Environmental Monitoring Flashcards
Are the people that do room assessments certified or licensed by anyone?
no
how many cubic feet are in a cubic meter?
35.31
how many liters are in a cubic foot?
28 liters
What is the finger tip test? describe it
the authorized personnel goes through the garbing and cleaning procedure and even puts on the gloves but then when they get into the buffer room they do not use the hand sanitizer. he/she walks to the hood and puts her hands down on the agar plates. the agar plates are then incubated
how many colonies are allowed on the personnel’s first finger tip test?
zero
how many times must the test be done on the new employee when they first get hired?
3 times
can the personnel work until they get their lab results back that they have passed?
no, they have to pass before they can work
how often to they have to take the test and pass? how many colonies are allowed in those results?
every 12 months, and there can be less than or equal to 3 colony forming units (cfu)
How do you calculate the air exchanges per hour needed for a room?
(airflow into the room times 60 minutes) divided by the volume of the room
is ACPH monitored in only the buffer room?
ACPH is monitored in the buffer room and the ante room
what is the ACPH of a buffer room?
30 ACPH always
what is the ACPH of an ante room connected to a negative pressure buffer room?
30 ACPH
what is the ACPH of an ante room connected to a positive pressure buffer room?
20 ACPH
What is surface sampling?
a sterile cotton swab is rubbed on various surfaces and then on the agar plate and then the plate is incubated to see what grows
What should surface sampling be done on?
- inside the PEC
- all equipment
- work areas near the PEC
- frequently touched surfaces
- pass through chambers
- the floor
What is non-viable airborne particle sampling?
this is air sampling where a machine collects 1-2 liters of air with a minimum sample time of 1 minute
How many particles can be in an ISO class 8 room?
3,520,000 particles per cubic meter
How many particles can be in an ISO class 7 room?
352,000 particles per cubic meter
How many particles can be in an ISO class 5 hood?
3,520 particles per cubic meter
What is viable airborne particle testing?
this is a sampling method that collects between 400 and 1000L of air per sample by a machine pulling air into the petri dish on the top. it is then incubated for 2 days to check for bacteria growth and then 5 more days to grow mold or fungus.
how many samples are required per room?
it depends on the room size
how do we determine how many samples are required per room?
the ISO 14644-1 2015 table
how many colonies are allowed per cubic meter of an ISO class 8 room?
> 100 cfu
how many colonies are allowed per cubic meter of an ISO class 7 room?
> 10 cfu
how many colonies are allowed per cubic meter of an ISO class 5 hood?
> 1 cfu
What three pieces of information do you need to know when testing for particles?
- brand and serial number of the machine used
- cubic feet or liters the machine pulls per minute
- time the technician ran the machine to take the sample
make sure you check the technicians math! do not simply accept the number that they give you
what is the training process for personnel and compounding sterile preparations?
They have to watch a video, perform a didactic review and take and exam (and pass) on media-fill testing. They also must be re-certified for low and medium risk compounding annually and high risk compounding semiannually.
what is the important equation we need to know for this section?
Air exchanges/hour = (CFM x 60 minutes)/volume of the room
