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12 Cards in this Set
- Front
- Back
What is typical ACPH of an isolator?
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>300 |
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Pressurization: |
2. FDA guidelines= 0.07-0.2 |
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Exhaust Stacks? |
2. 100% exhausted 3. Extend at least 10' above adjacent roofline 4. Exhaust airflow alarm (whose operation must be verified) |
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CAI= what placement?
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Can be uncontrolled, isolator should be proven to prevent transfer of unfiltered room air into isolator during material transfer or compounding. |
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CACI recirculating= what placement?
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no exhaust needed apparently for non-volatile drugs |
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Two types of gloves/sleeves
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Two part= glove and sleeve are separate and connected at the sleeve (gauntlet) by some type of seal system. Allows easy change out of gloves. |
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Double glove system common practice.
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3 Types of Isolator PTs: |
2. Dilution Airflow 3. Unidirectional Airflow |
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Static PT: |
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Dilution and Unidirectional Airflow PTs: |
2. Cannot open both doors of PT at same time. Locks and/or timers should be installed. 3. Surface contamination still always an issue. |
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Airborne Particle Level Testing |
CETA recommends test under dynamic. Recommends work zone and surrounding cleanroom space. |
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CAIs should be placed in ISO 7 unless? 3 items |
2. Particle counts approx. 6-12" upstream of critical site maintain ISO 5 during compounding operations. 3. ISO 5 shall be maintained during material xfer, with probe located as near to xfer door as possible. |