ISO Class 7 definition

ISO Class 7 or “Class 10,000 condition” means an atmospheric environment that contains less than 10,000 particles, 0.5 microns or larger in diameter per cubic foot of air, according to ISO standards. “ISO Class 8” or “Class 100,000 condition” means an atmospheric environment that contains less than 100,000 particles, 0.5 microns or larger in diameter per cubic foot of air, according to ISO standards. “Laminar airflow workbench” or “LAFW” means an apparatus designed to provide an ISO Class
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ISO Class 7 means conditions in which the air particle count is no greater than a total of 352,000 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 7 or “Class 10,000 condition” means an atmospheric environment that contains less than 10,000 particles, 0.5 microns or larger in diameter per cubic foot of air, according to ISO standards.
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Examples of ISO Class 7 in a sentence

  • The air quality of the buffer or clean room and the anteroom area shall be in conformity with ISO Class 7 and ISO Class 8 requirements, as appropriate.

  • Pharmacies shall employ the use of either laminar airflow workbenches (LAFWs) or a barrier isolator system to prepare CSPs. These devices shall be located within a buffer or clean-room area that maintains at least an ISO Class 7 environment.

  • The emperor then chose another Conservative, the viscount of Rio Branco, who succeeded with the help of Souza Franco and a group of Liberal senators, to pass this law on September 28, 1871.

  • A separate controlled limited access area (also called a buffer area or buffer room) shall have a certified and inspected ISO Class 7 or better environment for compounding sterile solutions.

  • The Buffer area is to be maintained within ISO Class 7 level of particulate contamination.

  • Buffer area: An ISO Class 7 or better area where the primary engineering control is physically located that is constructed and used in a manner to minimize the introduc- tion, generation, and retention of particles inside the room and in which other relevant variables (e.g., temperature, humidity, and pressure) are controlled as necessary.

  • The pressure between the ISO Class 7 and the general pharmacy area shall not be less than 5 Pa (0.02 inch water column).

  • ISO Class 7: An area with less than three hundred fifty-two thousand (352,000) particles (0.5 μm and larger in size) per cubic meter.

  • Before sterilization, non-sterile procedures such as weighing and mixing are conducted in air quality worse than ISO Class 7, compounding personnel are improperly garbed and gloved, or water-containing preparations are stored for more than 6 hours.

  • USP Chapter 797 provides as follows in the “Facility Design and Environmental Controls” section: “An ISO Class 7 (see Table 1) buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPH of not less than 30.


More Definitions of ISO Class 7

ISO Class 7 means conditions in which the air particle count is no greater than a total of 352,000 particles of 0.5 microm-
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Related to ISO Class 7

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

  • 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;

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

  • 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.

  • Scheduled Classes As specified in the Preliminary Statement.

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

  • Settlement Classes means the following:

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

  • Class S 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.

  • 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.

  • Support Classes As specified 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.

  • Class HI B-2 Formula Interest Distribution Amount" means, as to any Payment Date, the sum of (a) the amount specified in clause (a) of the definition of the term "Class HI: B-2 Formula Distribution Amount" and (b) the Unpaid Class HI: B-2 Interest Shortfall, if any.

  • Initial Class A-2 Note Balance means $235,000,000.

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

  • 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).

  • 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.

  • 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.

  • Senior Class means (a) with respect to the Class B Notes, the Class A Notes and (b) with respect to the Class C Notes, the Class A Notes and the Class B Notes.

  • 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.

  • Settlement Class means, in respect of each Proceeding, the settlement class defined in Schedule A.

  • Initial Class C Note Balance means $156,670,000.

  • 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.

  • 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.

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