Naplex 2026 Ch 16 sterile compounding

Name the drug formulations that require sterile compounding

Injections such as IV, IM, Subq

Eye drops

Irrigations

Inhalations

USP Terminology:

CSP

Compounded sterile product

USP Terminology:

SVP

Small volume parenteral (≤ 100 mL)

USP Terminology:

LVP

Large volume parenteral (> 100 mL)

USP Terminology:

PPE

Personal protective equipment

don = put on

doff = take off

PEC

Primary engineering control

Sterile hood that provides ISO 5 air for compounding

USP Terminology:

LAFW

Laminar airflow workbench

A type of PEC.

USP Terminology:

SEC

Secondary engineering control

Room with ISO 7 air and hood; aka buffer room

USP Terminology:

SCA

Segregated compounding area

Contains ISO 5 sterile hood (PEC) but not part of a cleanroom suite; air in the space is not ISO-related

USP Terminology:

CAI

Compounding aseptic isolator

aka "glovebox" ISO 5 hood

USP Terminology:

RABS

Restricted access barrier system

Any closed-front ISO 5 hood (eg CAI) aka "glovebox"

What is ISO

International Standards Organization

They set the standards for air quality by the # particles/volume of air

Critical areas, such as inside the sterile hood (PEC) must be an ISO (5/6/7/8) ?

ISO 5

The buffer area, the SEC, must be at least an ISO ...?

ISO 7

The anteroom, where hand washing and garbing occurs, must be at least an ISO ... if it opens into a positive-pressure buffer area

ISO 8

For an ISO 7 room, there must be at least ___ ACPH (Air changes per hour)

30 ACPH

For nonhazardous sterile compounding, rooms must have (positive/negative) pressure

positive

What type of compounding room is this called?

It contains one or more sterile hoods (ISO 5 PECs) inside an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom.

Cleanroom suite

What type of compounding room is this called?

It has an ISO 5 PEC, often an isolator "glovebox", located in a segregated place with unclassified air.

Segregated compounding area (SCA)

Inside a PEC, the space directly in front of the HEPA filter is called... and the air is called...

direct compounding air;

first air

HEPA filters in a PEC must be recertified by a specialist every __ months

6

The line that separates the clean and dirty areas of an anteroom is called

The line of demarcation.

Shoe covers must be applied one at a time while stepping over this line.

Sterile compounding training must be given by a designated person. Initial training and then continuous training every ___ months is required.

Glove finger-tip test and media-fill test must be done initially then every __ months for category 1 and 2 CSPS

General training: q 12 months

Aseptic testing: q 6 months

How many gloved fingertip samples must be taken after garbing when doing the fingertip test

3 samples

Air sampling must be done every __ months

Surface sampling every __ days

Air sampling must be done every 6 months

Surface sampling every 30 days

PECs should be running (all day/only before compounding)

all day

There was a power outage which affected the PEC. The power is back, and you need to compound. What do you do?

Clean with sterile 70% isopropyl alcohol (ISA)and wait for PEC to be on for 30 minutes

How often should a PEC be cleaned

Daily (only on days when compounding occurs) and throughout the day when compounding

Use detergent and then 70% IPA

How to clean a PEC hood?

four steps

From dirtiest to cleanest: top to bottom, back to front

1) ceiling

2) back

3) bar

4) side walls

How often to clean and disinfect pass-through chambers and work surfaces outside the PEC?

Daily (only on days when compounding occurs)

What type of alcohol-based surgical hand scrub is often used during garbing?

What can be used if there is an allergic rxn to that agent?

Chlorhexidine

Allergy alternative: povidone-iodine

What type of syringes are used in sterile compounding?

Hypodermic (parenteral)

What is a luer lock

An adaptor that makes secure, leak-free connections b/w syringes, needles, catheters and IV lines

What is needed to pull drug from an ampule?

Filter needle or filter straw

Then change needle before adding to IV bagWdsdsds

For vials that contain liquid, what must the compounder first do to extract liquid?

Inject a volume of air equal to the volume of drug to be withdrawn to equalize the pressure

What is ADD-Vantage?

A type of ready-to-use vial to bag system for nurses. NOT considered compounding

What must be done before adding an item into a sterile hood PEC?

Wipe it with 70% IPA prior to adding into the PEC

All work within the PEC must be performed at least ___ inches from the front

6 inch

What is coring?

When small pieces of the rubber stopper of a vial fall into the liquid upon puncturing the vial, contaminating the liquid inside

What is terminal sterilization?

Proteins such as --- and --- need to sterilized how?

Steaming with an autoclave or dry heat sterilization, needs to be done for CSPs that are compounded with a nonsterile ingredient

Hormones and insulin are heat-sensitive, and can be sterilized with filtration using a 0.22 micron filter.

If filtration is done for terminal sterilization, the manufacturer may require a test done for filter integrity called the ....

bubble point test

Bacteria and fungi can produce pyrogens such as endotoxins.

Pyrogens can come from tap water.

Therefore, sterile glassware and utensils should be cleaned how?

Rinsed with sterile water and depyrogenated with dry heat sterilization

USP categorizes CSPs by the risk of ____. The risk levels are __, __, and ___. These risk lvls are used to determine appropriate BUDs.

USP categorizes CSPs by the risk of contamination. The risk levels are 1, 2, and 3.

What is the BUD for Category 1 CSPs and why

Fridge: ≤ 24 hrs

Room temp ≤ 12 hrs

Frozen: N/A

CSPs are made in an ISO 5 PEC placed in a segregated compounding area (SCA) which has unclassified air, therefore they have the shorted BUD

Where are Category 2 CSPs compounded?

What is the BUD?

In a cleanroom suite =>

it contains one or more sterile hoods (ISO 5 PECs) inside an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom

Fridge: 1-45 days

Room temp: 4-60 days

Frozen: 45-90 days

What is the BUD for Category 3 CSPs and why

BUD can be up to 180 days due to compounding by specific requirements such as sterility testing

Room temp: 60-90 days

Fridge: 90-120 days

Frozen: 120-180 days

What is the BUD temperature in Celsius for:

Room temp

20 to 25 C

What is the BUD temperature in Celsius for:

Fridge

2 to 8 C

What is the BUD temperature in Celsius for:

Frozen

-25 to -10 C

What is the BUD for sterile compounding in emergencies, i.e. the compound was made under suboptimal conditions due to time

"immediate-use" compounding

BUD of 4 hours

What are the label requires for a compounded drug?

1) Names and amts of concentrations of ingredients

2) BUD

3) Route of admin

4) Storage requirements

5) Auxiliary labels for special handling instructions: eg) high-alert

If there is a recall on a category 3 CSP due to not passing sterility testing but they were already dispensed to patients, what action needs to be taken?

1) Immediate notification of prescriber

2) recall

3) investigate