USP 797 Part 1

what is USP?

nonprofit scientific organization - a standard-setting organization NOT a regulatory or enforcement agency; they publish USP compounding compendium

who enforces USP standards and/or include them in their standards?

regulatory bodies (CMS, FDA, state board of pharmacy, state department of health) and accreditation organizations (The Joint Commission)

what is USPs mission

to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods

what is USP 797

standards for preparing compounded sterile medications to ensure patient benefit and reduce the risk of contamination, infection, or incorrect dosing

T/F: USP is not a guidelines and must be compliant with the entire chapter

true

who does 797 apply to?

all persons who prepare compounded sterile preparations and all places where CSPs are prepared for human and animal patients (pharmacists, technicians, nurses, physicians, veterinarians, dentists, hospitals/healthcare institutions, infusion treatments…)

according to 797 sterile preparations include:

infusions, injection, aqueous preparations for pulmonary inhalations, irrigations for internal body cavities, ophthalmics (including drops), implants, bath and soaks for live organs/tissues

T/F: prepackaging and repackaging sterile products/preparations also must comply with 797

true

who sets standards for air quality

international organization for standardization (ISO)

what is air quality determined by?

number and size of particles per volume of air - lower particle count = cleaner air

particle count of and ISO class 5

3520par

particle count for an ISO class 7

352,000

particle count for an ISO class 8

3,520,000

what are primary engineering controls (PECs)?

a device or zone that provides an ISO class 5 air quality environment for sterile compounding

examples of primary engineering controls (PECs):

laminar airflow workbench, isolator - commonly called a “hood”

what are secondary engineering controls (SECs)?

the area where the PEC is placed; incorporates specific design and operational parameters required to minimize risk of contamination within the compounding area

examples of secondary engineering controls (SEC):

cleanroom (the room in which the hood is placed)

ISO class for the secondary engineering control (SEC)?

ISO 7

ISO class for the anteroom (room adjacent to buffer room/SEC)

8

what does HEPA stand for?

high efficiency particulate air

purpose of HEPA filtration

responsible for maintaining air quality - removes 99.97% of all particles 0.3 microns or larger (dust, pollen, mold, bacteria, etc.)

where are HEPA filters located?

within the PEC

what is first air

the place where compounding should be performed (performed in the cleanest air coming directly from HEPA filter)

when must HEPA filters be recertified?

every 6 months and anytime the PEC has been moved

other names for laminar airflow

unidirectional airflow and air flow in one direction

what are horizontal laminar air flow workbenches (LAFW)

filtered air flows horizontally towards the compounder from a HEPA filter located at the back of the hood - most common LAF hood for non-hazardous sterile compounding

what are vertical laminar air flow workbenches (LAFW)?

biological safety cabinet (BSC), filtered air flows top to bottom, protects the compounder

what type of compounding is typically done in vertical LAFW

hazardous medication preparations

air pressure for non-hazardous compounding

PEC and SEC are both positive - avoids contamination and toxicity is not a concern

minimum air change per hour (ACPH) in anteroom that opens only into positive buffer room(s)

20

minimum air change per hour (ACPH) in anteroom that opens into any negative buffer room

30

minimum air change per hour (ACPH) in positive pressure buffer room

30

minimum air change per hour (ACPH) in negative pressure buffer room

30

facts regarding the compounding environments/rooms

surfaces of ceilings, walls, floors, fixtures, shelving, cabinets, counters should be smooth, impervious and free from cracks/crevices - easier to clean and disinfectT/

T/F: objects that shed particles should not be brought into the cleanroom

true

what are restricted-access barrier systems (RABS)

enclosure that provides HEPA-filtered ISO class 5 unidirectional air that allows for the passage of materials through defined openings that are generally not to be opened during operations - sterile gloves are required when working in a compounding isolator on the sleeve and over the sleeve

what is a compounding aseptic isolator (CAI)

a type of RABS that uses HEPA filtration to provide an ISO class 5 unidirectional air environment designed for the compounding of sterile non-hazardous drugs

where are RABS located?

can be located within a buffer room, but typically used in a segregated compounding area (SCA)

what are segregated compounding areas (SCA)

SEC, but does not have the controls of a cleanroom suite - area dedicated to sterile compounding; separate room if not visible perimeter to establish boundary

ISO specified class for segregated compounding area (SCA)

room air - no ISO specified class

hand-washing procedure:

remove visible debris from underneath fingernails under warm running water using a disposable nail cleaner, wash hands and forearms up to the elbows with soap and water for at least 30 seconds, dry hands and forearms to the elbows completely with low-lint disposable towels or wipers

T/F: alcohol-based hand sanitizer is a replacement for soap andw ater hand wash

false

when is hand sanitizer applied to hands?

after hands are washed with soap and water but before donning sterile gloves

where must sterile gloved be donned?

in a classified room or segregated compounding area (SCA)

hand sanitizing procedures:

apply and alcohol-based hand rub to dry skin following the manufacturer’s instructions for the volume of product to use, apply product to one hand and rub hands together covering all surfaces of hands and fingers, until hands are dry, allow ands to dry thoroughly before donning sterile gloves

what type of gloves should be used

sterile, powder-free gloves

rules for gloves:

apply 70% isopropyl alcohol (IPA) to gloves regularly throughout compounding (whenever nonsterile surfaces such as vials, counter tops, carts are touched), replace gloves when they are soiled or contaminated, DO NOT wash gloves

garbng requirements:

low-lint garment with sleeves that fit snugly around the wrists and an enclosed neck, low-lint covers for shoes, low-lint cover for head that covers the hair and ears, and if applicable, cover for facial hair, low-lint face mask, sterile powder-free gloves

order of garbing:

order must reduce risk of contamination (dependent on placement of sink/workflow, to be determined by the facility and documented in the facility’s SOP)

where must donning and doffing occur?

anteroom

when to replace garbs

if visible soiled

when can garbs be re-used?

can be re-used within the same shift if gown maintained in a classified area/inside perimeter of SCA

garbing requirements:

remove outer garments, no earbuds/headphones, no artificial nails/polish, no jewelry/cosmetics, no food, gum, or mints

example order of garbings:

1. remove all jewelry, jackets, vests, hats, etc.

2. don shoe covers, stepping over line of demarcation

3. don face mask, head/hair covers

4. wash hands

5. don gown

6. enter cleanroom

7. hand cleansing with alcohol based product

8. don sterile gloves

9. routinely disinfect gloves with sterile 70% isopropyl alcohol

how to clean the hood

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

what is used to clean the hood?

70% IPA - use a new wipe for each surface cleaned (do not spray cleaner inside the PEC)

if the diffuser (back of horizontal hood) is to be cleaned, when should it be cleaned?

clean first

frequency of cleaning hood:

before each shift, every 30 minutes while working, before/after each batch, and whenever visibly soiled

T/F: the outside of all materials should be wiped with 70% IPA before brining them into the hood

true

what is considered the direct compounding area?

working at least 6 inches into the hood

where should critical points be facing?

into first air - do not obstruct first air with hands or supplies

T/F: no item should be between sterile object and HEPA filter in a horizontal LAFW or above a sterile object in a vertical LAFW

true