COUMPOUNDING STERILE PREPARATIONS

aseptic technique

• a set of methods used to keep objects and areas free of microorganisms and thereby minimize infection risk to the patient

• accomplished through practices that maintain the microbe count at an irreducible minimum

sterile preparation

a drug or nutritional substance that is free from living microorganisms and is compounded, manipulated, or repackaged by pharmacy personnel using aseptic technique and other quality assurance procedures

contamination

undesired introduction of impurities of a chemical or microbiological nature of foreign matter into or onto a raw material, intermediate, or compounded preparation during production, sampling, packaging or repackaging, storage, or transport

types of contamination

• microorganisms

• pyrogens

• particulate matter

sources of contamination

• people: touch, shedding cells or hair

• supply air: heating and air conditioning

• infiltration: particles from adjacent spaces (anteroom)

• internal generation: walls, floors, ceilings, packaging, equipment

anteroom

• ISO class 8

• fixed walls and doors

• where personnel hand hygiene, garbing procedures, and other activities that generate high particulate levels are performed

• transition room between unclassified area of the facility and the buffer room

buffer room

• ISO class 7

• fixed walls and doors

• where PECs are physically located

• only accessed through the anteroom or another buffer room

segregated compounding area

• designated space, area, or room that is not required to be classified and is defined with a visible perimeter

• must contain a PEC and is suitable for preparation of cat 1 CSPs only

primary engineering control (PEC)

a device or zone that provides an ISO class 5 air quality environment for sterile compounding

types of PECs

• laminar airflow workbenches (LAFW)

• biological safety cabinet (BSC)

• compounding aseptic isolators (CAI)

• compounding aseptic containment isolators (CACI)

secondary engineering control (SEC)

• area where the PEC is placed

  • cleanroom suite or segregated compounding area

• incorporates specific design and operational parameters required to minimize the risk of contamination within the compounding area

laminar airflow workbench (LAFW)

• ISO class 5

• unidirectional HEPA-filtered airflow

• can be horizontal or vertical airflow

horizontal LAFW

aseptic manipulations must be performed at least 6 in inside the workbench to remain within the “first air” space

vertical LAFW

for HDs when you don’t want air flowing towards you

first air

air exiting the HEPA filter in a unidirectional air stream

direct compounding area (DCA)

a critical area within the ISO class 5 PEC where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air

class 2 biological safety cabinet (BSC)

• ventilated cabinet with an open front and inward and downward unidirectional HEPA-filtered airflow and HEPA-filtered exhaust

• designed to protect worker from exposure to airborne drugs

• ISO class 5

• exhaust air much be externally vented for preparation of antineoplastic and/or API HDs

compounding aseptic isolator (CAI)

• designed for compounding non-HD CSPs

• ISO class 5

• air exchange into the CAI from the surrounding environment must not occur unless the air has first passed through a HEPA filter

compounding aseptic containment isolator

• compounding sterile HD preparations

• ISO class 5

• protects works from exposure to undesirable levels of airborne drugs throughout the compounding and material transfer process

high-efficiency particulate air filter (HEPA)

• removes 99.97% of particles 0.3 micron or larger

• composed of pleats of filters separated by rigid sheets of corrugated paper or aluminum foil that direct the flow of air forced through the filter in a uniform parallel flow