Cag-003-2006-13 Cnbt Stuidy Guide

Front 1

Test equipment should be normalized to what?

Back 1

1. Manufacturer's directions

2. 35-105F

Front 2

Critical Site:

Back 2

Any component or fluid pathway surfaces or openings at risk of direct contact with air, moisture, or touch contamination.

Risk increases with size, and exposure time.

Front 3

Direct Compounding Area (DCA)

Back 3

Critical aer within ISO 5 PEC where critical sites are exposed to unidirectional HEPA filtered air (first pass air)

Front 4

First Air:

Back 4

1. air exiting HEPA

2. Unidirectional

3. essentially particle free

Front 5

Effective Area of HEPA filters

Back 5

1. actual face area of filter medium where air is passing.

2. measure to inside edge of potting compound or caulk bead.

3. subtract filter bar if needed

Front 6

Acceptance criteria to design requirements and initial cert data?

Back 6

Generally +-20% as long as exceeding 797 minimums

Front 7

When to certify?

Back 7

1. Initially

2. At least every 6 months

3. when relocated/altered

4. When major service performed

Front 8

Calculating ACPH when:

Line of demarcation separates two areas of different purpose, simply dividing dirty /clean sides, then entire walled area used to calculate one air exchange rate.

If separating two ISO classes, only independent if there is HEPA supply to each space. Use line of demarcation as imaginary wall to separate areas.

If only supplied to one side, then rate incorporates both sides. If HEPA over line, same thing.

Front 9

Should backpressure compensation be used?

Back 9

Yes!

non-back pressure and back pressure compensated readings should be same for fast acting constant volume air terminals, otherwise hood must be in place long enough for controller to re-attain to the set point.

Front 10

Pressure gauges should be performance verified at every certification.

Front 11

Airflow Displacement

4 items

Back 11

1. low pressure, high airflow

2. 40fpm min from cleaner zone toward less clean zone

3. These limits are at low end of most instreuments

4. Support measurements with visual smoke pattern analysis

Front 12

Airflow Displacement: Procedure

Back 12

1. Divide into grid not to exceed 1 ft 2 and 6" within all opening edges

2. Measure and allow 5 seconds. Record average at each position once stabilized.

3. All readings >40fpm

4. Smoke along entire perimeter and opening should show no reverse flow.

Front 13

Non-viable PC procedure:

Back 13

1. 0.5 micron detection, calibrated within year to NIST traceability, verify with zero count filter.

2. Verify system running.

3. Direction of airflow, or vertically upward for turbulent

Front 14

Non-viable PC reporting:

Back 14

1. ISO Class

2. Occupancy State

3. Considered particle size

4. Acceptance

Front 15

BSCs

Back 15

Certifiers should be certified by NSF for certification of Class II BSCs.

Annex F of NSF/ANSI 49

ADDITIONALLY! Certify to ISO 5.

Front 16

Example Grid in a BSC:

Back 16

Each corner 6" from interior walls, and one at geometric center.

Minimum 1 sample positioned 6-12" directly upstream of the critical site.

Front 17

Airflow Visualization Test (Smoke Pattern)

AVT!

At rest= what?

Dynamic= what?

Back 17

determine if device is performing as designed and properly integrated into facility.

Ensures device provides adequate unidirectional airflow to support aseptic operations as required

Front 18

AVT: Selecting a fog tracer

Back 18

1. Convenient to deploy within PEC

2. Doesn't disrupt airflow patterns

3. Might need a tripod for video recording device

Front 19

AVT: Visually verify what?

Back 19

1. HVAC airflow, doors, traffic patterns, cross drafts, products, etc. must no disturb flow of air and be documented as part of certification.

Front 20

AVT: Visually verify what within PEC?

Back 20

No dead spots, or reflux at the DCA

Front 21

AVT: Determines what? shows what?

Back 21

Determines optimum layout with DCA, and shows personnel correct way to take advantage of unidirectional airflow.

Also shows device fits intended purpose.

Front 22

Smoke source?

Back 22

1. Such as glycol based fog generator or ventilation smoke tube. Water based such as ?CO2 and liquid nitrogen is heavy and not necessarily always adequate. Smoke should not fall out or drop when created in no-airflow environment.

Front 23

Where to generate?

Back 23

directly downstream from diffuser and observed as it flows across critical site and DCA, and to a return or out of critical site. Air SHOULD NOT reenter.

Front 24

FDA Statement:

From FDA guidance document "Sterile Drug Products Producted by Aseptic Processing - Current Good Manufacturing Practice"

Back 24

"In situ air pattern analysis should be conducted at the critical area to demonstrate unidirectional airflow and sweeping action over and away form the product under dynamic conditions".

Front 25

Report

Back 25

Written with a definitive statement, preferably supported with video.