Quiz - Environmental Considerations Of Usp
- 1.Who do the USP chapter <797> standards apply?
- A.
Hospitals, healthcare institutions, pharmacies
- B.
Physicians and nurses
- C.
Pharmacists and pharmacy technicians
- D.
All of the above
- 2.What could cause potential harm to patients if compounding is not done aseptically?
- A.
Microbial, chemical and physical contamination
- B.
Variability in the intended strength of ingredients
- C.
Incorrect types and qualities of ingredients in CSPs
- D.
All of the above
- 3.What are the contamination risk levels?
- A.
Low, Medium and High Risk Levels
- B.
First, Second and Third Risk Levels
- C.
Level A, B and C
- D.
None of the above
- 4.What ISO class are low-risk level CSP’s compounded in?
- A.
ISO Class 8
- B.
ISO Class 7
- C.
ISO Class 6
- D.
ISO Class 5
- 5.For a CSP to be considered for medium risk level compounding, only two sterile products must be used.
- A.
True
- B.
False
- 6.CSPs that have been weighed and mixed in air quality worse than ISO Class 7 conditions are considered to be what risk level?
- A.
Low Risk
- B.
Medium Risk
- C.
High Risk
- D.
All of the Above
- 7.For medium-risk conditions, how long can CSPs be stored at refrigeration temperatures?
- A.
≤ 48 Hours
- B.
≤ 3 days
- C.
≤ 9 days
- D.
≤ 45 days
- 8.Non-hazardous buffer areas require _______ ________ and _______ inches of water column for the pressure?
- A.
Positive pressure and ≤ 0.02
- B.
Negative pressure and ≤ 0.02
- C.
Positive pressure and 0.02 - 0.05
- D.
Negative pressure and 0.02 – 0.05
- 9.How many total room air changes per hour (ACPH) are required for an ISO 7 (buffer area) environment?
- A.
No less than 30
- B.
No less than 20
- C.
No less than 15
- D.
No less than 5
- 10.How often should the ISO 5 Engineering Control (BSC, LAFW, CAI) be cleaned and disinfected?
- A.
At the start of each shift
- B.
Daily
- C.
Weekly
- D.
Monthly
- 11.A person who has a sunburn cannot work within the ISO class 5 or ISO class 7 environment until their burn has healed.
- A.
True
- B.
False
- 12.Prior to entering the cleanroom, what must you remove before entering?
- A.
Socks and shoes
- B.
Gown and shoe covers
- C.
Hair cover and face mask
- D.
Jewelry and make up
- 13.When re-entering the buffer area, you can wear the same hair cover, beard cover, face mask and shoe covers that you took off when you exited the buffer area?
- A.
True
- B.
False
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