Feasibility / Budget Proposal — Rev 0 · 11 Aug 2026

Two master plans. One sterile campus strategy.

A coordinated engineering, validation and regulatory proposal for the Aqua Pure sterile IV-fluid facility — evaluating the full two-line AQI-D3 build against the compact, phased AQI-D4 option.

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📍 Butt Chemicals Pvt Ltd, Harriya Tibbi, Sheikhupura, Punjab · 31.457280° N, 74.301440° E Client: Highfine Group / Bolton Pharma
Aqua Pure IV manufacturing campus aerial rendering
D3 / D4 CAMPUS — COORDINATED PROPOSAL VISUALIZATION
195,050sq ft
Usable plot area · 35.0 kanals
24,000BPH
VIM optical inspection throughput
3,564pallets
D4 warehouse capacity (+200% vs D3)
34items
Deliverables tracked across 10 disciplines
Executive Overview

Facility scope & cleanroom architecture

A sterile large-volume parenteral (LVP) line built around ISBM blow-fill-seal technology, terminal sterilization and automated end-of-line inspection — sized for 24,000 BPH.

Facility scope & capabilities

  • 📍
    Site: Butt Chemicals Pvt Ltd campus (31.457280° N, 74.301440° E), 31 km Lahore–Sheikhupura–Faisalabad Road.
  • ✓
    ISBM Technology: Injection Stretch Blow Molding & blow-fill-seal all-in-one production line.
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    High-speed robotics: EFORT ER210-2700 6-axis robot for automated carton palletizing.
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    Pyrogen-free water system: Multi-effect distillation with 10-ton & 20-ton WFI storage tanks.
  • ✓
    Packaging speed: ≥400 bpm labeling and pillow-packing throughput.

Cleanroom pressure cascade

Grade B (ISO 5) — Filling & autoclave in+45 Pa
Grade C (ISO 7) — Compounding & dispensing+30 Pa
Grade D (ISO 8) — Packaging & autoclave out+15 Pa
Unclassified (CNC) — corridors & warehouse0 Pa ref.
Option Selection

Master plan: AQI-D3 vs AQI-D4

Same 195,050 sq ft usable plot, two development strategies — full two-line capacity versus a compact, phased build with reserved expansion.

ParameterAQI-D3AQI-D4Unit

AQI-D3 — Expanded Shell

190,780 sq ft
  • Production area77,680 sq ft
  • Packing hall21,400 sq ft
  • Finished goods store52,420 sq ft
  • Pallet capacity1,188 pallets
  • Best forMulti-line future expansion

AQI-D4 — Compact & High-Density

138,335 sq ft · −27.5%
  • Production area36,275 sq ft
  • Packing hall10,000 sq ft
  • Finished goods store52,780 sq ft
  • Pallet capacity3,564 pallets (+200%)
  • Best forOptimal CAPEX, high-volume buffer
AQI-D3 master plan dimensional reference
AQI-D3 Master Plan — Dimensional Reference
AQI-D4 master plan dimensional reference
AQI-D4 Master Plan — Dimensional Reference
Personnel Flow

Gowning & GMP entry sequence

Sequential changing rooms, step-over benches and airlock interlocks aligned to EU Annex 1 and WHO TRS 1044 principles.

Grade D outer personnel airlock and hand wash station
Grade D Outer PAL & Hand Wash StationSensor-activated hands-free wash basin, HEPA warm-air hand dryer, Step-Over Bench (SOB 1). Sinks restricted to Grade D only per EU Annex 1.
Sterile cleanroom gowning airlock
Grade B/C Interlocked Gowning AirlockStep-over benches (SOB 2 & 3), continuous filament sterile jumpsuit gowning, electromagnetic door interlocks with LED status lights.
Step 1

CNC Outer Locker

Street clothing & outdoor shoe removal. Hairnet application.

Step 2 · SOB 1

Grade D Outer PAL

Hand wash, HEPA dryer, Grade D coat & shoes, sensor IPA rub.

Step 3 · SOB 2

Grade C Intermediate

Non-linting jumpsuit, hood, goggles, clean boots & nitrile gloves. No sinks.

