UK-based Ezi-Dock Systems has launched what it feels will be the most far-reaching piece of ‘disruptive technology’ – an innovative aseptic transfer system using UV-C light in place of traditional vaporised hydrogen peroxide (VHP) systems.
Ezi-Dock UV-C System
Ezi-Dock's Ezi-Flow UV-C Aseptic Transer system
What makes some of the world’s leading pharma companies place orders for a new product months before its launch? That’s what happened in 2018 when Ezi-Dock Systems managing director and sales director, Steve McAleavy and Mike Brimson, began to talk to customers about their concept for a simple but highly-effective replacement for the industry-standard approach to aseptic transfer.
Ezi-Dock’s design team and project partners Crystal IS, a division of the Asahi Kasei Group have progressed at light speed to develop and validate the new system which will be launched officially at Interphex 2019, New York. However, the first orders were placed long ago by pharma giants who have come to trust Ezi-Dock’s habit of developing customer driven radical ideas into game-changing process technology.
“VHP based aseptic product transfer systems have always been time-consuming and overly complex, requiring the provision of several services at the point of use,” said McAleavy.
“Our approach to the contained transfer of APIs has always been to reduce complexity and cost whilst improving performance. We first took this approach with our Ezi-Flow CSV system, and this is now used all around the world. Indeed, it’s become so readily-accepted that people almost universally refer to it as ‘an Ezi-Dock’, which is completely incorrect, but I suppose we shouldn’t complain at the brand penetration that reflects!
Ezi-Flow UV-C System
Assembly of the Ezi-Flow CSV system which won a Queen's Award for Enterprise for 2013.
“Aided by Crystal IS’s extensive background in UV-C technology, we have been able to adapt our existing, well-proven high containment transfer system to deliver aseptic transfer using UV-C light rather than vaporised hydrogen peroxide,” McAleavy added.
“The result is a genuine game-changer for this particular process. Essentially, we have been able to provide the industry with a safer, simple ‘plug and play’ solution that provides a massive upgrade in performance whilst using less time and fewer resources at a significantly lower cost. Indeed, if you have access to an electric socket, the Ezi-Flow UV-C system can be deployed immediately!”
Benefits of UV-C Aseptic Technology
In researching and developing this new system the Ezi-Dock team discovered that levels of satisfaction with existing aseptic transfer processes were very low.
“The industry knows that there is great difficulty in this area,” said Brimson. “There is a level of ‘wipe and pray’ mentality out there. What this means, of course, is lots of testing, retesting, and wasted time and product.
“The plain fact is that Clostridium difficile (C. Diff) can’t be reliably wiped away, and isopropyl alcohol doesn’t kill it. Flooding with UV-C, at the levels achieved by our new Aseptic system and verified in independent testing, kills C. Diff and E. Coli. Gassing with peroxide vapour is frankly almost medieval in comparison to using UV-C, and it’s costly, unsafe and wasteful.
“With the Ezi-Flow CSV High Containment Transfer System we took the existing technology – expensive and low-performance split butterfly valves – and created a simpler, neater, and radically more cost-effective solution that required very little training. Taking the same view of Aseptic Transfer, we wanted a radically new approach that did away with complexity and toxic vapours and replaced them with a simple, effective process. We’ve worked in and around these production environments for many years and I can honestly say I can’t imagine that anyone will choose to continue with VHP when they realise a cheaper, easier and more-effective solution is available.”
Launching the Ezi-Flow CSV High Containment Transfer System
In 2010 a discussion at a UK pharma plant revealed that the incumbent contained transfer system had been failing miserably, and the production manager could find no suitable solution, McAleavy and Brimson were eager to provide an answer. They took just three months to develop the Ezi-Flow CSV system. The system is based on a two-part passive and active, similar in concept to most split butterfly valves, but offering significant advantages in cost and performance. Both parts are interlocked to ensure operator & product safety, and the Ezi-Flow proved so easy to use and so cost-effective that take up of the design was immediate and has now continued through a series of revisions.
At the start of the project, McAleavy and Brimson aimed to achieve a 1–10 µg OEL (operator exposure limit), but they actually managed to achieve less than 1 µg, which is as good as, if not better, than many split butterfly valves, according to McAleavy. “That’s how we started to make real inroads into the pharma market,” he said. “Within a few years we were supplying 10 of the top 12 pharma companies and many had come to see us as process development partners, able to quickly develop solutions to specific manufacturing problems.
“Gaining the trust of the pharma industry and developing a positive reputation for ‘disruptive’ designs that really break the mould and provide measurable benefits has been the key to speed of our expansion.”
What Comes Next?
Unlike many UK-based manufacturers currently, Ezi-Dock is looking forward eagerly to the future. “We have no great Brexit concerns,” said McAleavy. “Of the 36 countries we sell to only 14 are EU, so we’re used to any amount of regulation. Whatever happens we will cope with it. We’re more concerned at the moment with the creation of our own clean room injection moulding facility which will bring a vital part of our manufacturing in house and under our own close control.
Visitors to Interphex, New York, will be able to see the launch of the Ezi-Flow UV-C Aseptic Transfer system at the company’s booth (3259). The show runs from 2-4 April at the Javits Center New York City and represents a significant event for Ezi-Dock.
“Above everything, though, the key factor for us is the launch of our Ezi-Flow UV-C Aseptic Transfer system, which will perform a vital role in our planned growth by taking us firmly into global biopharma markets. We’re just excited to see where the journey takes us next!,” McAleavy said