Written by Armin Scheuermann
An operator in full protective gear stands in front of an isolator, reaching into the airlock with long gloves. On its way to filling: a sterile powder with toxicological classification OEB 5. In the past, stainless steel containers, autoclaves and hours of cleaning cycles would have been standard here. Today, a pre-sterilised bag with a crimp seal is sufficient; afterwards: dispose, reconnect, continue production.
What sounds like pragmatism is actually a strategic change. Single-use containment has evolved from a special case to a system standard in many areas of pharmaceutical manufacturing. POWTECH TECHNOPHARM 2025 provided the proof: leading suppliers presented solutions for the safe, fast and regulatory-compliant handling of highly potent or aseptic materials.
A key driver here is Annex 1 of the EU GMP Directive. It requires closed systems, minimised human intervention and comprehensive contamination control strategies (CCS). As a result, isolators with rapid transfer ports, aseptic split butterfly valves and single-use BetaBags are no longer optional extras, but mandatory. Powder transfers into sterile reactors with H₂O₂ decontamination – sterility assurance level (SAL) 10⁻⁶ included – are particularly relevant in this context.
Not only was the variety of systems on display remarkable, but also the context: with the return of TECHNOPHARM to Nuremberg, which now refocuses the pharmaceutical part of POWTECH, process and containment technology for the pharmaceutical industry clearly took centre stage. Many exhibitors explicitly showcased GMP-relevant systems, and numerous discussions and presentations revolved around Annex 1 compliance, cleaning validation and aseptic transfers. The trade fair was not only a showcase for new components, but also a barometer of sentiment in an industry undergoing radical change: increasingly moving away from rigid steel towards flexible single-use solutions. The range of single-use solutions on display was correspondingly impressive:
These technologies enable sterile transfer in and out, liquid transfers and sampling – all with the most complete barrier protection possible. The trade fair clearly showed that the biopharmaceutical industry is thinking modular, closed and increasingly single-use – and suppliers are delivering the right systems for this.
Total cost of ownership (TCO) and life cycle assessments (LCA) paint a clear picture: single-use solutions reduce operating costs by eliminating CIP/SIP processes, shortening downtimes and enabling faster product changes. Studies show that, despite the additional plastic waste, the ecological balance of single-use systems is often more positive than that of stainless steel because water and energy consumption are drastically reduced. However, disposal remains a challenge. Manufacturers such as ILC Dover are working on recycling initiatives and carbon footprint assessments (PCF) to make environmental impacts more transparent and controllable.
Criterion | Stainless steel systems | Single-use containment |
Cleaning effort | High (CIP/SIP, validation) | Not applicable (disposable, pre-sterilised) |
Product changeover time | Hours to days | Minutes to a few hours |
Investment costs (CapEx) | High (including infrastructure) | Low (few skids, compact design) |
Operating costs (OpEx) | Energy, water and chemical consumption | Consumables, disposal costs |
Flexibility | Low for multi-product operation | High – ideal for small batches/campaigns |
Sustainability (LCA) | Better for long-running products & stable energy | Better for frequent changes (less energy) |
Operating limits | Temperature, pressure, chemicals → robust | Material limits with solvents, heat, etc. |
Stainless steel remains unbeatable for high throughputs, aggressive media or heavy components. But where speed, small quantities, personalised medicine and compliance are paramount, a hybrid model is gaining ground: robust stainless steel cores, supplemented by single-use components at critical interfaces. And so a fundamental question is also changing for operators: no longer whether, but where single-use systems bring the greatest added value – technically, economically and regulatorily.
POWTECH TECHNOPHARM 2025 has shown that single-use containment is not a fad, but a method. The combination of regulatory pressure, technological progress and economic considerations has firmly anchored the concept in practice. The future of pharmaceutical production? More flexible. Faster. More closed.
