Glossario Microbiologia (Inglese)
A
Adhesion - The force exerted across a surface of contact between liquids and solids, or solids and solids, that resists their separation
Aerosol - A gaseous suspension of fine solids or liquid particles
Aerosol air generated - The aerosol that results when the pneumatic force of a high-velocity stream of air breaks up a specific room-temperature liquid into droplets
Aerosol photometer - An instrument that measures mass concentrations of aerosol by using the forward light-scattering principle.
Airborne particle - Particles suspended in moving or stationary air
Airborne particulate cleanliness class - A numerical designation that signifies a maximum allowable concentration of airborne particles of a specified particle size. As established by FED-STD-209, the numerical value of a class is related to the concentration of particles in the size range of 0,5 um and larger
Airflow - Movement of air in a given direction with respect to a specified reference plane or other designated physical reference. The rate of airflow is expressed in terms of volume per unit time
Airflow, parallel - Unidirectional airflow, as demonstrated by a measured deviation of not more than 14 degrees from straight line flow.
Airflow, uniform - A unidirectional airflow pattern in which the point-to-point readings are within +/- 20% of the average air flow velocity for the total area of the unidirectional flow work zone
Anemometer - An instrument for measuring airflow velocity
Anisokinetic Sampling - The condition of sampling in which the mean velocity of the air entering the inlet of the sampling probe. Because of particle inertia, anisokinetic sampling can cause the concentration of particles in the sample to differ from the concentration of particles in the being sampled
Aseptic processing - Production activities that exclude all extraneous living matter, especially microscopic forms such as bacteria and fungi, from the production units being assembled, filled, packaged, or built
B
Bacterial spore - A resistant body produced by a vegetative bacterial cell. These spores may be resistant to heat, ultraviolet light, and may remain dormant for extended periods of time
Bactericide - A substance or formulation capable of destroying bacteria
Bacteriostat - A compound or formulation that retards or prevent the growth of bacteria. Bacteriostats act reversibly; when they are removed, cells resume their normal growth patterns
Bioburden - A measure of the number of micro-organisms resident or within products and inanimate objects. A common synonyms is micro-count
C
Certificate of Compliance - A written statement signed by a qualified person and accompanied by substantiating information, attesting that the items or services are in accordance with specified requirements
Certification - The culmination of procedures leading for validation, expressed in the form of written evidence (certificate of compliance) that verification has been accomplished in accordance with specified testing procedures such as FED-STD-209
CFU - Colony Forming Unit - An individual or an aggregate of many microbial cells which, when cultivated on solid media, will develop into a single visual colony
Challenge Aerosol - An aerosol derived from the selected aerosol source material and used as the test challenge for filter medium testing
Chemical compatibility - The ability of a material to withstand chemical contact with minimal interaction
Chemical degradation - Changes in materials that occur when they come into contact with chemicals. Degradation may take such forms as swelling, loss of tensile strength, or loss of abrasion resistance
Class (airborne particulate) - The cleanliness class as defined by FED-STD-209
Clean Air Device - A clean bench, clean work station, download module, or other equipment designed to control particulate air cleanliness in a localised working area and incorporating, as a minimum, a HEPA filter and a blower
Clean Air Device (laminar flow) - This term is no longer in use. See clean-air device, unidirectional flow
Clean Air Device (unidirectional flow) - A clean work station or other device that incorporates one or more HEPA or ULPA filters and one or more motor-blowers for the purpose of supplying unidirectional-flow clean air to a controlled work space
Clean Air System - A system designed to maintain the cleanliness of air in a clean room or clean zone at or below a specified airborne particulate cleanliness class
Cleaning agent - A liquid that enhance the removal of contaminants from surfaces, by such mechanism as dissolution, reducing surface tension, and neutralising electrostatic charge. Cleaning agents can also be disinfectants.
Cleanroom - A room in which the concentration of airborne particles is controlled and which contains one or more clean zones
Cleanroom facility as-built - A cleanroom that is complete and ready for operation, with all services connected and functional , but without production equipments or personnel within the facility
Cleanroom facility at-rest - A cleanroom facility that is complete and has the production equipments installed and operating, but is without personnel within the facility
Cleanroom facility operational - A cleanroom facility in normal operation with all services functioning and with production equipments and personnel, if applicable, present and performing their normal work function in the facility
Cleanroom, laminar air flow - This term is no longer in use. See cleanroom, unidirectional
Cleanroom mixed airflow - A hybrid cleanroom consisting of a combination of an unidirectional airflow cleanroom and a nonunidirectional-flow cleanroom
Cleanroom non unidirectional airflow - A cleanroom in which airflow exist with a multiplicity of flow directions or multiple-pass circulations or both
Cleanroom turbulent airflow - This term is no longer in use. See cleanroom, nonunidirectional airflow
Cleanroom unidirectional airflow - A cleanroom in which airflows have generally parallel streamlines operating in a single direction and with uniform velocity over the cross section
Contaminant - Any unwanted substance present in or a material or an surface within a clean zone
Contamination - The result of the addition of contaminants to a material or to any surface within a clean zone.
