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

  • 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.

  • Radiopharmaceuticals shall be compounded using appropriately shielded vials and syringes in a properly functioning and certified vertical LAFW, Class II Type B2 BSC, or other suitable containment device (e.g., CAI) located in an ISO Class 8 or cleaner air environment to permit compliance with special handling, shielding, and negative air flow requirements.

  • ISO Class 8 (formerly Class 100,000) is an atmospheric environment that contains less than 3,520,000 particles 0.5 microns in diameter per cubic meter of air (formerly stated as 100,000 particles 0.5 microns in diameter per cubic foot of air).

  • 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.

  • Technetium 99/Molybdnenum 99 generator systems shall be stored and eluted in an ISO Class 8 or cleaner environment to permit special handling, shielding, and airflow requirements.

  • Radiopharmaceuticals shall be compounded using appropriately shielded vials and syringes in a properly functioning ISO Class 5 PEC (Primary Engineering Control), located in an ISO Class 8 or better buffer area environment in compliance with special handling, shielding, air flow requirements, and radiation safety programs to maintain radiation exposure as low as reasonably achievable.

  • A transition area from the general pharmacy (also called ante area or ante room) shall have a certified and inspected ISO Class 8 or better area which may contain a sink.

  • The environment for compounding must contain an ante area that is ISO Class 8 quality air or better.

  • Packaged compounding supplies and components, such as needles, syringes, tubing sets, and small and large-volume parenteral, should be taken from cartons and wiped down with a disinfectant that does not leave a residue, when possible in an ante-are of ISO Class 8 air quality, before being passed into the buffer areas.

  • Work surfaces in the ISO Class 7 buffer areas and ISO Class 8 ante-areas as well as segregated compounding areas shall be cleaned and disinfected at least daily, and dust and debris shall be removed when necessary from storage sites for compounding ingredients and supplies using a method that does not degrade the ISO Class 7 or 8 air quality.

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;

  • 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.

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

  • 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.

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

  • 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.

  • Initial Class Certificate Balance As to each Class of Certificates, the Class Certificate Balance set forth 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 $13,564,000.

  • 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.

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

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

  • Class B-4 Certificates The Certificates designated as “Class B-4” on the face thereof in substantially the form attached hereto as Exhibit A.