Turnkey Pharmaceutical Projects — From Concept to Production

AIPAK Engineering delivers complete pharmaceutical production lines and plants under one contract — process design, equipment, cleanroom, utilities, installation, validation and training. One partner, from your first drawing to your first validated batch.

  • One contract, one point of responsibility — no coordinating multiple suppliers
  • Full EPC scope: process, equipment, cleanroom, utilities, validation
  • Delivered across the Middle East, Central Asia and beyond

Why a Turnkey Project, Not Just Machines

Building or expanding a pharmaceutical facility involves far more than buying equipment. Process design, cleanroom construction, water and HVAC utilities, equipment integration, validation and regulatory documentation must all fit together. When these come from different suppliers, the integration risk — and the blame when something doesn't line up — falls on you.

Buying machines separately

Multiple suppliers, multiple contracts

You coordinate integration & interfaces

Documentation gaps between vendors

Blame-shifting when lines don't fit

You manage the project

AIPAK turnkey project

One contract, one partner

We integrate the whole line/plant

One consistent validation package

Single point of responsibility

We manage the project to hand-over

Our Turnkey Project Process

Every AIPAK turnkey project follows a structured process — so you always know what stage you are at and what comes next.

Consultation & Requirements

We start from your product, capacity target, market and regulatory requirements, and define the User Requirement Specification (URS).

Consultation & Requirements

Concept & Layout Design

Process flow (PFD/P&ID), cleanroom zoning, personnel/material flow and utility load calculation — delivered as a plant layout and 3D concept.

Concept & Layout Design

Proposal & Engineering Design

Detailed engineering: equipment specification, cleanroom design, HVAC, water system, and a full project scope aligned to EU-GMP / PIC/S.

Proposal & Engineering Design

Manufacturing & FAT

Equipment is manufactured and tested at our factory; you or your consultant join the Factory Acceptance Test (FAT) before shipment.

Manufacturing & FAT

Delivery & Logistics

Packing, shipping and customs support to your site, coordinated for the Middle East, Central Asia and other regions.

Delivery & Logistics

Installation & Commissioning

Our engineers install and commission the line on site, integrating equipment, cleanroom and utilities.

Installation & Commissioning

SAT & Qualification

Site Acceptance Test (SAT), then IQ / OQ / PQ qualification to verify installation, operation and performance.

SAT & Qualification

Training & Hand-over

Operator and maintenance training, complete documentation package hand-over, and support to your first production batches.

Training & Hand-over

After-sales & Support

Ongoing spare parts, remote and on-site support, and assistance for your GMP audits.

After-sales & Support

From your first enquiry to your first validated batch — one team, one plan, one responsibility.

What Our Turnkey Scope Covers

Process & Engineering

  • URS response & process design (PFD / P&ID)
  • Plant layout & 3D design
  • Utility load & cleanroom zoning

Equipment

  • Sterile & LVP lines (vial, ampoule, BFS, soft bag, ISBM, lyophilization, PFS)
  • Oral & non-sterile liquid lines
  • Filling, inspection, packaging

Utilities & Facility

  • Pharmaceutical water system (WFI, pure steam, RO/EDI)
  • Preparation & CIP/SIP systems
  • Cleanroom EPC (HVAC, Annex 1 design)
  • Sterilization equipment

Validation & Compliance

  • DQ / IQ / OQ / PQ, FAT / SAT
  • 21 CFR Part 11 / GAMP5
  • GMP audit support

Turnkey Projects Delivered

From large-volume infusion lines to sterile injectable lines, our turnkey process has been applied across real pharmaceutical projects — each engineered from requirements to a complete, integrated line.

Southeast Asia BFS Large-Volume Infusion Line (1L)

[BFS]  [Sterile & LVP]
Integrated turnkey line for a dialysis solution manufacturer — water system, preparation, custom BFS (2,000 bph), sterilization, inspection and packing. Included a full URS and water-system engineering review.

Middle East High-Speed Ampoule Filling Line A Confirmed Order

[Ampoule]  [Sterile & LVP]  [Order Confirmed]
confirmed order for a sterile preparations manufacturer — full-servo washing, depyrogenation, filling and sealing with SIP and particle monitoring. Won through technical transparency and a factory visit.

Middle East Non-PVC Soft Bag Line (Enteral Nutrition)

[Non-PVC Soft Bag]  [Sterile & LVP]  [Order Confirmed]
A confirmed order — guided from concept to a complete line: 3,600-unit capacity, open RABS filling, dedicated sterilization and secondary packaging.

Middle East ISBM Large-Volume Infusion Line (500ml & 1L)

[ISBM] [Sterile & LVP]
A high-speed (12,000 bph) turnkey proposal for a long-standing customer — where we recommended two-step ISBM over BFS and balanced capacity against practical engineering constraints.

Why AIPAK as Your Turnkey Partner

One point of responsibility

Process, equipment, cleanroom, utilities and validation under one contract.

Full validation package

URS-to-PQ documentation aligned with PIC/S and EU-GMP — audit-ready.

Engineering depth

Process design, utility calculation and cleanroom (Annex 1) design in-house.

Regional delivery

Experience delivering and installing in the Middle East and Central Asia, with logistics and after-sales support.

Start Your Turnkey Project

Tell us your product, target capacity and market — we'll prepare a preliminary scope and layout proposal.

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