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What are the standards for oil content, water content, suspended particles, and microorganisms in clean compressed air used in the production of injectable preparations?
Clean compressed air used in the production of injectables must comply with both GMP and ISO 8573‑1 standards: oil content ≤ 0.01 mg/m³, pressure dew point ≤ −40°C, particles ≥ 0.5 μm ≤ 10⁶ per m³, and microorganisms…
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