Step 4 · SOB 3

Grade B Sterile PAL

Sterile jumpsuit, sterile over-boots, sterile surgical gloves & IPA spray purge.

EU GMP Annex 1 & WHO TRS Compliance Rules

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    No sinks in Grade C/B: Hand washing sinks and HEPA dryers are strictly limited to Grade D PAL to prevent microbial contamination further downstream.
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    Door interlocks & purge timer: Electromagnetic interlocks prevent opening outer and inner doors simultaneously. 30–45s air flush cycle.
  • •
    Unidirectional exit PAL: Separate exit personnel airlock with reverse de-gowning sequence prevents cross-contamination.
Coordinated Scope

12 master engineering & regulatory packages

Click any package to open full specifications — architectural, process, HVAC, electrical, utilities, validation and licensing.

Bill of Quantities

Equipment BOQ & specifications

20 tagged equipment items across water, compounding, molding, sterilization & packaging
TagEquipmentSpecificationQtyZoneUtilities
Central Engineering

Utilities & HVAC matrix

Central engineering utilities

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Electrical Power

400/230V, 50Hz, 3-phase 5-wire system connected to control cabinets.

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Compressed Air

DN15 connection, 6–8 bar operating pressure for solenoid valves.

♨️

Industrial Steam

3–8 bar operating pressure; requires dedicated condensate discharge.

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Raw & Pure Water

DN50 raw inlet at 2–4 bar; SS316L loop distribution for PW & WFI.

Civil & HVAC criteria

Ceiling clear height≥ 6.0 m
Max room temperature< 30°C
Clean corridor width2,500 mm
Floor drainsSS Ø100 mm
Room condition baseline20–24°C, 40–60% RH
Pressure differential10–15 Pa nominal
Proposal Design Basis · Rev 0

Regulatory & technical basis

Not an Issued-for-Construction package. Supports option selection, budget pricing, authority engagement and appointment of specialist designers.

Regulatory & Technical Basis

  • Drug Regulatory Authority of Pakistan (DRAP) GMP and applicable Drugs Act/rules.
  • WHO TRS 1044 Annex 2 for sterile pharmaceutical products; WHO guidance for pharmaceutical water and validation.
  • PIC/S / EU GMP Annex 1 contamination-control principles, as adopted by the project quality team.
  • Building Code of Pakistan 2021 plus applicable Punjab/local building, fire, environmental and labour requirements.
  • Applicable IEC electrical, NFPA fire, ASHRAE ventilation, ISO 14644 cleanroom, and ASME/BPE requirements, subject to formal code register.
  • Provisional seismic basis: Sheikhupura Zone 2A — final parameters from structural engineer and geotechnical report.

Provisional Cleanroom & HVAC Basis

  • Critical open sterile exposure: Grade A / ISO 5 at point of operation, unidirectional protection.
  • Background to critical operation: Grade B or justified alternative, subject to CCS.
  • Compounding & controlled preparation: Grade C, positive pressure, HEPA supply.
  • Support / terminally sterilized ops: Grade C/D by risk assessment.
  • Dedicated AHUs by incompatible zone; terminal HEPA filtration; BMS trending & room pressure alarms.

Available Information

  • A3 master plans AQI-D3 and AQI-D4 dated 07-08-2026.
  • CAD/PDF layouts for BFS/injection-blow-fill, packing, sterilization, inspection, compounding, PW/WFI and WFI tanks.
  • Site pin: Butt Chemicals Pvt Ltd, approximate coordinates 31.457280, 74.301440.
  • Not yet provided: certified survey, geotechnical report, utility confirmations, water analysis, final product dossier, vendor URS, environmental baseline, authority comments.

Validation & qualification lifecycle

Concept through process readiness

Status
Feasibility / Budget Proposal
Permitted use
Budget pricing, space reservation, design coordination
Not permitted
Construction, procurement release, validation acceptance
Master Deliverables & Gap Register

What's confirmed, assumed, and still open

A transparent register of 34 tracked deliverables, 12 assumptions with verification hold points, and the 10 source documents this proposal is built on.

IDDisciplineProposal assumptionRiskRequired verificationOwner
IDSourceFormatUseLimitation
Project Files

Drawing catalog — 18 files