Examples of ISO Class 7 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.
Pharmacies shall employ the use of either laminar airflow workbenches (LAFWs) or a barrier isolator system to prepare CSPs. These devices shall be located within a buffer or clean-room area that maintains at least an ISO Class 7 environment.
The primary engineering control device shall be placed in a buffer area where HEPA filters are employed and the air quality is maintained at ISO Class 7.
Buffer area: An ISO Class 7 or better area where the primary engineering control is physically located that is constructed and used in a manner to minimize the introduc- tion, generation, and retention of particles inside the room and in which other relevant variables (e.g., temperature, humidity, and pressure) are controlled as necessary.
USP Chapter 797 provides as follows in the “Facility Design and Environmental Controls” section: “An ISO Class 7 (see Table 1) buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPH of not less than 30.
Before sterilization, non-sterile procedures such as weighing and mixing are conducted in air quality worse than ISO Class 7, compounding personnel are improperly garbed and gloved, or water-containing preparations are stored for more than 6 hours.
A separate controlled limited access area (also called a buffer area or buffer room) shall have a certified and inspected ISO Class 7 or better environment for compounding sterile solutions.
The pressure between the ISO Class 7 and the general pharmacy area shall not be less than 5 Pa (0.02 inch water column).
The Buffer area is to be maintained within ISO Class 7 level of particulate contamination.
ISO Class 7: An area with less than three hundred fifty-two thousand (352,000) particles (0.5 μm and larger in size) per cubic meter.