WHO TRS 961 PIC/S PE 009-17 Annex 1 EU GMP Annex 1 ISO 14644 Rev 01 Β· 07-08-2026

Project Aqua Pure IV Turnkey Sterile Facility

A complete turnkey engineering proposal for a greenfield sterile large-volume and small-volume parenteral manufacturing campus β€” architectural master planning, ISBM/blow-fill-seal process line, clean utilities, cleanroom HVAC and full regulatory validation delivery.

0
Useable Plot Β· sq ft
0
Built-Up Area Β· sq ft
0
Inspection Rate Β· BPH
0
Pallet Slots Β· High-Bay
Page 1 Β· Master Boards

Two Master Plan Options, One Plot

Both design options are developed on the same 195,050 sq ft useable plot with an identical utility block, raw material store and QC/admin core. They differ in production train configuration and warehouse strategy. All figures below are taken directly from the issued master plan drawings dated 07-08-2026 β€” no values are estimated.

AQI-D3 master plan CLICK TO ZOOM
Option 1 Β· Dual-Train

AQI-D3 β€” Full Build Master Plan

190,780 sq ft built-up (35.00 kanals). Largest production and packing envelope, 77,680 sq ft production hall, 2,808-pallet finish goods store.

AQI-D4 master plan CLICK TO ZOOM
Option 2 Β· Compact High-Bay

AQI-D4 β€” Phased Master Plan

138,335 sq ft built-up (25.40 kanals). Compact 36,275 sq ft production core with the highest storage density β€” 3,564 pallet slots.

Comparative Area Statement

Functional BlockAQI-D3 Β· sq ftAQI-D3 Β· kanals AQI-D4 Β· sq ftAQI-D4 Β· kanals
Production Area77,68014.2636,2756.66
Packing Hall21,4003.9310,0001.83
Finish Goods Store52,4209.6252,7809.69
Raw Material Store6,6501.226,6501.22
Reserved Raw Material Store20,3503.7320,3503.73
Utility Block6,4601.186,4601.18
Q.C, Admin & Production Entrance5,8201.065,8201.06
Total Built-Up Area190,78035.00138,33525.40

Useable plot area for both options = 195,050 sq ft. Area statement is stated per the drawings as β€œfor one line”. Finish goods storage capacity: AQI-D3 = 2,808 pallets Β· AQI-D4 = 3,564 pallets Β· reserved raw material store 1,188 pallets plus a 288-pallet zone.

Page 2 Β· 3D Campus

Interactive WebGL Digital Twin

Drag to orbit, scroll to zoom. Switch between both master plan options, jump to camera presets and toggle model layers. Cleanroom floors are colour-coded by GMP classification.

Variant Camera Layers
initialising…
Class B β€” Filling & Sealing, Airlocks Class C β€” Compounding, Moulding, Dispensing Class D β€” Corridors, Sterilisation, Stores Structure Β· Slab +6.00 m
Page 3 Β· 2D Drawings

Issued Drawing Register

Ten drawing sheets across architectural, process machinery and clean utilities disciplines, rendered at high resolution from the issued CAD set. Click any sheet to open the full-size vector-derived view; native DWG and PDF files are in the download register below.

AQI-D3 β€” Proposed Master Plan CLICK TO ZOOM
Architectural Β· IFC

AQI-D3 β€” Proposed Master Plan

Full dual-train campus master plan. 190,780 sq ft built-up on a 195,050 sq ft useable plot, 2,808-pallet finish goods store.

AQI-D4 β€” Proposed Master Plan CLICK TO ZOOM
Architectural Β· IFC

AQI-D4 β€” Proposed Master Plan

Compact high-bay phased variant. 138,335 sq ft built-up, 3,564-pallet high-bay finish goods store.

ISBM / Blow-Fill-Seal Line Layout CLICK TO ZOOM
Process Machinery Β· Vendor

ISBM / Blow-Fill-Seal Line Layout

Injection-stretch-blow-moulding and filling line general arrangement, drawing M-F26002.

Packing Line General Arrangement CLICK TO ZOOM
Packaging Β· Vendor

Packing Line General Arrangement

23-station packing line: 105 crescent slat conveyor, labeller β‰₯400 bph, JDZ-320P cartoners, case packing and coding.

