Project Aqua Pure
A scalable PIC/S-aligned sterile IV manufacturing campus connecting clean utilities, compounding, double-train ISPM blow–fill, terminal sterilization, inspection, packing and controlled logistics.
EXECUTIVE OVERVIEW
One controlled manufacturing chain, designed as a complete operating system.
The proposal consolidates the available master plans, equipment layouts and vendor references into a coordinated basis for design development, tendering, validation planning and regulatory engagement. D3 remains the baseline option; D4 is the strategic double-train configuration with approximately twice nominal production capacity.
VISUAL DESIGN RECORD
BTI coordinated image boards
Eleven full-resolution boards arranged as campus, process, utility and logistics chapters.
MASTER-PLAN DECISION
AQI-D3 baseline versus AQI-D4 double-train strategy

Reference operating configuration
190,780 sq. ft. building reference • 1,188 pallet positions • lower equipment count and simpler initial qualification.

Two production trains
138,335 sq. ft. compact building concept • 3,564 pallet positions • duplicated production trains and approximately 2× nominal capacity.
| Decision domain | AQI-D3 | AQI-D4 | Executive implication |
|---|
| System | Design basis | Cleanroom / location | Primary utility |
|---|
READ-ONLY DATA CONSOLIDATION
Site, building and controlled-environment baseline
Missing factual content incorporated from the reference dashboard and reformatted for the independent V10 proposal.
CLEANROOM PRESSURE CASCADE
Grade A → B → C → D
Dedicated hygienic AHUs and DDC control maintain the cascade through production rooms, PALs and MALs.
Street-clothing removal, hair covering, step-over bench, hand wash and HEPA drying, Grade D garment and footwear.
Non-linting jumpsuit, hood, goggles, clean boots and nitrile gloves. No sinks in Grade C.
Sterile jumpsuit, over-boots and sterile gloves through interlocked doors. No sinks in Grade B.
COMMERCIAL READINESS
Seven-division unpriced tender BOQ
Twenty-eight quantified line items covering civil/structural, cleanrooms, process equipment, clean utilities, HVAC/BMS, electrical/backup power and high-density racking.



