Compounded Sterile Products Flashcards
Minimum acceptable ISO air class for an ante area
ISO 8
Acceptable ante area activities
hand hygiene/garbing
staging of compounding materials
order entry/CSP labeling
Purpose of pressure relationships established by an ante area
Maintains pressure relationships to adjacent rooms
Air flows out: from clean to “dirty”
Minimum acceptable ISO air class for a buffer area and characteristics
ISO 7
Components and supplies for compounding
Location of the primary engineering control/hood
Physical location of a primary engineering control in relation to an ante area and buffer are
In ISO 7 air buffer area, away from doors, air vents, general traffic areas
Minimum acceptable ISO air class for a clean room
ISO 5 - same as the primary engineering control
Direction of airflow in a negative pressure room
Keeps contaminated air in.
Ante area is negative compared to the buffer area but still more positive than outside air.
Direction of airflow in a positive pressure room
Air flows outward
Clean air flows outward toward dirty air.
Direction of air flow: clean room > buffer > ante > outside
Minimum acceptable ISO class for primary engineering controls
ISO 5
Examples of devices/physical spaces that serve as primary engineering controls
Clean room or segregated compounding area
Features of Segregated compounding area
designated demarcated space/room w/ PEC that produces ISO 5 air.
Only includes activities/materials specific to CSP prep
Only low-risk CSPs w/ BUD < 12hrs
Max allowed particle count per cubic foot for ISO 5, ISO 7 and ISO 8
ISO 5: <100 particles
ISO 7: <10,000 particles
ISO 8: <100,000 particles
Frequency of inspection and certification of ISO 5 environments
Every 6 months and if relocated or if damage to the HEPA filter
Compounding Hazardous materials
Use special procedures to prevent cross contamination and proper disposal
Dedication of equipment/hoods for hazardous compounding
Medium-risk compounding
Low risk conditions and products are combined/pooled to administer multiple patients or one pt on multiple occasions (batch compounding)
Complex aseptic manipulations other than single volume transfer
ex: TPNs, use of automated compounding devices, elastomeric pumps
Requires unusually long duration for compounding
Combined more than 3 commercial products or more than 2 entries into a single container
High-risk compounding
Compounding under specific conditions or at high risk of contamination:
Non-sterile ingredients/devices employed before terminal sterilization
Personnel improperly garbed and gloved
Sterile contents of commercial products, CSPs that lack effective antimicrobial preservatives or sterile surfaces of devices and containers for prep, transfer, sterilization and packaging that were exposed to air worse than ISO 5 for >1 hr
Assuming and not verifying that chemical purity and content strength meet original specifications
Compounding Hazardous materials
Use special procedures to prevent cross contamination and proper disposal
Dedication of equipment/hoods for hazardous compounding
Immediate Use
Emergency or immediate patient administration needed
Simple transfer <3 non-hazardous commercial products (<2 entries into 1 container)
Give w/in 1 hr of prep
Labeled/initiated by preparer w/ exact 1hr BUD
Beyond Use Date (BUD)
the shorter of the chemical stability or microbial limits of sterility by USP 797 standards
Time limit of use for multiple needle entries into a single-dose vial exposed to ISO 5 or cleaner air
Preservative free: up to 6 hrs after initial puncture
Time limit of use for an opened single dose ampule exposed to ISO 5 or cleaner air
Shall not be stored
BUD after initial entry of a multi-dose container
With preservative: 28 days after needle puncture
Info to include on final product label
Name, ID#, room#, ingredients and amount per CSP, solution vehicle and volume, time due for admin, date/time of preparation, name/initials of pharmacists verifying, expiration/BUD, storage, special conditions
Immediate Use
Emergency or immediate patient administration needed
Simple transfer <3 non-hazardous commercial products (<2 entries into 1 container)
Give w/in 1 hr of prep
Labeled/initiated by preparer w/ exact 1 hr BUD
Low risk compounded in a segregated compounding area w/ ISO 5 hood BUD
Room temp: 12 hrs
Refrigerator: 12 hrs
High risk BUD
Room temp: 24 hr
Refrigerated: 3 days
Freezer: 45 days
Purpose of primary engineering controls
to produce clean air environment
Critical sites and critical pathways
