16- Sterile compounding

Cleaning/disinfecting sterile compounding PEC technique

Use slightly overlapping unidirectional strokes (not circular), replace wipes often, clean from top-to-bottom and back-to-front.

Sterile compounding cleaning frequency for counters and floors

Clean daily.

Wipes used to clean PEC (ISO 5 hood)

Lint-free sterile wipes.

PEC cleaning agents (USP 797)

Germicidal detergent first, then sterile 70% isopropyl alcohol (IPA).

Cleaning order in sterile compounding areas

Clean from cleanest to dirtiest: PEC first, then buffer room/SEC, then anteroom.

Definition of 'first air' in sterile compounding

ISO 5 air exiting directly from the HEPA filter, the cleanest air in the PEC.

First air rule (what not to do)

Do not block first air, do not place anything between HEPA filter and critical sites.

Laminar airflow definition

Airflow moves in one direction only (horizontal or vertical).

ISO air quality concept

Smaller ISO number = cleaner air (fewer particles).

Primary engineering control (PEC) definition

Device that provides ISO 5 environment for sterile compounding.

Examples of PECs for non-hazardous sterile compounding

• Laminar airflow workbench (LAFW)

• Compounding aseptic isolator (CAI)

Compounding aseptic isolator (glovebox) definition

Enclosed ISO 5 compounding device accessed through glove ports, materials pass through a chamber.

Segregated compounding area (SCA) air classification

Unclassified room air (no minimum ISO requirement).

Buffer room definition

Secondary engineering control (SEC).

Anteroom ISO requirement when opening into negative-pressure buffer room

At least ISO 7.

Anteroom ISO requirement when opening into positive-pressure buffer room

At least ISO 8 (ISO 7 is also acceptable but not required).

Category 1 CSP definition

Sterile compounding performed in an SCA (outside an ISO 7 buffer room).

Category 1 CSP maximum BUD at room temperature

12 hours.

Category 1 CSP maximum BUD refrigerated

24 hours.

Category 2 CSP definition

Sterile compounding in a cleanroom suite (ISO 5 PEC in ISO 7 buffer room with ISO 8 anteroom).

Category 3 CSP definition

Category 2 conditions plus additional requirements (example: sterility testing and enhanced controls).

Category 3 CSP maximum BUD at room temperature

90 days.

Immediate-use CSP definition

Emergency sterile preparation made outside ISO 5 conditions for immediate administration.

Immediate-use CSP maximum BUD

4 hours (cannot extend by refrigeration or freezing).

USP 797 BUD definition (sterile)

Date/time after which a CSP must not be used, calculated from compounding time.

BUD assignment rule when stability is shorter than USP 797

Use the shorter drug-specific stability (package insert) time.

Sterile gloves requirement for non-hazardous sterile compounding

One pair sterile, powder-free gloves.

Chemo gloves requirement

ASTM-rated chemotherapy gloves required for hazardous drug compounding.

Handwashing location before sterile compounding

Anteroom.

Garbing sequence principle

Don from dirtiest to cleanest.

Garbing order (core items)

Shoe covers, hair cover, face mask first, then handwashing, then gown, then alcohol-based surgical hand scrub, then sterile gloves after hands dry.

Agent used to disinfect gloved hands and hood during compounding

70% isopropyl alcohol (IPA).

What part of a syringe should not be touched during sterile compounding

Syringe plunger.

Filter needle/straw use case

Required when withdrawing medication from glass ampules.

Terminal sterilization filtration pore size

0.22 micron filter.

Bubble-point test purpose

Confirms integrity of a sterilizing filter by identifying largest pore size.

Bubble-point test failure implication

Pores too large allow microorganisms through, filtration not reliable.

Media-fill test failure indicator

Turbidity (cloudiness) indicates contamination.

Media-fill testing frequency for Category 1 and 2 compounding personnel

At least every 6 months (twice per year) after initial training.

Gloved fingertip test initial passing requirement

3 consecutive samples with 0 CFUs on both hands.

Gloved fingertip test frequency

Every 6 months for Category 1 and 2, every 3 months for Category 3.

Surface sampling timing

Perform at end of compounding shift.

Surface sampling sites

Include surfaces regularly exposed to staff.

Surface sampling minimum ISO areas

At least one sample from ISO 5, ISO 7, and ISO 8 areas.

Meaning of a positive surface sample

Contamination is present.

Surface sampling frequency

Every 30 days.

Surface sampling action levels (CFU thresholds)

• ISO 5: >3 CFUs

• ISO 7: >5 CFUs

• ISO 8: >100 CFUs

CSP label required elements

Ingredient name(s) and concentration, route, storage information, beyond-use date, auxiliary labels.

Sterile preparations that require sterile compounding

Parenteral nutrition (TPN), irrigations, pulmonary inhalations, ophthalmic preparations (eye drops).

Preparation that does NOT require sterile compounding

Suppositories (non-sterile).

PEC cleaning frequency during CSP production

Beginning of each shift, before and after each batch, every 30 minutes while working, after spills, anytime contamination suspected.

PEC placement rule during compounding

Work at least 6 inches inside the PEC.

PEC operational rule after power interruption

Run PEC at least 30 minutes before compounding, then clean/disinfect.

HEPA filter recertification frequency

Every 6 months or anytime the PEC is moved.

Minimum air quality inside PEC

Must maintain ISO 5.

Required environmental monitoring for sterile compounding compliance

Air sampling, surface sampling, gloved fingertip testing, cleaning/disinfection competency evaluation.

Visual inspection of finished CSPs

Inspect immediately against dark background for particulates, precipitates, cloudiness, leaks.

Primary engineering control requirements for non-hazardous sterile compounding

Positive pressure, ISO 5 air, laminar airflow.

Most common reconstitution diluent for IV medications

Sterile water for injection (SWFI).

Conventional amphotericin B dilution rule

Reconstitute with sterile water for injection, then further dilute in D5W.

Steam sterilization method

Autoclave (moist heat).

Moist heat sterilization mechanism

Denatures microbial proteins.

Protein-based drugs risk with heat sterilization

Heat can destroy hormones/proteins (example: insulin).

Endotoxin clinical relevance

Gram-negative endotoxins are potent and high-risk for patient safety.

Category 2 CSP maximum BUD refrigerated (only with terminal sterilization)

60 days.

Temperature monitoring requirement (USP 797)

Monitor and document SEC temperature at least once daily.