Chapter 16. Sterile Compounding

What formulations are examples of sterile compounds?

- Injections

- Eye drops

- Irrigations

- Pulmonary inhalations (not nasal)

Small Volume Parenteral (SVP)

≤100 mL

Large Volume Parenteral (LVP)

>100 mL

T or F - an SCA is iso-rated 7.

False, an SCA is not iso-rated

contains unclassified air

Restricted Access Barrier System (RABS)

Any closed-front ISO 5 sterile hood (includes CAIs)

Also referred to as "glovebox"

What is the ISO rating of the primary engineering control (PEC)?

ISO 5 (3520 particles/m^3)

What is the ISO rating of the SEC?

ISO 7 (352,000 particles/m^3)

What is the ISO of the anteroom?

ISO 7 or 8

8 is only acceptable if positive pressure buffer room (nonhazardous)

What is the minimum ACPH for a room with ISO 7 air in nonhazardous sterile compounding?

30

Is air pressure in the PEC and SEC positive or negative for nonhazardous sterile compounding?

positive - blows out into room

When must a HEPA filter be recertified by a specialist?

Every 6 months and every time a PEC is moved

What type of airflow does a laminar airflow workbench (LAFW) typically have?

Horizontal laminar airflow (positive-pressure)

What type of PEC is commmonly found in a segregated compounding area (SCA)?

Compounding aseptic isolater (CAI)

Closed front to maintain ISO 5 air within

Positive pressure in antechamber

If compounding only category 1 and 2 CSPs, how often do compounders need to complete gloved finger tip and media fill testing?

initially and every 6 months thereafter

How long must the a media fill test be incubated and stay clear (not turbid) to pass a test?

14 days

How often must air sampling be performed?

Every 6 months

How often must surface sampling be performed?

Every 30 days for all classified areas at the end of compounding shift

Air pressure testing ensures that airflow is ___________.

Unidirectional

if a PEC is turned off, what must be done prior to being able to resume compounding?

clean and disinfect, then sterile 70% isopropyl alcohol (IPA)

PEC must be on for at least 30 minutes

What is used to clean the PEC prior to using 70% IPA?

detergent and disinfectant (one step is okay)

What things need to be cleaned and disinfected daily?

PEC/equipment inside

Pass-through chambers

Work surfaces outside PEC

Floors

What are acceptable alcohol-based surgical hand scrubs with persistent antimicrobial activity for sterile compounding?

chlorhexidine

povidone-iodine (betadine) if allergy to chlorhexidine

How long may a gown be used for sterile compounding?

if not visibly soiled, reworn for the current work shift

What must a compounder do when withdrawing liquid from a vial?

Inject an equal amount of air to equalize pressure

What system may be used that interfaces with an EHR to compound parenteral nutrition for a patient?

Automated compounding devices (ACDs)

What automates preparation and verification of compounds through barcode scanning and photo capture?

IV workflow management systems (IVWMS)

How should items be placed in the hood?

side by side to prevent blocking first air (in horizontal HEPA)

Coring

small piece of rubber is from stopper is rubber from stopper aspirates into needle and ends up in solution in vial

Terminal Sterilization

Required for CSPs compounded with any non-sterile ingredients

includes steam (with an autoclave) and dry-heat (depyrogenation with steam) sterilization

How can we sterilize a heat-labile drug? (unstable w/ heat)

filtration using a sterile 0.22-micron filter

What test determines filter integrity?

Bubble-point test

may be required by mfr if filtering is used

Are endotoxins from gram positive or negative bacteria considered more potent and more of a threat?

negative

Where do pyrogens come from?

Glassware and utensils washed with tap water

How to prevent pyrogens?

rinse glassware and utensils with sterile water and depyrogenate with dry-heat (steam) sterilization in an autoclave

How does USP categorize CSPs?

by risk of contamination

Category 1 CSPs

- Prepared in an SCA in unclassified air

- ≤ 12 hours at room temp

OR

- ≤ 24 hours refrigerated

- frozen n/a

Category 2 CSPs

- Prepared in cleanrooms suite

- Room temp: 1-45 days

- Refrigerated: 4-60 days

- Frozen: 45-90 days

Category 3 CSPs

- Must be made in accordance w/ specific requirements

- Room temp: 60-90 days

- Refrigerated: 90-120 days

- Frozen: 120-180 days

- Sterility testing requirements

What is the BUD for an emergency/immediate-use CSP prepared in suboptimal conditions?

4 hours

When is a Master Formulation Record required?

CSPs for more than one patient OR from nonsterile ingredients

When is a Compounding Record required?

Category 1,2,3 and immediate-use CSPs for more than one patient