Contamination control - Any organized effort taken to reduce the level of contamination
Controlled environment - An environment in which parameters such as temperature, pressure, humidity, contaminant level are controlled within specified limits
D
Decontamination - The removal of contaminants present in or on a material
Decontamination factor - The ratio of the concentration of contaminant before and after decontamination, cleaning or treating
Disinfectant - An agent, chemical or physical, designed to reduce the population of micro-organisms
F
Filter - A device used to remove particulate matter or impurities from a fluid (liquid or gas) flowing through it
Filter, mechanical - Any device that remove particles from a fluid by mechanism of impaction, settling, screening, inertia, diffusion, or any combination thereof
Filter, membrane - A filter, generally thin and manufactured from polymeric plastics or from metal, the open structure of which is comprised of pores or capillaries in a controlled range of sizes
Flora - The type of microbiological organisms found in an environment
Fumigation - A process of decontamination in which the decontaminant is administered in gaseous, smoke or aerosol form at ambient pressure
Fungi - Non photosynthetic micro-organisms possessing cell wall and usually growing as amass of branching interlacing filaments known as mycelia. The mycelial forms are called moulds, and the nonmycelial forms are called yeast. Fungi are usually larger than 0,4 um in size
Fungicide - A substance that is capable of destroying fungi
Fungistat - A substance that retards or prevents the growth of fungi. The effects of fungistats are reversible; when the fungistats are removed, the fungi resume their normal growth patterns
G
Garments for cleanroopm - Specially designed items of clothing that are worn to prevent or reduce the dispersion of contaminants that may be shed or released by personnel (footwear, shoe cover, gloves, head covers)
Gram-negative bacteria - Bacteria that do not retain the purple colour of the crystal violet dye when treated with Gram’s stain microscopic technique
Gram-positive bacteria - Bacteria that retain the purple colour of the crystal violet dye when treated with Gram’s stain microscopic technique
Gravimetric analysis - A standard analytical technique used to determine the mass of a specified material and commonly used to quantify the amount of non volatile residue in a solvent
H
HEPA - High Efficiency Particulate Air filter
I
Impaction - Physical contact of particles with other surfaces in response to the application of an external force. The term is occasionally used synonymously with impingement
Impactor - A sampling device capable of removing particles from a suspension using he principle of impaction (impingement)
Impactor, cascade - A “cascade impactor” refers to a specific instrument that employs several impactions in series to collect particles of successively smaller sizes
Impingement - A sampling procedures whereby particles are removed from a gaseous suspension by forcibly directing the flowing gas against a collection surface
Impingement dry - Impingement in which the particle-colleting surface is a solid or a solid coated with an adhesive
Impingement wet - Impingement in which the particle-collecting surface is a liquid or is located beneath the surface of a liquid bath
Isoaxial - A condition of sampling in which the direction of the air flow into the sampling probe inlet is the same as that of the unidirectional airflow being sampled
Isokinetic sampling - The condition of isoaxial sampling in which the mean velocity of the air entering the sampling probe inlet is the same as the mean velocity of the unidirectional airflow at that location
L
Laminar air flow - The term is no longer in use. See unidirectional airflow
Launderability - The ability of an article such as glove or garment to be laundered to a specific level of cleanliness
Leak Test - A procedure for evaluating the potential for particle intrusion into a clean zone
M
Microbiological Clean Area - A defined space with a filtered air supply that is designed to accommodate the performance of activities for which the control of viable particles is essential
Monitoring - The routine determination of airborne particle concentrations, as well as other relevant parameters, in Clean Rooms and clean zones
N
Non corrosive - Term applied to substances that have a minimal effect on the integrity or appearance of surfaces with which they come in contact
Non ionic - A term used to describe materials that do not posses a net electrical charge
Nonunidirectional airflow - Airflow that does not qualify as unidirectional because it has a multiplicity of flow directions or multiple pass circulation, or both
P
Particle - An object that is solid, liquid or both, usually between 1 nanometer and 1 millimetre in size
Particle burden - The number of particles in the relevant size range per unit area of surface
Particle concentration - The number of particles per unit volume of fluid
Particle count - The number of particles detected (or reported) in a given volume of fluid
Particle counter, airborne - An instrument for continuous counting of airborne particles larger than a given threshold size. The sensing means may be optical, electrical, aerodynamic, etc.
