Absolute filter
See HEPA filter.
Activated carbon filter
See Gas-phase adsorber cell. See also Adsorption.
Adsorption
Adhesion of molecules of liquids, gases, and dissolved substances to surfaces of solids; as opposed to absorption, taking of molecules of one substance directly into another substance.
Aerosol generator
A device, used in conjunction with an aerosol photometer, which creates a polydispersed sub-micron aerosol to challenge integrity of HEPA filters and containment of safety cabinets.
Aerosol photometer
A device, typically used in conjunction with an aerosol generator, which determines particle concentration in air by measuring the mass concentration of scattered light.
Air barrier
Induction of room air through the front opening of safety cabinets to contain hazardous aerosols.
Air filter
An air cleaning device that removes particulate contamination from an airstream by straining, impingement, interception, electrostatic attraction or absorption.
Air sampler
A device such as a microbial sampler that samples air to detect the concentration of microorganisms, other particles or gaseous contaminants.
Airborne particle counter
See Particle counter – airborne
Airflow
Measured in cubic metres/second (m3/s), litres/second (L/s) or cubic feet/minute (ft3/min or cfm). 1 ft3/min = 0.0004719 m3/s
Airflow alarms on safety cabinets
Australian standards for safety cabinets specify that alarms be fitted that (inter alia) warn of reduction in exhaust airflow to the point where air barrier containment fails. Cabinets that use pressure switches to operate alarms have an inherent limitation of unreliable alarm sensitivity that is exacerbated when set up with the alarm trigger point well below safe airflow.
Airflow uniformity
In unidirectional/ laminar airflow systems, the required airflow pattern downstream of the HEPA filter installation where all velocity readings are within 20% of the average air velocity.
Antineoplastic
A substance that blocks the formation of neoplasms (growths that may become cancerous). See Cytotoxic drugs.
AS 1807
Australian Standard 1807.0 -2000: Cleanrooms, Workstations, Safety Cabinets and Pharmaceutical Isolators – Methods of Test. Describes apparatus and test methods for controlled environment applications, including HEPA filter installations; cleanrooms; laminar flow and safety cabinets and pharmaceutical isolators.
AS 2252
The Australian standard that specifies requirements for Class I and II biological safety cabinets in Parts 1 and 2 respectively.
AS 2647
The Australian standard that provides requirements and recommended practices for the correct installation and use of Class I and II biological safety cabinets.
Australian GMP Code for medicinal products
The Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002). See TGA.
Asepsis
The prevention of access by infecting organisms to the locus of potential infection.
Aseptic
A sterile environment, free from contaminating organisms or particles; or techniques used to achieve these conditions.
Australian Quarantine and Inspection Service (AQIS)
AQIS is part of the Australian Government Department of Agriculture, Fisheries and Forestry and provides quarantine inspection for international passengers, cargo, mail, animals, plants and animal or plant products arriving in Australia, and inspection and certification for a range of agricultural products exported from Australia.
Biocontainment
The containment of highly pathogenic organisms (such as viruses) by isolation in secure facilities to prevent their accidental release during scientific research. See AS 2243.3.
Bio-hazard
A biological agent, such as an infectious microorganism, or a condition that constitutes a threat to humans, especially in biological research or experimentation.
Biological safety cabinets
Self-contained laboratory enclosures that provide protection for personnel, environment and/ or products in work with hazardous microorganisms. Cabinets provide protection by creating an air barrier at the work opening and by HEPA filtration of exhaust air. Class I cabinets protect personnel and environment; but not products. Class II laminar flow cabinets protect personnel, environment and products. See Australian standard AS 2252 Parts I & II; and AS 2647.
Biological safety cabinets – installation
Biological safety cabinets should be installed in accordance with AS 2647, with particular attention to selecting locations away from sources of air movements that could influence cabinet airflows. A comprehensive Gelaire manual is available to assist with cabinet installations.
Biosafety cabinet
See Biological safety cabinets
Carcinogen
A cancer-causing substance or agent.
Certification
In the context of laminar flow and safety cabinets installations, documentation of test results showing the results of performance testing to Australian or other standards. On-site testing, mandatory for safety cabinets prior to use, is typically repeated annually and more frequent testing may be specified in highly critical applications.
Class I cabinet
A 100% exhaust biological safety cabinet that protects personnel and environment. See Australian standard AS 2252 Part I.
Class II cabinet
A laminar flow biological safety cabinet that protects personnel, environment and products. See Australian standard AS 2252 Part II.
