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Clean Rooms — Pharma/GMP | Maxwell Medical Engineering
Service

Clean Rooms (Pharma/GMP)

Turnkey classified suites—architecture, clean HVAC, interlocks & utilities engineered for ISO 5–8 and GMP compliance with full qualification support.

ISO classes

ISO 5–8 / EU-GMP

Modular panels

Flush doors, pass-boxes

Pressure cascades

Monitored & alarmed

Docs & PQ

DQ/IQ/OQ/PQ support

Scope

  • User requirements & zoning maps
  • Modular panels, covings & flush detailing
  • Doors, view panels, interlocks & pass-boxes
  • Clean HVAC with terminal HEPA / laminar modules
  • Pressure cascade design & monitoring
  • Flooring (ESD/vinyl/epoxy) & utilities (PW, drains)
  • Electrical, lighting & controls
  • Qualification: DQ, IQ, OQ, PQ with records

Deliverables

  • Design package, BOQs & interlock diagrams
  • As-built drawings & labeling
  • Qualification protocols & reports
  • O&M manuals, SOPs & training logs

Benefits

  • Audit-ready, compliant facilities
  • Robust particle & pressure control
  • Cleanable, maintainable finishes
  • Clear documentation trail

Built clean, validated clean

Corners, seams and flows that pass scrutiny.

Flush Detailing

Minimal ledges, continuous coving, sealed penetrations.

Controlled Interlocks

Airlocks & door logic protecting pressure cascades.

Qualification Support

From DQ to PQ with protocols, deviations & reports.

Technical specifications

  • Powder-coated / SS modular panels with flush view panels
  • Radius covings, chemical-resistant sealants
  • Pass-boxes (dynamic/static) with interlock logic
  • Air change targets by class; terminal HEPA & laminar modules
  • Room differential monitoring & alarms
  • Sampling points & PAO testing capability
  • DQ/IQ/OQ/PQ protocols & reports
  • Corrective actions & traceability
  • O&M manuals, SOPs & training records

Gallery

Planning a cleanroom suite?

We’ll design the cascade and validate rigorously for your process.

Talk to Maxwell