Examples of ISO Class 7 in a sentence
The Buffer area is to be maintained within ISO Class 7 level of particulate contamination.
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.
Sinks and drains are not present in any ISO Class 7 or better cleanroom, nor in a segregated sterile compounding area within three feet of an ISO Class 5 or better PEC, with the exception of emergency eye-rinsing stations.
At all times the Products shall be manufactured in an ISO Class 7 Clean Room, unless otherwise set forth in an amendment to this Agreement or the Exhibits hereto signed by both Parties.
Cleanroom or clean area or buffer area” means a physically separate room or area with walls and doors with HEPA-filtered air that provides at least an ISO Class 7 or better air quality where the primary engineering control (PEC) is physically located.
VIABLE AIR SAMPLING: TIMING AND LOCATIONS Volumetric active air sampling of all classified areas (e.g., ISO Class 5 PEC and ISO Class 7 and 8 areas) using an impaction device must be conducted during dynamic operating or simulated operating conditions at least every 6 months.Air sampling sites must be selected in all classified areas.
Ante-rooms providing access to negative pressure buffer rooms must meet at least ISO Class 7 classification (see á800ñ).
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.
A monitoring program for viable airborne particles must be developed and implemented to assess microbiological air quality in all classified areas.VIABLE AIR SAMPLING: TIMING AND LOCATIONSVolumetric active air sampling of all classified areas (e.g., ISO Class 5 PEC and ISO Class 7 and 8 areas) using an impaction device must be conducted during dynamic operating or simulated operating conditions at least every 6 months.Air sampling sites must be selected in all classified areas.