White Paper

Modern Containment Solutions In OSD Processes

Source: ILC Dover
ILC Dover - soloFLEX isolator

As oral solid dosage manufacturing evolves, your containment strategy may be the single greatest obstacle to handling highly potent active pharmaceutical ingredients at scale. HPAPI occupational exposure limits have tightened to below 0.10 µg/m³, batch sizes are shrinking, and contract manufacturing organizations are cycling through dozens of molecules annually.

If your facility still relies on legacy hard-wall isolators, you are likely facing capital expenditures exceeding $700,000 per unit, cleaning surface areas of 18,000 square inches or more, and delivery lead times stretching to 26 weeks. Flexible film single-use isolator systems change that calculus. A direct comparison shows equivalent containment performance at acquisition costs below $55,000, an 8-week delivery window, and 800% less surface area requiring cleaning between campaigns. One CDMO case study achieved EN689-compliant containment performance below 31 ng/m³ across a four-step dry granulation workflow, completing design without traditional mock-ups and realizing cost avoidance exceeding $1.4 million USD. Daisy-chain configurations support continuous workflows, while collapsible frame designs reclaim valuable floor space.

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