ISO Class 5 environment definition

ISO Class 5 environment means an atmospheric environ- ment that complies with the ISO/TC209 International Clean- room Standards, specifically ANSI/IEST/ISO-14644-1:1999: Cleanrooms and associated controlled environments--Part 1: Classification of air cleanliness, first edition dated May 1, 1999, (and no future amendments or editions), incorporated by reference and on file in the Board office.
Sample 1Sample 2Sample 3
ISO Class 5 environment means an atmospheric environment that complies with the ISO/TC209 International Cleanroom Standards, specifically ANSI/IEST/ISO-14644-1:1999: Cleanrooms and associated controlled environments--Part 1: Classifica- tion of air cleanliness, first edition dated May 1, 1999, (and no future amendments or editions), incorporated by reference and on file in the Board office.
Sample 1Sample 2
ISO Class 5 environment means having less than 100 particles 0.5 microns or larger per cubic foot.
Sample 1Sample 2Sample 3

Examples of ISO Class 5 environment in a sentence

  • Multiuse radiopharmaceutical vials, compounded with technetium-99m, exposed to ISO Class 5 environment and punctured by needles with no direct contact contamination may only be used up to twenty-four (24) hours post compounding.

  • Filtration sterilization of high-risk CSPs shall be performed with a sterile 0.22 micron porosity filter entirely within an ISO Class 5 environment.

  • All Risk Level 1 preparations shall be prepared with sterile equipment and sterile ingredients and solutions in an ISO Class 5 environment.

  • The selected sterilization method employed shall be based on experience and appropriate information sources.13.24(1) Presterilization requirements for high-risk preparations.a. During all compounding activities that precede terminal sterilization, such as weighing and mixing, compounding personnel shall be garbed and gloved in the same manner as when performing compounding in an ISO Class 5 environment.

  • All Risk Level 2 preparations shall be prepared with sterile equipment and sterile ingredients in an ISO Class 5 environment and with closed-system transfer methods.

  • The controlled limited access area shall have a certified and inspected ISO Class 5 environment.

  • When HEPA filters are used as a component of a horizontal- or ver- tical-laminar-airflow workbench, an environ- ment can be created consistent with standards for an ISO Class 5 environment.

  • The ISO Class 5 environment device or area is to be inspected and certified semiannually.

  • Audit quality and disclosures of other audit participants in PCAOB filings.

  • Primary Engineering Control--A device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding sterile preparations.


More Definitions of ISO Class 5 environment

ISO Class 5 environment means an atmospheric environment that complies with the ISO/TC209 International Cleanroom Standards, specifically ANSI/IEST/ISO-14644-1:1999: Cleanrooms and associated controlled environ- ments--Part 1: Classification of air cleanliness, first edition dated May 1, 1999, (and no future amendments or edi- tions), incorporated by reference and on file in the Board office.
Sample 1Sample 2Sample 3
ISO Class 5 environment means having less than 100 particles 0.5 microns or
Sample 1Sample 2
ISO Class 5 environment means an atmospheric environment that complies with the ISO/TC209 International Cleanroom
Sample 1

Related to ISO Class 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.

  • 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.

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

  • 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.

  • 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;

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

  • Wastewater treatment plant means a facility designed and constructed to receive, treat, or store waterborne or liquid wastes.

  • 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.

  • Solid waste facility means a site, location, tract of land, installation, or building used for incineration, composting, sanitary landfilling, or other methods of disposal of solid wastes or, if the solid wastes consist of scrap tires, for collection, storage, or processing of the solid wastes; or for the transfer of solid wastes.

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

  • Wastewater treatment tank means a tank that is designed to receive and treat an influent wastewater through physical, chemical, or biological methods.

  • 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.

  • Nuclear waste means a quantity of source, byproduct or special nuclear material (the definition of nuclear waste in this chapter is used in the same way as in 49 CFR 173.403) required to be in NRC-approved specification packaging while transported to, through or across a state boundary to a disposal site, or to a collection point for transport to a disposal site.

  • PTCE 95-60 As defined in Section 5.02(b). PUD: A planned unit development.

  • Phase I Environmental Site Assessment is an assessment of the environmental condition of the Property performed in accordance with the American Society of Testing and Materials (ASTM) Standard E1527-05 “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process,” or any successor to such ASTM Standard which is active at the time of the assessment.

  • Wastewater treatment facility means a treatment works, as

  • National Pollutant Discharge Elimination System (NPDES) means the national program for issuing, modifying, revoking and reissuing, terminating, monitoring, and enforcing permits and imposing and enforcing pretreatment requirements, under Sections 307, 318, 402, and 405 of CWA. The term includes an approved program.

  • Wastewater treatment system means any equipment, plants,

  • Non-Administrator Substance Use Disorder Treatment Facility means a Substance Use Disorder Treatment Facility that does not meet the definition of an Administrator Substance Use Disorder Treatment Facility.

  • Covered Environmental Losses means all environmental losses, damages, liabilities, claims, demands, causes of action, judgments, settlements, fines, penalties, costs and expenses (including, without limitation, costs and expenses of any Environmental Activity, court costs and reasonable attorney’s and experts’ fees) of any and every kind or character, by reason of or arising out of:

  • Yard waste means leaves, grass clippings, yard and garden debris and brush, including clean woody vegetative material no greater than 6 inches in diameter. This term does not include stumps, roots or shrubs with intact root balls.

  • 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.

  • Water treatment plant means that portion of the water supply system which in some way alters the physical, chemical, or bacteriological quality of the water.

  • Process Wastewater means any water which, during manufacturing or processing, comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, by-product, or waste product.

  • Nuclear Hazard means any nuclear reaction, radiation, or radioactive contamination, all whether controlled or uncontrolled or however caused, or any consequence of any of these.