Projects / ISO Class 7 Packaging Cleanroom Fit-Out
CASE STUDY // CLEANROOM•Sterile Pharmaceutical Manufacturer•3,200 m² clean production area
ISO Class 7 Packaging Cleanroom Fit-Out
FIELD RECORD // CLEANROOM & CONTROLLED FACILITY FIT-OUTS
Engineering Performance Metrics & Delivery Parameters
Cleanroom RatingISO Class 7
Air Changes/Hour38 ACH
Pressure Cascade15 Pa / zone
Audit ResultFirst-pass pass
FIGURE 1.0 // AS-BUILT SCHEMATICVerified by Lead Discipline Engineer
SECTION // ISO CLASS 7 PRESSURE CASCADEVAL-CR-701
The Technical Brief
Deliver a turnkey mechanical and architectural cleanroom suite expansion including walk-on ceiling panels, flush interlocked airlocks, and terminal HEPA filtration.
Site & Operating Constraints
Surrounding production suites remained active during fit-out. Strict negative air containment barriers were required at access penetrations to eliminate cross-contamination.
Execution Methodology & Works Delivered
- Erected 1,800 m² of PIR flush-bonded modular wall partitions with coved aluminum joints
- Installed 48 terminal gel-seal H14 HEPA filter modules with aerosol test injection ports
- Commissioned automated differential pressure cascade controls maintaining 15 Pa pressure differentials between stages
- Conducted airborne particulate count measurements across 64 test points in rest and operational states
- Provided comprehensive IQ/OQ validation protocols and factory calibration certificates for all instrumentation
Verified Outcome
Facility achieved ISO 14644-1 Class 7 certification on first inspection by external pharmaceutical auditors, handing over 36 hours ahead of the scheduled restart.
Discuss Similar Facility Scope
If your plant requires similar switchgear cutover, refrigeration overhaul, or cleanroom installation, speak directly with our team.
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Industry SectorPharmaceutical & Cleanroom Facilities
Core ServiceCleanroom & Controlled Facility Fit-Outs
Total Duration10 weeks offsite prefabrication, 12 days on-site installation
Downtime Allocation14-day planned annual shutdown window