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.
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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.
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ISO Class 5 environment means having less than 100 particles 0.5 microns or larger per cubic foot.
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Examples of ISO Class 5 environment in a sentence

  • 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.

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

  • The Board also received feedback from a number of prescriber groups (including dermatologists, podiatrists and plastic surgeons) regarding the need to use a drug opened outside of an ISO Class 5 environment (air quality) for longer than a 1-hour period.Prior to filing with CSI, the rules were reviewed and approved by the Board of Pharmacy.

  • 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.

  • In this case, the syringes may be opened and appropriately labeled outside of the ISO Class 5 environment and placed in disinfected shielding, immediately prior to the forthcoming dispensing cycle.

  • See Appendix 3 for details.Buffer room: A type of C-SEC under negative pressure that meets ISO Class 7 or better air quality where the C-PEC that generates and maintains an ISO Class 5 environment is physically located.

  • Class II and Class III BSCs provide an ISO Class 5 environment so are suitable for sterile compounding.

  • These preparations are limited to situations where there is a need for emergency or immediate patient administration of a compounded sterile product where preparation inside an ISO Class 5 environment would subject the patient to additional risk due to delays in therapy.

  • Yes No N/A□ 13.1.5.3. A barrier isolator that provides an ISO Class 5 environment for compounding.🞎 🞎 🞎 13.2. The pharmacy has a designated area for the compounding of sterile preparations for dispensing which shall: (24 CCR 505.12)□ 13.2.1. Be ventilated in a manner not interfering with laminar air flow.

  • This equipment provides an ISO Class 5 environment (or better) and is the standard for compounded 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 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 an atmospheric environment that complies with the ISO/TC209 International Cleanroom
Sample 1
ISO Class 5 environment means having less than 100 particles 0.5 microns or
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”)

  • 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;

  • 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.

  • Class D Coverage Tests means the Class D Interest Coverage Test and the Class D Par Value Test.

  • 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 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.

  • Nuclear waste means a quantity of source, byproduct or special nuclear material required to be in NRC−approved speci- fication 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.

  • 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.

  • Class A/B Coverage Tests means the Class A/B Interest Coverage Test and the Class A/B Par Value Test.

  • Wastewater treatment system means any equipment, plants,

  • 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.

  • Class C Coverage Tests means the Class C Interest Coverage Test and the Class C Par Value Test.

  • 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.