Spotting an area for growth, Christian Dunne entered the life sciences sector in 1999. What followed has been two decades of knowledge gathering, resulting in Dunne becoming the Director of Global Corporate Business for ChargePoint in February last year.
ChargePoint is a UK-based containment and sterile transfer company that was founded in 2009 and since then has been developing products to handle highly potent products, such as the widely praised split butterfly valve (SBV).
Not long after the company began, Dunne joined in 2013, working his way up to Head of Sterile Solutions, before his promotion to Director. Coming from Extract Technology, Dunne had been exposed to a huge range of different applications, from low and high containment to sterile processing. ChargePoint’s solutions physically knit a lot of these processes and machines together, Dunne explains. “Being involved in all these – and their regulatory requirements – [Extract] was a lot of variety – lots of different engineering solutions you had to come up with.”
The cleanroom grade applied to a process can be lowered if sealed processes are introduced
Understanding the nitty gritty of a sector is key to knowing what problems actually need solving. Spending working years as both a supplier and a customer, and having experienced the arduous task of the cleanroom gowning process, Dunne has first-hand experience with the plight of the operator. “The stringent commitment to sterile integrity and quality within cleanrooms is somewhat of an art form,” he says. “As providers of containment and equipment, we are trying to make this process much easier.”
Easier how?
Dunne explains that employing equipment which can improve not only the working environment for the operator but also the product quality is the way forward.
“The cleanroom grade applied to a process can be lowered if sealed processes are introduced,” he explains. “For example, if an aseptic isolator is used, the background area can be reduced to grade C/D. Where no isolator is used, this same process would be expected to take place in a grade A (ISO Class 5) environment.”
The theme of containment and automation comes up frequently speaking to Dunne, and it becomes evident that this is a trend he is enthusiastic to see come to the forefront. And with his new role focusing on business development, working mainly with the OEM (original equipment manufacturer), Engineering Consultancies and Big Pharma end users, he is in a prime place to make it happen.
“It is inevitable that automation will be more heavily relied upon in the pharmaceutical industry,” Dunne says. “Automation in continuous and semi-continuous processes. At ChargePoint we produce automated devices but are now looking to take this one step further and perhaps look to provide full automation with the implementation of robotics, where the operator can be completely remote from the process in the future.”
It is inevitable that automation will be more heavily relied upon in the pharmaceutical industry. Automation in continuous and semi-continuous processes
But Dunne explains that true automation goes beyond the primary function of a machine. “Innovations are already coming into play to help streamline [the Annex 1] required maintenance with the advancement of Smart Factory Technology,” he says. “These technologies help to automate manual maintenance procedures by providing operators with vital equipment performance data about their equipment. By generating an automatic audit trail, this technology alerts operators as to when maintenance is required, enabling health and safety and compliance teams to make informed decisions to proactively manage their maintenance and validation programmes.
In general, Dunne thinks the trends of continuous monitoring and automation of smart devices are more than just buzzwords, they are the future of cleanroom containment. Looking to the future, he thinks that the level of competition will grow in coming years due to the growth of the single-use sector they are in, but Dunne is confident that the company bringing bag and transfer solutions together under one roof makes them “fairly unique”.
Swings and roundabouts of a pandemic
The pandemic has had huge effects on the business world, some good, some terrible. Looking at silver linings, Dunne talks a bit about the innovations in the usability of digital tools. Such as the development of ChargePoint’s virtual solutions for its global customer base.
Dunne also speaks how communication channels have been improved, “I've been WFH for quite a while, but after COVID, there wasn’t the expectation to rush in to do face-to-face meetings,” he enthuses. “I can get hold of people so much easier, virtually! A short virtual meeting is much easier to organise and execute than face-to-face meeting on site.”
He follows up with a relatable comment on how he does not lament the hours lost sitting in traffic jams on the commute!
A short virtual meeting is much easier to organise and execute than face to face meeting on site
On the flip side of the WFH innovation and benefits, COVID has caused many not-so-positive effects on business. Supply chain frustrations have been the bane of many companies’ existence over the the last few years. Getting out in front of this, Dunne and ChargePoint did what others have been doing, and brought as much of their manufacturing process in house. The launch of the HiPure ULP7 PE film was carried out to meet the demands of the biopharma sector. “In response to ongoing global supply chain issues being experienced across a range of industries, we recognised that it was of vital importance to protect our customers across the pharmaceutical industry,” he says. “We now dictate the quality and the validation stream of our fully validated sterile material, which is fully produced and manufactured into bags within cleanroom spaces.”
Dunne explains that this launch, and other business moves such as the recent acquisition of the Purovaso range, are all steps to creating a reliable full material handling solution. A future launch in the works is the 150mm Single Use Passive for Q1 this year. This is a contained and economic solution for the transfer of powder ingredients between process steps or even facilities. As a major voice in the company’s business development, Dunne is excited about this launch and to generally just expand the product range.
Looking at cost in a cost-of-living crisis
There are many different pieces of the puzzle when choosing equipment, and in a cost-of-living crisis, cost-effectiveness is something the vast majority of customers are looking at.
Although effective, isolators and RABS can be a huge expenditure for smaller businesses, so cheaper alternatives are essential to allowing these companies to run.
In some applications, where material is required to be simply charged or discharged from process equipment Split Butterfly Valve (SBV) technology can be seen as a much more cost-effective and user-friendly approach to the problem. “with the single-use version this cost benefit is magnified further with reduce with cleaning and validation as it is designed for disposal after use.”
In many applications, Dunne thinks that SU tech is more cost-effective than the huge capital cost of stainless steel, incurring less validation for the clients, as well as removing ongoing washing and sterilisation expenditures. “If it’s a small batch (like APIs), [it] might just be one transfer once a week or month – so reduces the costs of this.”
The single use debate
Sustainability is hotly debated in the pharma world, with Single Use (SU) products being at the centre of it. Dunne has had many interesting conversations with his peers about it, and looks back at a specific one he had at a conference in recent years. “When you think of SU in any other industries like supermarkets - plastic straws – it dwarfs what is used by biopharma,” he says. But the person he was talking to also emphasised that these drugs will sustain thousands of people, “they aren’t like one hamburger that needs to be wrapped or a plastic straw”.
When you think of SU in any other industries like supermarkets - plastic straws – it dwarfs what is used by biopharma
Taking into consideration the level of societal necessity of a product, it then becomes a valuable point to argue that SU does not come with the same energy and cleaning material requirements as reusable products. Consumption efficiencies need to be looked at on the whole lifecycle of the product, and it is evident that Dunne will keep having these conversations to keep on the pulse.
Quick-fire Qs
Who does what at ChargePoint Technology?
Describing the setup of the company, Dunne explains that there are three divisions. They are the aseptic (aseptisafe), containment (pharma-safe), and single-use division.
“SU straddles both, complementing the other two.” The aseptic division provides sealed transfers and prevents contamination, whereas the containment division focuses on protection for the operator. “Some products need sterility protection and operator protection and in which case a combination of the two divisions would be offered.
Working on a COVID-19 drug?
“We were extremely busy during the pandemic. Our solution was used for one of the major COVID drugs. We worked with one of the big pharma sites and global engineering groups to come up with a solution on the formulation side of the process. Our SU solution was used on the dispensing and formulation. Taking ingredients from the dispensary and charging them into the various formulation tanks in a contained manner. For this process to work effectively we also developed a bespoke doubled-ended bag vs the traditional single-ended version. Albeit under difficult circumstances it was a challenge we all felt compelled to respond to