BCSCP key terms

A medication prepared by combining, diluting, or manipulating ingredients under conditions designed to keep it free of viable microorganisms, intended for administration by injection, infusion, or other sterile routes.

A set of practiced actions and behaviors-hand hygiene, proper garbing, disinfection, and controlled movement-that prevent microorganisms from entering a sterile preparation or critical site during compounding.

The air that exits a high-efficiency particulate air filter and has not yet passed over any object; it is the cleanest air in a laminar-flow work area and must reach critical sites before other surfaces.

Any opening or surface of a sterile preparation or container that could allow microorganisms or particles to enter, such as a needle puncture point, vial septum, or open syringe tip.

The date after which a compounded preparation must not be used, calculated from the start of preparation based on risk level, preservative status, storage conditions, and validated stability information.

Preparing multiple identical units of a sterile preparation from the same ingredients at one time, rather than making a single dose for one identified patient; it requires additional validation and quality checks.

A device or work area, such as a laminar airflow workbench or biological safety cabinet, that provides a localized environment of filtered air directly around the critical compounding site.

The cleanroom and its associated spaces that surround a primary engineering control and help maintain required air quality, pressure relationships, and cleanliness by controlling airflow and access.

The cleanroom space where primary engineering controls are located and where sterile compounding occurs; it is maintained at a specified ISO class and separated from less clean areas by doors and pressure differentials.

The transition room adjacent to a buffer area where personnel perform hand hygiene and don some garb; it is kept cleaner than the general pharmacy but less clean than the buffer area.

A high-efficiency particulate air filter that removes at least 99.97% of airborne particles 0.3 micron or larger, used in workbenches and cleanroom ventilation to supply particle-free air.

A cleanliness rating for air in a controlled space based on the maximum number of particles of a given size allowed per cubic meter; lower numbers mean cleaner air, with ISO Class 5 used at critical sites.

A measured difference in air pressure between two adjoining rooms that causes air to flow from the cleaner space toward the less clean space, helping keep contaminants out of compounding areas.

A test that releases visible fog or smoke near a workbench to show the direction and smoothness of airflow, confirming that first air bathes critical sites and that no turbulence disrupts it.

A planned program of sampling air, surfaces, and personnel in compounding areas to detect contamination trends and confirm that cleaning, airflow, and garbing practices are working.

Wiping or pressing a defined area of a workbench, wall, or equipment with a culture device to detect microorganisms and evaluate the effectiveness of cleaning and disinfection.

A simulation in which a person performs the full compounding process using a sterile growth medium instead of drug, then incubates the units to detect any microbial contamination that occurred during technique.

A laboratory test that incubates a sample of a compounded preparation in growth media to determine whether viable microorganisms are present before the batch is released.

A document that gives the exact instructions, ingredients, equipment, and acceptance criteria for making a particular compounded preparation, serving as the approved recipe that each batch follows.

The batch-specific or patient-specific document that records what was actually done-ingredients, lot numbers, quantities, equipment, personnel, and checks-so the preparation can be traced and reviewed.

The overall system of policies, procedures, audits, and reviews designed to ensure that compounded preparations consistently meet quality standards and that problems are identified and corrected.

The specific tests and measurements performed on ingredients, processes, or finished preparations to confirm they meet established specifications, such as potency, sterility, or pH checks.

The ordered process of putting on clean or sterile clothing-such as shoe covers, hair cover, mask, gown, and gloves-to reduce the chance that a person sheds particles or microorganisms into a compounding area.

Cleaning hands with soap and water or an alcohol-based rub at specified moments, including before garbing and before donning sterile gloves, to remove transient microorganisms and reduce contamination risk.

A periodic, documented evaluation of whether a person can correctly perform required tasks, such as aseptic technique, garbing, and calculations, using direct observation and testing rather than assuming initial training was enough.

Structured instruction and practice that gives personnel the knowledge and skills needed for their assigned compounding tasks, including standard operating procedures, aseptic technique, and safe handling of hazardous drugs.

Specialized clothing and equipment-such as gloves, gowns, masks, and eye protection-worn to protect the worker from exposure to hazardous drugs and to protect the preparation from contamination.

A medication that can cause harm to workers who handle it, such as cancer chemotherapy, some antivirals, and certain hormones, identified by criteria including carcinogenicity, teratogenicity, reproductive toxicity, and organ toxicity at low doses.

A United States Pharmacopeia chapter that sets standards for safe handling of hazardous drugs across the health care setting, covering facilities, engineering controls, PPE, deactivation, spill response, and medical surveillance.

A mechanism that mechanically prevents the transfer of airborne contaminants and hazardous drug vapors or aerosols between two connected components, such as a vial and a syringe, during drug preparation and administration.

A program of health evaluations, including history, physical exams, and laboratory tests, offered to workers who handle hazardous drugs to detect possible occupational exposure effects over time.

A drug that carries a heightened risk of serious harm when used incorrectly, such as insulin, heparin, opioids, and concentrated electrolytes, which therefore requires extra safeguards like independent double checks and distinct labeling.

A verification in which a second qualified person separately checks a high-risk step-such as a drug calculation, concentration, or pump setting-without relying on the first person's work, to catch errors before harm occurs.

A structured team review after a serious event or close call that asks why it happened and identifies underlying system weaknesses, rather than blaming an individual, so that repeat events can be prevented.

A proactive team method that lists the steps of a process, imagines how each step could fail, and ranks the risks so that the most serious weaknesses are fixed before an error reaches a patient.

An error or unsafe situation that was caught or corrected before it reached the patient, which is reported and studied because it reveals the same system weaknesses that can cause actual harm.