Question
A lab technician is reading a viable airborne particle air sampling result for an ISO Class 5 area. There are 3 CFUs present. Which of the following is true?
A. This result meets the action level/is within limits for ISO 5 area
B. This result exceeds the action level/is out of limits for an ISO 5 area
C. A designated person should be promptly notified of the excursion
D. No further action is needed aside from reviewing if this shows an adverse trend
E. An attempt must be made to identify any microorganism recovered to the genus level
F. Assistance should be sought or employed from a microbiologist to identify the microorganisms recovered.
G. Result should be trended
H. a, d, g
I. b, c, e, f, g
A. This result meets the action level/is within limits for ISO 5 area
B. This result exceeds the action level/is out of limits for an ISO 5 area
C. A designated person should be promptly notified of the excursion
D. No further action is needed aside from reviewing if this shows an adverse trend
E. An attempt must be made to identify any microorganism recovered to the genus level
F. Assistance should be sought or employed from a microbiologist to identify the microorganisms recovered.
G. Result should be trended
H. a, d, g
I. b, c, e, f, g
Answers
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In an ISO Class 5 area, the action levels for viable airborne particle counts are typically very low due to the stringent requirements for cleanliness in such controlled environments, especially in the context of areas used for aseptic processing.
For an ISO 5 area, the acceptable limits usually state:
- 3 CFUs in a 1 cubic meter sample is generally considered acceptable, but it also depends on the specific protocols and criteria set by the facility or regulatory body.
Given this context, let's evaluate the options:
A. This result meets the action level/is within limits for ISO 5 area - This statement could be seen as true depending on the facility's specific limits, but generally, 3 CFUs is likely to be at or near the action threshold.
B. This result exceeds the action level/is out of limits for an ISO 5 area - Unlikely, as 3 CFUs often would be interpreted as acceptable but could be concerning.
C. A designated person should be promptly notified of the excursion - Depending on the facility's protocol, if the CFUs are at the action limit, it may warrant notification.
D. No further action is needed aside from reviewing if this shows an adverse trend - This may also depend on facility protocols.
E. An attempt must be made to identify any microorganism recovered to the genus level - Identification may not be necessary unless it shows a trend or exceeds limits.
F. Assistance should be sought or employed from a microbiologist to identify the microorganisms recovered - Identifying the microorganisms may be necessary for further monitoring and action.
G. Result should be trended - It's generally good practice to trend results to monitor for changes over time.
H. a, d, g - This combination considers that the results are within action limits, indicating no immediate concern but should be trended.
I. b, c, e, f, g - This combination suggests there is a significant concern with the results and requires immediate investigation.
Considering these points, if the result of 3 CFUs is at the limits (or perceived to be exceeding the threshold based on strict regulation), the most accurate choices would be to notify a designated person, potentially identify the microorganisms, and trend the results.
Therefore, **the best option is I. b, c, e, f, g** if considering a more cautious approach in laboratory settings. Otherwise, under the assumption of accepted limits, **H. a, d, g** could still hold relevance. It's crucial to follow specific facility protocols in interpretation.
For an ISO 5 area, the acceptable limits usually state:
- 3 CFUs in a 1 cubic meter sample is generally considered acceptable, but it also depends on the specific protocols and criteria set by the facility or regulatory body.
Given this context, let's evaluate the options:
A. This result meets the action level/is within limits for ISO 5 area - This statement could be seen as true depending on the facility's specific limits, but generally, 3 CFUs is likely to be at or near the action threshold.
B. This result exceeds the action level/is out of limits for an ISO 5 area - Unlikely, as 3 CFUs often would be interpreted as acceptable but could be concerning.
C. A designated person should be promptly notified of the excursion - Depending on the facility's protocol, if the CFUs are at the action limit, it may warrant notification.
D. No further action is needed aside from reviewing if this shows an adverse trend - This may also depend on facility protocols.
E. An attempt must be made to identify any microorganism recovered to the genus level - Identification may not be necessary unless it shows a trend or exceeds limits.
F. Assistance should be sought or employed from a microbiologist to identify the microorganisms recovered - Identifying the microorganisms may be necessary for further monitoring and action.
G. Result should be trended - It's generally good practice to trend results to monitor for changes over time.
H. a, d, g - This combination considers that the results are within action limits, indicating no immediate concern but should be trended.
I. b, c, e, f, g - This combination suggests there is a significant concern with the results and requires immediate investigation.
Considering these points, if the result of 3 CFUs is at the limits (or perceived to be exceeding the threshold based on strict regulation), the most accurate choices would be to notify a designated person, potentially identify the microorganisms, and trend the results.
Therefore, **the best option is I. b, c, e, f, g** if considering a more cautious approach in laboratory settings. Otherwise, under the assumption of accepted limits, **H. a, d, g** could still hold relevance. It's crucial to follow specific facility protocols in interpretation.
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