Class III cabinet
A totally enclosed, 100%-exhaust cabinet with HEPA filtration of intake and exhaust air for work with highly infectious organisms. Double-filtration of exhaust air is commonly used and all work is conducted through attached rubber gloves.
Clean bench
See Clean-air device, laminar flow.
Clean-air device, laminar flow
A laminar flow enclosure, clean bench, clean work station, wall or suspended ceiling module, or other device (except a cleanroom) which incorporates a HEPA filter(s) and a fan(s) to supply laminar flow clean air to a controlled work space.
Cleanroom
A room or suite of rooms in which controlled limits may be set for:
- air flow patterns
- air cleanliness
- viable and non-viable airborne particles
- temperature and relative humidity
- air pressure
- operating procedures
Cleanroom garments
Special clothing designed to protect cleanroom environments from contaminants released by workers. Special apparel includes non-shedding gowns or coveralls, head covers, face masks, gloves, footwear or shoe covers.
Contained Space
A building, building zone, room, micro-environment, glovebox, or other enclosure in which air supply and exhaust are controlled.
Containment
The use of HEPA filters, controlled airflow and pressures inside a cabinet; or other enclosure; or room to capture and contain hazardous aerosols. Examples are containment laboratories in accordance with AS 2243.3 or cytotoxic drug manufacturing facilities in accordance with AS 2639.
Cytostatic
Inhibiting or suppressing cellular growth and multiplication. A cytostatic agent. See Cytotoxic drugs.
Cytotoxic drug safety cabinets
Laminar flow safety cabinets that protect operators, environment, products and service personnel. Cabinets are described in AS 2567 and have different HEPA filter systems from Class II biological safety cabinets – that are unsuitable for work with toxic or carcinogenic agents.
Cytotoxic drugs
Drugs that control or kill neoplastic cells; used in chemotherapy to kill cancer cells; all have unpleasant side effects that may include nausea, vomiting, hair loss and suppression of bone marrow function.
Cytotoxic drugs in Class II cabinets – hazards
Class II cabinets used with cytotoxic drugs in animal studies pose a potential risk to service personnel. Class II cabinets are unsuitable for use with cytotoxic drugs and other toxic chemicals, as these materials cannot be deactivated by fumigation prior to service procedures. See AS 2567 and AS 2647.
Cytotoxics cleanroom
A special cleanroom with HEPA filtration of supply and exhaust air for the installation of cytotoxic drug safety cabinets in pharmaceutical applications. See AS 2639.
Decontamination
See fumigation.
DOP
Dioctyl Phthalate – a fluid pthalate esther used as a pnuematically-generated aerosol for integrity testing of HEPA filters. An aerosol photometer detects penetration of aerosol through the filter. Alternative fluids with similar particle-size distribution, such as BP-grade paraffins and Poly-Alfa-Olefins (PAOs) are widely used.
Floor stand – laminar flow or safety cabinets
Floor-standing support frames that are supplied with the option of castors (wheels) or levelling feet and may be fitted with an electric height-adjusting mechanism.
Flow hood
See Hood. Also describes a device used to measure air volume supplied to rooms through ceiling grilles or high efficiency filters.
Gas-phase adsorber cell
A gas-phase adsorption filter for single-pass or recirculating air-cleaning systems where removal of gaseous contaminants is required. Also known as Molecular filters.
Germicidal UV
See Ultraviolet (UV) radiation.
Glovebox
An enclosure, fitted with sealed gloves that allows external manual manipulations in controlled or hazardous environments. Applications include nuclear, biomedical, semiconductor, chemical industries; and research laboratories – where isolation of the controlled zone is required.
HEPA filter
A High Efficiency Particulate Air filter as defined in AS 4260 and EN 1822.
HEPA filter module
A HEPA filter fitted into a lightweight, disposable housing that is designed for terminal installation in cleanroom ceilings.
Hood
Non-specific term, common in USA, for laminar flow cabinet, safety cabinet or fume cupboard/ cabinet.
ISO cleanroom classifications
Adoption of ISO standards makes national standards such as AS 1386 redundant. Air cleanliness classifications are in ISO-14644-1 Classification by Airborne Particles. This is complemented by ISO-14698, dealing with bio-contamination control and monitoring.
Laminar air flow
A HEPA-filtered air stream moving within a confined space, along parallel flow lines, with uniform velocity. ‘Laminar air flow’ is a misnomer and is more correctly termed ‘unidirectional flow’.
