Chapter 15: Compounding I: Basics Flashcards
What is the PEC?
primary engineering control = the hood
What is the SEC?
secondary engineering control = the buffer room in which the hood sits
what does the C in C-SEC and C-PEC mean?
containment –> for handling hazardous drugs
contain the drug in a confinded space to protect the compounder
What is the CAI?
compounding aseptic isolator =
glovebox for non-HDs
What is the CACI?
compounding aseptic containment isolator = glovebox for HDs
What is the BSC?
biologic safety cabinet = chemo hood (Class II or III) for sterile HD, a type of C-PEC
Who sets the standards for compounding preparations, strength, quality and purity of human and animal drugs?
US Pharmacopeia (USP)
Which USP chapter is related to non-sterile compounding?
USP 795
Which USP chapter is related to sterile compounding?
USP 797
Which USP chapter is related to handling hazardous drugs?
USP 800
Who determines which drugs are hazardous?
The National Institute for Occupational Safety and Health (NIOSH)
Besides USP chapters, where else can pharmacists find detailed guidance on implementing USP standards?
American Society of Health-System Pharmacists (ASHP)
What particle size is counted in ISO 5?
If particles ≥ 0.5 microns
ISO rating for a PEC
ISO 5
ISO rating for a SEC
ISO 7
SEC = buffer room, contains the PEC (hood)
ISO rating for an anteroom with
1. SEC with positive pressure air
2. SEC with negative pressure air
- ISO 8
- ISO 7
What is the air directly from the HEPA filterin the hood called?
first air
this is the direct compounding area
How often must a HEPA filter be recertififed by a specialist?
every 6 months, anytime PEC is moved
SCA (segregated compounding area) has what type of air?
unclassified air
Compounds made in SCA (segregated compounding area) have a BUD of what?
12 hours - due to being made in unclassified air
What are the 4 characteristics that make a drug hazardous?
- Carcinogenic
- Teratogenic
- Causes organ toxicity at low doses
- Genotoxic (damages the DNA)
- labeled by manufacturer for special handling
What must be included in a sterile compounding space?
- anteroom
- buffer area
- primary engineering control (PEC) or a segregated compounding area (SCA)
What requirements must be met for a non-sterile HD to be prepared in a C-PEC inside a C-SEC?
- The C-SEC must maintain ISO 7 air
- There must be separate sterile and non-sterile C-PECs kept at least 1 meter apart
- Particle-generating activity, such as working with powders, cannot be performed when any sterile compounding is being performed in the same C-SEC
C-PECs (containment primary engineering control) and C-SECs (containment secondary engineering control) must have ______
negative air pressure
protects compounder
In space where non-sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)
12
In space where sterile HDs are compounded, there must be at least __ air changes per hour (ACPH)
30
What does it mean when air that has been contaminated with HDs must be externally exhausted?
The air is moved out of the space and cannot be recirculated and returned to the room
What is an alternative option to an external exhaust (for non-sterile HD compounding only)?
Redundant-HEPA filters
What is a class II biologic safety cabinet (BSC)
The chemo hood for sterile chemo drugs and other sterile HDs (aka a C-PEC)
The International Standards Organization (ISO) sets the standards for air quality, which is determined by the number and size of ___ per ___ of air
Particles per volume (the lower the particle count, the cleaner the air)
HEPA filters are >99.97% efficient in removing particles as small as ____ wide or larger, including bacteria, fungi, viruses, and dust
0.3 microns
In a ___ airflow biologic safety cabinet (BSC) or C-PEC, the HEPA filter is at the top of the sterile hood
Vertical
In a ____ airflow, or PEC, the HEPA filter is at the back of the sterile hood
Horizontal (laminar airflow workbench)
Running down the center of the anteroom is a large visible line called ____, which separates the room into clean and dirty sections
the line of demarcation
Air pressure inside the PEC and inside a non-hazardous SEC can both be ____ (positive or negative)
Positive
With hazardous compounding, the C-PEC and the C-SEC must have ____ pressure to keep the toxic air contained in the space (positive or negative)
Negative
Another name for and isolator PEC/glove box?
