The defining engineering decision in biotech facility design is single-use against stainless steel, and it is made early, on incomplete information, and it determines almost everything that follows. Single-use lowers capital cost and cleaning validation burden but raises consumable cost, storage volume and waste. Stainless raises capital and validation cost but scales better and costs less to run. The right answer depends on titre, campaign length and product life expectancy, none of which are certain at the point the building has to be designed.

Projex Solutions provides engineering design, facility delivery and qualification support for biotech and life sciences processing, from upstream cell culture through downstream purification and fill-finish support.

What makes this work different

The single-use decision cascades. It determines clean utility demand, cleanroom area, warehouse volume, waste handling and the qualification burden. Reversing it later is a rebuild, not a modification.

Bioburden control is a facility property. Flow of materials, personnel and waste, pressure regime and surface finish all determine whether contamination control holds in practice. Design to BS EN ISO 14644-4:2022 gives that a defensible basis.

Clean utilities are frequently the capacity constraint. Water for injection, purified water and clean steam demand rises with campaign intensity, and the utility plant is often sized against an initial process assumption that production then outgrows.

Biological agents bring their own duties. Containment level, inactivation of effluent and the handling of genetically modified organisms carry obligations distinct from chemical hazard, and the plant has to demonstrate them.

Scale-up is not linear. Mixing, oxygen transfer and shear behave differently at scale, and a process that performs at bench or pilot may not at commercial volume.

Where we help

  • Single-use against stainless options appraisal, evaluated on total cost and facility consequence rather than capital alone
  • Cleanroom design and classification to BS EN ISO 14644-4:2022
  • Clean utility design for WFI, purified water, clean steam and process gases, sized against realistic campaign demand
  • Bioburden control design, covering flows, pressure regime and finishes
  • Effluent inactivation and containment design
  • Commissioning and qualification to Annex 15, from URS through to PQ
  • Scale-up engineering from pilot to commercial
  • Feasibility, FEED, detailed design and EPCM delivery under ISO 9001:2015

Typical reasons clients get in touch

  • A new facility requires the single-use against stainless decision to be made properly
  • Clean utility capacity has been outgrown by production
  • Scale-up from pilot needs engineering rather than extrapolation
  • A contamination event has raised questions the facility design cannot currently answer
  • Cleanroom classification needs extending, requalifying or redesigning
  • Production is transferring in and the facility has to be adapted around it

Related

Part of our work across the pharmaceutical sector and the medical sector. See also API, formulation and non-GMP plant.

Standards and regulations we work to

  • EU/UK GMP Annex 1, in force since August 2023 and fully applicable since August 2024
  • EU/UK GMP Annex 15, Qualification and Validation
  • BS EN ISO 14644-4:2022 for cleanroom design, construction and start-up, with Parts 1 and 2 for classification and monitoring
  • COSHH 2002, with ACOP L5 (sixth edition, 2013), including biological agents
  • Genetically Modified Organisms (Contained Use) Regulations 2014 where applicable
  • PSSR 2000, with guidance L122 (2014)
  • PUWER 1998, with ACOP L22 (fourth edition, 2014, amended 2018)
  • CDM 2015 and ISO 9001:2015

Frequently asked questions

How do we decide between single-use and stainless?
On total cost and facility consequence, not capital cost alone. Single-use reduces capital and cleaning validation but raises consumable spend, storage volume and waste handling. Stainless costs more up front and validates harder but scales better. The deciding variables are usually titre, campaign length and expected product lifespan, and the honest answer is that some of those are uncertain when the decision has to be made.

Why does that decision affect the building?
Because it drives clean utility demand, cleanroom area, warehouse volume and waste routes. Reversing it later is a rebuild rather than a modification, which is why it deserves proper options appraisal rather than a default.

Our clean utilities are struggling. Is that fixable without a new plant room?
Sometimes. Demand profile, distribution loop design and sanitisation regime often offer capacity before new generation plant is needed. We would want to measure actual demand rather than sum up nameplate figures.

How do we handle scale-up?
As an engineering exercise rather than an extrapolation. Oxygen transfer, mixing and shear do not scale linearly, and a process that performs at pilot can fail at commercial volume for entirely predictable reasons.

Can you support a facility already under construction?
Yes, though the earlier the better. Once the building envelope and utility routes are fixed, the options for changing pressure regime or clean utility capacity narrow considerably.

How do you approach effluent inactivation?
As part of the containment strategy rather than as an end-of-pipe addition. Inactivation method, hold capacity and verification all interact with the process schedule, and treating it as an afterthought usually produces a system that constrains production.

Talk to us about your facility. Request a call