Rethinking Sterile Design From the Ground Up

Some new US facilities are testing integrated washer-sterilizers as a focused alternative to traditional layouts

21 Nov 2025

A small number of newly built US pharmaceutical facilities are testing integrated washer-sterilizer systems as an alternative to traditional sterile processing layouts, reflecting selective experimentation rather than a broader industry shift.

One of the most prominent examples is the sterile drug production site in Dallas operated by Mark Cuban Cost Plus Drug Company. The facility incorporates integrated washer-sterilizer equipment supplied by Fedegari, combining washing, sterilisation and drying functions within a single enclosed unit. While such systems remain uncommon in US healthcare and pharmaceutical settings, their use in a high-profile project has drawn attention from designers and planners.

Conventional sterile processing operations typically rely on separate washers, sterilizers and dryers. Each unit requires its own floor space, utilities, validation protocols and operator training. Integrated systems are presented as an alternative configuration, particularly suited to greenfield projects where layouts can be designed around defined production targets.

Equipment suppliers and some facility designers cite potential benefits, including fewer machines, simplified material flows and reduced qualification activities. Combining functions into one system may also limit manual handling steps and lower space requirements, factors that can be significant in new construction.

However, wider market data and trade reporting do not yet indicate broad adoption in the US. Most hospitals and pharmaceutical manufacturers continue to favour modular equipment strategies, which offer operational flexibility, redundancy and familiarity for both staff and inspectors.

Interest in integrated systems comes as sterile operations face sustained pressures. Labour shortages persist across technical roles, while manufacturers remain under pressure to control capital and operating costs without weakening compliance standards. In that context, equipment configurations that promise streamlined workflows are drawing exploratory interest.

For now, integrated washer-sterilizers represent a niche design choice rather than an established industry direction. Their use in selected projects suggests cautious evaluation rather than consensus. Further operating data and independent assessment are likely to shape whether the approach gains broader acceptance in future facility designs.