Where are they located?
compounding aseptic isolators (CAI) or compounding aseptic containment isolators (CACI)
Located in a segregated compounding area (SCA) or C-SCA for HD
The maximum beyond-use dates (BUD) for CSPs made in an isolator in a segregated compounding area (SCA) is _____
12 hours
If the anteroom is ISO 8, the air will be dirtier than inside the SEC. To keep the air from the anteroom out, the SEC will need to have _____ air pressure to push the air out of the SEC and into the anteroom
Positive
For sterile, non-hazardous preparation, ____ laminar airflow is used
Horizontal
For sterile hazardous preparation, ___ laminar airflow is used
Vertical
Adequate aseptic technique in hand hygiene, garbing and gloving is demonstrated by passing which test?
The gloved fingertip test
Adequate aseptic technique in sterile drug preparation is demonstrated by passing which test?
Media-fill test
A passing score on the gloved fingertip test & media-fill test is required initially, then _ (if compounding low- and medium-risk compounded sterile products) and _ (if compounding high risk compounded sterile products)
Annually
Semi-annually
How do you pass a gloved fingertip test?
3 consecutive gloved fingertip samples with zero colony-formulating units (CFUs) for both hands
How do you pass a media-fill test?
The liquid must stay clear after 14 days of incubation
How often must temperature be monitored in the SEC?
Once daily
What should the temperature be kept at in the SEC?
20°C (68° F) or cooler
How often must refrigerator and freezer temperature be monitored?
Daily
What temperature should the refrigerator be kept at?
Between 2 - 8°C
What temperature should the freezer be kept at?
Between -50 and -15°C
Air sampling identifies contaminants in the air and should be performed at least every ____ by a person certified in air sampling or by a qualified compounding staff member
6 months
What provides a good growth medium for surface sampling
Tryptic soy agar (TSA)
____ and ____ are added to TSA in surface sampling to neutralize the effect of any disinfecting agents on the surfaces
Polysorbate 80 and lecithin
When should surface sampling occur ?
At the end of the day when the surfaces are in the poorest state
After surface sampling, the plates should have zero CFUs. Action must be taken if ___ CFUs are identified in the ISO 5 area, ___ CFUs in the ISO 7 area, and ___ CFUs in the ISO 8 area
> 3
5
100
The air pressure testing confirms that there is the correct ____ between two spaces and ensures that the airflow is ____
Differential (difference in pressures)
Unidirectional
How often should surface sampling be done?
periodically, goal is 0 CFUs
How often should humidity be checked?
goal
daily (minimally)
< 60%
Pressure gauges are installed in the cleanroom space and checked minimally ____
Once daily or with every work shift
T or F: All PECs and C-PECs are kept running at all times to help keep the surfaces clean
True
If there is a power outage, all compounding must stop and the PECs will need to be cleaned with ____ and then disinfected with ____ prior to the re-initiation of a compounding activity
A germicidal detergent
Sterile 70% isopropyl alcohol (IPA)
If the power has been off, in addition to cleaning and disinfecting (or sanitation for C-PEC) the PEC or C-PEC must be on for at least ____ before compounding can begin
30 minutes
T or F: You should use circular motions to clean the PEC
F - use slightly overlapping, unidirectional strokes
Which direction is a PEC cleaned in?
From top to bottom, then back to front (cleanest areas are cleaned first)
What is the order for sanitizing hazardous drug areas and equipment?
- Deactivation & Decontamination (2% bleach or peroxide)
- Cleaning (germicidal detergent - Quat, Ammonium, Phenolics)
- Disinfection (sterile 70% isopropyl alcohol)
How can you prevent corrosion on stainless steel surfaces with bleach?
Neutralize it by wiping surfaces afterwards with sodium thiosulfate, sterile alcohol, sterile water or germicidal detergent
What goes in the black waste bin?
Bulk hazardous drug waste (including containers with a clearly visible amount of an HD, supplies to administer HDs, or to clean up HD spills)
What goes in the yellow waste bin?
For trace HD waste (empty syringes, IV bags, used PPE)
What goes in the red waste bin?
Infectious waste (IV tubing and used culture dishes)
What goes in the red sharps container?