Laminar flow cabinets
Self-contained ISO Class 5 ( AS 1386 Class 3.5) horizontal or vertical laminar flow workstations designed to provide protection for process products and apparatus in laboratory and production facilities. These cabinets are intended for work involving the handling of non-hazardous materials. Also termed ‘clean benches’.
Microbial air sampler
See Air sampler.
Microelectronics
The design and manufacture of integrated circuits and of equipment that uses integrated circuits.
Micrometre
See Micron.
Micron
A unit of measurement equal to one-millionth of a metre; or one-thousandth of a millimetre; or approximately 0.00003937 inch. Expressed as µm.
Minipleat HEPA filter
HEPA & ULPA filters of light weight, low-depth construction with very close pleating of the medium; separation of media pleats achieved by continuous, narrow beads of a hot-melt compound. A typical 70 mm deep minipleat filter has similar airflow/ pressure drop characteristics to a 149 mm conventional filter of the same face dimensions.
NATA
NATA is Australia’s national provider of laboratory and inspection accreditation services and GLP compliance monitoring.
Office of the Gene Technology Regulator (OGTR)
The Australian regulatory agency responsible for a national scheme to regulate dealings with genetically modified organisms (GMOs). Laboratories accredited by OGTR for work with specific classes of organisms must have safety cabinets and other equipment that fully comply with Australian standards.
PAO (Poly-Alfa-Olefins)
One of the liquids used in aerosol generators as an alternative to Di [2-ethyhexyl] phthalate (aka DOP or DEHP).
Particle counter – airborne
An electronic instrument for continuous counting of airborne particles larger than a selected diameter. The light-scattering principle is used to display and record the number and size of discrete particles.
Pass-through hatches
Hatches with double doors that protect critical environments while allowing transfer or materials to or from adjoining rooms. Typical installations are in the walls of cleanrooms and biological containment laboratories. In these applications, materials must be transferred with minimal loss of room pressure; and without the need for personnel movement between rooms.
PC3 containment facility
Physical Containment Level 3 facilities are negative-pressure containment laboratories specified in AS/NZS 2243.3:2002. PC3 facilities are suitable for work with Risk Group 3 pathogens and certain Genetically Modified Organisms.
PCR (polymerase chain reaction)
A technique in molecular genetics that permits the analysis of any short sequence of DNA (or RNA) without having to clone it. PCR is used to reproduce (amplify) selected sections of DNA. Laminar flow cabinets provide the ultra-clean work environment that is needed to obtain reliable results in clinical and diagnostic PCR work.
Powder containment cabinets
Compact containment cabinets with inward airflow and HEPA filtration that provide protection for operators and the environment from powders generated by processes such as compounding of pharmaceuticals.
Pressure drop & room pressure
Measured in Pascals (Pa); mm of H20; or inches water gauge. 1″ w.g. = 249.088 Pa. In-situ instrumentation to indicate room pressure is typically a Dwyer Instruments Magnehelic gauge(s).
Risk groups for microorganisms
AS 2243.3 classifies infective microorganisms according to degree of risk. Class I and II biological safety cabinets are intended for work with microorganisms of Risk Groups 2 and 3.
Room pressure
See Pressure drop & room pressure. Pressure differentials between cleanrooms and adjoining zones are typically specified as ≥ 15 Pa.
Separative devices
See Clean-air device, laminar flow. ‘Separative devices’ is the terminology adopted for ultra-clean enclosures in ISO 14644-7, Cleanrooms and associate controlled environments – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments).
Sterile air
Air supply that is filtered to exclude microbiological life, e.g. bacteria, yeasts, moulds, fungi and viruses.
TGA
The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
TGA Code
See Australian GMP Code for medicinal products.
Turbulent flow cleanroom
A non-unidirectional flow cleanroom in which air enters the room with non-uniform velocity; or with turbulent flow. Examples are ISO 14644-1 cleanrooms of Class 6, 7 and 8.
ULPA filter
An Ultra Low Penetration Air filter. A HEPA-type filter with higher efficiency filter medium. Originally developed for cleanroom applications in semiconductor manufacture.
Ultraviolet radiation (germicidal)
UV radiation (UVC) with wavelengths between 200 and 290 nm, used to sterilise workspaces and tools in biology laboratories and medical facilities.
UV lamp
See Ultraviolet (UV) radiation.
Validation
Procedures to create documented evidence that a facility meets design, construction and/or performance specifications.