Sites: where ever the product may contact the environment
Pathways: any route by which the product may become exposed to contamination
ex: septum, uncapped needles, filter straws, spike from tubing, open ampules, bag/bottle connections, compounder connections
Features of laminar airflow that prevent airborne contaminants from entering the hood
HEPA filter removes 99.9% particulate matter at least 50 microns in diameter
Features of horizontal airflow hoods and methods to prevent disruption of sterile air to critical sites
Only product protection
Pre-filter > HEPA filter > sterile air from the back of the cabinet
Nothing should be placed between a sterile object and the HEPA filter
Features of vertical airflow hoods and methods to prevent disruption of sterile air to critical sites
Only product protection
Pre-filter > HEPA filter > sterile air from the top of the cabinet
Nothing should be placed between a sterile object and the HEPA filter
Type of protection possible w/ horizontal and vertical LAFW
product protection
Type of protection possible w/ biological safety cabinet
Provides personnel protection against harmful agents, preparation protection, and environmental protection from contamination by the harmful agent
Purpose of secondary engineering controls: Buffer area
Controls conc. of airborne particles through HEPA filtration, continuous circulation of air and a barrier between less clean environments
Maintains appropriate temp, humidity, air pressure and flow patterns
Purpose of secondary engineering controls: ante room
non-aseptic environment used for order entry, gowning and handling stock
3 principle contamination models that can occur in LAFW
Down stream
Backwash
Cross stream
Causes of downstream contamination
when critical site located downstream from an object blocking the flow of first air
Length of turbulent flow downstream from an object placed in the middle or at the side of the horizontal LAFW
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
Causes of backwash contamination
Room air washes back into the front of the hood
The first 6 inches of air inside the hood should be considered contaminated.
ex: air currents from ventilation/central heat/air, movement of personnel in front of the hood and in the hood
Causes of cross-stream contamination
disturbance in airflow 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 clean room behavior and actions to avoid
avoid talking, coughing, sneezing into hood (direct actions away from the hood)
avoid excess/erratic movements
eating, drinking, chewing gum
Quality control procedures required by Oklahoma Pharmacy Law
- Daily temp documentation where CSPs are stored/compounded
- daily documentation of accuracy and precision on devices
Proper temperature ranges required for storing refrigerated compounds
36-46F (2-8C)
Quality assurance required by Oklahoma Pharmacy Law
- Routine disinfection
- Visual confirmation of garbing/gowning
- Review CSP against orders ensuring correct identity and quality of ingredients
- Visual inspection for particulates, leaks and accuracy/thoroughness of labeling
- Clean rooms meet specified standards
- Compounding area is separate/distinct from non-sterile
- PEC used for all sterile compounding
- Semi-annual certification of PECs, all ISO5-8 environments, segregated compounding areas
- PEC filters inspected monthly, cleaned/changed quarterly and documented
- PEC HEPA filter repaired/replaced according to mfg
- initial and annual competencies
Initial and annual competencies:
Written test Hand hygiene and garbing Gloved fingertip sampling Aseptic manipulation, aseptic media-fill test Cleaning and disinfecting Surface sampling Equipment Routine visual inspection of CSPs Provision of education for immediate use
Quality control procedures required by Oklahoma Pharmacy Law
- Daily temp documented where CSPs are stored/compounded
- daily documentation of accuracy and precision on devices
- Recording keeping: PEC maintenance/certification, cert stamp on hood
- Storage for prep/dispensing CSPs
Proper temperature ranges required for storing refrigerated compounds
36-46F (2-8C)
Barrier controls
Gowns Hair covers Face masks Shoe covers Gloves
Purpose of gowns
minimize contaminant shedding and provide personnel protection
Purpose of hair covers
minimize hair/skin shedding
Purpose of face masks
physical barrier to prevent sputum contamination
Purpose of shoe covers
prevents tracking contaminants in and out
Purpose of gloves
barrier to limit transfer of contaminants to and from hands
