiologist

24
Q

T or F: Designing facilities in an optimal way is a part of environmental control and where environmental monitoring becomes a tool in the assessment of control

A

True

25
Q

With no risk able to be reduced completely to zero, there remains an important role for __________

A

Environmental monitoring

26
Q

T or F: The value of viable microbial sampling of the air in the compounding environment is realized when the data are used to identify and correct an unacceptable situation

A

True

27
Q

___________ shall be collected and reviewed on a __________ basis

A

Sampling data, periodic

28
Q

T or F: Any CFU count that exceeds its respective action level should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location

A

True

29
Q

What sources could be used for determining CFU counts?

A

HVAC systems, damaged HEPA filters, changes in personnel garbing or work practices

30
Q

T or F: The source of the problem shall be eliminated, affected area cleaned, and resampling performed

A

True

31
Q

These are used as an approximate measure of the environmental microbial bioburden

A

Counts of CFU

32
Q

These are determined on the basis of CFU data gathered at each sampling location that has trended over time

A

Action levels

33
Q

T or F: Values in the Table should be followed as is

A

False, it should only be used as a guide only

34
Q

[Table 11.1 Recommended Action Levels for Microbial Contamination]

ISO Class 5

A

Air sample >1

35
Q

[Table 11.1 Recommended Action Levels for Microbial Contamination]

ISO Class 7

A

Air sample >10

36
Q

[Table 11.1 Recommended Action Levels for Microbial Contamination]

ISO Class 8 or worse

A

Air sample >100

37
Q

REMEMBER

A

CFU per cubic meter [1000 liters] of air per plate

38
Q

Agar plates are exposed in a buffer area and one of each in an ante-area for how many days?

A

2-5 days

39
Q

Incubate TSA plates at ______ for how long _____?

A

30 to 35 degrees Celsius for 48-72 hours

40
Q

Incubate SDA plates at ______ for how long _____?

A

26 to 30 degrees Celsius for 5 to 7 days

PHA6114 (6 decks)

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