Environmental Monitoring

Question 1

Are the people that do room assessments certified or licensed by anyone?

Answer 1

no

Question 2

how many cubic feet are in a cubic meter?

Answer 2

35.31

Question 3

how many liters are in a cubic foot?

Answer 3

28 liters

Question 4

What is the finger tip test? describe it

Answer 4

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

Question 5

how many colonies are allowed on the personnel’s first finger tip test?

Answer 5

zero

Question 6

how many times must the test be done on the new employee when they first get hired?

Answer 6

3 times

Question 7

can the personnel work until they get their lab results back that they have passed?

Answer 7

no, they have to pass before they can work

Question 8

how often to they have to take the test and pass? how many colonies are allowed in those results?

Answer 8

every 12 months, and there can be less than or equal to 3 colony forming units (cfu)

Question 9

How do you calculate the air exchanges per hour needed for a room?

Answer 9

(airflow into the room times 60 minutes) divided by the volume of the room

Question 10

is ACPH monitored in only the buffer room?

Answer 10

ACPH is monitored in the buffer room and the ante room

Question 11

what is the ACPH of a buffer room?

Answer 11

30 ACPH always

Question 12

what is the ACPH of an ante room connected to a negative pressure buffer room?

Answer 12

30 ACPH

Question 13

what is the ACPH of an ante room connected to a positive pressure buffer room?

Answer 13

20 ACPH

Question 14

What is surface sampling?

Answer 14

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

Question 15

What should surface sampling be done on?

Answer 15

• inside the PEC
• all equipment
• work areas near the PEC
• frequently touched surfaces
• pass through chambers
• the floor

Question 16

What is non-viable airborne particle sampling?

Answer 16

this is air sampling where a machine collects 1-2 liters of air with a minimum sample time of 1 minute

Question 17

How many particles can be in an ISO class 8 room?

Answer 17

3,520,000 particles per cubic meter

Question 18

How many particles can be in an ISO class 7 room?

Answer 18

352,000 particles per cubic meter

Question 19

How many particles can be in an ISO class 5 hood?

Answer 19

3,520 particles per cubic meter

Question 20

What is viable airborne particle testing?

Answer 20

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.

Question 21

how many samples are required per room?

Answer 21

it depends on the room size

Question 22

how do we determine how many samples are required per room?

Answer 22

the ISO 14644-1 2015 table

Question 23

how many colonies are allowed per cubic meter of an ISO class 8 room?

Answer 23

> 100 cfu

Question 24

how many colonies are allowed per cubic meter of an ISO class 7 room?

Answer 24

> 10 cfu

Question 25

how many colonies are allowed per cubic meter of an ISO class 5 hood?

Answer 25

> 1 cfu

Question 26

What three pieces of information do you need to know when testing for particles?

Answer 26

• 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

Question 27

what is the training process for personnel and compounding sterile preparations?

Answer 27

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.

Question 28

what is the important equation we need to know for this section?

Answer 28

Air exchanges/hour = (CFM x 60 minutes)/volume of the room