ISO 5 environment definition

ISO 5 environment means an atmospheric environment that contains fewer than 3,520 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100.
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Examples of ISO 5 environment in a sentence

  • The rule also includes time restrictions for the use of drugs compounded outside of ISO 5 environment.

  • In the typical ISO 5 environment microbial contamination is only rarely detected, and even the most aggressive sampling plans only sample a limited amount of the air or surfaces.1 A further drawback of viable environmental monitoring is that using common growth and recovery methods results are unavailable in real time.

  • Determine if monitoring records and any checklists or logs indicate that the ISO 5 environment was in good state of control (serious environmental quality or equipment repair issues) at the time of the sterility test.

  • This media fill process qualification for injectable suspensions includes the homogenization process in the ISO 5 LAFW for the maximum duration and the aseptic fill in the ISO 5 environment as outlined in SOP ST-004 Media Fills (Exhibit 4A-1), and the Media Fill Master Validation Plan (Exhibit 4A-2).

  • All particle count measurements were collected in an ISO 5 environment with full bunny suit requirements.

  • A Beckman MetOne HHPC6+ handheld particle counter was used to monitor airborne particle generation from recorded actions by personnel in the ISO 5 environment.

  • Where the filling equipment per- mits, the solution could be filled into a large container that has been prepared in an ISO 5 environment, after which the contents can be filtered and evaluated microscopically for the presence of visible (≥ 100 µm) particles.

  • Each process is performed using aseptic technique within the ISO 5 environment using the IVX Pharmacy Compounding Station.

  • That said, there is certainly a need to review core elements of protection policies and immigration control strategies.

  • The Petitioner was requesting to be able to utilize leftover drugs for subsequent patients’ admixtures from SDVs that are stable for 6 hours or less at 2- 8°C after initial opening or entry in an ISO 5 environment that is moved to an ISO 7 environment using the PhaSeal CSDTD.

Related to ISO 5 environment

  • ICT Environment means the Authority System and the Contractor System. “Information” has the meaning given under section 84 of the FOIA.

  • Customer Environment means Customer’s data network/equipment and premises environment.

  • Natural environment means the air, land and water, or any combination or part thereof, of the Province of Ontario; (“environnement naturel”)

  • Operating Environment means, collectively, the platform, environment and conditions on, in or under which the Software is intended to be installed and operate, as set forth in the Statement of Work, including such structural, functional and other features, conditions and components as hardware, operating software and system architecture and configuration.

  • Production Environment means a logical group of virtual or physical computers comprised within the Cloud Environment to which the Customer will be provided with access and use the purchased Cloud Application(s) in production and for its generally marketed purpose.

  • Hostile environment means a situation in which bullying among students is sufficiently severe or pervasive to alter the conditions of the school climate;

  • Initial Environmental Examination or “IEE” means an initial environmental examination for a Subproject, including any update thereto, prepared and submitted by the Borrower pursuant to the requirements set forth in the EARF and cleared by ADB;

  • Adverse Environmental Condition shall refer to (i) the existence or the continuation of the existence, of an Environmental Emission (including, without limitation, a sudden or non-sudden accidental or non-accidental Environmental Emission), of, or exposure to, any substance, chemical, material, pollutant, Contaminant, odor or audible noise or other release or emission in, into or onto the environment (including, without limitation, the air, ground, water or any surface) at, in, by, from or related to any Equipment, (ii) the environmental aspect of the transportation, storage, treatment or disposal of materials in connection with the operation of any Equipment or (iii) the violation, or alleged violation of any statutes, ordinances, orders, rules regulations, permits or licenses of, by or from any governmental authority, agency or court relating to environmental matters connected with any Equipment.

  • Materials of Environmental Concern any gasoline or petroleum (including crude oil or any fraction thereof) or petroleum products or any hazardous or toxic substances, materials or wastes, defined or regulated as such in or under any Environmental Law, including asbestos, polychlorinated biphenyls and urea-formaldehyde insulation.

  • Stand-Alone Test Environment or "SATE" shall have the meaning set forth in Section 12.2.9.3.2.

  • Phase I Environmental Assessment A “Phase I assessment” as described in, and meeting the criteria of, the ASTM, plus a radon and asbestos inspection.

  • Least restrictive environment means the environment in which the interventions in the lives of people with mental illness can be carried out with a minimum of limitation, intrusion, disruption, and departure from commonly accepted patterns of living.

  • major environmental rule means a rule the specific intent of which is to protect the environment or reduce risks to human health from environmental exposure and that may adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, or the public health and safety of the state or a sector of the state.

  • Environment means ambient air, indoor air, surface water, groundwater, drinking water, soil, surface and subsurface strata, and natural resources such as wetland, flora and fauna.

  • Processes with Significant Environmental Aspects means the Equipment which, during regular operation or if not properly operated or maintained, may cause or are likely to cause an adverse effect.

