Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing : Current
Good Manufacturing Process - ANSWER- U.S. Department of Health and Human
Services
A. Acronym: NIOSH
B. Used for: __________ - ANSWER- A. National Institute of Occupational Safety and
Health
IEST-RP-CC013.2 - ANSWER- Calibration Procedures and Guidelines for Select
Equipment Used in Testing Cleanrooms and Other Controlled Environments
IEST-RP-CC034.3 - ANSWER- HEPA and ULPA Filter Leak Tests
ISO 14644-1 - ANSWER- Cleanroom and Associated Controlled Environments -
Classification of Air Cleanliness by Particle Concentration
ISO 14644-2 - ANSWER- Cleanroom and Associated Controlled Environments -
Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness
by Particle Concentration
ISO 14644-3 - ANSWER- Cleanroom and Associated Controlled Environments - Test
Methods
,ISO 14644-4 - ANSWER- Cleanroom and Associated Controlled Environments -
Design, Construction and Start-up
ISO - ANSWER- International Organization of Standards
CETA - ANSWER- Controlled Environment Testing Association
CAG - ANSWER- Certification Application Guide
IEST - ANSWER- Institute of Environmental Sciences and Technology
OSHA - ANSWER- Occupational Safety and Health Administration
ASHP - ANSWER- American Society of Hospital Pharmacists
Critical Area - ANSWER- ISO 5 Environment
How often, at a minimum, should Buffer Room floors be cleaned?
A. Daily
B. Weekly
C. Hourly
D. Yearly - ANSWER- A. Daily
How often, at a minimum, should Ante Room floors be cleaned?
A. Daily
B. Weekly
C. Hourly
D. Yearly - ANSWER- A. Daily
How often, at a minimum, should Buffer Room Shelves be cleaned?
A. Daily
B. Weekly
C. Monthly
D. Yearly - ANSWER- C. Monthly
How often, at a minimum, should Buffer Room ceilings be cleaned?
A. Daily
B. Monthly
C. Hourly
D. Yearly - ANSWER- B. Monthly
How often, at a minimum, should Buffer Room walls be cleaned?
A. Daily
B. Weekly
C. Hourly
D. Monthly - ANSWER- D. Monthly
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