USP 797 Basics

Question 1

ISO Class 5 Air Particle Count

Answer 1

3520

Question 2

ISO Class 7 Air Particle Count

Answer 2

352,000

Question 3

ISO Class 8 Air Particle Count

Answer 3

3,520,000

Question 4

_____ sets the standards for air quality, determined by the number and size of particles per volume of air.

Answer 4

International Organization for standardization.

Question 5

____ is a device or zone that provides ISO class 5 air quality environment for sterile compounding.

Answer 5

Primary Engineering Controls “Laminar Flow Hoods”

Question 6

____ 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.

Answer 6

Secondary Engineering Control (Cleanroom)

Question 7

PEC Air Quality

Answer 7

Iso Class 5 Air

Question 8

SEC Air Quality

Answer 8

ISO Class 7 Air

Question 9

Anteroom Air Quality

Answer 9

ISO Class 8 Air

Question 10

HEPA filters remove 99.97% of all particles ___ or larger.

Answer 10

0.3 microns

Question 11

How often should HEPA filters be recertified? 2

Answer 11

1) Every 6 months
2) Anytime the PEC is moved.

Question 12

____ filter air horizontally toward the compounder from a HEPA filter located at the back of the hood.

Answer 12

Horizontal Laminar Air Flow Workbench

Question 13

___ filter airflow from the top to the bottom in a unidirectional manner to protect the compounder from hazardous materials.

Answer 13

Vertical laminar airflow workbench.

Question 14

Which type of hood is used typically for nonhazardous materials?

Answer 14

Horizontal LAFW

Question 15

Which type of hood is typically used for hazardous materials?

Answer 15

Vertical LAFW

Question 16

In non-hazardous compounding, the air pressure within the PEC and SEC are both ____.

Answer 16

Positive–> air will flow out to main pharmacy where pressure is lower.

Question 17

What is the minimum ACPH in a positive or negative pressure buffer room? What is ACPH?

Answer 17

ACPH= Air changes per hour

30 is the minimum ACPH

Question 18

What is the minimum ACPH for an anteroom that opens only into a positive buffer room?

Answer 18

20 ACPH

Question 19

What is the minimum ACPH for an anteroom which opens into any negative buffer room?

Answer 19

30

Question 20

____ 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.

Answer 20

Restricted Access Barrier Systems

These are typically located in a segregated compounding area (SCA) or a buffer room.

Question 21

____ 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.

Answer 21

Compounding Aseptic Isolator.

Question 22

Are sterile gloves required when working in a restricted access barrier system such as a compounding aseptic isolator?

Answer 22

Yes. Both on the sleeve and over the sleeve.

Question 23

_____ 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.

Answer 23

Segregated Compounding Area

Question 24

May a segregated compounding area be in a hallway?

Answer 24

No, it must be in a separate room or at least have a visible perimeter to establish boundary.

Question 25

May you don gloves before entering the sterile compounding room or other classified area?

Answer 25

No.

Question 26

May hand sanitizer be used in replacement of soap when washing hands for sterile compounding?

Answer 26

No

Question 27

____ should be applied to gloves regularly throughout compounding and whenever non-sterile surfaces are touched.

Answer 27

70% isopropyl alcohol.

Question 28

May gowns be re-used within the same shift?

Answer 28

Yes only if gown is maintained in a classified area/inside perimeter of a segregated compounding area.

Question 29

General Garbing Procedure for Non-hazardous medication preparation.

Answer 29

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.

Question 30

How should a horizontal LAFW be cleaned?

Answer 30

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.

Question 31

How should you clean the diffuser if needed?

Answer 31

Should be done first if it is to be done. This is facility dependent and considered controversial however.

Question 32

How often should you clean the hood?

Answer 32

1) Before Every Shift 2) Every 30 minutes while working 3) Before/After each batch 4) Whenever visibly soiled.

Question 33

What should be done to all items before placing them within the hood?

Answer 33

Wipe off with 70% isopropyl alcohol.

Question 34

How far should you work within the hood when performing sterile compounding?

Answer 34

six inches.

Question 35

How should items be placed into the hood?

Answer 35

Side by side, with all critical points pointing into the first air.