Compounding & Hazardous Drugs: Chapter 16 Sterile Compounding

Vocabulary flashcards covering sterile compounding standards, air quality requirements, aseptic techniques, and beyond-use dating based on Chapter 16.

Sterile Compounding

The act of combining, admixing, reconstituting, diluting, or repackaging a drug to create a preparation free of microorganisms and contaminants for administration into sites like blood, the bladder cavity, or the eyes.

USP Chapter 797

The U.S. Pharmacopeia chapter that sets the minimum acceptable standards for sterile compounding in any setting for humans or animals.

CSP

Compounded sterile product; an intravenous or other drug that requires sterile manipulation.

Small Volume Parenteral (SVP)

An intravenous bag or container with a volume of $\le 100\,mL$.

Large Volume Parenteral (LVP)

An intravenous bag or container with a volume of $> 100\,mL$.

Personal Protective Equipment (PPE)

Also known as garb; includes items such as gowns, gloves, and masks used during compounding.

Primary Engineering Control (PEC)

A sterile hood or isolator that provides an ISO 5 environment for sterile compounding.

Laminar Airflow Workbench (LAFW)

A type of open-front sterile hood (PEC) where air flows in one direction (unidirectional).

Secondary Engineering Control (SEC)

The room containing ISO 7 air where the sterile hood (PEC) is located; also called the buffer room.

Segregated Compounding Area (SCA)

A designated space containing an ISO 5 PEC that is not part of a cleanroom suite and has unclassified room air.

ISO Rating

A standard set by the International Standards Organization for air quality based on the number and size of particles per volume of air; lower counts represent cleaner air.

ISO 5

Air quality containing no more than $3,520$ particles ($0.5\,microns$ or larger) per cubic meter; required inside the PEC.

ISO 7

Air quality containing no more than $352,000$ particles per cubic meter; required for the buffer area (SEC).

ISO 8

Air quality containing no more than $3,520,000$ particles per cubic meter; required for the anteroom if it opens into a positive-pressure buffer area.

Air Changes Per Hour (ACPH)

The number of times per hour that the air in a room is replaced; requires at least $30$ for ISO 7 and $20$ for ISO 8.

Positive Air Pressure

Airflow used in nonhazardous compounding PECs and SECs to protect CSPs from contamination by blowing air out toward dirtier adjacent spaces.

High-Efficiency Particulate Air (HEPA) Filters

Filters that are $\ge 99.97\%$ efficient in removing particles as small as $0.3\,microns$, including bacteria and viruses.

Direct Compounding Area (DCA)

The critical area inside a PEC located directly in front of the HEPA filter where compounding occurs.

First Air

The cleaner air coming directly out of the HEPA filter that must not be obstructed during compounding.

Compounding Aseptic Isolator (CAI)

A closed-front ISO 5 PEC, commonly referred to as a glovebox, used for nonhazardous drug compounding.

Restricted Access Barrier System (RABS)

A general term for any closed-front ISO 5 sterile hood, such as a CAI.

Buffer Room

Another name for the SEC, providing a buffer of clean air (ISO 7) around the PEC (ISO 5).

Anteroom

The room adjacent to the SEC where hand washing, garbing, and staging of components occur.

Line of Demarcation

A visible line in the anteroom separating the dirty side (garbing starts) from the clean side (hand washing and gowning occur).

Initial Training

Training where knowledge and competency in compounding must be demonstrated before performing job functions independently.

Continuous Training

Ongoing training for compounding staff that must be completed at least every $12$ months.

Gloved Fingertip Test

A test to evaluate garbing and gloving technique by rolling finger pads on agar plates to check for microbial growth.

Tryptic Soy Agar (TSA)

The microbial growth medium used in the gloved fingertip test to identify contamination.

Colony-Forming Units (CFUs)

Visible spots of microbial growth on a test plate that indicate contamination.

Media-Fill Test

A test where Tryptic Soy Broth (TSB) is used instead of a drug to determine if a compounder can prepare CSPs aseptically.

Tryptic Soy Broth (TSB)

A growth medium used in the media-fill test to assess the sterility of a compounder's technique.

Turbidity

Cloudiness in a liquid medium, such as TSB, which indicates that bacterial contamination is present.

Media-Fill Passing Criteria

The liquid stays clear after $14$ days of incubation.

SEC Temperature Standard

The buffer room should be maintained at $20^\circ C\, (68^\circ F)$ or cooler, checked once daily.

Relative Humidity Limit

Humidity in the SEC should be kept at $60\%$ or less to prevent bacterial growth.

Air Sampling Frequency

A test performed at least every $6$ months to identify environmental contaminants.

Surface Sampling Frequency

A test performed every $30$ days for all classified areas and pass-through spaces to detect contamination.

Sporicidal Disinfectant

A cleaning agent required to be used in the PEC and SEC at least monthly (for Category 1 and 2 CSPs) to kill spores.

