SAS 8: Sterile Preparations and Admixture Programs

Ante area / Anteroom

• ISO Class 8 or better air quality area

• personnel perform hand hygiene, and garbing procedures

Aseptic technique

Manipulate manufacturer-supplied sterile products so that they remain sterile as compounded sterile preparations

Biological Safety Cabinet (BSC)

a ventilated cabinet for CSPs, personnel, product, and environmental protection having an open front with inward airflow for personnel protection

BUD

• The date or time a drug or material can no longer be used

• The drug is ineffective after this date

Buffer Area / Room

• An area where the primary engineering control (PEC) is physically located

• Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSPs

Clean Area

• A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class

• Microorganisms in the environment are monitored

Components

The individual ingredients, containers, and closures that are used to compound sterile preparations

Critical Site

An area exposed to air or touch, such as vial, needle, or ampule.

Direct Compounding Area

A critical area within the ISO class 5 PEC where critical sites are exposed to unidirectional HEPA-filtered air (aka first air)

Garb

Clothing worn by personnel during the compounding of sterile preparations

Laminar Air Flow Workbench (LAFW)

Media-fill Test

A test performed on compounded products to ensure NO CONTAMINATION has occurred DURING the PREPARATION phase

Negative-pressure room

A room in which air flows into the room and away from adjacent rooms, which results in positive pressure in the room

Positive-pressure room

A room in which air flows out of or toward adjacent rooms, which results in a lower pressure in the room.

Primary Engineering Control (PEC)

A device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding CSPs.

Secondary Engineering Controls

The ante area and buffer area

ISO Class 5

no more than 100 particles 0.5 micron or larger per cubic foot of air

ISO Class 7

no more than 10,000 particles 0.5 micron or larger per cubic foot of air

ISO Class 9

no more than 100,000 particles 0.5 micron or larger per cubic foot of air

USP Chapter <797> Pharmaceutical Compounding

A set of enforceable sterile compounding standards issued by the United States Pharmacopeia that set the standards that apply to all settings in which sterile preparations are compounded

Sterile Compounding

involves the dilution, mixing, and injection of various medication products using aseptic technique.

Low Risk

• compounded within an ISO Class 5 or better air environment

• transfer, measuring, and mixing of not more than THREE packages of sterile products

• there cannot be more then TWO ingredients entered into one sterile container

• sterile needles and syringes must be open disinfected ampules or vials

• exceed 48 hours at controlled room temperature

Examples of Low-Risk Compounding

• Single-volume transfers of sterile dosage forms

• Simple aseptic measuring and transferring with not more than three packages of manufactured sterile products

Medium Risk

• Multiple individual or small doses of sterile products are combined

• Compounding process takes a long time to complete

• The time period from the completion cannot exceed 30 hours at controlled room temperature

Examples of Medium-Risk Compounding

• Compounding of total parenteral nutrition fluids

• Filling of reservoirs of injection and infusion devices

• Transfer of volumes from multiple ampules or vials

High-Risk

• uses nonsterile ingredients not intended for sterile routs of administration

• air quality is less than ISO Class 5 for 1 hour or longer

• personnel are not properly garbed and gloved

• non-sterile water-containing compounds are stored for more than 6 hours before being sterilized

HEPA Filter

• High Efficiency Particulate Air filter

• removes 99.97% of all particles 0.3mm or larger

Horizontal Laminar Flow Hood

• move air from the BACK of the unit and to the FRONT of the work surface

  • preparing IVs

  • TPNs

  • eye solutions

  • any non-hazardous drugs

Vertical Laminar Flow Hood

• move air from the TOP of the unit and DOWN to the work surface

  • chemotherapy

  • mixing live viruses

  • cytotoxic agents

  • radioactive agents

  • antimicrobial agents