Single-use versus stainless steel in biopharma: which technology to choose?

Single use versus stainless steel in biopharma - definition: The choice between single use (SU) technology and stainless steel (SS) systems in biopharma comes down to capital investment, flexibility, cleaning validation burden, production scale and sustainability. Hybrid strategies combine SU for upstream flexibility with SS for downstream high-volume processing.

Key points: single use versus stainless steel biopharma comparison

Capital cost vs operating cost: SU systems have 40-60% lower capital expenditure (CAPEX) but higher variable costs due to disposable materials. SS installations are capital-intensive but have low consumable costs long-term. Break-even occurs at larger batch volumes and high utilization rates.
Cleaning validation: SS systems require full CIP/SIP validation per product changeover per EU GMP Annex 15. SU eliminates this entirely, delivering 20-40% time savings per campaign in multi-product facilities and reducing inspection risk.
Flexibility and time-to-market: SU systems are faster to install (weeks vs months), easier to reconfigure for new molecules, and suited to clinical phase I/II production. SS is optimal for commercially validated processes with stable volume.
Sustainability profile: SU generates plastic waste but saves significantly on water consumption (WFI for CIP), steam energy and cleaning agents. Lifecycle analyses show mixed results depending on energy mix, water price and waste processing route.
Scalability and process intensification: SS remains dominant for volumes above 2000 litres of fermentation and high-titre applications with multiple batches per week. SU is ideal for batches up to 2000 litres, multi-product sites and fast-growing biopharma with a variable product portfolio.

Compare technology choices for your biopharma facility via our page on containment systems, discover validation options at our Test & Trial Centre, or view our solutions for big bag discharge stations for bulk raw material handling in pharmaceutical manufacturing.

The Core Question: Single Use or Stainless Steel?

When designing or expanding a biopharma manufacturing facility, the choice between Single Use Technology (SUT) and traditional stainless steel (SS) equipment is one of the most strategic decisions. There is no universal answer — the optimal choice depends on production volume, product portfolio, investment horizon and operational strategy.

Hecht Technology supports pharmaceutical and biopharmaceutical manufacturers in making this choice with a structured technology evaluation, including total cost of ownership (TCO) analysis and facility strategy. In this article we outline the key differences and decision criteria.

Comparison on the Key Dimensions

Capital Expenditure (CAPEX)

Single use wins on CAPEX for new facilities. Eliminating the CIP/SIP installation (piping, pumps, vessels, validation) significantly lowers construction costs. Studies from ISPE and Biophorum show CAPEX reductions of 25–40% for comparable SUT facilities versus fully stainless steel facilities at clinical scale (up to ~500L).

At large commercial production volumes (multiple batches per year >1000L), the balance tips: the high consumable costs of bags outweigh the CAPEX savings on utilities.

Operating Expenditure (OPEX)

Here SS wins at scale. Single use consumables (bags, sensors, tubing) are significantly more expensive than the operating costs of a well-managed SS installation at large volumes. A 2000L single use bag typically costs €3,000–8,000; a comparable SS batch has lower direct material costs but higher labour and energy costs for CIP/SIP.

Rule of thumb: at production titres >5 g/L and volumes >1000L per batch, SS often becomes cheaper in OPEX.

Flexibility and Multi-Product Manufacturing

Single use wins convincingly on flexibility. Switching between products only requires replacing the disposable components — no validation of cleaning procedures per product combination. For multi-product facilities with varying campaigns, SUT is almost always preferred.

Scale Limits

SS has no scale limits; commercial bioreactors of 20,000L and more are common. Single use bioreactors are commercially available up to ~2000L working volume. Above this limit, SS is the only option, or a hybrid approach where the upstream SUB feeds the SS downstream.

Cross-Contamination Risk

Single use wins. New plastic per batch eliminates the risk of insufficient cleaning or carry-over from previous campaigns. This is particularly relevant for HPAPI products and multi-product facilities.

Sustainability

SS wins on sustainability at high volumes and long facility horizons. Plastic waste from SUT is a drawback, although the reduction in water and energy consumption for CIP/SIP partially offsets this.

Decision Matrix: When to Choose What?

Clinical production (Phase I/II): → SUT, always. Speed and flexibility dominate.
Multi-product commercial manufacturing: → SUT or hybrid. Flexibility advantage weighs heavily.
Single-product large-volume commercial (>2000L/batch): → SS, or hybrid with SUT upstream.
New facility, limited budget: → SUT for lower initial investment.
Expanding an existing SS facility: → Hybrid: add SUT for flexibility, keep SS for core processes.
Cell and gene therapy, mRNA: → SUT, almost always. Small volumes, high product value, strong flexibility required.

The Hybrid Model: The Best of Both Worlds

An increasing number of manufacturers are choosing a hybrid approach: single use for upstream (seed train, production bioreactor up to 500L) and stainless steel for downstream (chromatography, ultrafiltration, formulation). This combines the flexibility advantages of SUT with the scale advantages of SS at the purification steps, where volumes are smaller and the OPEX burden is manageable.

Total Cost of Ownership: The Right Calculation Method

A sound SUT versus SS decision requires a 10-year TCO analysis that accounts for all factors: CAPEX, consumable costs, energy, water, waste processing, labour, validation and downtime. Hecht Technology performs these TCO analyses as part of facility strategy projects.

FAQ - Single Use versus Stainless Steel Biopharma

When do you choose single use and when stainless steel in biopharma?

Single use is ideal for: clinical phase I/II production, multi-product facilities with frequent product changeovers, low to medium volumes (up to 2000 L), fast time-to-market and limited cleaning validation budget. Stainless steel is better suited to: high-volume commercial product, stable process portfolio, high utilization rate and long-term cost optimisation.

What are the total costs of single use vs stainless steel over 10 years?

At volumes up to 500 litres and fewer than 3 batches per week, SU is typically cheaper over 10 years. Above 1000 litres with high utilization, the balance shifts to SS. Add cleaning validation costs (50,000-200,000 euros per product), WFI water consumption and depreciation to the TCO calculation for an accurate comparison.

Can single use and stainless steel systems be combined in the same facility?

Yes, hybrid strategies are common in commercial biopharma. Typically: SU bioreactors and SU mixing systems upstream combined with SS centrifuges, SS chromatography columns and SS UF/DF systems downstream. This optimises flexibility upstream and process intensity downstream.

How does the FDA assess the use of single use systems versus traditional stainless steel?

The FDA fully accepts SU systems provided the following can be demonstrated: extractables/leachables study (USP <665>), sterility assurance on delivery, integrity testing per batch, supplier DMF and batch traceability. Process Analytical Technology (PAT) enables monitoring in SU bags in line with FDA PAT Guidance.

What is the environmental impact of single use systems compared to stainless steel?

SU saves up to 87% water consumption and up to 30% energy compared to SS with CIP/SIP, but generates plastic waste (5-15 kg per batch for a 200-litre system). Lifecycle analyses (LCA) show that the net CO2 footprint depends on the local energy mix and waste processing infrastructure. Suppliers are working on recyclable multilayer films.

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