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 having less than 100 particles 0.5 microns or larger per cubic foot.
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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 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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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.

  • 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.

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

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

  • Radiopharmaceuticals designed for multi use, compounded with Tc-99m, exposed to an ISO Class 5 environment by components with no direct contact contamination, may be used up until the time indicated by manufacturers recommendations.

  • 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.


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.

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

  • 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.

  • 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,

  • 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.

  • 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.