Compounded Sterile Product (CSP) Flashcards
ISO classes value and relation to sterility
the lower the number, the cleaner the air
What is the ante area’s ISO class?
Class 8
What is the buffer area’s ISO class?
Class 7
What can you do in an ante area?
- For personnel hand hygiene/garbing
- Staging of compounding materials
- Order entry and CSP labeling
- Maintains pressure relationships to adjacent rooms
What can you do in a bugger area?
- Staging of components and supplies for compounding CSPs
- The location of the primary engineering control (PEC) for compounding
Where is the PEC located?
in the buffer area
What is the purpose of maintaining pressure relationships established in the ante area?
clean air must move towards dirty air which is maintained by pressure gradients
What is a clean room’s ISO class?
Class 5
Direction of airflow for positive pressure
- pressure flows out to the dirtier areas
- ex. ISO 5 -> ISO 7 -> ISO 8
What is the ISO class for a PEC?
- primary engineering control
- ISO class 5
What are the features of a segregated compounding area?
- Designated demarcated space or room
- Contains a primary engineering control which produces ISO Class 5 air quality
- Only includes activities/materials specific to CSP preparation (no general traffic)
- Only low-risk CSPs with beyond-use date (BUD) of < 12 hours
How often should the walls, ceilings, and storage shelves be cleaned?
monthly
How often should the counters, work surfaces, and floors be cleaned?
daily
How often should the PEC be cleaned?
- At the beginning of each shift
- Before each CSP batch
- Not longer than 30 minutes after previous cleaning when CSP preparation is ongoing
- After spills
- If surface contamination known/suspected
Low risk CSPs
- must be done in ISO Class 5 air
- Source ingredients, devices, components were sterile at baseline
- Cannot mix more than 3 commercial sterile products (including the bag)
- Cannot puncture more than 2 entries into any one sterile container or package (including final container)
Medium risk CSPs
- Aseptic manipulations under low-risk conditions and 1 or more conditions exist:
• products are combined/pooled to administer to multiple patients OR one patient on multiple occasions (batch compounding)
• complex aseptic manipulations other than single volume transfer
• requires unusually long duration for compounding
• combining more than 3 commercial products or more than 2 entries into a single container - include Total parenteral nutrition compounding
- include Use of automated compounding devices, elastomeric pumps
High risk CSPs
- Preparations compounded under specific conditions are contaminated or at high risk of contamination
• Non-sterile ingredients or devices employed prior to terminal sterilization
• Personnel improperly garbed and gloved
• Sterile water-containing preparations stored for more than 6 hours before sterilization - Any of the following are exposed to air quality worse than ISO 5 for > 1 hour
• sterile contents of commercial products
• CSPs that lack effective antimicrobial preservatives
• sterile surfaces of devices and containers for preparation, transfer, sterilization and packaging of CSPs - Assuming and not verifying by examination of label and documentation of suppliers or direct determination
immediate use
- must be administered within 1 hour of preparation
- must be low risk
immediate use, room temp BUD
1 hour
immediate use, refrigerated BUD
1 hour
immediate use, freezer BUD
N/A
low risk, room temp BUD
48 hours
low risk, refrigerated BUD
14 days
low risk, freezer BUD
45 days
medium risk, room temp BUD
30 hours
medium risk, refrigerated BUD
9 days
medium risk, freezer BUD
45 days
high risk, room temp BUD
24 hours
high risk, refrigerated BUD
3 days
high risk, freezer BUD
45 days
segregated compounding area BUD
- 12 hours in fridge and room temp
- N/A for freezer
Supplies within the PEC (ISO class 5 air)
- Single-dose vials may be used for multiple needle entries up to 6 hours after initial needle puncture (check facility policy)
- Opened ampules shall not be stored for any time
- Multiple-dose containers (with preservatives) after needle puncture can have 28 day BUD unless otherwise specified by manufacturer
What is the BUD for a multiple dose vial that has been punctured?
28 days
What are things that needs to be on a patient label?
- Name, ID#, room#
- Ingredients and amount per CSP
- Solution vehicle and volume quantity
- Due time (for administration)
- Date/time of preparation
- Name/initials of pharmacist verifying CSP
- Expiration/BUD, storage, special conditions
What is the BUD for a single dose vial that has been punctured?
6 hours
ISO 5 particles
≤ 100 particles/ft3 (class 100)
ISO 7 particles
≤ 10,000 particles/ft3 (class 10,000)
ISO 8 particles
≤ 100,000 particles/ft3 (class 100,000)
Direction of airflow for negative pressure room
inward airflow to contain any airborne drug
How often should the PEC be certified?
semiannually
How often should ISO 5-8 be certified?
semiannually
How often should the PEC prefilters be inspected?
- inspected monthly
- cleaned or changed at least quarterly
How often should a HEPA filter be changed?
repaired or replaced when recommended by a qualified certifier
How often should temperature be documented?
daily
How often should the accuracy and precision of devices such as automated compounders and repeater pumps be documented?
daily
List the proper sequence of steps/method for cleaning a horizontal LAFW.