Visual Inspection Machine β€” 24,000 BPH CLICK TO ZOOM
Process Machinery Β· Vendor

Visual Inspection Machine β€” 24,000 BPH

Automatic visual inspection machine with re-inspection function and two electrical cabinets; external dimensions.

Terminal Sterilisation / Autoclave Room CLICK TO ZOOM
Process Machinery Β· Vendor

Terminal Sterilisation / Autoclave Room

Water-bath terminal steriliser room, 38,760 Γ— 12,500 mm envelope, sterilisation carts, report printer and monitoring PC.

Compounding & Holding β€” PG15T3 + PG15T3 CLICK TO ZOOM
Process Machinery Β· Vendor

Compounding & Holding β€” PG15T3 + PG15T3

Mixing tanks, API tank, vacuum system, 3 m pipe-support platform and electrical cabinet. Room height β‰₯ 6 m.

Clean Utilities β€” PW / WFI / Distribution CLICK TO ZOOM
Clean Utilities Β· Vendor

Clean Utilities β€” PW / WFI / Distribution

15-item water train: multi-media filter, softener, activated carbon, pH dosing, RO, PW tank, multi-effect distiller, WFI tank, CIP.

Horizontal WFI Storage Tank β€” 10 T CLICK TO ZOOM
Clean Utilities Β· Vendor

Horizontal WFI Storage Tank β€” 10 T

Horizontal water-for-injection storage vessel, 10 tonne capacity.

Horizontal WFI Storage Tank β€” 20 T CLICK TO ZOOM
Clean Utilities Β· Vendor

Horizontal WFI Storage Tank β€” 20 T

Horizontal water-for-injection storage vessel, 20 tonne capacity.

Page 5 Β· Tender BOQ

Unpriced Master Bill of Quantities

Seven engineering divisions. Quantities marked TBC are to be confirmed at detailed design stage and are deliberately not estimated here.

UNPRICED BILL OF QUANTITIES β€” FOR TENDER PURPOSES ONLY

1. Civil, Structural & Precast Double-Tee Roof

Item No.DescriptionUnitQtyRemarks
1.1Excavation, filling & sub-structure works for 195,050 sq ft useable plotLSTBCFoundations for 2-storey frame + truck dock platform at 8 ft 9 in
1.2Reinforced concrete 2-storey frame with slab at +6.0 mmΒ³TBCManufacturing/compounding room clear height β‰₯ 6 m; water system room β‰₯ 4.5 m
1.3Prestressed precast double-tee concrete roof systemmΒ²TBCDouble-tee spanning; superstructure roofing over production block
1.4Compounding pipe-support platform (steel, 3 m height)EATBCSupports PG15T3+PG15T3 compounding/mixing system
1.5Truck dock platform (height 8 ft 9 in)EATBCLoading/unloading interface
1.6Variant AQI-D3 β€” total built area 190,780 sq ft (35.00 kanals)mΒ²TBCProduction 77,680; Packing Hall 21,400; Finish Goods 52,420; RM Store 6,650; Reserved RM 20,350; Utility 6,460; QC/Admin 5,820
1.7Variant AQI-D4 β€” total built area 138,335 sq ft (25.40 kanals)mΒ²TBCProduction 36,275; Packing Hall 10,000; Finish Goods 52,780; RM Store 6,650; Reserved RM 20,350; Utility 6,460; QC/Admin 5,820

2. Modular Cleanroom Panels, Doors & Flooring

Item No.DescriptionUnitQtyRemarks
2.1GMP cleanroom envelope β€” Classes B, C and DmΒ²TBCSegregated grades per process flow
2.2Modular cleanroom wall & ceiling panels (Class B/C/D rooms)mΒ²TBCNamed rooms: Injection Molding & Blowing, Filling & Sealing, Compounding, Dispensing (2 booths), Dispensed Material Storage, Granules Feeding, Autoclave Loading, Cooling Zone, Terminal Sterilization, Centralized Sterilization Monitoring, IPQC, PPM Material Day Stock, Washing/Laundry, Sampling Area & Booth, Material Receiving, Material Dispatch, De-Dusting Airlock-1/-2, Material Airlock, Raw Material Airlock, CR-1 to CR-4, Airlock-1/-2
2.3Cleanroom doors & interlocked airlock doorsetsEATBCIncludes De-Dusting Airlocks, Material Airlocks, Change Rooms CR-1 to CR-4
2.4Cleanroom grade epoxy / vinyl flooringmΒ²TBCSeamless, coved, cleanable finish
2.5Corridors (2500 mm wide) cleanroom constructionmTBCMain personnel & material circulation spine
2.6Support & administrative spaces (offices, visitor corridor, drivers waiting, battery charging, tool room, workshop, janitorial)mΒ²TBCManager Office, Engineer Office, Offices 1-2, Future Extension for Offices