Particle deposition - The portion of the transient particle population that does not remain airborne, typically with respect to a specified period of time, under the influence of ambient airflow conditions, air and surface temperature, and localised electrostatic charges
Particle diameter, mass median - A measure of median particle diameter based on the particle mass
Particle size - The apparent maximum linear dimension of a particle in the plane of observation, observed with an optical microscope or the equivalent diameter of a particle detected by automatic instrumentation
Particle size distribution - The relative mass or number of particles present in a series of discrete subdivision of the overall range of designed particle sizes
Particulate - An adjective referring to particles (e.g.: particulate matter)
Pathogen - A micro-organism capable of causing disease
Plenum chamber - An enclosed, positive pressure section of a gas supply system, designed to ensure even distribution of flow. Examples include: (a) the point of origin for air distribution in air conditioning and ventilation; (b) the supply source for a filtration system to create even distribution of the gas to each filter unit
Precision - The closeness of agreement between values obtained by repeated measurements of the same quantity under the identical conditions; also known as repeatability or reproducibility
Pre-filter - A cleaning unit installed upstream of another unit to protect the latter from high concentration of contaminants. Pre-filters are usually less efficient and less expensive that the units they protect
Prep-Area (Decontamination area) - A cleanroom or clean zone in which preliminary cleaning or other preparatory procedures are performed before entry into the operational cleanroom. The prep area typically is less clean than the operational cleanroom
Pressure differential - The difference in pressure between two points of a system, which may be separated by a solid or fluid barrier
Pressure gauge - The amount by which the total absolute pressure exceeds the ambient atmospheric pressure
Pressure, total - The sum of static pressure and velocity pressure at the point of measurement
Pressure, velocity - The impact pressure associated with the velocity of a flowing fluid. It is related to the kinetic energy per unit volume of the flow
Primary surface - A surface that is in direct contact with the product
Pyrogen - A substance capable of producing a fever. Common pyrogens are endotoxins, a class of lipopolysaccharides that comprise the outer wall of Gram-negative bacteria and are themselves by-products of cell metabolism
R
Re-circulated air - The portion of the clean room air supply that has been re-circulated by the air-handling equipment
Recommended Practice - A published document that provides technical guidance, philosophy, or preferred procedures regarding a given topic
Residence time - The finite period of time during which a material is contained within a handling or processing system, wherein component of the material may be subjected to change.
S
Sampling - A process consisting of the withdrawal or isolation of a fractional part of a whole. In air or gas analysis, the separation of a portion of an ambient atmosphere with or without the simultaneous isolation of selected components
Sampling, continuous - Sampling without interruption throughout an operation or for a predetermined time
Sampling, instantaneous - Sampling of a period of time that is negligible in comparison to the duration of the operation or to the total period of time being studied
Sampling, intermittent - Sampling successively for a limited period of time throughout an operation or for a pre-determined period of time. The duration of sampling periods and of the intervals between are not necessarily regular and are not specified
SAS Surface Air System - Microbiological air sampler
Secondary surface - A surface that is not in contact with the product, but which indirectly affects the product
Simultaneous counting system - A system that uses a pair of detectors to simultaneously determine the concentrations of the test aerosol both upstream and downstream of the filter medium
Sporicide - A substance or formulation capable of destroying bacterial spores
Standard air - Air at 50% relative humidity, with a temperature of 21°C and pressure of 760 mm Hg
Sterilisation - A physical or chemical process that completely destroys or eliminates all forms of microbial life
T
Tunnel - A mini-environment in which an enclosure separates the tools and wafer-handling robot aisle from the general clean room; or an enclosed single-wafer track for transport into and between tools
U
Unidirectional air flow - Air that flows in a single pass in a single direction through a clean room or clean zone with generally parallel streamlines. Formerly referred to as laminar airflow
V
Validation - Establishment, by means of a specified testing program, that a system or facility under test is capable of performing as intended
Verification - The procedure for determining compliance of air in a clean room or clean zone to a specified airborne particulate cleanliness class limit or U descriptor; also the result of determining such compliance
Viable particle - A particle capable of reproduction ; a living organism
Virus - An obligate intracellular parasite, typically in the size range of 0.01 to 0.1 um, that can infect and cause disease in man, animals, plants, and insects
W
Wiper - A piece of fabric or cloth designed for cleaning and removing liquids from critical surfaces.
Fonte: Manual of Microbiology