Non-HD sharps, such as used syringes
If no Assessment of Risk (AOR) is conducted for lower-risk HDs, the pharmacy must…
Follow the full USP 800 requirements
USP 797 risk categories are based on the risk of …
Contamination of the sterile product
When a drug or chemical is exposed in one’s eye, flood the affected eye at an eyewash fountain or with water or an isotonic eyewash for at least ____
15 minutes
When HDs are unpacked and they are not contained in plastic, the staff member should wear ____
An elastomeric half-mask, with a multi-gas cartridge and P100-filter
What must be included in a spill kit?
Protective gown, latex gloves, N95 respirator mask plus goggles with side shields
HD waste bag, chemo pads
HD spill report exposure form
T or F: two pairs of gloves must be worn when administering HDs
True
When is a closed-system transfer device (CSTD) recommended? When are they required?
When compounding HDs
When administering antineoplastics
If manipulation (i.e. crushing tablets, opening capsules) is required for HDs, it should be done in ____ to contain any dust or particles
Plastic bag
The outer chemotherapy gloves worn during compounding are discarded in ____ located inside the C-PEC or put in a sealable bag if discarded outside the C-PEC
Yellow trace chemo waste bin
PPE for non-sterile HD compounding includes:
double gloves, gown, mask, disposable pad
PPE for sterile HD compounding includes:
Head covers, face mask, & beard cover
Two pairs of shoe covers
A gown impermeable to liquids
Two pairs of ASTM D6978 (chemo)-rated gloves
A full-face piece respirator or a face shield with goggles when there is a risk for spills or splashes
What is the order for garbing before sterile compounding?
- head cover
- shoe cover (x2 for HD)
- wash hand thoroughly - circular motion for 30 seconds
- garb gown
- enter buffer area
- put alcohol based cleaner on hands
- gloves (x2 for HD)
- apply alcohol to gloves
How often must chemo gloves be changed?
Every 30 minutes or when torn, punctured or contaminated
How often must chemo gowns be changed?
Every 2-3 hours or immediately after a spill or splash
___ is a series of safety documents required by OSHA to be accessible to all employees who are working with hazardous materials
SDS
Non-sterile compounding is primarily used to:
- Change the formulation of a med
- Avoid an excipient
- Prepare a dose or formulation that is not commercially available
- Add a flavor
sterile compounding is primarily used to prepare:
- Non-hazardous sterile IV drugs
- Hazardous sterile IV drugs
- Radiopharmaceuticals
- Eyedrops
- Irrigation
- pulmonary inhalations (not nasal)
Powders can cause air contamination and are best when used within a
Powder containment hood
A hood that has ventilation, including HEPA filtered air, pressurized air (negative pressure to keep powder inside the hood) and exhaust systems
Ventilated Compounding Enclosure (VCE)
Hazardous drugs must be stored separately from non-HD in an externally ventilated, negative-pressure room with at least ___ ACPH
12
A small volume parenteral (SVP) is an IV container up to ___ mL & a large volume parenteral (LVP) is an IV container > __ mL
≤ 100
100
The PECs in a non-HD cleanroom can be either:
- CAI
- Laminar Airflow Workbench
A C-PEC can be either:
- CACI
- Biological safety cabinet (BSC)
T/F: CAIs do not have an external vent, whereas CACIs do
True
During the gloved fingertip test, the evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers over a surface which contains
Tryptic Soy Agar (TSA)
The test container for the media-fill test contains
Tryptic soy broth (TSB)
USP 795 risk categories are based on the …
complexity of the preparation
USP 795 simple risk means
simply following instructions
USP 795 moderate risk means
Compounding a preparation that has no established stability data, or a preparation with specialized calculations or procedures
USP 795 complex risk means
specialized training, facilities, equipment or procedures are needed
The gloves used in compounding & cleaning up spills are called
ASTM D6978-rated gloves
How many gloves should be used for HD receiving and storage
single gloves
____ should be worn for cleaning up large HD spills, sanitizing the undertray of a C-PEC or when there is known or suspected airborne exposure to powders or vapors
Powered air-purifying respirator (PAPR)
What is the best material for a chemo gown
Polyethylene-coated polypropylene or other laminate material