3. Process Machinery & Packaging Line

Item No.DescriptionUnitQtyRemarks
3.1Injection-Stretch-Blow-Moulding / Blow-Fill-Seal all-in-one lineEATBCIntegrated ISBM-BFS monobloc
3.2Automatic visual inspection machine (VIM), rated 24,000 BPH with re-inspectionEA1Includes 2 electric cabinets
3.3Manual visual inspection stationEATBCBack-up / secondary inspection
3.4Water-bath terminal sterilizer (autoclave) with sterilisation report printer & monitoring PCEATBCRoom envelope 38,760 mm Γ— 12,500 mm; 2500/1500 mm clearances; sterilisation carts
3.5Compounding/mixing system 'PG15T3+PG15T3'EATBCMixing tank, API tank, vacuum system, pipe-support platform, electrical cabinet
3.6105 crescent slat conveyor with SEW motorsEATBCPacking-line transport
3.7Automatic labelling machine (tertiary inspection + white-bottle inspection + rejection)EATBCSpeed β‰₯ 400 bottles/min
3.8Pillow packing machine (100 ml)EATBCSpeed β‰₯ 200 bottles/min
3.9Cartoning machine (100 ml)EATBCSpeed β‰₯ 200 bottles/min
3.10JDZ-320P high-speed cartoners (twin-rotary-disc feed)EA22 off as verified on vendor drawing
3.11Pillow-bag case packer (3 cartons per loading)EATBCSpeed β‰₯ 400 bottles/min
3.12Carton case packer (3 cartons per loading)EATBCSpeed β‰₯ 400 bottles/min
3.13Case erectorEATBCSpeed β‰₯ 13 cartons/min
3.14Carton erector with pad placementEATBCβ€”
3.15CheckweigherEATBCIn-line weight verification
3.16Leaflet & certificate feederEATBCβ€”
3.17Case sealerEATBCβ€”
3.18Corner labelerEATBCβ€”
3.19Case date & lot printing with inspectionEATBCCoding + vision inspection
3.20Pillow-pack 3-jaw fixtures for 100 / 250 / 500 / 1000 mlSETTBC4 size fixtures per line

4. Clean Utilities β€” Purified Water, WFI & Distribution

Item No.DescriptionUnitQtyRemarks
4.1Raw water tankEATBCFeed to pre-treatment
4.2Raw water pumpEATBCβ€”
4.3Plate-type heat exchangerEATBCβ€”
4.4Multi-media filterEATBCβ€”
4.5SoftenerEATBCWith brine tank
4.6Brine tankEATBCRegeneration media
4.7Activated carbon filterEATBCβ€”
4.8pH dosing deviceEATBCβ€”
4.9RO unitEATBCPre-purification
4.10PW tankEATBCPurified Water storage
4.11PW/WFI distribution moduleEATBCLoop & distribution skid
4.12Multi-effect water distillerEATBCWFI generation
4.13WFI tankEATBCWFI storage
4.14Horizontal WFI storage tanks (10 T and 20 T)EATBCDual-capacity tanks per vendor list
4.15CIP tankEATBCβ€”
4.16CIP pumpEATBCβ€”
4.17Utility tie-ins β€” raw water inlet DN50 @ 2-4 barEATBCSite connection
4.18Utility tie-ins β€” cooling water 2-4 bar @ 7-12 Β°C; industrial steam 3-8 bar; condensate separate dischargeEATBCUtility room services

