Compounding Flashcards
What is meant by ISO 5 room?
This is the level of air quality when compounding. The smaller the number, the less particle count and the cleaner the air.
ISO 5 - used in critical areas such as the sterile hood (PEC)
3520 particles/m3
ISO 7
The further away from the PEC, the dirtier the air.
ISO 7: the buffer area (SEC) - this contains the PEC
ISO 8
The anteroom must be ISO 8. This is where the hand washing and garbing occurs
Anteroom must be
-ISO 8, if opened up to a positive pressure room (non-HD sterile compounding)
-ISO 7, if opened up to a negative pressure room (HD sterile compounding)
HEPA Filters
-Removes >99.97% of particles as small as 0.3 microns
-Must be re-certified by a specialist every 6 months and anytime the PEC has been moved.
-Compound at least 6 inches inside the sterile hood to prevent exposing CSPs to dirtier ISO 7 air from the SEC.
Air Pressure when compounding HD and non-HD
Positive Air Pressure - when compounding non-HD
Negative Air Pressure - when compounding HD
What is a CAI?
Compounding Aseptic Isolator is a closed front PEC that can be located in a buffer room (SEC).
The closed front keeps the unclassified air around it from mixing with the clean air inside the PEC.
What is the SEC?
SEC - Secondary Engineering Control
The SEC contains the PEC or multiple PECs. It is commonly referred to as the “Buffer Area”
What is the Anteroom?
-This room connects the rest of the pharmacy to the buffer room (SEC).
-It contains a sink, cabinets and benches to facilitate garbing and preparation for compounding.
Line of Demarcation - this is a large visible line which separates the room into clean and dirty sections.
-The side closer to the access to the rest of the pharmacy is considered the ‘dirty’ side, and here the hair and face covers are donned.
-Shoe covers must be applied one at a time while stepping over the demarcation line.
-Handwashing and donning of gown occurs on the clean side of the anteroom.
What is an SCA?
SCA - Segregated Compounding Area
-This is an option when a cleanroom is not able to be installed.
-It is a designated area with unclassified air, such as a corner of a pharmacy
-It does not have a buffer area or anteroom, and can only be used for low-risk CSPs
MAX BUD: 12 hours
C-PECs for Hazardous Compounding
1) Biological Safety Cabinets (BSCs) - These have vertical laminar airflow and negative air pressure
2) Containment ventilated enclosures (CVE)a re powder containment hoods with HEPA-filtered air and negative air pressure for non-sterile compounding only.
3) Compounding Aseptic Containment isolators (CACI) are closed-front C-PECs (gloveboxes) that can be located in a buffer room (SEC).
Can we keep a sterile C-PEC and a non-sterile C-PEC in the same room?
yes, 1 meter apart
Air Changes and HD Compounding
Non-sterile HD: 12 ACPH (Air changes per hour)
Sterile HD: 30 ACPH
Hazardous Drugs Storage
-Stored separately
-Externally ventilated area
-Negative-pressure room
-12 ACPH
How to tell if staff has good aseptic technique when garbing and gloving?
Gloved Fingertip Test
-A passing score on the gloved fingertip test is required initially, then annually (low and medium risk CSPs) or semi-annually (high-risk CSPs).
-Passing requires 3 consecutive gloved fingertip samples taken after garbing, with 0 CFUs (Colony-forming units) for both hands.
-Ongoing competency: at least one sample taken from each hand immediately after completion of the media-fill test, with a goal of <= 3 CFUs total for both hands.
-The evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers and thumb over a surface which contains tryptic soy agar (TSA).
-The plates are incubated for 2-3 days and then inspected for microbial growth
How can you tell if adequate aseptic technique is done when preparing sterile drugs?
Media-fill test
-Preformed initially during training and at least annually
-Tryptic soy broth takes the place of the drug in the preparation. Multiple aseptic manipulations are done and then the product is incubated and checked for bacterial growth. Turbidity means contamination is present!
-IF the liquid stays clear after 14 days of incubation, the compounder passed the test
Temperature Monitoring
-Monitoring and documentation must be done on days when compounding occurs
ONCE DAILY: SEC room, Refrigerator and Freezer
TWICE DAILY: Refrigerator and Freezer if they contain vaccines.
SEC: <= 20 C
Refrigerator: 2-8 C
Freezer: -25 to -10 C
Air and Surface Testing
1) Air Sampling: Every 6 months
2) Surface Sampling: End of the day
3) Air Pressure Testing: Once daily to confirm the correct differential between 2 spaces and ensure that the airflow is unidirectional.
4) Humidity: Once daily. Maintained below 60%
Cleaning a Horizontal Laminar Airflow PEC
1- Clean the ceiling of the hood, from back to front
2- Clean the grill over the HEPA filter, from top to bottom
3- Clean the side walls starting from back to front, wiping up and down in a long sweeping motion. Clean the IV bar and hooks. Either the side walls or the bar can be cleaned first.
4- Clean anyting kept in the hood
5- Clean the bottom surface (the work area) starting from back to front, with a side to side motion.
Do not start compounding until the surfaces have dried.
