JBA Written Exam key terms

A graded set of containment practices, safety equipment, and facility design requirements matched to the risk group of the agents handled, ranging from BSL-1 for low-risk work to BSL-4 for the most dangerous pathogens.

A classification of a biological agent by its individual and community hazard, based on pathogenicity, transmissibility, availability of treatment, and endemicity, used to decide the containment level required for work with it.

A structured process that identifies hazardous biological agents and activities, estimates the likelihood and severity of harm, and defines the controls needed to reduce that risk to an acceptable level before work begins.

The first barrier protecting people and the environment from biological agents, typically engineering controls such as a biological safety cabinet or sealed centrifuge rotor, combined with good microbiological technique.

The facility-level barriers that protect people outside the laboratory and the surrounding environment, including room finishes, air-handling systems, controlled access zones, and waste treatment infrastructure.

An enclosed ventilated work station that uses directional airflow and HEPA-filtered supply and exhaust air to protect the operator, the sample, and the environment from aerosols generated during handling of biological materials.

High-efficiency particulate air filtration that removes at least 99.97 percent of particles of 0.3 micrometres in diameter, used to treat exhaust air and protect personnel and the environment from airborne biological agents.

A suspension of fine solid or liquid particles in air, often generated invisibly by pipetting, centrifuging, or vortexing, that can carry infectious agents into the respiratory tract or across containment boundaries.

Wearable barriers such as gloves, gowns, eye protection, and respiratory protection that shield the worker from contact with biological agents but never replace engineering controls and safe technique.

A predefined procedure for containing, disinfecting, and disposing of spilled biological material, including evacuation, ventilation, appropriate disinfectant contact time, and reporting of exposures or releases.

A process that destroys or inactivates most pathogenic microorganisms on surfaces or in liquids, but not necessarily bacterial spores, using validated chemical agents, heat, or radiation under defined contact conditions.

A validated process that destroys all forms of microbial life, including bacterial spores, typically achieved by moist heat, dry heat, ethylene oxide, or filtration for heat-sensitive liquids.

Documented evidence that a steam sterilization cycle reliably achieves the required temperature and exposure time throughout the load, demonstrated with physical monitoring, chemical indicators, and biological indicators.

A preparation of defined viable spores with known resistance used to demonstrate that a sterilization process has achieved the conditions needed to inactivate microorganisms.

An institution that acquires, authenticates, preserves, and distributes biological materials and associated data under a recognised quality management system, acting as a trusted repository for research and industry.

A documented, unbroken record of who handled a biological material, when, and under what conditions, from collection or creation through storage and transfer, supporting traceability and integrity.

Verification that a cultured cell line matches its claimed identity and is not cross-contaminated or misidentified, commonly by short tandem repeat profiling compared with a reference profile.

A large, homogeneous, extensively characterised aliquot of cells prepared from a single source and stored under defined conditions, from which working cell banks are derived for routine production.

A homogeneous pool of cells derived from a master cell bank by limited passage and used to initiate production batches, controlled so that the number of generations remains within validated limits.

A defined, characterised suspension of a microorganism or virus used as the starting material for production, controlled in passage number and stored to ensure consistent manufacture.

The set of regulatory requirements ensuring medicinal products are consistently produced and controlled to quality standards appropriate to their intended use, covering premises, equipment, personnel, documentation, and processes.

The organised activities and systems that provide confidence that quality requirements will be met, including oversight of documentation, audits, deviation handling, and change control across the product lifecycle.

The testing and inspection activities performed on samples, materials, and products to verify that they meet specified acceptance criteria before release or use.

Documented evidence providing a high degree of assurance that a process, method, or system consistently produces a result meeting predetermined specifications and quality attributes.

The staged verification of equipment or facilities through installation, operational, and performance stages, confirming that a system is correctly installed, functions as intended, and performs reliably in routine use.

A written, approved instruction describing how to perform a routine activity consistently, including scope, responsibilities, materials, stepwise method, and documentation requirements, subject to version control and periodic review.

A structured process for investigating the root cause of a detected problem and implementing actions that eliminate it, plus actions that prevent similar problems from arising elsewhere.

A documented departure from an approved procedure, specification, or regulatory requirement, which must be recorded, assessed for impact, investigated, and resolved before affected material is released.

A documented list of tests, references to analytical procedures, and acceptance criteria that a material or product must meet to be considered acceptable for its intended use.

A local oversight body that reviews and approves research involving recombinant DNA or hazardous biological agents, assesses containment and risk, and monitors compliance with applicable biosafety requirements.

The voluntary agreement of a person to participate in research or treatment after receiving and understanding information about purpose, procedures, risks, benefits, and alternatives, documented without coercion.

The principles governing conduct of research with humans, animals, and biological materials, including respect for persons, beneficence, non-maleficence, and justice, enforced through review and oversight.

A contract governing the transfer of biological materials between parties, defining permitted uses, ownership, confidentiality, publication rights, and liability, and often required before shipping samples.

The packaging, labelling, and documentation of biological substances for shipment under dangerous goods rules, using the appropriate UN packing instruction and category designation for the hazard presented.

The manipulation of genetic material by joining DNA sequences from different sources and introducing them into a host organism, enabling production of proteins, modified organisms, and research models.

An antibody population of identical specificity produced from a single clone of antibody-forming cells, widely used as therapeutics, diagnostics, and research reagents.

An in vitro method that amplifies a specific DNA segment through repeated cycles of denaturation, primer annealing, and extension, enabling detection and quantification of minute amounts of target sequence.

A controlled vessel in which cells, microorganisms, or enzymes are cultivated under monitored conditions of temperature, pH, dissolved oxygen, and mixing to produce a biological product at scale.