5. Cleanroom HVAC, Utilities & BMS

Item No.DescriptionUnitQtyRemarks
5.1HVAC air-handling units for GMP Classes B, C and DEATBCGrade-specific air change rates
5.2HEPA/ULPA terminal filtration & containmentEATBCClass B critical zones
5.3Compressed air supply DN15 @ 6-8 bar to each solenoid valve boxEATBCPer equipment box tie-in
5.4Building Management System (BMS) & monitoringLSTBCEnvironmental & utility monitoring
5.5Room temperature control (utility room below 30 Β°C)EATBCEnvironmental specification
5.6Drainage trench W300 Γ— H300 with DN100 floor drainsmTBCProcess & utility drainage; condensate separately discharged

6. Electrical Substation, LT Distribution & Emergency Power

Item No.DescriptionUnitQtyRemarks
6.1Electrical substation & LV incomingLSTBCSite power intake
6.2LT distribution boards & cablingLSTBCBuilding-wide power
6.3Power supply 380 V / 50 Hz three-phase five-wire to each control cabinetEATBCPer vendor equipment requirement
6.4Emergency power β€” generator & automatic transferEATBCCritical & life-safety loads
6.5UPS & emergency lightingLSTBCCleanroom & BMS continuity

7. High-Density Warehouse Racking & Material Handling

Item No.DescriptionUnitQtyRemarks
7.1Finish Goods Store racking β€” Variant AQI-D3 (2,808 pallets)PALLET280852,420 sq ft store; pallet positions per verified layout
7.2Finish Goods Store racking β€” Variant AQI-D4 (3,564 pallets)PALLET356452,780 sq ft store; pallet positions per verified layout
7.3Raw Material Store racking (6,650 sq ft)PALLETTBCβ€”
7.4Reserved Raw Material Store racking (20,350 sq ft)PALLET1188Plus a 288-pallet area; 1,188 pallets per verified layout
7.5Reserved RM Store additional pallet area (288 pallets)PALLET288Separate area within reserved RM store
7.6Material handling equipment (forklift, pallet trucks, battery charging)EATBCBattery charging room provided
Page 6 Β· 12 Master Packages

Regulatory, Validation & Engineering Packages

Click any package to open its deliverable schedule and governing references.

PKG 01 β€” Statutory DRAP Licensing & Site Master File

Establish the legal manufacturing authorisation and site documentation baseline with DRAP.

  • Draft and submit DRAP establishment/manufacturing licence application dossier.
  • Compile the Site Master File (SMF) covering site, personnel, premises, equipment and production.
  • Prepare drug registration and product authorisation supporting documentation.
  • Map national GMP compliance gaps against DRAP inspection requirements.
  • Define the site organisational chart, responsibilities and qualified-person structure.
  • Coordinate pre-licensing DRAP inspection readiness and response plan.
  • Liaise with DRAP for variation and post-approval change control.

Governing references: DRAP Act & Rules; DRAP Good Manufacturing Practices; Site Master File format.

PKG 02 β€” WHO TRS 961 GMP Compliance

Align facility design and operations to WHO Good Manufacturing Practices (TRS 961).

  • Conduct WHO TRS 961 GMP compliance gap assessment of the design.
  • Define premises and environmental-control requirements for sterile products.
  • Establish personnel hygiene, training and qualification programme.
  • Specify documentation, self-inspection and quality-assurance systems.
  • Define production, packaging and materials-control procedures.
  • Prepare complaint, recall and CAPA procedures per TRS 961.
  • Issue a compliance roadmap and inspection-readiness dossier.

Governing references: WHO TRS 961 (Good Manufacturing Practices for pharmaceutical products).

PKG 03 β€” PIC/S PE 009-17 Annex 1 Sterile Manufacture

Implement PIC/S sterile-manufacture requirements for LVP/SVP IV solutions.

  • Apply PIC/S PE 009-17 Annex 1 principles to aseptic and terminal-sterilised processes.
  • Define cleanroom grade segregation (B, C, D) and unidirectional flow design.
  • Specify environmental monitoring (EM) programme for viable and non-viable particles.
  • Establish aseptic process simulation (media fill) requirements for BFS operations.
  • Define sterilisation and depyrogenation controls for terminal sterilisation.
  • Document personnel gowning and intervention limits for Grade A/B zones.
  • Prepare PIC/S inspection-readiness evidence file.

Governing references: PIC/S PE 009-17 Annex 1 (Manufacture of Sterile Medicinal Products).

