D3
Full two-line campus
190,780 sq ft · 35.00 kanals
- 77,680 sq ft production
- 21,400 sq ft packing
- 52,420 sq ft finished goods
- Two-line utility duty with justified standby
Sheikhupura, Punjab · 31.457280, 74.301440
Two master plans.
One sterile strategy.
A coordinated proposal for a PIC/S-compliant IV-fluid campus built around ISPM all-in-one blow–fill technology, terminal sterilization and automated end-of-line inspection.
195,050sq ft usable plot
2proposal pathways
PE 009-17PIC/S design basis
30%proposal maturity
Executive proposition
A resilient platform for sterile IV growth
This proposal advances the available vendor layouts into a coordinated 30% engineering concept. Every unverified site, product and utility input is carried as an allowance or hold point. It is suitable for investment approval, design development and vendor alignment—not construction release.
Master planning
D3 full build-out or D4 phased entry
D3 maximizes capacity with two production trains. D4 reduces initial capital while preserving common infrastructure and physical interfaces for expansion.
D4
Phased capital pathway
138,335 sq ft · 25.40 kanals
- 36,275 sq ft production
- 10,000 sq ft packing
- 52,780 sq ft finished goods
- Expansion-ready utility and tie-in corridors
ISPM all-in-one technology
Blow. Fill. Seal. Inspect.
The container is formed, filled and hermetically sealed within one automated machine cycle. The design minimizes operator intervention and treats the critical zone, sterile product path, polymer handling, interventions and environmental monitoring as one contamination-control system.
01Resin + raw materials→
02Compounding→
03Sterile filtration→
04ISPM all-in-one blow–fill→
05Terminal sterilization→
06Visual inspection→
07Automated packing→
08Finished-goods quarantine
Design principles
- Grade A critical processing environment, defined by CCS and machine barrier design.
- Sterile bulk connection, sterilizing filtration, integrity testing and closed transfer.
- Qualified sterile air, extrusion control, mold protection and automated rejects.
- Intervention taxonomy, line clearance, batch genealogy and audit-trailed recipe control.
- Terminal sterilization cycle development and parametric/biological validation strategy.
- 100% inspection, container-closure integrity and automated secondary packing.
Vendor name and model are carried as “ISPM all-in-one blow–fill” per client direction. Final performance, fill range, polymer, sterility boundary and utility values require the approved vendor URS and GA.
Preliminary engineering
P&IDs, HVAC, utilities and power
These schedules define the control intent and proposal allowances required to progress detailed design. Values are deliberately presented as design ranges until batch schedules and vendor data are frozen.
Process P&ID system architecture
| System | Preliminary flow path | Critical instrumentation / control |
|---|---|---|
| P-100 Raw/PW | Raw tank → multimedia → softener → carbon → RO/EDI → PW tank | Conductivity, TOC, flow, pressure, temperature; hygienic recirculation |
| P-200 WFI | PW → multi-effect distiller → 10/20 t WFI tank → hot loop → users | 80 °C target basis; spray device, sterile vent, return temperature and online conductivity/TOC |
| P-300 Compounding | WFI/API → 2 × 15 t vessels → sterile filter train → holding/filler | Load cells, agitation, temperature, filter integrity, CIP/SIP permissives |
| P-400 ISPM BFS | Sterile bulk + polymer + sterile air → form/blow/fill/seal → discharge | Grade A critical zone, intervention logging, vacuum/air/fill controls, reject verification |
| P-500 CIP/SIP | CIP tank → supply pump → user circuits → return/neutralization | Time, temperature, conductivity, flow and recipe endpoints |
| P-600 Clean utilities | Clean steam / oil-free air / nitrogen as required → ring mains → users | Quality monitoring, sterile filtration, condensate and dew-point controls |
HVAC zoning and contamination control
| Zone | Function | Classification basis | Control intent |
|---|---|---|---|
| A | Critical exposed sterile zone within BFS | ISO 5 / Grade A | Unidirectional protection; continuous particle monitoring |
| B | Background where required by CCS | Grade B | Terminal HEPA, qualified recovery, pressure alarm |
| C | Compounding, preparation, clean support | Grade C | Dedicated AHU; 10–15 Pa cascade basis |
| D | Sterilizer loading/unloading and controlled corridors | Grade D / risk-based | Segregated airlocks; temperature/RH control |
| N | Packing, warehouse, utilities | Controlled non-classified | Product/storage conditions; dust and heat extraction |
Utility balance — proposal ranges
| Utility | D3 allowance | D4 allowance | Qualification / hold point |
|---|---|---|---|
| PW/WFI peak | D3: 25–35 m³/h | D4: 14–20 m³/h | ±30% proposal allowance; confirm batch schedule |
| WFI storage | 20 t duty + expansion/standby | 10 t initial; reserve 20 t | Final by simultaneous-use and turnover study |
