Washington Administrative Code › Title 296 - Labor and Industries, Department of › Chapter 296-62 - General occupational health standards › Part R - HAZARDOUS DRUGS › Section 296-62-50010 - Definitions

Current through Register Vol. 24-14, July 15, 2024
Biological safety cabinet.
A ventilated cabinet
				  for compounding pharmaceutical ingredients, personnel, product, and
				  environmental protection having an open front with inward airflow for personnel
				  protection, downward high-efficiency air (HEPA)-filtered laminar airflow for
				  product protection, and HEPA-filtered exhausted air for environmental
				  protection. For a complete description of the different types of biologic
				  safety cabinets see the Centers for Disease Control and Prevention
				  (CDC)/National Institutes of Health (NIH) document
Primary Containment
				  for Biohazards: Selection, Installation and Use of Biological Safety
				  Cabinets
.
Chemotherapy glove.
A medical glove that has
				  been approved by the Food and Drug Administration (FDA) and that meets the
				  permeability standards of the American Society for Testing Materials (ASTM)
				  Standard D6978 - 05.
Closed system drug-transfer device.
A
				  drug-transfer device that mechanically prohibits the transfer of environmental
				  contaminants into the system and the escape of hazardous drug or vapor
				  concentrations outside of the system.
Decontamination.
Inactivation, neutralization,
				  or removal of toxic agents, usually by chemical means.
Engineering controls.
Devices designed to
				  eliminate or reduce worker exposure to hazards. Examples include biological
				  safety cabinets, laboratory fume hoods, containment isolators, safer sharps
				  devices, and safety interlocks.
Hazardous drugs.
Any drug identified as
				  hazardous by the National Institute for Occupational Safety and Health (NIOSH)
				  at the Centers for Disease Control (CDC) or any drug that meets at least one of
				  the following six criteria:
(a) 
				Carcinogenicity.
(b) 
				Teratogenicity or developmental toxicity.
(c)
				 Reproductive toxicity in humans.
(d)  Organ toxicity at low doses in humans or
				animals.
(e) 
				Genotoxicity.
(f)  New drugs that
				mimic existing hazardous drugs in structure and toxicity.
Health care facilities.
All hospitals, clinics,
				  nursing homes, laboratories, offices or similar places where a health care
				  provider provides health care to patients. For purposes of this chapter this
				  includes veterinary medicine, retail pharmacies, home health care agencies and
				  also those research laboratories in settings where a health care provider
				  provides health care to patients. It does not include the drug manufacturing
				  sector or research laboratories where health care providers do not provide
				  health care to patients.
HEPA filter.
A high-efficiency particulate air
				  filter rated 99.97% efficient in capturing 0.3-micron-diameter
				  particles.
*
Isolator.
A device that is sealed or is
				  supplied with air through a microbially retentive filtration system (HEPA
				  minimum) and may be reproducibly decontaminated. When closed, an isolator uses
				  only decontaminated interfaces (when necessary) or rapid transfer ports (RTPs)
				  for materials transfer. When open, it allows for the ingress and/or egress of
				  materials through defined openings that have been designed and validated to
				  preclude the transfer of contaminants or unfiltered air to adjacent
				  environments. An isolator can be used for aseptic processing, for containment
				  of potent compounds, or for simultaneous asepsis and containment. Some isolator
				  designs allow operations within the isolator to be conducted through attached
				  rubber gloves without compromising asepsis and/or containment.
*
Aseptic isolator.
A ventilated isolator
				  designed to exclude external contamination from entering the critical zone
				  inside the isolator.
*
Aseptic containment isolator.
A ventilated
				  isolator designed to meet the requirements of both an aseptic isolator and a
				  containment isolator.
*
Containment isolator.
A ventilated isolator
				  designed to prevent the toxic materials processed inside it from escaping to
				  the surrounding environment.
Occupational exposure.
Reasonably anticipated
				  inhalation, skin, ingestion, or injection contact with hazardous drugs as a
				  result of the performance of an employee's duties. Some drugs defined as
				  hazardous may not pose a significant risk of occupational exposure because of
				  their dosage formulation (for example, coated tablets or capsules that are
				  administered to patients without modifying the formulation). However, they may
				  pose a risk if altered (for example, if tablets are crushed or dissolved, or if
				  capsules are pierced or opened).
Safety data sheet (SDS).
A summary provided by
				  the manufacturer to describe the chemical properties and hazards of specific
				  chemicals and ways in which workers can protect themselves from exposure to
				  these chemicals.
Ventilated cabinet.
A type of engineering
				  control designed for purposes of worker protection. These devices are designed
				  to minimize worker exposures by controlling emissions of airborne contaminants
				  through the following:
(a)  The full
				or partial enclosure of a potential contaminant source.
(b)  The use of airflow capture velocities to
				capture and remove airborne contaminants near their point of
				generation.
(c)  The use of air
				pressure relationships that define the direction of airflow into the cabinet.
Examples of ventilated cabinets include biological safety
				  cabinets and containment isolators.
Statutory Authority:
					 RCW
					 49.17.010,
					 49.17.040,
					 49.17.050,
					 49.17.060, and 2011 c 39.
					 12-02-053, § 296-62-50010, filed 1/3/12, effective
					 1/1/14.