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

  • Certification that each LAFW, barrier isolator, and biological safety cabinet is working properly and meets the air quality requirement of ISO Class 5 shall be conducted every six (6) months and whenever the LAFW, barrier isolator, or biological safety cabinet is relocated.

  • 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.

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

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

  • If the area has an ISO Class 5 (see Table 1) recirculating devise, a minimum of 15 ACPHs through the area supply HEPA filters is adequate, providing the combined ACPH is not less than 30.

  • The device shall be capable of maintaining ISO Class 5 air quality during normal activity.

  • The primary engineering control device shall be capable of maintaining at least ISO Class 5 air quality in the area where critical objects are exposed and critical activities are performed.

  • 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.

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

  • 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.


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;

  • Unimpaired Class means an unimpaired Class within the meaning of section 1124 of the Bankruptcy Code.

  • Class H designation on the face thereof, substantially in the form of Exhibit A-4 attached hereto, and evidencing a portion of a class of "regular interests" in REMIC III for purposes of the REMIC Provisions.

  • Released Class Claims means the claims being released as described in Paragraph 6.2 below.

  • Scheduled Classes As specified in the Preliminary Statement.

  • 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 2 A-1 Certificates and Class 1-X Component 2. Group 2 Certificates................ Group 2 Senior Certificates and the Subordinated Component related to Loan Group 2.

  • Class S designation on the face thereof, substantially in the form of Exhibit A-5 attached hereto, and evidencing a portion of a class of "regular interests" in REMIC III for purposes of the REMIC Provisions.

  • Subordinated Class means, with respect to the Class A Notes, the Class B Notes.

  • Initial Class Certificate Balance As to each Class of Certificates, the Class Certificate Balance set forth in the Preliminary Statement.

  • Class P designation on the face thereof, substantially in the form of Exhibit A-5 attached hereto, and evidencing a portion of a class of "regular interests" in REMIC III for purposes of the REMIC Provisions.

  • Initial Class D Note Balance means $13,564,000.

  • Impaired Class means an impaired Class within the meaning of section 1124 of the Bankruptcy Code.

  • Subclass With respect to the Class A-V Certificates, any Subclass thereof issued pursuant to Section 5.01(c). Any such Subclass will represent the Uncertificated Class A-V REMIC Regular Interest or Interests specified by the initial Holder of the Class A-V Certificates pursuant to Section 5.01(c).

  • Subordinate Class Percentage With respect to any Distribution Date and any Class of Subordinate Certificates, a fraction, expressed as a percentage, the numerator of which is the aggregate Certificate Principal Balance of such Class of Subordinate Certificates immediately prior to such date and the denominator of which is the aggregate Stated Principal Balance of all of the Mortgage Loans (or related REO Properties) (other than the related Discount Fraction of each Discount Mortgage Loan) immediately prior to such Distribution Date.

  • Requisite Class Lenders means, at any time of determination (i) for the Class of Lenders having Revolving Loan Exposure, Lenders having or holding more than 50% of the aggregate Revolving Loan Exposure of all Lenders, and (ii) for the Class of Lenders having Term Loan Exposure, Lenders having or holding more than 50% of the aggregate Term Loan Exposure of all Lenders.

  • Initial Class C Note Balance means $152,941,000.

  • 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.

  • Initial Class B Note Balance means $163,150,000.

  • Class D Certificates “Class E Certificates,” “Class F Certificates,” “Class G Certificates,” “Class H Certificates,” “Class V Certificates” and “Class R Certificates” mean, in each such case, the Certificates designated as “Class A-1,” “Class A-2,” “Class A-SB,” “Class A-3,” “Class A-4,” “Class A-5,” “Class A-S,” “Class X-A,” “Class X-B,” “Class X-C,” “Class B,” “Class PST,” “Class C,” “Class D,” “Class E,” “Class F,” “Class G,” “Class H,” “Class V” and “Class R,” respectively, on the face thereof, in substantially the forms attached hereto as Exhibits A-1 to A-20.

  • Required Class Lenders means, with respect to any Class on any date of determination, Lenders having more than 50% of the sum of (i) the outstanding Loans under such Class and (ii) the aggregate unused Commitments under such Facility; provided that the unused Commitments of, and the portion of the outstanding Loans under such Class held or deemed held by, any Defaulting Lender shall be excluded for purposes of making a determination of the Required Class Lenders; provided, further, that, to the same extent set forth in Section 10.07(n) with respect to determination of Required Lenders, the Loans of any Affiliated Lender shall in each case be excluded for purposes of making a determination of Required Class Lenders.

  • Class C Certificates Any one of the Class C Certificates executed by the Trustee, and authenticated and delivered by the Certificate Registrar, substantially in the form annexed hereto as Exhibit A-18, representing the right to distributions as set forth herein and therein and evidencing a regular interest in REMIC 4.