  • Applicable Environmental Law means any Law, statute, ordinance, rule, regulation, order or determination of any Governmental Authority or any board of fire underwriters (or other body exercising similar functions), affecting any real or personal property owned, operated or leased by any Credit Party or any other operation of any Credit Party in any way pertaining to health, safety or the environment, including all applicable zoning ordinances and building codes, flood disaster Laws and health, safety and environmental Laws and regulations, and further including (a) the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended by the Superfund Amendments and Reauthorization Act of 1986 (as amended from time to time, herein referred to as “CERCLA”), (b) the Resource Conservation and Recovery Act of 1976, as amended by the Used Oil Recycling Act of 1980, the Solid Waste Recovery Act of 1976, as amended by the Solid Waste Disposal Act of 1980, and the Hazardous and Solid Waste Amendments of 1984 (as amended from time to time, herein referred to as “RCRA”), (c) the Safe Drinking Water Act, as amended, (d) the Toxic Substances Control Act, as amended, (e) the Clean Air Act, as amended, (f) the Occupational Safety and Health Act of 1970, as amended, (g) the Laws, rules and regulations of any state having jurisdiction over any real or personal property owned, operated or leased by any credit Party or any other operation of any Credit Party which relates to health, safety or the environment, as each may be amended from time to time, and (h) any federal, state or municipal Laws, ordinances or regulations which may now or hereafter require removal of asbestos or other hazardous wastes or impose any liability related to asbestos or other hazardous wastes. The terms “hazardous substance”, “petroleum”, “release” and “threatened release” have the meanings specified in CERCLA, and the terms “solid waste” and “disposal” (or “disposed”) have the meanings specified in RCRA; provided that, in the event either CERCLA or RCRA is amended so as to broaden the meaning of any term defined thereby, such broader meaning shall apply subsequent to the effective date of such amendment with respect to all provisions of this Agreement; provided further that, to the extent the Laws of the state in which any real or personal property owned, operated or leased by any Credit Party is located establish a meaning for “hazardous substance”, “petroleum”, “release”, “solid waste” or “disposal” which is broader than that specified in either CERCLA or RCRA, such broader meaning shall apply in so far as such broader meaning is applicable to the real or personal property owned, operated or leased by any such Credit Party and located in such state.

  • Material of Environmental Concern means and includes pollutants, --------------------------------- contaminants, hazardous wastes, and toxic, radioactive, caustic or otherwise hazardous substances, including petroleum, its derivatives, by-products and other hydrocarbons, or any substance having any constituent elements displaying any of the foregoing characteristics.

  • Phase I Environmental Report means a report by an Independent Person who regularly conducts environmental site assessments in accordance with then current standards imposed by institutional commercial mortgage lenders and who has a reasonable amount of experience conducting such assessments.

  • Environmental Safeguards means the principles and requirements set forth in Chapter V, Appendix 1, and Appendix 4 (as applicable) of the SPS;

  • Insured Environmental Event As defined in Section 3.07(d).

  • Hazardous Air Pollutant (HAP means any pollutant listed by the EPA as a hazardous air pollutant in conformance with Section 112(b) of the Clean Air Act. A list of these pollutants is available at the Division of Air Quality.

  • Requirements of Environmental Law means all requirements imposed by any law (including for example and without limitation The Resource Conservation and Recovery Act and The Comprehensive Environmental Response, Compensation, and Liability Act), rule, regulation, or order of any federal, state or local executive, legislative, judicial, regulatory or administrative agency, board or authority in effect at the applicable time which relate to (i) noise; (ii) pollution, protection or clean-up of the air, surface water, ground water or land; (iii) solid, gaseous or liquid waste generation, treatment, storage, disposal or transportation; (iv) exposure to Hazardous Substances; (v) the safety or health of employees or (vi) regulation of the manufacture, processing, distribution in commerce, use, discharge or storage of Hazardous Substances.

  • Hazardous chemical has the meaning given in subregulation 5(1) of the Work Health and Safety Regulations 2011 (Cth) and includes: prohibited carcinogen, as defined in subregulation 5(1) of the Work Health and Safety Regulations 2011 (Cth); restricted carcinogen, as defined in subregulation 5(1) of the Work Health and Safety Regulations 2011 (Cth); hazardous chemicals the use of which is restricted under regulation 382 of the Work Health and Safety Regulations 2011 (Cth), including polychlorinated biphenyls; Schedule 11 Hazardous Chemicals; hazardous chemicals listed in Table 14.1 of Schedule 14 of the Work Health and Safety Regulations 2011 (Cth); Schedule 15 Chemicals; and lead as defined in subregulation 5(1) of the Work Health and Safety Regulations 2011 (Cth).

  • the Environmental Statement means the document certified as the environmental statement by the Secretary of State for the purposes of the Order;

  • Applicable Environmental Laws means any applicable federal, state, or local government law (including common law), statute, rule, regulation, ordinance, permit, license, requirement, agreement or approval, or any applicable determination, judgment, injunction, directive, prohibition or order of any governmental authority with jurisdiction at any level of federal, state, or local government, relating to pollution or protection of the environment, ecology, natural resources, or public health or safety.

  • Hazardous air pollutant means any air pollutant listed as a hazardous air pollutant pursuant to Section 112(b) of the FCAA.