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Pharmaceutical plant design in six stages
Stages 1 to 3 are the design.
Stages 4 to 6 buy, build and test what was designed. The documents named in each stage are the usual ones, and your contract sets the exact list.
Key fact Detail
- Fabtech's team
- 1000+ Life Engineers, our people
- CPCM, Algeria
- Consultancy for the tablet and capsule section, and 2,712 square metres of modular panels
- Sudair Pharma, Saudi Arabia
- A production facility of 6,285 square metres: cleanroom, air system and clean utilities by Fabtech
- Fidson Healthcare, Nigeria
- A stopped project. We started and tested our scope in 15 months
- FabAssure
- Our digital platform, which tracks the activities of each project
Look at one room of the plant: the room where a liquid medicine is mixed in a vessel (a closed tank).
Over six stages, it is shown as a sketch, a layout and a diagram, and then it is built.
1. Concept design
The work starts from your user requirement specification (URS), the list of what the plant must do. Our engineers decide which rooms the plant needs, how clean each must be, and how people and materials move.
The mixing room is a box on a sketch. You receive the concept design and the basis of design, which records the main decisions.
2. Basic engineering
The sketch becomes a layout with exact dimensions. The mixing room gets its size, its doors and its air class.
The air class says how clean its air must be. The engineers calculate how much air, water, steam and power the room needs, and draw the first process diagrams.
You receive the layout, the equipment list and a cost estimate.
3. Detailed engineering
Our engineers give every pipe, air duct, cable and instrument its size and position. The mixing vessel and its pipes now appear on a complete piping and instrumentation diagram (P&ID).
It shows each pipe, valve and instrument and how they connect. You receive the P&IDs, the piping and equipment layouts, and the equipment schedules, which list every item to buy.
4. Procurement
Procurement means buying. Fabtech orders and supplies the items in the equipment schedules.
The vessel is tested at the factory that made it, before it ships. This is the factory acceptance test (FAT).
The room is not finished yet. On a turnkey project, design, buying and building overlap.
You receive the specification and the FAT record for each main machine.
5. Construction management
Fabtech's site team manages the site, the suppliers and the schedule. We track each activity on FabAssure.
Wall panels, ducts, pipes and machines go into the room in a planned order. The mixing room is now built.
You receive progress reports against one schedule, and the as-built drawings. They show the room as it was built.
6. Commissioning and handover
We start each system and test that it runs. This is commissioning.
We then train your operators. The last steps of qualification follow.
Qualification means proving, with written tests, that the plant works as designed. The mixing room now runs.
You receive the test records, the manuals and a plant that is ready for inspection.
Engineering only, engineering plus procurement, or full turnkey
The scope is the work that the contract covers.
It decides what you do yourself and what the engineering company signs for. To sign for a scope means to be responsible for it under the contract.
| Scope | What you do yourself | What the engineering company signs for |
|---|---|---|
| Engineering only (stages 1 to 3) | You buy the equipment, hire the builders and manage the site. You are responsible for how the suppliers' work fits together | The design and its documents |
| Engineering plus procurement (stages 1 to 4) | You hire the builders and manage the site. You are responsible for the installation | The design, and equipment that has passed its factory test |
| Turnkey for part of the plant (all six stages) | You buy the other systems, for example the process machines. You are responsible for how they fit with the rest | The systems in the contract, designed, built and tested |
| Full turnkey (all six stages) | You decide the product and the market | The finished plant, on one schedule and at one price |
Fabtech signs for the full scope.
On some projects, Fabtech signs for part of the plant, and the owner buys the rest from other suppliers.
Sudair Pharma in Saudi Arabia built a production facility of 6,285 square metres. Sudair sent a team to inspect our factories and assess our technical teams.
It then awarded Fabtech the cleanroom, the HVAC (heating, ventilation and air conditioning) and the clean utilities, such as high purity water. Sudair bought the process machines from European makers.
When some of those makers refused to install their machines, we completed the installation. The plant is now fully operational.
Tell us at the start what you plan to buy or build yourself.
Pharmaceutical engineering services for GMP facility design: the disciplines
Pharmaceutical engineering is the work of designing and building the plants, machines and systems that make medicines.
