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chapter 12
Aseptic technique and sterile compounding
| Term | Definition |
|---|---|
| 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 | a contained and controlled environment in the pharmacy that has a low level of environmental pollutants |
| Compounding aseptic containment isolator (CACI) | ISO Class 5 compounding area used to prepare hazardous drugs |
| Compounded sterile preparations (CSPs) | Preparations prepared in a sterile environment using nonsterile ingredients or devices that must be sterilized before administration |
| Critical site | Any surface or area exposed to first air, which is exposed or at risk for touch, or direct air (ie, vial tops, open ampules, needle hubs, or injection ports) |
| first air | Air exiting the 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 |
| 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; the term parenteral most commonly describes medications given by injection, such as intravenously or intramuscularly |
| 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) | Intravenous 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 Class 5 environment for sterile compounding (ie, hoods) |
| Reconstituted | A substance that has had a diluent (eg, 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 reduces 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 intravenous nutrition administered through a central vein (eg, subclavian vein), which allows for a higher concentration of solutions |
| United States Pharmacopeia <797> (USP <797>) | a set of enforceable sterile compounding standards; describes the guidelines, procedures, and compliance requirements for compounding sterile preparations |
| United States Pharmacopeia <800> (USP <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 environment. |
| 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 |
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