ISO Class 5 definition

ISO Class 5 or “Class 100 condition” means an atmospheric environment that contains less than 100 particles, 0.5 microns or larger in diameter per cubic foot of air, according to ISO standards.
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ISO Class 5 means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air.
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ISO Class 5 means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 microme- ters and larger per cubic meter of air that is supplied by HEPA or HEPA−filtered air.
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Examples of ISO Class 5 in a sentence

  • Provides preparation protection with high-efficiency particulate air (HEPA) filtered laminar airflow, ISO Class 5.

  • Perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces.b. Select and appropriately don protective garb.c. Maintain or achieve sterility of preparations in ISO Class 5 primary engineering control devices.d. Identify, weigh, and measure ingredients.

  • 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.

  • Once begun, this test is completed without interruption within an ISO Class 5 air quality environment.

  • Contents are intended for use in a pharmacy admixture program and are restricted to use in a suitable ISO Class 5 environment.FFEE.

  • Quality assurance practices include, but are not limited to the following: (-a-) Routine disinfection and air quality testing of the direct compounding environment to minimize microbial surface contamination and maintain ISO Class 5 air quality.

  • Sinks and drains are not present in any ISO Class 7 or better cleanroom, nor in a segregated sterile compounding area within three feet of an ISO Class 5 or better PEC, with the exception of emergency eye-rinsing stations.

  • Handlers of radiopharmaceuticals may utilize techniques to increase distance, such as using remote handling tools, including within an ISO Class 5 PEC.


More Definitions of ISO Class 5

ISO Class 5 means the description of an atmospheric environment characterized by the number of particles within a diameter per cubic foot of air. which contains fewer than 100 particles 0.5 microns in diameter per cubic foot of air, according to Federal Standard 209E and the International Organization for Standardization (ISO)
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Related to ISO Class 5

  • Backward Classes means any socially and educationally Backward Classes of citizens recognized by the Government for purpose of clause (4) of article 15 of the Constitution of India;

  • Class 3 means, at any time, all Class 3 Loans at such time.

  • Released Class Claims means the claims being released as described in Paragraph 5.2 below.

  • Related Classes As to any Uncertificated REMIC I Regular Interest, those classes of Certificates identified as "Related Classes of Certificates" to such Uncertificated REMIC I Regular Interest in the definition of Uncertificated REMIC I Regular Interest.

  • Class size means the maximum number of students who can receive instruction together in a special class or resource room program and the number of teachers and supplementary school personnel assigned to the class.