ISO Class 8 definition

ISO Class 8 means conditions in which the air particle count is no greater than a total of 3,520,000 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 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.
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Examples of ISO Class 8 in a sentence

  • All presterilization procedures shall be completed in an ISO Class 8 or superior environment.b. Immediately before use, all nonsterile measuring, mixing, and purifying devices used in the compounding process shall be thoroughly rinsed with sterile, pyrogen-free water, and then thoroughly drained or dried.13.24(2) Sterilization methods for high-risk preparations.a. Sterilization by filtration.

  • Except for a CAI that meets the conditions specified in subrule 13.27(3) exempting the CAI from placement in an ISO Class 7 cleanroom, an anteroom or ante areashall be located adjacent to the buffer area and maintained at ISO Class 8 air quality.

  • An anteroom or ante area shall be located adjacent to the buffer area and maintained at ISO Class 8 air quality.

  • Presterilization procedures can be performed in unclassified environments for Category 1 CSPs. For Category 2 and Category 3 CSPs, presterilization procedures must be completed in an ISO Class 8 or better environment (e.g., anteroom or buffer room) wherein the compounder uses a containment device (e.g., single-use containment glove bags, containment ventilated enclosure (CVE), BSC, or CACI) to minimize the risk of airborne contamination.

  • Circuit 1 will be located within an ISO Class 8 clean room while Circuit 3 will be located within a ISO Class 7 clean room.

  • In EU2, there was an analysis of the maintenance process used in what the company believed to be its best-organized and best-working project.

  • Classified areas in which the air quality is controlled (see Table 2) include ante-rooms, buffer rooms, and PECs.• Ante-rooms providing access to positive pressure buffer rooms must meet at least ISO Class 8 classification.

  • A visual smoke study uses a visible source of smoke, which is neutrally buoyant, to verify an absence of stagnant airflow where particulates can accumulate in ISO Class 7 and ISO Class 8 rooms that do not have unidirectional airflow.

  • In contrast, if a CAI or CACI is used to prepare Category 2 CSPs, the CAI or CACI must be placed in a cleanroom suite with an ISO Class 7 or better positive-pressure buffer room with an ISO Class 8 or better positive-pressure anteroom.

  • The manufacture of the Product will be conducted in a suitably controlled ISO Class 7 (Class 10,000) or ISO Class 8 (Class 100,000) clean room environment, and such facilities will be regularly monitored to demonstrate and maintain compliance with Current Good Manufacturing Practices.

Related to ISO Class 8

  • 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;

  • New Class Loans shall have the meaning assigned to such term in Section 9.08(f).

  • 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.

  • Class HI M-1 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: M-1 Formula Distribution Amount" and (b) the Unpaid Class HI: M-1 Interest Shortfall, if any.

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

  • Group II Class A Certificates The Class A-2a Certificates, the Class A-2b Certificates, the Class A-2c Certificates and the Class A-2d Certificates, collectively.

  • 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.

  • Scheduled Classes As specified in the Preliminary Statement.

  • 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.

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

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

  • Class 2 means, at any time, all Class 2 Loans at such time.

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

  • Support Classes As specified in the Preliminary Statement.

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

  • 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.

  • 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).

  • 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.

  • 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.

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

  • Initial Class D Note Balance means $142,370,000.

  • Initial Class B Note Balance means $129,750,000.

  • 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.

  • Class” or “Classes means any class or classes of Shares as may from time to time be issued by the Company;