USP 797 Basics Flashcards
ISO Class 5 Air Particle Count
3520
ISO Class 7 Air Particle Count
352,000
ISO Class 8 Air Particle Count
3,520,000
_____ sets the standards for air quality, determined by the number and size of particles per volume of air.
International Organization for standardization.
____ is a device or zone that provides ISO class 5 air quality environment for sterile compounding.
Primary Engineering Controls “Laminar Flow Hoods”
____ is the place where PEC is placed. These incorporate a specific design and operational parameter to minimize the risk of contamination within the compounding area.
Secondary Engineering Control (Cleanroom)
PEC Air Quality
Iso Class 5 Air
SEC Air Quality
ISO Class 7 Air
Anteroom Air Quality
ISO Class 8 Air
HEPA filters remove 99.97% of all particles ___ or larger.
0.3 microns
How often should HEPA filters be recertified? 2
1) Every 6 months
2) Anytime the PEC is moved.
____ filter air horizontally toward the compounder from a HEPA filter located at the back of the hood.
Horizontal Laminar Air Flow Workbench
___ filter airflow from the top to the bottom in a unidirectional manner to protect the compounder from hazardous materials.
Vertical laminar airflow workbench.
Which type of hood is used typically for nonhazardous materials?
Horizontal LAFW
Which type of hood is typically used for hazardous materials?
Vertical LAFW
In non-hazardous compounding, the air pressure within the PEC and SEC are both ____.
Positive–> air will flow out to main pharmacy where pressure is lower.
What is the minimum ACPH in a positive or negative pressure buffer room? What is ACPH?
ACPH= Air changes per hour
30 is the minimum ACPH
What is the minimum ACPH for an anteroom that opens only into a positive buffer room?
20 ACPH
What is the minimum ACPH for an anteroom which opens into any negative buffer room?
30
____ are enclosures which provide HEPA-filtered ISO class 5 unidirectional air which allows for the passage of materials through defined openings that are generally not to be opened during operations.
Restricted Access Barrier Systems
These are typically located in a segregated compounding area (SCA) or a buffer room.
____ are a type of restricted-access barrier system which uses HEPA filtration to provide ISO class 5 unidirectional air flow for the purpose of compounding sterile non-hazardous drugs.
Compounding Aseptic Isolator.
Are sterile gloves required when working in a restricted access barrier system such as a compounding aseptic isolator?
Yes. Both on the sleeve and over the sleeve.
_____ is an SEC without the controls of a cleanroom. This is an area dedicated to sterile compounding which is exposed to room air as opposed to ISO-class air.
Segregated Compounding Area
May a segregated compounding area be in a hallway?
No, it must be in a separate room or at least have a visible perimeter to establish boundary.
May you don gloves before entering the sterile compounding room or other classified area?
No.
May hand sanitizer be used in replacement of soap when washing hands for sterile compounding?
No
____ should be applied to gloves regularly throughout compounding and whenever non-sterile surfaces are touched.
70% isopropyl alcohol.
May gowns be re-used within the same shift?
Yes only if gown is maintained in a classified area/inside perimeter of a segregated compounding area.
General Garbing Procedure for Non-hazardous medication preparation.
1) Remove all jewelry, jackets, vests, etc.
2) Don shoe covers, stepping over line of demarcations
3) Don face mask, hand/hair covers
4) Wash hands (30 seconds)
5) Don Gown
6) Enter Clean room
7) Hand Cleansing with alcohol-based product
8) Don Sterile Gloves
9) Routinely disinfect gloves with sterile 70% isopropyl alcohol.
How should a horizontal LAFW be cleaned?
1) Top using side-to-side motion from inside out.
2) Hanging pole using gripping motion
3) Sides, using top-to-bottom motion from inside out.
4) Bottom, using side-to-side motion from inside out.
This should be done using a 70% isopropyl alcohol wipe. NEVER SPRAY CLEANSER INSIDE THE PEC.
How should you clean the diffuser if needed?
Should be done first if it is to be done. This is facility dependent and considered controversial however.
How often should you clean the hood?
1) Before Every Shift
2) Every 30 minutes while working
3) Before/After each batch
4) Whenever visibly soiled.
What should be done to all items before placing them within the hood?
Wipe off with 70% isopropyl alcohol.
How far should you work within the hood when performing sterile compounding?
six inches.
How should items be placed into the hood?
Side by side, with all critical points pointing into the first air.
