Engineering Design and Project Delivery for Pharmaceutical Manufacturing

In pharmaceutical manufacturing the facility is part of the product. Air classification, pressure cascade, material and personnel flow, and the design of clean utilities all form part of the evidence that what leaves the site is safe. That is why facility engineering in this sector cannot be separated from the quality case, and why a design decision taken for cost reasons can surface years later as an inspection finding.

Projex Solutions provides multi-disciplinary engineering design, qualification support and EPCM project delivery to pharmaceutical and life sciences manufacturers across the UK. We work on GMP and non-GMP plant, on new facilities and on the more common and more difficult job of changing a facility that has to keep producing.

The pressures our pharmaceutical clients are managing

The revised Annex 1. The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, was published in August 2022 and came into operation in August 2023, with the lyophilisation requirements at point 8.123 applying from August 2024. It is now fully applicable. Its practical effect is architectural as much as procedural: a Contamination Control Strategy that has to be evidenced, a clear expectation of barrier and isolator technology over open processing, and scrutiny of HVAC, pressure cascade and clean utility design.

Annex 15 and the qualification chain. Qualification and Validation has been in operation since October 2015 and governs the URS through DQ, IQ, OQ and PQ sequence, along with commissioning and process validation. Where that chain is assembled retrospectively it is expensive; where it is designed in from the URS it is simply the project.

Annex 11 and computerised systems. The January 2011 version remains the text in force. A revision, together with a proposed new Annex 22 covering artificial intelligence, went to consultation during 2025 but is still in draft. We design to what is in force and keep an eye on what is coming.

DSEAR, which pharmaceutical sites routinely underestimate. Solvent handling on API plant, spray drying, and powder and dust handling all bring the Dangerous Substances and Explosive Atmospheres Regulations 2002 into scope, along with hazardous area classification to BS EN IEC 60079-10-1:2021. A GMP-led project team will not always have this competence in the room.

Containment. High-potency APIs bring occupational exposure banding, containment strategy and verification into the design at concept stage, not at commissioning.

Where we add value

Annex 1 gap closure. Assessment of existing facilities against the revised Annex 1, supporting the Contamination Control Strategy with engineering evidence, and designing the route from open processing to RABS or isolator technology without stopping production for longer than the business can bear.

Cleanroom design and classification. Design to BS EN ISO 14644-4:2022, with classification and monitoring aligned to Parts 1 and 2, covering airflow strategy, pressure cascade, material and personnel flow, and the change regime around them.

Clean utilities. Purified water, water for injection, clean steam, process gases and compressed air, designed with sampling, sanitisation and the qualification protocol in mind.

Commissioning and qualification. URS development, DQ, IQ, OQ and PQ protocol authoring and execution to Annex 15, and process validation support. We can lead the C&Q workstream or supplement a client team that is short of capacity.

Containment and occupational exposure design. Containment strategy for potent compounds, equipment selection, and verification planning.

DSEAR and hazardous area classification for solvent, powder and dust handling, with CompEx-certified engineers.

Technology transfer and scale-up. Moving a process from development, or from a CDMO, into a plant that has to be designed around it.

Non-GMP support plant. Solvent recovery, effluent treatment and site utilities, designed to a standard that does not compromise the GMP envelope they serve.

EPCM delivery under ISO 9001:2015 certified project methodology, with CDM 2015 duty holder support where construction sits inside a live facility.

Sub-sectors we work across

Pharmaceutical manufacturing covers a wide range of plant, and the engineering problem changes considerably across it. Where GMP begins in a synthesis route is a defined decision, and it determines which parts of a facility carry qualification obligations and which do not.

• API, formulation and non-GMP plant – Solvent inventory and DSEAR on a site regulated as pharmaceutical, plus potent compound containment.
• Life sciences and biotech processing – Single-use against stainless, clean utilities, bioburden control and scale-up.

Closely related: the medical sector, and nutraceuticals and dietary supplements where food-grade facilities are moving towards pharmaceutical-grade expectations.

See all the sectors and industries we work in

When clients typically call us

• An Annex 1 gap assessment has identified facility changes that need engineering, not just procedure
• An MHRA inspection has raised findings against facility design, segregation, cross-contamination control or utilities
• A new facility or expansion needs a qualification strategy built in from the URS
• A process is transferring in from development or from a contract manufacturer
• Non-GMP plant needs building alongside GMP operations without creating a quality risk
• A potent compound is entering the portfolio and containment has to be designed rather than retrofitted

Why pharmaceutical manufacturers work with Projex

We bring process engineering discipline to an environment that is often dominated by quality documentation. Both matter. A Contamination Control Strategy that is not supported by a working pressure cascade is a document, not a control.

Our teams work from Brighouse in West Yorkshire and the Wilton Centre in Redcar. We are certified to ISO 9001:2015, SafeContractor approved, and hold a Bronze EcoVadis sustainability rating.

We are used to working inside operating facilities, where the constraint is rarely the engineering and almost always the shutdown window.

Frequently asked questions

Can you write and execute qualification protocols?
Yes. We author and execute DQ, IQ, OQ and PQ protocols to Annex 15, and we can develop the URS that the whole chain depends on.

Do you work on sterile facilities?
Yes, including assessment and upgrade against the revised Annex 1 and design to BS EN ISO 14644-4:2022.

We are GMP-led and have no DSEAR competence in-house. Can you cover that?
Yes. Solvent and powder handling routinely brings DSEAR and hazardous area classification into scope on pharmaceutical sites, and our engineers hold CompEx certification.

Can you work around our production schedule?
That is the normal condition of the work rather than the exception. Most of our facility projects are executed in and around live operations and planned shutdowns.

Talk to us about your facility. Request a call