ISO 5 environment definition

ISO 5 environment means an atmospheric environment that contains fewer than 3,520 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100.
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Examples of ISO 5 environment in a sentence

  • Variances may be granted at the discretion of the Board upon good cause shown as long as the compounding is performed in an ISO 5 environment.

  • The rule also includes time restrictions for the use of drugs compounded outside of ISO 5 environment.

  • Primary engineering control (PEC): A system that provides an ISO 5 environment for the exposure of critical sites when com- pounding sterile preparations.

  • However, most of the mass of the solution concentrates on the observed subdomain, and neglects the rest of the domain where the prior mainly concentrates.

  • Aseptic manipulations within an ISO 5 environment using prolonged and complex mixing and transfer, more than three sterile products and entries into any container, and pooling ingredients from multiple sterile products to prepare multiple CSPs.

  • For example, an incident rate of 1% would mean that only 1% of the samples taken have any contamination regardless of colony number.” According to the suggested initial contamination recovery rate in aseptic environment in USP Chapter <1116>, the CRR for active air sample, settle plate (4 hour exposure), contact plate or swab, and gloves and garment in ISO 5 environment are all < 0.1%.

  • Includes other family types, not shown separately.Source: U.S. Census Bureau, United States and Puerto Rico: DP-1, ‘‘Profile of General Demographic Characteristics: 2000 (area)’’ and DP-2, ‘‘Profile of Selected Social Characteristics Characteristics: 2000 (area)’’; Virgin Islands, Guam, and Northern Mariana Islands: ‘‘Population and Housing Profile: 2000 (area)’’.

  • Determine if monitoring records and any checklists or logs indicate that the ISO 5 environment was in good state of control (serious environmental quality or equipment repair issues) at the time of the sterility test.

  • In the typical ISO 5 environment microbial contamination is only rarely detected, and even the most aggressive sampling plans only sample a limited amount of the air or surfaces.1 A further drawback of viable environmental monitoring is that using common growth and recovery methods results are unavailable in real time.

  • You stated that the sterile wipes will not be contaminated since they are held open in the ISO 5 environment.

Related to ISO 5 environment

  • ICT Environment means the Authority system and the Contractor system.

  • Production Environment means a logical group of virtual or physical computers comprised within the Cloud Environment to which the Customer will be provided with access and use the purchased Cloud Application(s) in production and for its generally marketed purpose.

  • Hostile environment means a situation in which bullying among students is sufficiently severe or pervasive to alter the conditions of the school climate;

  • Materials of Environmental Concern any gasoline or petroleum (including crude oil or any fraction thereof) or petroleum products or any hazardous or toxic substances, materials or wastes, defined or regulated as such in or under any Environmental Law, including asbestos, polychlorinated biphenyls and urea-formaldehyde insulation.

  • Environment means soil, land surface or subsurface strata, surface waters (including navigable waters and ocean waters), groundwaters, drinking water supply, stream sediments, ambient air (including indoor air), plant and animal life and any other environmental medium or natural resource.

  • Minister for the Environment means the Minister to whom the Governor has for the time being committed the administration of the EP Act;