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25 Cards in this Set
- Front
- Back
Test equipment should be normalized to what?
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2. 35-105F |
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Critical Site: |
Risk increases with size, and exposure time. |
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Direct Compounding Area (DCA) |
Critical aer within ISO 5 PEC where critical sites are exposed to unidirectional HEPA filtered air (first pass air) |
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First Air: |
1. air exiting HEPA 2. Unidirectional 3. essentially particle free |
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Effective Area of HEPA filters |
2. measure to inside edge of potting compound or caulk bead. 3. subtract filter bar if needed |
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Acceptance criteria to design requirements and initial cert data? |
Generally +-20% as long as exceeding 797 minimums |
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When to certify? |
2. At least every 6 months 3. when relocated/altered 4. When major service performed |
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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. |
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Should backpressure compensation be used?
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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. |
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Pressure gauges should be performance verified at every certification.
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4 items |
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 |
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Airflow Displacement: Procedure
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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. |
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Non-viable PC procedure:
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2. Verify system running. 3. Direction of airflow, or vertically upward for turbulent |
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Non-viable PC reporting:
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2. Occupancy State 3. Considered particle size 4. Acceptance |
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BSCs
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Annex F of NSF/ANSI 49 ADDITIONALLY! Certify to ISO 5. |
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Example Grid in a BSC: |
Each corner 6" from interior walls, and one at geometric center. Minimum 1 sample positioned 6-12" directly upstream of the critical site. |
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Airflow Visualization Test (Smoke Pattern) AVT! At rest= what? Dynamic= what? |
Ensures device provides adequate unidirectional airflow to support aseptic operations as required |
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AVT: Selecting a fog tracer
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2. Doesn't disrupt airflow patterns 3. Might need a tripod for video recording device |
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AVT: Visually verify what?
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1. HVAC airflow, doors, traffic patterns, cross drafts, products, etc. must no disturb flow of air and be documented as part of certification. |
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AVT: Visually verify what within PEC?
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No dead spots, or reflux at the DCA |
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AVT: Determines what? shows what? |
Also shows device fits intended purpose. |
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Smoke source?
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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. |
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Where to generate?
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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. |
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From FDA guidance document "Sterile Drug Products Producted by Aseptic Processing - Current Good Manufacturing Practice" |
"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". |
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Report
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Written with a definitive statement, preferably supported with video. |