Ch 12 Aseptic Technique and Sterile Compounding

Anteroom

The room adjacent to the “clean room” used for donning all personal protective equipment (PPE) and wiping down all supplies that will be used in the compounding area

Aseptic technique

The procedures used to eliminate the possibility of a drug becoming contaminated with microbes or particles

Beyond use date (BUD)

Defined by USP 797 as the date or time after which a compounded sterile preparation (CSP) shall not be administered, stored, or transported; it is determined from the date the preparation is compounded

Biological safety cabinet (BSC)

A vertical flow hood that should be used for making hazardous sterile preparations in the clean room

Clean room

In pharmacy, a container and controlled environment in the pharmacy that has a low level of environmental pollutants (dust, microbes, etc); used for preparing sterile medication products

Compounded sterile preparations (CSPs)

Preparations prepared in a sterile environment using nonsterile ingredients or devices that must be sterilized before administration

Compounding aseptic containment isolator (CACI)

ISO class 5 compounding area used to prepare hazardous drugs

Critical site

Any surface or area exposed to first air, which is exposed or at risk for touch, or direct air (vial tops, open ampules, needle hubs, or injection ports)

First air

Air exiting the high efficiency particulate air (HEPA) filter in a unidirectional air stream

Gauges

The sizes of needle openings

Hazardous drug

Any drug that has been proven to have dangerous effects during animal or human testing; may cause cancer or may harm certain organs of pregnant women

Hazardous waste

Any waste that meets the resource conservation and recovery act (RCRA) criteria of ignitability, corrosiveness, reactivity, or toxicity

Health care associated infection (HAI)

An infection that patients acquire during the course of receiving treatments for other conditions in an institutional setting

Horizontal laminar flow hood

An environment for the preparation of compounded sterile preparations in which air originating from the back of the hood moves forward across the hood and into the room

Hyperalimentation

Parenteral nutrition for individuals who are unable to eat solids or liquids

Infection control

Policies and procedures put in place to minimize the risk for spreading infections in hospitals or other health care facilities

Laminar air flow workbench (LAFW)

An environment for the preparation of sterile products

Parenteral medications

Medications that bypass the digestive system but are intended for systemic action; most commonly describes medications given by injection, such as IV or IM

Peripheral parenteral

Injection of a medication into the veins on the periphery of the body instead of into a central vein or artery

Peripheral parenteral nutrition (PPN)

IV nutrition administered through veins on the periphery of the body rather than through a central vein or artery

Precipitate

To separate from solution or suspension; a solid that emerges from a liquid solution

Primary engineering control (PEC)

A device or zone that provides a Class 5 environment for sterile compounding (ex. Hoods)

Reconstituted

A substance that has had a diluent (ex. Saline or sterile water) added to a powder

Standard operating procedures (SOPs)

Written guidelines and criteria that list specific steps for various competencies

Standard precautions (universal precautions)

A set of standards that reduce the possibility of contamination and the risk for transmission of infectious disease; these standards are used throughout a health care facility, including to prepare medications

Sterile preparation

A preparation that contains no living microorganisms

Total parenteral nutrition (TPN)

Large volume IV nutrition administered through a central vein (ex. Subclavian vein), which allows for a higher concentration of solutions

United States Pharmacopeia <797> (USP 797)

Ch 797 “pharmaceutical compounding- sterile preparations,” of the USP National formulary. It contains a set of enforceable sterile compounding standards; described the guidelines, procedures, and compliance requirements for compounding sterile preparations; and sets the standards that apply to all settings in which sterile preparations are compounded

United States Pharmacopeia <800> (USP 800)

Ch 800, a new general chapter created to identify the requirements for receipt, storage, mixing, preparing, compounding, dispensing, and administration of hazardous drugs to protect the patient, health care personnel, and the envious

Vertical laminar flow hood

An environment for the preparation of chemotherapeutic and other hazardous agents in which air originating from the roof of the hood moves downward (over the agent) and is captured in a vent on the floor of the hood