GMP means good manufacturing practice: the rules that regulators check when they inspect a pharmaceutical plant. Pharmaceutical facility design under these rules needs several kinds of engineer, working from one layout.
| Discipline | What the engineers decide | What Fabtech supplies |
|---|---|---|
| Process | The size of each machine for your batch, and how the product moves between steps | Pharma process equipment |
| HVAC and cleanrooms | HVAC design for pharmaceutical facilities sets the air class, pressure, temperature and humidity of each room | Cleanroom HVAC systems and cleanroom and clean air equipment |
| Water and steam | The grade and amount of water at each place where it is used: purified water, water for injection (WFI) and pure steam | Purified water, WFI and pure steam systems |
| Containment | Which steps need containment, which means keeping a harmful product away from the people who make it. One tool is the isolator, a sealed cabinet that the operator works in through gloves fixed in its wall | Pharmaceutical isolators |
| Automation | What the control systems measure and record. Controls that keep electronic records are designed for 21 CFR Part 11, the US rule for such records | The controls of the machines we supply |
Fabtech's own engineers design the HVAC and the utilities. Civil, structural and electrical design is agreed project by project.
If you need only a cleanroom, and the project is in India, speak to our group company Fabtech Technologies Cleanrooms Ltd.
Design by kind of plant
The design changes with the product. For injectables, which must be sterile (free of all living germs), read sterile facility design and construction.
Engineering solutions for biopharma, such as the design of a vaccine plant, are on our turnkey biopharmaceutical facilities page. See also oncology manufacturing facility, oral solid dosage facility design and hospital cleanroom.
Qualification, and the GMP standards the plant is designed to
Qualification starts before stage 6.
The design is checked against your URS before anything is built. This step is design qualification (DQ).
Three steps follow on site: installation, operation and performance. Each test traces back to a line of your URS, so the plant is proved against the list that started the work.
Machines and systems that can affect the product are qualified in all four steps. The four steps are known as DQ/IQ/OQ/PQ, and our equipment qualification page explains each one.
Fabtech builds facilities that are GMP and WHO compliant. This means they follow good manufacturing practice, including the version written by the World Health Organization (WHO).
We design plants to cGMP (current good manufacturing practice) and EU GMP, the European Union's rules. They are built to withstand inspection under USFDA (United States), MHRA (United Kingdom) and TGA (Australia).
Pharmaceutical plants our engineers designed and built
At CPCM in Algeria, the consultancy and the build came from one company. Fabtech provided the consultancy for the tablet and capsule section.
The cleanroom equipment was a turnkey project. Our scope covered 2,712 square metres of modular panels, the HVAC, the electrical work and the utility piping.
Fidson Healthcare in Nigeria planned six dosage lines in one plant. A dosage line is a production line for one type of medicine.
Fabtech's contract covered the cleanrooms, HVAC, utilities, high purity water and laboratory.
The project had stopped for more than 18 months when we took it over. We did the design and the engineering, then the supply, the installation, the validation and the commissioning.
Validation is the testing that proves each system works as it should. We commissioned our scope in 15 months.
See more plants under projects and installations.
FAQ
What do pharmaceutical engineering services include?
Pharmaceutical engineering services, also called pharma engineering services, cover concept design, basic engineering and detailed engineering. On a turnkey project, procurement, construction management, commissioning and qualification follow. The list of disciplines is process, HVAC and cleanrooms, water and steam, containment and automation.
What is process engineering in the pharmaceutical industry?
Process engineering decides which machines, pipes and controls each step of making a medicine needs. The process engineer calculates the size of each machine for your batch and plans how the product moves between steps. The piping and instrumentation diagrams record these decisions.
What are the requirements for a GMP facility?
A GMP facility must meet the rules of the regulator that inspects it, and those rules differ by regulator. The design principles are much the same. Material moves in one direction, and people and materials usually enter by separate routes. Rooms are easy to clean, and their air is controlled to suit the product. Written tests prove all of this.
Are GMP and WHO GMP the same?
GMP is the general name for the rules. WHO GMP is the World Health Organization's version, and many countries base their own rules on it. The United States has cGMP, and the European Union has EU GMP. The countries you will sell in decide which version applies.
How do pharmaceutical engineering consultants differ from a pharmaceutical engineering company?
Consultants usually design the plant and write its documents. A pharmaceutical engineering company can also buy the equipment, manage the site and test the finished plant. Fabtech is one of the pharmaceutical engineering firms that also build the plant. At CPCM in Algeria, Fabtech provided the consultancy for the tablet and capsule section and delivered the cleanrooms.
Why hire an engineering company when we have our own engineering department?
Your engineering department keeps your plants running. A new plant needs many kinds of engineer at once. An engineering company brings them for the project. Your department approves the design and takes over the plant.
Tell us what you plan to make and where, and our engineers will reply with the first design questions