Cag-001 Use Of Isolators In Healthcare Cnbt Study Guide

Front 1

What is typical ACPH of an isolator?

Back 1

>300

Front 2

Pressurization:

Back 2

1. Typically minimum of 0.1" W.G. for positive isolators.

2. FDA guidelines= 0.07-0.2

Front 3

Exhaust Stacks?

Back 3

1. Per NSF/ANSI Standard 49 - 2004

2. 100% exhausted

3. Extend at least 10' above adjacent roofline

4. Exhaust airflow alarm (whose operation must be verified)

Front 4

CAI= what placement?

Back 4

Can be uncontrolled, isolator should be proven to prevent transfer of unfiltered room air into isolator during material transfer or compounding.

Front 5

CACI recirculating= what placement?

Back 5

Same as CAI, and also room should be 0.01" negative, and have min of 12 ACPH

no exhaust needed apparently for non-volatile drugs

Front 6

Two types of gloves/sleeves

Back 6

One part= glove and sleeve are single unbroken unit.

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.

Front 7

Double glove system common practice.

Front 8

3 Types of Isolator PTs:

Back 8

1. Static Air

2. Dilution Airflow

3. Unidirectional Airflow

Front 9

Static PT:

Back 9

1. Generally not considered appropriate for sterile compounding.

Front 10

Dilution and Unidirectional Airflow PTs:

Back 10

1. Reduces particulate load within PT prior to opening door into main chamber. Uni is better of course.

2. Cannot open both doors of PT at same time. Locks and/or timers should be installed.

3. Surface contamination still always an issue.

Front 11

Airborne Particle Level Testing

Back 11

797 says critical work area= ISO 5

CETA recommends test under dynamic.

Recommends work zone and surrounding cleanroom space.

Front 12

CAIs should be placed in ISO 7 unless?

3 items

Back 12

1. Isolates from room, and maintains ISO 5 during dynamic including materials transfer.

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.