Customer Benefits
Controlled particulate/bioburden, lower foreign-matter & mold risk, audit-ready traceability.
Zoning & Footprint
Compounding (ISO 8, 60–120 m²) → Casting/Drying (ISO 7–8, 150–400 m²) → Slitting/Die-cut (ISO 8, 80–200 m²) → Packaging/Coding (ISO 8, 80–200 m²) → Retains/QC (ISO 8, 40–80 m²) → Storage (temp/RH-controlled, 100–300 m²).
One-way personnel/material flows, airlocks, gowning; clean/dirty segregation; ESD control points.
Controls
22–26 °C, 45–55% RH; differential ≥10–15 Pa in critical zones; routine viable/non-viable monitoring with alarms & CAPA.
Upkeep & Qualification
Scheduled cleaning/PM/pest control; environmental mapping & periodic re-qualification; cleaning validation & residue limits.
Risks & Mitigations
High humidity seasons: pre-dehumid + dew-point loops; low-RH “islands” in packaging.
Cross-contamination: dedicated tools/colors/one-way logistics; time-segregated runs if needed.
Client Inputs
Target market standards, microbial limits, label/storage needs; low-humidity or higher-class requirements if any.