| Clean steam | 3,000–4,500 kg/h | 1,800–2,800 kg/h | Sterilizer/SIP diversity required |
| Plant steam | 6,000–9,000 kg/h | 3,500–5,500 kg/h | Includes process/HVAC allowance |
| Compressed air | 2,500–3,500 Nm³/h | 1,500–2,200 Nm³/h | Oil-free; 7 bar; N+1 compressor philosophy |
| Cooling demand | 2.5–3.5 MW | 1.4–2.2 MW | Vendor and climatic loads pending |
| Electrical maximum demand | 4.5–6.0 MVA | 2.8–4.0 MVA | Includes 20% growth; diversity preliminary |
| Fire water | Authority/hydraulic calculation | Authority/hydraulic calculation | Tank/pumps after commodity and sprinkler study |
PW / WFI architecturePretreatment → PW → multi-effect WFI → hygienic storage and recirculation
Electrical connected-load basis
| Load group | D3 kW | D4 kW | Supply philosophy |
|---|---|---|---|
| Process/BFS/packing | 1,850 | 1,050 | Normal + selected UPS controls |
| HVAC/chillers | 2,200 | 1,350 | Emergency only for critical ventilation |
| Water/steam/utilities | 950 | 620 | Sequential restart and essential standby |
| Warehouse/admin/ELV | 420 | 350 | Life safety and IT separated |
| Growth allowance | 1,080 | 730 | D3 20%; D4 expansion interfaces |
Utility grid
11/33 kV — confirm
→11/33 kV — confirm
MV switchgear
metering + protection
→metering + protection
N+1 transformers
segregated buses
→segregated buses
Main LV boards
normal / essential
→normal / essential
MCCs · UPS · BMS
selective coordination
selective coordination
Standby generators → essential bus · UPS → GxP controls / EMS / data · life safety → independent protected circuits
PIC/S compliance
Validation is designed in—not added later
Pakistan adopted PIC/S GMP guidance through S.R.O. 1587(I)/2025. The facility strategy is aligned with PE 009-17, revised Annex 1, Annex 11 and Annex 15, supported by ICH Q9 quality risk management.
1
Quality planning
VMP, CCS, QRM plan, system inventory, criticality and data-integrity assessments
2
Requirements/design
URS, DQ, GMP reviews, HAZOP, cleanroom concept, P&ID and software design review
3
Vendor assurance
FAT, supplier audits, material/weld records, calibration, software tests and traceability
4
Commissioning
SAT, loop checks, balancing, functional tests, passivation, cleaning and turnover dossiers
5
Qualification
IQ/OQ/PQ: HVAC, PW/WFI, clean steam, gases, sterilizers, BFS, inspection and packaging
6
Process readiness
APS/media fills as applicable, sterilization, cleaning, water PQ, EM qualification and hold times
7
Continued verification
CPV, APR/PQR, EM trending, utility review, requalification and change control
CCSIntegrated contamination-control strategy
QRMScience- and risk-based decisions
APSAseptic process simulation where applicable
EMViable/non-viable monitoring and trending
CSVData integrity and computerized systems
CPVContinued process verification
Budget BOQ framework
Investment structure before false precision
A reliable monetary BOQ requires local rates, vendor quotations, quantities and the selected option. At proposal stage, the correct control is a structured cost model with class-4 contingency—not invented prices.
| Pkg | Cost package | Typical share | Included basis / exclusion |
|---|---|---|---|
| A | Preliminaries, design, permits, QA | 8–12% | Surveys, detailed design, authority fees, project controls |
| B | Civil, structure, envelope | 15–20% | Ground improvement excluded until geotechnical study |
| C | GMP architecture/cleanrooms | 10–14% | Panels, doors, ceilings, finishes and pass-throughs |
| D | Process equipment and packing | 24–32% | ISPM line, compounding, sterilization, inspection, packing |
| E | Water/clean utilities/process piping | 12–17% | PW/WFI, clean steam, air, CIP/SIP and hygienic piping |
| F | HVAC/BMS/EMS | 12–16% | AHUs, chillers, ducts, HEPA, controls and monitoring |
| G | Electrical/ELV/backup power | 8–12% | Transformers, generators, UPS, panels, cables, fire alarm and IT |
| H | Validation/start-up/spares | 5–8% | C&Q, CSV, consumables, training, initial spares |
| I | Risk contingency | 15–25% | Class-4 estimate range until scope and site data mature |
Recommended commercial issue: D3 and D4 priced independently in PKR and USD after receiving budget quotations from ISPM, sterilizer, water-system, HVAC/cleanroom and power-generation vendors. Accuracy target at this maturity: approximately −30% / +50%, tightened progressively through design freeze.
Decision gates
What must be proven next
The proposal is engineered to advance without pretending unknowns are facts.
Site truth
Boundary/topographic survey, geotechnical investigation, groundwater and flood/drainage assessment.
Product truth
Approved product matrix, batches, fill volumes, polymers, sterilization cycles and annual demand.
Utility truth
Raw-water analysis, grid capacity/fault level, fuel, sewer, emissions and authority constraints.
Vendor truth
URS, GA, maintenance clearances, heat rejection, clean utilities, automation and FAT protocols.