MPJE USP Compounding

Question 1

Any form of batching CSPs is ____ risk .

Answer 1

Any form of batching CSPs is medium risk .

Question 2

A biological safety cabinet is a type of ____.

Answer 2

A biological safety cabinet is a type of containment primary engineering control.

Question 3

A containment secondary engineering control (C-SEC) has ____ pressure; while a ____ has positive pressure.

Answer 3

A containment secondary engineering control (C-SEC) has negative pressure; while a secondary engineering control (SEC) has positive pressure.

• Containment Secondary Engineering Control (C-SEC)
• Secondary Engineering Control (SEC)

Question 4

CSP with ≤ 3 sterile ingredients (including diluent) is ____ risk.

Answer 4

CSP with ≤ 3 sterile ingredients (including diluent) is low risk.

Question 5

Determine the risk:

Using non sterile equipment to prepare a CSP done in an ISO Class 5 PEC.

Answer 5

high

anything done with nonsterile equipment/ingredients is high risk

Question 6

Low risk is limited to ____, ____, & ____ manipulations.

Answer 6

Low risk CSP is limited to transferring, measuring, & mixing manipulations.

Question 7

Determine the risk:

Using a MDC vial of antibiotic & transferring single-doses to several IV bags of normal saline for multiple patients.

Answer 7

medium

Question 8

Determine the risk:

Preparing total parenteral nutrition in an ISO class 5 PEC

Answer 8

medium

Question 9

Determine the BUD:

Immediate use

BUD (beyond use date)

Answer 9

Immediate use BUD: 1 hour

Question 10

Determine the risk:

Reconstituting a single dose antibiotic with sterile water & transfer into an IV bag with NS in an ISO class 5 PEC

Answer 10

low

Question 11

Determine the BUD:

Low risk CSP made in an ISO Class 5 PEC within a segregated compounding area

Answer 11

12 hours

anything made in a segregated compounding area is 12 hours

Question 12

A ____ contains an ISO Class 5 PEC but is NOT in a clean room suite.

Answer 12

A segregated compounding area contains an ISO Class 5 PEC but is NOT in a clean room suite.

Question 13

____ is synonymous with buffer room.

Answer 13

Secondary engineering control is synonymous with buffer room.

Question 14

A ____ PEC is ventilated and contains negative pressure for the compounding of ____ and other ____ drugs.

Answer 14

A containment PEC is ventilated and contains negative pressure for the compounding of chemotherapy and other hazardous drugs.

Question 15

CAI stands for ____.

Answer 15

CAI stands for compounding aseptic isolator.

Question 16

CACI stands for ____.

Answer 16

CACI stands for compounding aseptic containment isolator.

Question 17

Determine the BUD:

Single dose container opened inside an ISO Class 5 environment.

Answer 17

6 hours (from puncture)

this includes vials, bags, bottles, & syringes

Question 18

BSC stands for ____.

Answer 18

BSC stands for biological safety cabinet.

Question 19

Determine the BUD:

Low risk chemotherapy made in a C-PEC within an C-SCA

Answer 19

12 hours

anything made in a SCA (segregated compounding area) is 12 hours

Question 20

Determine the risk:

Joe used a nonsterile bulk drug powder to make a prep inside an ISO Class 5 PEC, then sterilized the product within an hour of compounding.

Answer 20

high

Question 21

Determine the BUD:

single dose container ampule

Answer 21

must discard after use

Question 22

More than 3 sterile ingredients, or ____ doses withdrawn from the same vial, to make ____ CSPs is defined as ____ risk.

Answer 22

More than 3 sterile ingredients, or multiple doses withdrawn from the same vial, to make multiple CSPs is defined as medium risk.

Question 23

Determine the BUD:

MDC opened and maintained within an ISO Class 5 environment

Answer 23

28 days

Question 24

When the buffer room has positive pressure the ante room ISO classification MUST be at least ____.

Answer 24

When the buffer room has positive pressure the ante room ISO classification MUST be at least 8.

Question 25

When the buffer room has negative pressure the ante room ISO classification MUST be at least ____.

Answer 25

When the buffer room has negative pressure the ante room ISO classification MUST be at least 7.

Question 26

All ante rooms have ____ pressure.

Answer 26

All ante rooms have positive pressure.

Question 27

Where is the PEC location?

Answer 27

SEC (or the “buffer room”)

Question 28

An SDC is a ____ container & an MDC is a ____ container.

Answer 28

An SDC is a single dose container & an MDC is a multi dose container.

SDC - single dose container
MDC - multi dose container

Question 29

Determine the BUD:

SDC opened outside of an ISO Class 5 environment.

Answer 29

1 hour (from needle puncture)

Question 30

SEC stands for ____.

Answer 30

SEC stands for secondary engineering control.

Question 31

The air in an SCA (or C-SCA) is not required to be ____.

Answer 31

The air in an SCA (or C-SCA) is not required to be ISO classified.

Question 32

Low, medium, & high risk CSPs can be made in all of the following ISO air qualifications/areas:
* ISO ____ (#) PEC
* ISO ____ (#) buffer area
* ISO 7 & ISO 8 ____ (area)

Answer 32

Low, medium, & high risk CSPs can be made in all of the following ISO air qualifications/areas:
* ISO 5 PEC
* ISO 7 buffer area
* ISO 7 & ISO 8 ante area

Question 33

Determine the BUD:

Low risk CSPs
* room temp: ____
* refrigerator: ____
* frozen: ____

Answer 33

BUD for low risk CSPs
* room temp: 48 hours
* refrigerator: 14 days
* frozen: 45 days

Question 34

Determine the BUD:

High risk CSPs
* room temp: ____
* refrigerator: ____
* frozen: ____

Answer 34

BUD for high risk CSPs
* room temp: 24 hours
* refrigerator: 3 days
* frozen: 45 days

Question 35

Determine the BUD:

Medium risk CSPs
* room temp: ____
* refrigerator: ____
* frozen: ____

Answer 35

BUD for medium risk CSPs
* room temp: 30 hours
* refrigerator: 9 days
* frozen: 45 days