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

  • Variances may be granted at the discretion of the Board upon good cause shown as long as the compounding is performed in an ISO 5 environment.

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

  • Primary engineering control (PEC): A system that provides an ISO 5 environment for the exposure of critical sites when com- pounding sterile preparations.

  • However, most of the mass of the solution concentrates on the observed subdomain, and neglects the rest of the domain where the prior mainly concentrates.

  • Aseptic manipulations within an ISO 5 environment using prolonged and complex mixing and transfer, more than three sterile products and entries into any container, and pooling ingredients from multiple sterile products to prepare multiple CSPs.

  • For example, an incident rate of 1% would mean that only 1% of the samples taken have any contamination regardless of colony number.” According to the suggested initial contamination recovery rate in aseptic environment in USP Chapter <1116>, the CRR for active air sample, settle plate (4 hour exposure), contact plate or swab, and gloves and garment in ISO 5 environment are all < 0.1%.

  • Includes other family types, not shown separately.Source: U.S. Census Bureau, United States and Puerto Rico: DP-1, ‘‘Profile of General Demographic Characteristics: 2000 (area)’’ and DP-2, ‘‘Profile of Selected Social Characteristics Characteristics: 2000 (area)’’; Virgin Islands, Guam, and Northern Mariana Islands: ‘‘Population and Housing Profile: 2000 (area)’’.

  • 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.

  • 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.

  • You stated that the sterile wipes will not be contaminated since they are held open in the ISO 5 environment.

Related to ISO 5 environment

  • ICT Environment means the Authority system and the Contractor system.

  • 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 the initial environmental examination for the Project, including any update thereto, prepared and submitted by the Borrower and cleared by ADB;

  • Adverse Environmental Condition means (i) the existence or the continuation of the existence, of an Environmental Contamination (including, without limitation, a sudden or non-sudden accidental or non-accidental Environmental Contamination), of, or exposure to, any substance, chemical, material, pollutant, Hazardous Substance, 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 Environmental Law, permits or licenses of, by or from any governmental authority, agency or court relating to environmental matters connected with any of the Equipment.

  • Phase I Environmental Site Assessment means a Phase I environmental property assessment of the Assets that satisfies the basic assessment requirements set forth under the current ASTM International Standard Practice for Environmental Site Assessments (Designation E1527-13) or any other visual site assessment or review of records, reports or documents.

  • 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.

  • Computing Environment means the SAP provided data center facilities, servers, networking equipment, operating systems, and data storage mechanisms selected and used by SAP to provide the HEC Services for the Customer, and includes the Production Computing Environment (PRD), and any other Computing Environment used for non-production purposes (NON-PRD) as agreed in the Order Form.

  • 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.

  • Environment means soil, land surface or subsurface strata, surface waters (including navigable waters and ocean waters), groundwaters, drinking water supply, stream sediments, ambient air (including indoor air), plant and animal life and any other environmental medium or natural resource.

  • 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 all Applicable Laws pertaining to the protection of the environment (e.g., prevention of pollution and remediation of contamination) and human health and safety, including, without limitation, the Clean Air Act, 42 U.S.C. § 7401 et seq.; the Clean Water Act, 33 U.S.C. § 1251 et seq.; the Oil Pollution Act of 1990, 33 U.S.C. § 2702 et seq.; the Marine Protection, Research, and Sanctuaries Act, 33 U.S.C. § 1401 et seq.; the National Environmental Policy Act, 42 U.S.C. § 4321 et seq.; the Noise Control Act, 42. U.S.C. § 4901 et seq.; the Occupational Safety and Health Act, 29 U.S.C. § 651 et seq.; the Resource Conservation and Recovery Act (“RCRA”), 42 U.S.C. § 6901 et seq., as amended by the Hazardous and Solid Waste Amendments of 1984; the Safe Drinking Water Act, 42 U.S.C. § 300f et seq.; the Comprehensive Environmental Response, Compensation and Liability Act (“CERCLA”), 42 U.S.C. § 9601 et seq., as amended by the Superfund Amendments and Reauthorization Act; the Emergency Planning and Community Xxxxx-xx-Xxxx Xxx, 00 X.X.X. § 00000 et seq.; the Toxic Substances Control Act, 15 U.S.C. § 2601 et seq.; the Hazardous Materials Transportation Act, 49 U.S.C. § 1801 et seq.; the Atomic Energy Act, 42 U.S.C. § 2011 et seq.; and the Nuclear Waste Policy Act of 1982, 42 U.S.C. § 10101 et seq.; and all analogous applicable state and local Applicable Laws, including, without limitation, Tex. Nat. Res. Code, Title 3 (Oil and Gas) and 16 Tex. Admin. Code. pt. 1 (Railroad Commission of Texas).

  • 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;

  • Minister for the Environment means the Minister to whom the Governor has for the time being committed the administration of the EP Act;

  • 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).

  • 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.