PKG 04 β€” EU GMP Annex 1 Gowning & Personnel Flow

Design personnel gowning and flow controls to EU GMP Annex 1.

  • Design gowning sequences and change rooms (CR-1 to CR-4) per EU Annex 1.
  • Define personnel and material flow to prevent cross-contamination.
  • Specify gown qualification, donning order and aseptic behaviours.
  • Establish airlock sequencing (Airlock-1/-2, De-Dusting Airlock-1/-2, Material/RM airlocks).
  • Define training, monitoring and re-qualification of personnel.
  • Document personnel-count limits and movement logging in Grade A/B.
  • Implement visitor and contractor flow via visitor corridor and drivers waiting.

Governing references: EU GMP Annex 1 (Manufacture of Sterile Medicinal Products); PIC/S PE 009-17 Annex 1.

PKG 05 β€” Validation Master Plan (VMP)

Author the site Validation Master Plan governing all qualification and validation.

  • Draft the Validation Master Plan scope, rationale and lifecycle approach.
  • Define validation responsibilities, organisation and documentation standards.
  • List all validation activities across facilities, utilities, equipment and processes.
  • Establish risk-based validation prioritisation (e.g. ICH Q9 principles).
  • Define change control, re-validation triggers and periodic review.
  • Set acceptance criteria and deviation/exception handling for validation.
  • Provide the VMP as the controlling index for all protocol execution.

Governing references: WHO TRS 961; EU GMP Annex 1; PIC/S PE 009-17 Annex 1; ISO 14644.

PKG 06 β€” Contamination Control Strategy (CCS)

Develop the Contamination Control Strategy for sterile LVP/SVP manufacture.

  • Build the CCS covering facility, utilities, equipment, personnel and process.
  • Define contamination sources, risks and control measures (microbial, particulate, pyrogen).
  • Specify cleanroom zoning, airlocks and pressure-cascade controls.
  • Establish environmental monitoring and trending as CCS evidence.
  • Define single-use vs re-usable component controls and sanitisation.
  • Integrate CCS with risk management and change control.
  • Periodically review and update the CCS with scientific justification.

Governing references: EU GMP Annex 1; PIC/S PE 009-17 Annex 1; ISO 14644.

PKG 07 β€” Qualification Protocols DQ/IQ/OQ/PQ

Execute design through performance qualification for facilities, utilities and equipment.

  • Author Design Qualification (DQ) against user and GMP requirements.
  • Perform Installation Qualification (IQ) of equipment, utilities and systems.
  • Perform Operational Qualification (OQ) across operating ranges.
  • Perform Performance Qualification (PQ) under routine conditions.
  • Define requalification intervals and change-triggered re-qualification.
  • Compile qualification reports with deviation management and approvals.
  • Maintain the qualification status register for all GMP systems.

Governing references: WHO TRS 961; EU GMP Annex 1; PIC/S PE 009-17 Annex 1; ISO 14644.

PKG 08 β€” Water System Validation (PW/WFI, 3-Phase)

Validate Purified Water and WFI generation, storage and distribution in three phases.

  • Conduct Phase 1 (initial) validation: 2-4 weeks intensive monitoring of PW and WFI.
  • Conduct Phase 2 (continued) validation under simulated routine operation.
  • Conduct Phase 3 (ongoing) validation aligned to routine production.
  • Validate RO unit, multi-effect distiller, PW/WFI tanks and distribution loop.
  • Define microbial, endotoxin and conductivity/TOC sampling plans.
  • Qualify sanitisation (hot/cold loop) and dead-leg / flow-velocity controls.
  • Issue the water-system Validation Summary Report with trend analysis.

Governing references: WHO TRS 961; EU GMP Annex 1; PIC/S PE 009-17 Annex 1.

PKG 09 β€” HVAC Qualification & Cleanroom Classification to ISO 14644

Qualify HVAC and classify cleanrooms to ISO 14644 for Grades B, C and D.

  • Perform HVAC IQ/OQ/PQ including airflow, recovery and pressure-cascade tests.
  • Conduct ISO 14644-1 particle classification of Grade B, C and D rooms.
  • Perform ISO 14644-2 monitoring and test-frequency definition.
  • Validate HEPA/ULPA terminal filter integrity (DOP/PAO) at Grade A/B.
  • Define temperature, humidity and differential-pressure alarm setpoints.
  • Establish environmental monitoring correlation with classification.
  • Compile classification and requalification reports.

