Sterile Compounding - 02_02 Clean Room Cert + Environmental Monitoring

Sterile Compounding - 02/02 Clean Room
Cert + Environmental Monitoring

When do clean rooms and hoods need to be recertified and what do the tests include? -
ANS-Every 6 months under dynamic/typical/worst conditions

Airflow volume
ACPH
Room pressurization
HEPA filter leak test
Smoke pattern test
Non-viable particulate count
Viable air and surface count

What are the air pressure relationships in each area? - ANS-Ante room to unclassified:
positive

Nonhazardous buffer to ante: 0.02 to 0.05

Hazardous buffer to ante: -0.01 to -0.03

What are the air exchanges per hr in each area? - ANS-Both 30 APCH

What is nonviable air testing measuring? - ANS-Engineering control performance

Number of particles 0.5micrometers or bigger/m3

What is the frequency of non-viable air sampling? - ANS-Q6M

What is the nonviable air sampling max for each ISO class? - ANS-ISO 5 (PEC): ≤3250
ISO 7 (buffer): ≤325000
ISO 8 (ante): ≤3250000

What does viable air testing measure? - ANS-Colony forming units/m3

Measures proper hand hygiene, garbing, aseptic tech, pressure of surface
contamination, employee competency