PTCB CSDP key terms

The device, such as a laminar airflow workbench or compounding isolator, that provides the ISO Class 5 environment where sterile ingredients are exposed and manipulated. It is the first line of protection for the product.

An air cleanliness classification allowing no more than 3,520 particles of 0.5 micron or larger per cubic meter. It is the required environment for exposing sterile ingredients during compounding.

A hood that draws room air through a HEPA filter and delivers it in a unidirectional horizontal stream across the work area. It must be placed in an ISO Class 7 buffer area to maintain ISO Class 5 at the critical site.

A closed-barrier primary engineering control that recirculates air within its own enclosure and does not draw in room air. It can maintain ISO Class 5 internally even when placed in an unclassified room.

A closed-barrier primary engineering control designed to protect both the sterile product and the operator from exposure to hazardous drugs. It maintains negative pressure inside the enclosure relative to the surrounding room.

A ventilated enclosure that uses HEPA-filtered unidirectional airflow plus exhaust to protect the product and the operator. Class II types are commonly used for sterile compounding of hazardous drugs.

A high-efficiency particulate air filter that removes at least 99.97 percent of particles 0.3 micron or larger. It is the standard filter used in hoods, isolators, and cleanroom air handling systems.

The cleanroom space where the primary engineering control is located and where hand hygiene, garbing, and staging of supplies occur. It must meet at least ISO Class 7 air quality.

The transition room adjacent to the buffer area where staff perform hand hygiene and don sterile garb before entering. It is separated from the buffer area and held to at least ISO Class 8 when required.

The number of times the total volume of air in a space is replaced each hour. Higher rates help dilute airborne particles and are specified for buffer areas and ante areas.

Any exposed surface or opening that could allow microorganisms or particles to enter a sterile product, such as a needle hub, vial stopper, or open syringe tip. It must be protected with unidirectional airflow.

The HEPA-filtered air that exits the filter and has not yet passed over any object or person. Compounding must occur in first air to keep the critical site free of contamination.

A set of practices that keep sterile products free of microorganisms during handling, including hand hygiene, sterile garb, disinfection of surfaces, and avoiding contact with critical sites.

The sequence of donning protective apparel such as shoe covers, hair cover, face mask, sterile gown, and sterile gloves before entering a cleanroom. Correct order prevents contamination of outer layers.

The defined area within a primary engineering control where only sterile items and properly garbed hands may enter. Anything that touches it must be sterile.

A disinfectant used to wipe vial stoppers, ampule necks, and work surfaces before compounding. The 70 percent concentration balances killing power with enough water for adequate contact time.

The process of reducing or destroying microorganisms on inanimate surfaces, but not necessarily bacterial spores. It is used for work surfaces and equipment rather than for sterilizing products.

A process that destroys all forms of microbial life, including bacterial spores, on an object or in a product. Common methods include moist heat, dry heat, and filtration.

A disinfectant capable of killing bacterial spores, such as certain peroxygen or chlorine-based products. Sporicidal activity is needed for periodic deep cleaning of compounding areas.

Sterilizing a finished compounded preparation after it is sealed in its final container. It is generally preferred over aseptic processing when the product and container can withstand the process.

The date after which a compounded preparation must not be used. It is assigned from the start of compounding based on the risk level, storage conditions, and whether sterility testing was performed.

The manufacturer-assigned date beyond which an unopened commercial product may no longer be used. It is distinct from a beyond-use date assigned after compounding.

A classification of compounded sterile preparations based on how likely contamination is during preparation, ranging from low to high risk. The level determines the maximum allowed beyond-use date.

The organization that publishes enforceable standards for compounding, including general chapters on sterile preparations, hazardous drugs, and pharmacy practice. Its chapters are referenced by state boards and accreditation bodies.

A medication that can cause harm to workers through exposure, such as carcinogenicity, reproductive toxicity, or organ damage. Handling requires special containment, protective equipment, and documented procedures.

A published list of hazardous drugs maintained by the National Institute for Occupational Safety and Health. It groups drugs by hazard and is used to decide which handling precautions apply.

A device that mechanically prevents the transfer of hazardous drug vapor or aerosol between a vial and a syringe. It is required when compounding certain hazardous drugs to protect workers.

Apparel and devices worn to protect the worker from exposure, such as gloves, gowns, masks, and eye protection. Selection depends on the hazard and the task being performed.

A prepared set of absorbent materials, gloves, and disposal bags kept on hand to clean up hazardous drug spills safely. Staff should know its location and how to use it before a spill occurs.

Routine sampling of air and surfaces in compounding areas to confirm that cleanliness standards are being met. It may include particle counts, surface sampling, and air sampling.

A test in which the gloved fingertips of compounding staff are pressed onto growth media to detect contamination. It verifies that hand hygiene and glove technique are effective.

A simulation in which sterile growth medium is processed through the same steps as a real preparation to check whether the process produces contamination. It is a key check on aseptic technique.

A laboratory test that checks whether a sample of a compounded preparation contains viable microorganisms. It supports extended beyond-use dating for certain risk levels.

Adding a liquid such as sterile water or saline to a dry powder to make a usable solution. The resulting volume and concentration must be calculated before further dilution.

Reducing the concentration of a solution by adding more solvent. The amount of drug stays the same while the total volume increases.

The amount of drug present in a given volume or mass of preparation, often expressed as milligrams per milliliter or percent. It is used to calculate doses and dilution volumes.

A calculation method that combines two preparations of different strengths to produce a mixture of a desired intermediate strength. It uses the ratio of parts of each starting strength.

Determining the volume per unit time to deliver, such as milliliters per hour for an infusion. It uses the total volume and the ordered infusion time, sometimes with a drop factor.

The ratio of a substance's density to the density of water. It is used to convert between weight and volume when preparing solutions and checking ingredient amounts.