Governing references: ISO 14644; EU GMP Annex 1; PIC/S PE 009-17 Annex 1; WHO TRS 961.

PKG 10 β€” Sterilisation / Autoclave Validation & Load Patterns

Validate the water-bath terminal sterilizer and define qualified load patterns.

  • Issue the autoclave IQ/OQ covering chamber, controls and report printer/PC.
  • Perform sterilisation cycle development and PQ with biological indicators.
  • Define and qualify representative load patterns on sterilisation carts.
  • Map heat-penetration and F0 distribution within autoclave envelope 38,760 Γ— 12,500 mm.
  • Validate cooling-water and steam utility performance to the sterilizer.
  • Establish load release, parametric release and deviation procedures.
  • Maintain sterilisation trending and requalification schedule.

Governing references: EU GMP Annex 1; PIC/S PE 009-17 Annex 1; WHO TRS 961.

PKG 11 β€” Computerised System Validation & Data Integrity (ALCOA+)

Validate GMP computerised systems and assure data integrity to ALCOA+.

  • Perform CSV lifecycle (planning, specification, IQ/OQ/PQ) for BMS and equipment cabinets.
  • Validate monitoring PCs, report printers and vision-inspection systems.
  • Apply ALCOA+ principles: attributable, legible, contemporaneous, original, accurate (+complete, consistent, enduring, available).
  • Define audit-trail review, access control and electronic-records controls.
  • Specify backup, archive and business-continuity for GMP records.
  • Conduct data-integrity risk assessment and remediation.
  • Issue CSV and data-integrity evidence for regulatory inspection.

Governing references: ALCOA+ data integrity principles; EU GMP Annex 1; PIC/S PE 009-17 Annex 1; WHO TRS 961.

PKG 12 β€” Engineering Handover / As-Built & O&M Dossier

Deliver as-built documentation and operation & maintenance dossier at handover.

  • Compile as-built drawings (civil, structural, precast double-tee, MEP) versus verified layout.
  • Deliver equipment datasheets, manuals and spare-parts lists for all packages.
  • Issue Operation & Maintenance (O&M) manuals for HVAC, water and electrical systems.
  • Provide P&IDs, loop diagrams and control cabinet documentation.
  • Hand over calibration, qualification and validation status registers.
  • Conduct operator and maintenance training and competency sign-off.
  • Formalise commissioning and beneficial-occupancy handover certificate.

Governing references: WHO TRS 961; EU GMP Annex 1; PIC/S PE 009-17 Annex 1; ISO 14644.

Page 7 Β· Utilities & Specs

Central Engineering Utilities & Civil Criteria

Utility tie-in parameters and structural criteria as stated on the issued vendor and architectural drawings.

Utility Tie-In Schedule

Raw water inlet
DN50 Β· 2–4 bar
Compressed air
DN15 Β· 6–8 bar
Power supply
380 V / 50 Hz Β· 3-ph 5-wire
Industrial steam
3–8 bar
Cooling water
2–4 bar Β· 7–12 Β°C
Drainage trench
W300 Γ— H300 mm
Floor drains
DN100 (Ø100 mm)
Ambient room temp.
< 30 Β°C

Civil & Structural Criteria

Structural system
2-storey frame
Roof system
Prestressed precast double-tee
Structural slab level
+6.00 m
Manufacturing hall clear height
β‰₯ 6.0 m
Water system room clear height
β‰₯ 4.5 m
Compounding platform height
3.0 m
Truck dock platform height
8'-9" (2.67 m)
Cleanroom corridor width
2,500 mm

Clean Utilities Equipment Train

  • Raw water tank & raw water pump
  • Plate-type heat exchanger
  • Multi-media filter Β· softener Β· brine tank
  • Activated carbon filter Β· pH dosing device
  • Reverse osmosis (RO) unit
  • Purified water (PW) tank
  • Multi-effect water distiller
  • WFI tank Β· horizontal WFI storage 10 T & 20 T
  • PW / WFI distribution module
  • CIP tank & CIP pump
Drawing Register

Native CAD & PDF Downloads

Original issued files β€” native AutoCAD DWG and vector PDF, exactly as received from the design and vendor teams.