- Wipe parallel to the HEPA filter
- Clean top surface first (if a solid panel)
- Clean IV pole (if present)
- Clean sides (top to bottom)
- Clean the bottom work surface last
What product should you use to clean a horizontal LAFW?
Sterile 70% isopropyl alcohol
Demonstrate and/or recognize proper procedures for hand hygiene
- Remove all jewelry, watches, etc
- Wet hands/arms up to elbows
- Apply bactericidal soap
- Thoroughly scrub up to elbows, > 30 seconds
• Front/back of hands, between fingers, nails / nailbeds
• Rinse down hands toward elbows
• Use clean, lint free towel to dry hands/arms and turn off faucet
• Touch only gowning supplies until gloves applied
List and/or recognize examples of and/or the purpose of barrier controls
- Gowns: Minimize shedding, personnel protection
- Hair covers: Minimize shedding of hair/skin
- Face masks: Physical barrier to prevent contamination from sputum particles
- Shoe covers: Prevent tracking contamination
When do you need to double glove?
during hazardous compounding
proper procedures for garbing / gowning
- Apply garbing apparel from head down
• Face mask/beard cover
• Hair cover
• Shoe covers
purpose of PEC
- to produce a clean air environment
- prevents room air from entering sterile environment
critical sites
- any location at which the product may contact the environment
- examples: septum, uncapped needles, filter straws, spikes from tubing, open ampules, bag/bottle connections, compounder connections
critical pathways
any route by which the product may become exposed to contamination
First air
- flows directly from the face of the HEPA filter and is essentially sterile
- if first air is disturbed or blocked, it’s not possible to assure sterile air will reach critical sites
How can hood airflow is disrupted?
- erratic movements near the front of the hood
- talking into the hood
- central heat/air ventilation systems in the room
- rapid hand movements in the hood
flow through the horizontal laminar flow hood
- provide only product protection
- Intake through a pre-filter in the front/below workbench to remove gross particles
- Next the pre-filtered air moves up through the HEPA and plenum before emerging horizontally from back to front in parallel streams
- No object should be placed between a sterile object and the HEPA filter, to avoid disruption of sterile airflow to the critical areas/sites
flow through the vertical laminar flow hood
- provide only product protection
- Intake down through the grids in front and back, pre-filtered and HEPAfiltered before sterile air emerges from the top of the cabinet vertically down across the workbench
- No object should be placed above a sterile object to disrupt airflow from the HEPA filter downward over the critical areas/sites
Biological safety cabinets (BSC)
- Can provide personnel protection against harmful agents
- Can provide preparation protection
- Can provide environmental protection from contamination by the harmful agent(s)
- have vertical laminar airflow to limit emergence of air from the PEC
- different types vary in their ability to protect personnel, the preparation, and the environment
buffer area
- Controls concentration of airborne particles through HEPA filtration, continuous circulation of air, and a barrier between less clean environments
- Maintains appropriate temperature, humidity, air pressure and flow patterns
- May also have additional features such as ultraviolet irradiation, airlock entry portals, sticky mats on floors, and positive air pressure to minimize contaminated air entry
- The lower the classification number, the cleaner the environment
- Must be free of materials introducing particulates such as cardboard boxes
- Should not allow for regular traffic
ante room
- Adjacent to the buffer area or clean room
- A non-aseptic environment used for order entry, gowning and handling stock
What are the types of contamination?
- downstream contamination
- backwash contamination
- cross-stream contamination
downstream contamination
- occurs when a critical site is located downstream from an object blocking the flow of first air
- Improper placement of objects within the hood creates turbulent flow
• 3 times the diameter of an object placed in the middle of the hood
• 6 times the diameter of an object placed against the side of the hood
backwash contamination
- room air washes back into the front of the hood
- the first 6 inches of air inside the hood should be presumed contaminated
- air currents from ventilation or central heat/air
- movements of personnel around the front of the cabinet
- personnel movements within the hood
cross-stream contamination
- disturbance in air flow currents carry contamination from one object to another in a cross-wise manner
- objects placed too close to each other
- rapid hand movements across objects
Proper cleanroom behavior
- Avoid talking, coughing, sneezing into the laminar airflow cabinet or direct such actions away from the sterile environment
- Avoid excessive or erratic movements around the laminar airflow cabinet
- Eating, drinking or chewing gum are strictly prohibited in the environment
temperature range for refrigerated compounds
36‐46° F or 2‐8° C
transient flora
- comprises 15% on the skin
- can be removed with washing)
resident flora
- comprises 85% on the skin – deep in sebaceous glands
- renews the transient flora shortly following handwashing
level of sterility of gloves
- gloves provide a bacteriostatic surface that can be disinfected frequently to reduce contaminant transfer
- do not remain sterile
- wash gloves to remove particles
- disinfect with sterile 70% isopropyl alcohol before use and frequently during use
How long does a horizontal laminar flow workbench (LAFW) must be in operation prior to compounding?
24 hours or 30 min continuously prior to sterile compounding
