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. ## Footnote 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**