*Module 5: 797 Flashcards
How many designated people are required to oversee compounding activities?
At least 1
The designated person(s) overseeing compounding activities must be designated in the ______
Standard Operating Procedures (SOP)
Does the person overseeing compounding activities have to be a pharmacist?
No
What are the responsibilities of designated individuals overseeing compounding activities?
- selecting components
- oversee training & ensure competency
- ensure SOPs are fully implemented
- monitor and observe compounding to immediately identify and correct errors
- establish, monitor, and document procedures
- recall method must be in place
What details does the SOP include?
- facility
- equipment
- personnel
- storage
(USP 797) What is the definition of Administration?
Direct application of a sterile product or preparation to a single patient by injecting, infusing, or otherwise providing a sterile product or preparation in its final form
(USP 797) What is considered preparation per approved labeling?
Mixing per manufacturer’s labels for a single dose for an individual patient is NOT considered compounding
What does Immediate-Use CSP entail?
- administration begins within 4 hours following the start of preparation
- preparation involved not more than 3 sterile products
Anything injected into the blood must be free of?
- bacteria, viruses, fungi
- contaminants such as glass shards, precipitates, particles, etc
What formulations must be compounded in a sterile environment?
- IV, IM, subcutaneous injectables
- Radiopharmaceuticals (nuclear medicine)
- eye drops
- irrigations (washes that go through a body cavity, excluding rectal and sinus cavity)
- pulmonary inhalations (not nasal)
Any particle that is _______ is included in the particle count.
0.5 microns or larger
What type of air is not classified by ISO?
Room (ambient)
ISO class _____ is required for critical areas that are closest to the sterile drugs and sterile containers.
5
ISO 5 requires no more than _____ particles per cubic meter.
3,520
What must a sterile compounding area include?
- anteroom
- secondary engineering control (SEC)
- primary engineering control (PEC)
True or false: each space has its own ISO requirement.
true
What can you have instead of an anteroom, SEC, and PEC?
Compounding aseptic isolator (CAI) in a segregated compounding area (SCA)
What is the device or room that provides the ISO 5 requirement?
Primary Engineering Control (PEC)
The most common way to achieve an ISO 5 is by using a __________.
sterile hood
Example of a sterile hood?
Laminar Airflow Workbench (LAFW)
A _______ is another PEC. Often found in a SCA and commonly called a _________.
- compounding aseptic isolator (CAI)
- glovebox
ISO ___ required for SEC.
7
What is the room that contains the PEC(s)?
SEC
SEC is commonly called a _______/________.
buffer area/buffer room
ISO class ______ required if anteroom opens to a positive pressure buffer area.
8
ISO class ______ required if anteroom opens to a negative pressure buffer area.
7
Where does garbing and handwashing take place?
(This is the room that connects the buffer room to the rest of the pharmacy) anteroom
What is not allowed in the clean room?
- sinks
- drains in floor
- doors to outside
- unsealed windows
There are 3 CSP categories. Category 1 includes CSP assigned BUD of ___________ at room temp and __________ in the fridge.
- 12 hours or less
- 24 hours or less
Categories 1, 2, and 3 compounded sterile products can be compounded by using?
- all sterile ingredients from the start
- all non-sterile ingredients from the start
- or a combo
If any ingredient is non-sterile, the whole compound must be made sterile via?
terminal sterilization
The __ day the product is made is considered day 1.
first
Unless directly administered by the person who prepared it or administration is witnessed by the preparer, the Immediate-Use CSP must be labeled with:
- the names and amounts of all active ingredients
- the name or initials of the person who prepared the preparation
- the 4-hour time period within which administration must begin
Frequency of cleaning and disinfecting: Direct Compounding Area (DCA)
• At the beginning of each shift
• Before batching
• Every 30 minutes it is being used 70% IPA is applied
• Any time it is visibly soiled
Frequency of cleaning and disinfecting: counters, work surfaces
daily
Frequency of cleaning and disinfecting: floors
daily
Frequency of cleaning and disinfecting: walls
monthly
Frequency of cleaning and disinfecting: ceilings
monthly
Frequency of cleaning and disinfecting: storage shelving
monthly
Supplies must be?
low lint, disposable
Reusable cleaning tools must be?
dedicated to the space and not removed from the area
Who must be trained?
Compounders, anyone with direct oversight of compounders, and personnel who do not compound but restock, clean/disinfect the SCA, etc.
Staffing must demonstrate adequate _________, ____________, __________, & ________ prior to independently compounding a sterile product.
• Hand hygiene
• Garbing and gloving
• Cleaning and disinfecting sterile space/equipment
• Sterile drug preparation
How do they demonstrate they have appropriate garbing competency?
- visual observation
- pass the “gloved fingertip and thumb sampling test” on both hands
- the initial competency must be completed correctly at least 3 separate times in a row
In Category 1 & 2 what is the only type of garb that can be reused if worn by same person?
Gown
How often are Ongoing Garbing Competency Evaluations & Ongoing Aseptic Manipulation Competency Evaluations conducted?
- Category 1 & 2: at least every 6 months, Category 3: at least every 3 months
- at least every 12 months
Initial Aseptic Manipulation Competency evaluation includes:
- visual observation
- media fill testing with post-GFT
- surface sampling
Compounders and those with direct oversight must complete ______ successful aseptic manipulation.
one
TSA from GFT test is incubated at __________ for ___________ AND then at __________ for no less than _____ additional days.
- 30-35C
- no less than 48 h
- 20-25C
- 5
Media-fill tests are used to:
determine if good aseptic technique was used
What indicated contamination in the media-fill test?
turbidity (cloudiness)
Media-fill test is incubated for _________.
14 days
Temperature and humidity in the SEC must be monitored and documented how often?
once daily minimum
In the SEC, maintain temperature equal to or less than?
20C (68F)
In the SEC, maintain humidity at equal to or less than _____%.
60
Temperature monitoring devices must be calibrated every ________ months.
12
In the storage area, the temperature must be monitored and documented how often?
once daily minimum
Fridge must be ___ to ____ C.
2-8
Freezer must be ___ to ____ C.
-25 to -10
Airborne particle sampling is done how often?
every 6 months
Air pressure is checked at least ___________ or________ using a continuous monitoring device.
- once daily
- with every work shift
Microbial air and Surface Monitoring provides us with information on:
the quality of the compounding environment
Surface sampling (before cleaning and disinfecting) is done when?
• Every 30 days for all classified areas and pass-through spaces
• End of each shift for the dirtiest areas (which are the ones touched most frequently—door handles, inside PEC, etc.)
What happens when contamination criteria are exceeded?
A root cause investigation must be launched
Visible air sampling is done how often?
- Category 1 & 2: every 6 months
- Category 3: monthly
Surface sampling is done how often?
- Category 1 & 2: monthly
- Category 3: weekly
