PTCB HD key terms

The device, such as a laminar airflow workbench or compounding isolator, that provides the clean air environment where sterile compounding actually occurs. It is the first line of protection for the exposed product.

The cleanroom or buffer area that houses the primary engineering control. It provides a controlled background environment that protects the PEC and limits contamination entering the critical zone.

An air cleanliness classification allowing no more than 3,520 particles of 0.5 micron or larger per cubic meter. It is the required air quality for the critical zone of a sterile compounding PEC.

The area inside a primary engineering control where sterile ingredients, containers, and the exposed product are handled. Only first air should contact this zone, and it must meet ISO Class 5.

Air that has passed through the HEPA filter and has not yet touched any object or person. It is the cleanest air available and must bathe the critical zone during compounding.

A high-efficiency particulate air filter that removes at least 99.97 percent of particles 0.3 micron or larger. It supplies the filtered air that creates the ISO Class 5 environment in a PEC.

Air moving in a single, parallel direction at a consistent velocity so that clean air sweeps contaminants away from the critical zone rather than mixing with them. Also called laminar flow.

The room or zone where the primary engineering control is physically located. It must meet a specified ISO class and serves as the controlled environment surrounding the PEC.

The transition room where personnel perform hand hygiene, don PPE, and stage supplies before entering the buffer area. It separates the less controlled outer space from the clean compounding space.

A closed-system primary engineering control that uses recirculated air and isolator gloves or sleeves to separate the operator from the critical zone. It is used for nonhazardous sterile compounding.

A closed-system primary engineering control designed for hazardous drugs. It keeps the product sterile while protecting the operator from exposure through negative pressure and isolation from the work zone.

A room or device condition where air flows inward from cleaner or surrounding spaces, preventing contaminants or hazardous drug particles from escaping into adjacent areas.

A measured difference in air pressure between two connected spaces that determines the direction air flows. It is monitored to keep clean areas protected and hazardous areas contained.

The specific portion of the critical zone where the needle, syringe, or container opening is handled and where first air must reach. It is the most contamination-sensitive spot during a transfer.

A ventilated cabinet that protects both the product and the operator through HEPA-filtered supply and exhaust air. It is used as a primary engineering control for hazardous sterile compounding.

Removing visible soil, residue, and organic material from a surface using a detergent or disinfectant wipe. Cleaning must happen before disinfection because soil can shield microorganisms.

Applying a chemical agent to kill or inactivate microorganisms on inanimate surfaces. It is performed after cleaning and uses a product with a documented contact time for the target organisms.

A disinfectant proven to kill bacterial spores, which are the toughest organisms to eliminate. It is required for routine decontamination of sterile compounding areas and for known spore contamination events.

The length of time a surface must stay visibly wet with a disinfectant for the product to work as labeled. Wiping it dry early reduces the kill and leaves the surface inadequately disinfected.

Wiping a surface with sterile water or another specified agent after a disinfectant has dried, to remove chemical film. Leftover residue can interfere with later disinfection and contaminate products.

A scheduled program of surface sampling and air testing used to detect microbial contamination in compounding areas. Results confirm whether cleaning and engineering controls are working.

Cleaning hands with soap and water or an alcohol-based rub before garbing and before compounding. It is the first step in the garbing sequence and reduces transfer of organisms to sterile supplies.

The ordered process of putting on protective apparel, from shoe covers and hair cover through gown and sterile gloves, before entering a clean compounding area. The sequence minimizes contamination of outer layers.

Apparel and barriers worn to protect the worker and the product, such as gowns, gloves, masks, eye protection, and shoe covers. The type chosen depends on the task and hazard level.

Gloves that have been sterilized and packaged so the outside remains contamination free. They are worn for sterile compounding and must be donned without touching the outer surface.

Gloves tested for resistance to hazardous drugs and used when handling antineoplastic agents. They are worn in pairs and changed regularly because permeation can occur without visible damage.

A medication that poses a risk of harm to workers through exposure, such as many antineoplastics. Handling requires containment controls, protective equipment, and specific disposal procedures.

A mechanism attached to vials and tubing that prevents the escape of hazardous drug vapor, aerosol, or liquid during transfer. It mechanically blocks the exchange of contaminants with the environment.

A fitted mask or respirator worn to keep the wearer from inhaling airborne particles or vapors. It is selected by hazard and must be fit-tested to seal properly.

The process of accepting delivered products, checking them against the order, and inspecting them for damage, temperature excursion, or tampering before they enter inventory.

A period when a product's temperature goes outside its labeled storage range. The product is set aside and evaluated before use because potency or stability may be affected.

The continuous system of refrigerated storage and transport that keeps temperature-sensitive products within range from manufacturer to patient. Any break in the chain must be documented and assessed.

A device that records temperature over time during storage or shipment. Its data are reviewed on receipt to confirm the product stayed within the required range.

Physically separating a product and marking it as not for use until its status is resolved. It prevents suspect or recalled stock from being dispensed by mistake.

A manufacturer or regulator action to remove a product from use because of a defect or safety issue. Staff must locate affected stock, segregate it, and document the response.

The documented record of who handled a product and when, from receipt through storage and dispensing. It supports traceability if a problem or recall occurs.

The finished preparation, such as an IV bag, syringe, or compounded cream, that is ready to be given to the patient. It must be checked for identity, strength, sterility, and labeling before release.

The date after which a compounded preparation must not be used. It is assigned from stability information and the risk level of the preparation and its storage conditions.

The last check of a completed preparation before it leaves the pharmacy, confirming drug, dose, diluent, container, and labeling against the prescription. It is often performed by a pharmacist.

Comparing the printed label to the order to confirm the patient, drug name, strength, volume, route, and expiration are correct. Errors caught here prevent a wrong-dose administration.

A written, approved set of step-by-step instructions for performing a task consistently. Staff are trained on SOPs, and deviations are documented and reviewed.

The contemporaneous written record of what was done, by whom, and when, including cleaning logs, temperature records, and compounding records. It provides the evidence that procedures were followed.

A periodic evaluation that confirms a worker can correctly perform assigned tasks, such as aseptic technique or garbing. It typically includes observation and may include a written or practical test.

The planned system of checks and reviews that confirms work meets defined standards and that problems are corrected. It includes monitoring, audits, and follow-up on deviations.