Compounding Flashcards
If there are separate sterile and non-sterile C-PECs in the same C-SEC, how far must they be apart?
1 meter
What kind of pressure do C-PECs, C-SECs, and C-SCAs have to have?
negative pressure
In space where non-sterile HDs are compounded and in a C-SCA, how many air changes per hour (ACPH) should there be?
12
In a sterile C-SEC, how many ACPHs should there be?
30
Redundant HEPA filters can only be used in what type of compounding?
non-sterile HD compounding
How do HDs have to be stored?
stored separately from non-HDs in an externally ventilated, negative pressure room with at least 12 ACPH
What is the media-fill test used for?
sterile drug preparation
What is the gloved fingertip test used for?
hand hygiene, garbing, and gloving
How often do you have to pass a gloved fingertip test if compounding low and medium-risk CSPs?
What about high risk CSPs?
Annually
Semi-annually
How often does a media fill test need to be performed for low and medium risk CSPs?
annually
Tryptic soy broth (TSB) is used for what test?
media fill test
Tryptic soy agar (TSA) is used for what test?
gloved fingertip test and surface sampling
What temp should the fridge stay at?
2-8 C
What temp should the freezer be kept at?
between -25 and -10C
If a freezer contains vaccines, what temp should it be kept at?
between -50 to -15 C
How often should air sampling be done?
every 6 months
In surface sampling, action must be taken if CFUs are greater than what in ISO 5, ISO 7, and ISO 8 areas?
ISO 5: > 3 CFUs
ISO 7: > 5 CFUs
ISO 8: > 100 CFUs
How often should air pressure be checked?
Every work shift or once daily (minimally)
How often should humidity be checked?
daily
How long do you have to wait to start compounding in a PEC or C-PEC if the power was shut off?
30 minutes
What kind of wipes are used to clean a PEC?
lint-free sterile wipes
What is the order that PECs should be cleaned?
top to bottom, back to front
cleanest areas are cleaned first and dirtiest areas are cleaned last
ISO 5 PECs are cleaned how often (4)?
before each shift
every 30 minutes while working
before and after each batch of CSPs
whenever needed, including after spills
What items can be cleaned monthly in sterile compounding (6)?
ceiling, walls, shelves, chairs, bins, carts
What is the correct order of sanitization of HDs?
- Deactivation and decontamination
- Cleaning
- Disinfection
What’s used in deactivation and decontamination?
2% bleach (sodium hydrochlorite) or peroxide
reduces HD toxicity, then removes HD residues
deactivation and contamination
What’s used in cleaning?
germicidal detergent (quat, ammonium, phenolics)
removes dirt and microbial contamination
cleaning
What’s used in disinfection?
sterile 70% isopropyl alcohol
inhibits or destroys microorganism
required step in sterile compounding
disinfection
To prevent corrosion from bleach on surfaces, what should you do after using bleach?
wipe surfaces with sodium thiosulfate, sterile alcohol, sterile water, or a germicidal detergent
Name the items that go in black, yellow, and red bins.
Black = bulk HD waste
Yellow = trace HD waste
Red = non-hazardous sharps
What bin do HD syringes go in?
yellow
any containers (drug vials, IV bags) that contain a clearly visible amount of HD and any supplies that were used top administer HDs or to clean up HD spills
bulk HD waste (black bin)
empty syringes, IV bags, used PPE (gowns, gloves, masks, and shoe covers)
trace HD waste (yellow bin)
Pharmacists involved in hazardous compounding should perform wipe sampling of all compounding surfaces how often?
every 6 months
When HDs are unpacked and they aren’t contained in plastic, what kind of mask should the staff member wear?
elastomeric half-mask, with a multi-gas cartridge and P100 filter
What mask is sufficient for most HD compounding, but doesn’t provide adequate protection against gases, vapors, or direct liquid splashes?
N95 respirator
When there is a risk of respiratory exposure, what 2 masks can be worn?
respirator mask with attached gas canisters
powered air-purifying respirator (PAPR)
When administering any HD, what needs to be worn?
2 pairs of chemo gloves
A single pair of chemo gloves can be used when?
HD receiving and storage
How often should a gown be changed?
every 2-3 hours or immediately after a spill or splash
How often do gloves need to be changed?
every 30 minutes
For low-risk non-sterile HDs (intact tablets), how many pairs of gloves can be worn?
1
What is the max recommended temp inside an SEC?
20 C (68 F)
In what motion should the PEC be cleaned?
slightly overlapping, unidirectional strokes
How often should counters and floors be cleaned in a sterile compounding area?
daily
Metal spatulas should not be used with compounds containing what?
metal ions
A graduate should not be used to measure volumes < __ of the graduate’s capacity.
20%
What type of equipment is useful for measuring glycerin and mineral oil?
syringes (they are especially useful at measuring viscous liquids, which include glycerin and mineral oil)
What part of a syringe should not be touched?
plunger
Class A balance
Class III torsion balance
Analytical balance
electronic balance
Mortar used for liquids and for mixing compounds that are oily or can stain
glass mortar
Mortar that has a rough surface and are preferred for grinding dry crystals and hard powders
wedgwood mortar
Mortar that has a smooth surface and are preferred for blending powders and pulverizing gummy consistencies
porcelain mortar
can be used as a work surface if the water content of the mixture won’t cause the paper to tear
disposable parchment ointment pads
Electric mixing equipment that reduce the particle size, which increases the surface area and the rate of drug absorption
ointment mills, homogenizers, and grinders
Electric mortar and pestle that can be used to mix ointments, creams, or other semi-solid particles
homogenizer
Draws the ointment between rollers that grind and homogenize the ingredients
ointment mills
Capsule shells can be made of what 2 things?
gelatin (pork-derived)
hypromellose (plant-derived)
Largest capsule size for human use
000
Smallest capsule size for human use
5
If any substance comes from a non-FDA registered facility, what should be obtained and what does it confirm?
Certificate of Analysis
Confirms the specifications and quality of the substance
If there is an ingredient without an expiration date, a pharmacist can assign a date that’s no more than how many years from the date of receipt?
3 years
lowers the surface tension between 2 ingredients in a preparation to make them more miscible
surfactant
Type of surfactant that reduces the surface tension between a liquid and a solid to permit the substance to more easily spread
wetting agent
Type of surfactant that helps keep the liquid droplets dispersed throughout the liquid vehicle when added to a mixture with two or more liquids that are immiscible
emulsifier
Type of surfactant that help keep solid particles from settling
suspending agent
Type of surfactant added to aid in grinding particles down
levigating agent
Levigating agent used for lipophilic compounds
mineral oil
Levigating agents used for aqueous compounds
propylene glycol or glycerin
Compounds that are commonly oxidized have what group attached to it?
hydroxyl (-OH) group
BUD for non-aqueous formulations (e.g., drug in petrolatum)
6 months
store at room temp
BUD for water-containing formulations (PO suspension)
14 days when stored at controlled cold temps
store in fridge
BUD for water-containing topical/dermal and mucosal liquid and semisolid formulations (cream or lotion)
30 days
store at room temp
