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? -
Answers :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 highly pathogenic microorganism that require immediate remediation? -
Answers :Coagulase positive staphylococcus
Gram negative rods
Fungi (yeasts, molds)

What are environmental test results needed for effective ante room? - Answers :30
APCH

Positive pressure to pharmacy department

Viable and non-viable tests based on ISO 8

HEPA filter leak test

What are environmental test results needed for effective buffer room? - Answers :30
APCH

Nonhazardous: positive pressure to ante room (0.02 to 0.05)

Hazardous: negative pressure to ante room (-0.01 to -0.03)

Viable and non-viable tests based on ISO 7

HEPA filter leak test

What are environmental test results needed for effective PEC? - Answers :Viable and
non-viable tests based on ISO 7

HEPA filter leak test

Smoke study test