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CETA – All COMBINED LATEST UPDATE
CETA – All COMBINED LATEST 
UPDATE 
Critical Area - ANSWER An ISO Class 5 environment 
Critical Site - ANSWER A location that includes any component or fluid 
pathway surfaces (e.g., vial septa, injection ports, beakers) or openings 
(e.g., opened ampules, needle hubs) exposed and at risk of direct contact 
with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and 
mucosal secretions), or touch contamination. Risk of microbial particulate 
contamination of the critical site incr...
- Exam (elaborations)
- • 20 pages •
CETA – All COMBINED LATEST 
UPDATE 
Critical Area - ANSWER An ISO Class 5 environment 
Critical Site - ANSWER A location that includes any component or fluid 
pathway surfaces (e.g., vial septa, injection ports, beakers) or openings 
(e.g., opened ampules, needle hubs) exposed and at risk of direct contact 
with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and 
mucosal secretions), or touch contamination. Risk of microbial particulate 
contamination of the critical site incr...