What is ISO 5/7/8?
Cleanroom classifications per ISO 14644-1, specifying maximum allowable particle counts per cubic meter of air. ISO 5 is the cleanest (used in PECs), ISO 7 for buffer rooms, and ISO 8 for ante rooms.
The classification limits particles of 0.5 µm and larger per cubic meter: ISO 5 allows no more than 3,520, ISO 7 no more than 352,000, and ISO 8 no more than 3,520,000. In sterile compounding, the PEC provides ISO 5 at the critical site, the buffer room provides an ISO 7 background, and the ante room provides ISO 8 (or ISO 7 for hazardous-drug suites where required).
Classification is demonstrated through certification testing and maintained through air changes, pressure relationships, cleaning, and controlled personnel flow. Environmental monitoring — particle counts, viable air, and surface sampling — provides the ongoing evidence that the space performs as classified.
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