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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2Sample 3
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.
Sample 1

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)
Sample 1

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;

  • 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 D Note Balance means $119,840,000.

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

  • Initial Class C Note Balance means $178,840,000.

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

  • Required Class Lenders means, at any time with respect to any Class of Loans or Commitments, Lenders having Total Credit Exposures with respect to such Class representing more than 50% of the Total Credit Exposures of all Lenders of such Class. The Total Credit Exposure of any Defaulting Lender with respect to such Class shall be disregarded in determining Required Class Lenders at any time.