Company insight
Revolutionising component transfer on the line
In aseptic pharmaceutical manufacturing, innovation is often incremental. But occasionally, a solution arrives that changes the rules of the game. Steripass, developed by LDI Protection, is doing just that – thanks to its unique rectangular shape, the first and only of its kind in sterile transfer technology.
B
y rethinking the way sterile components are packaged and introduced, Steripass by LDI Protection eliminates the need for traditional sterilisation processes, delivering a revolutionary step forward for fill and finish lines worldwide. Until now, sterile transfer devices have followed conventional, circular formats. Steripass breaks this mould with a rectangular design that optimises both capacity and handling. This shape is not just a visual difference – it represents a fundamental improvement in how pharmaceutical components are prepared, stored and transferred into isolators and cleanrooms.
The rectangular format allows pre- packaged sterile components – stoppers, caps, plungers or vials – to be introduced directly onto the fill and finish line. The need for additional sterilisation steps is eliminated, reducing complexity, saving time and removing a significant source of risk. This single innovation transforms sterile transfer from a procedural burden into a seamless, efficient operation.
Eliminating sterilisation Traditional sterilisation cycles are resource- intensive, time-consuming and subject to variability. They require specialist equipment, trained personnel and strict validation. Any deviation can result in costly delays or rejected batches. With Steripass, this is no longer necessary. Components are delivered pre-sterilised and ready-to-use within the rectangular unit. Operators simply connect the device to the isolator or cleanroom environment and introduce the components with no further preparation. This shift not only saves hours on the fill and finish line; it also dramatically reduces the risk of contamination. By removing sterilisation as a step, Steripass closes one of the most critical gaps in aseptic processing. The unique shape of Steripass also brings efficiency benefits beyond sterilisation. Its flat surfaces and rectangular geometry make it easier to handle, stack and transport within manufacturing facilities. It integrates seamlessly into automated systems, supporting the industry’s drive toward closed processing and pharma 4.0.
At the same time, Steripass directly supports compliance with EU GMP Annex 1 and FDA aseptic guidance. Its validated, single-use format minimises human intervention and ensures consistent, reproducible results. For manufacturers facing ever-stricter regulatory expectations, Steripass provides a clear path to compliance while reducing operational burden. On the fill and finish line, Steripass delivers a new level of performance. Whether for small-batch clinical production or high- volume commercial runs, it offers a fast, reliable and safe method of introducing sterile components.
For manufacturers handling biologics, vaccines or advanced therapies, these advantages translate into greater speed to market and improved patient safety. Steripass has already attracted attention from leading pharmaceutical companies for its unique design and transformative potential. Its rectangular format represents a genuine industry first – a simple yet powerful innovation that redefines expectations for sterile transfer. As pharmaceutical manufacturing faces growing pressure to increase efficiency, ensure compliance and reduce costs, Steripass offers a future-proof solution. It is more than just a new product – it is a new benchmark for aseptic processing.
A revolution in shape and function Sometimes the simplest changes make the biggest impact. With its unique rectangular shape, Steripass makes sterile transfer faster, safer and more efficient than ever before. By eliminating the need for sterilisation and offering a ready-to-use, validated solution, it allows manufacturers to focus on what matters most: delivering safe, effective medicines to patients. Steripass is not just an evolution in sterile transfer – it is a revolution in both shape and function. ●
Accelerate production cycles, reduce risk of contamination, cut operating costs and simplify procedures.
www.worldpharmaceuticals.net
www.ldi-protection.com 43
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