70% Isopropyl Alcohol (IPA)

A sterile disinfectant used to clean the PEC and to sanitize items before they enter the PEC.

Shedding

The release of particles from objects like cardboard boxes or makeup, which is prohibited in sterile compounding areas.

Don

The term used for putting on PPE or garb.

Doff

The term used for taking off PPE or garb.

Gown Reuse Policy

Gowns may be taken off and kept on the clean side of the anteroom to be re-worn for the current work shift if not visibly soiled.

Luer Lock

A secure, leak-free connection where the ends of syringes and needles twist together to form a tight seal.

Ampule

A small, sealed glass container for liquid medication that must be broken at the neck to access the drug.

Filter Needle

A specialized needle required when withdrawing liquid from an ampule to remove any glass shards.

Lyophilized Powder

A freeze-dried powder that must be reconstituted with a diluent before it can be added to an IV bag.

Diluent

A liquid such as sterile water for injection or bacteriostatic water for injection used to reconstitute powders.

IV Piggyback (IVPB)

An SVP bag containing a drug that is attached to a primary LVP line for administration.

Ready-to-Use Medications (RTUs)

Prepared IV bags or prefilled syringes that do not require compounding and have manufacturer-provided expiration dates.

ADD-Vantage / Minibag Plus

Proprietary vial/bag systems where a vial is attached to a bag for reconstitution at the bedside or in the cleanroom.

Automated Compounding Device (ACD)

Equipment used to aseptically transfer ingredients into a final container, often used for parenteral nutrition.

IV Workflow Management Systems (IVWMS)

Technology that automates the preparation, verification, and documentation of CSPs using barcode scanning and photo capture.

IV Robots

Automated systems used to compound high-volume solutions or products requiring large batch preparations.

Six-Inch Rule

The requirement that all work inside a PEC must be performed at least $6\,inches$ from the front edge to avoid ISO 7 air mixing with ISO 5 air.

Vial Puncture Technique

Puncturing the rubber top with the needle bevel up at a $45$-degree angle to prevent coring.

Coring

The aspiration of a small piece of the rubber stopper into the needle, which can then contaminate the drug solution.

Syringe Measurement Point

The volume is measured at the point of contact between the rubber piston and the side of the syringe barrel.

Syringe Pull-Back Method

A non-recommended verification method where the pharmacist checks volume in an empty syringe after the drug has already been added.

Terminal Sterilization

Sterilization methods like steam (autoclave) or dry heat required for CSPs made with nonsterile ingredients.

Heat-Labile Drugs

Drugs sensitive to heat, such as hormones and insulin, which must be sterilized via filtration instead of an autoclave.

0.22-micron Filter

A filter used for sterilization that removes microorganisms larger than $0.22\,microns$, including bacteria and fungi.

Bubble Point Test

A test to determine the integrity of a filter by measuring the pressure required to see bubbles.

Endotoxins

Pyrogens produced by gram-positive and gram-negative bacteria and fungi that pose a serious threat to patient safety.

Depyrogenation

The process of removing pyrogens from glassware and utensils using dry heat sterilization.

Beyond-Use Date (BUD)

The date and time after which a CSP should not be used, determined by its category and storage conditions.

Category 1 CSP

A CSP prepared in an ISO 5 PEC in an SCA; BUD is $\le 12\,hours$ at room temperature or $\le 24\,hours$ refrigerated.

Category 2 CSP

A CSP prepared in a cleanroom suite (ISO 5 PEC in ISO 7 SEC) with longer BUDs than Category 1.

Category 3 CSP

CSPs prepared with additional requirements allowing for BUDS up to $180\,days$.

Emergency-Use CSP

Immediate-use drugs prepared under suboptimal conditions (e.g., code blue) that must be assigned a short BUD of $4\,hours$.

controlled room temperature

A storage temperature range of $20$ to $25^\circ C$.

refrigerator temperature

A storage temperature range of $2$ to $8^\circ C$.

freezer temperature

A storage temperature range of $-25$ to $-10^\circ C$.

Single-Dose Container (SDC) BUD

Up to $12\,hours$ from puncture if opened and kept in an ISO 5 environment.

Multi-Dose Container (MDC) BUD

Up to $28\,days$ from puncture or opening, whether inside or outside an ISO 5 environment.

Master Formulation Record

Internal documentation required for CSPs prepared for more than one patient or from nonsterile ingredients.

Compounding Record

Documentation needed for Category 1, 2, and 3 CSPs; can be the prescription or medication order itself.

Recall Procedure

The process initiated when a CSP dispensed before sterility test results are back fails testing, involving prescriber notification and quarantining stock.

Root Cause Analysis

An investigation initiated following a medication error or safety issue to identify the underlying problem.

High-Alert Medications

Drugs like potassium or paralyzing agents that carry a high risk of causing significant harm if used incorrectly.