When you think about pharmaceuticals, you may picture tablets, capsules or liquid drugs that are used to safely treat illnesses and save lives every day.
It’s easy to forget that the people developing, manufacturing and dispensing these drugs are in danger of being exposed to harmful, sometimes deadly, chemical compounds, particularly with the increase in the use of high potent ingredients for cancer and other treatments. Yet their work is essential to the steady supply of ever more complex medicines that keep many of us healthy.
We sat down with Mark Arnold, Managing Director of containment specialist ONFAB, part of Envair Technology, to understand more about the business of keeping people and drugs safe throughout the manufacturing process.
“At ONFAB, we work with pharmaceutical manufacturers (CMOs) and drug development companies (CDMOs) who need to handle high potent active pharmaceutical ingredients (HPAPIs) safely within their existing non-contained manufacturing process. We design, manufacture and install single-use flexible isolator systems to achieve containment performance levels below 1μg/m3 (OEB 5). These are bespoke to the site and each process,” he tells us.
ONFAB protects users from the dangerous effects of exposure to hazardous potents, whilst also avoiding cross contamination of the drugs, by designing isolators which house the compounds in an enclosed controlled space. These systems might cover one or multiple parts of the process, ranging from weighing, mixing, milling, spray drying to packaging. Negative or positive pressures are used to create different environments inside the isolator, such as low humidity, low oxygen, aseptic or ATEX; this provides protection and GMP conditioning for both the product and process. The operator then safely handles the ingredient through a glove sleeve from outside of the containment unit.
So why choose a flexible system?
ONFAB’s impressive growth over the last 16 years has been driven by clients’ requirements to reduce cleaning validation time and cost, plus avoid large capital expenditure on rigid isolator systems. As Arnold notes, “cleaning validation in pharma is very expensive, it can run into thousands of euros per day. If you can encapsulate that process within a flexible isolator, you can reduce that cost significantly or in some instances, eliminate it altogether.”
“It still surprises me how few companies understand that upgrading their existing non-contained equipment is a possibility, particularly when they’re under pressure to quickly become HPAPI-ready. This is especially true for those with newer super-potent oncology, cardiovascular and diabetes medicines, and where a GMP compliant environment is essential. Instead, the market has seen an influx of single-use products alongside rigid containment measures.”
To put it into context, Arnold mentions that the cost difference between a contained rigid system and flexible system is about tenfold. “If you were to build a rigid process isolator costing about £100,000, an equivalent retrofitted in-process flexible isolator would typically cost you around £10,000 and achieve the same containment levels,” he says. “And over the years, we have learnt that we are able to retrofit around 98% of all existing process equipment.”
Flexible isolator technology arguably also offers a better solution to contract manufacturers, simply due to how adaptable it is. It allows for simple engineering change out and has been shown to improve productivity - more batches can be carried out due to less downtime. Rigid isolators are more suited to circumstances when a manufacturer is making the same product continuously.
A flexible isolator can be used for a number of months and when no longer needed, put away for storage after the single-use glove bags have been safely disposed of. If the contract manufacturer wins another urgent project requiring high containment, then the system can be rolled out again, keeping the original frame and control system and needing just a new glove bag and HEPA filtration.
Success through taking pride
Founded in 2004, ONFAB is a fast-growing company which has recently made a number of business acquisitions to help it expand. In 2017, the company received investment from London based private equity managers Foresight, which was followed by the acquisition of UK market leader in rigid isolators, Envair Ltd. This led to the formation of parent company Envair Technology and this summer’s further acquisition of industrial fume cupboard specialist TCS, to enhance the group’s positioning as the global leader in contained clean air solutions.
Throughout our conversation Arnold comes across as someone who is especially passionate about the work he and his staff do throughout the pharma industry. I ask him what he puts the company’s success down to.
“For me, as leader of the business, I think it’s vital to listen to my staff, create a positive company culture and always look for the best in my team. I lead by example and roll my sleeves up to support every department, switching from planning future growth strategy to working on site,” he tells me.
The conversation shifts to the Covid-19 pandemic and sustainability within pharma. Arnold mentions how ONFAB has been fortunate, given that pharma manufacturing has continued as usual and drug discovery work has expanded in Europe and the USA. He forecasts further growth for the business in 2020.
On sustainability, Arnold is aware that it is a particularly tough industry to affect change in and though he isn’t convinced that single-use products are always more environmentally friendly, as some of the industry argue, he is convinced of the necessity for action.
The company has just appointed a quality and environmental manager to assess all of its processes and identify where ONFAB can improve, which shows it is looking towards the future not only from a business sense, but also from an ethical one.
As we finish the conversation, Arnold offers one last thought. Earlier in the chat, he paused at a question on what the culture of ONFAB is like. On reflection, it seems to him that it all comes down to pride in what you’re doing.
“We do genuinely care, that comes from the top. I go on about this a lot but simply you need to care about what you do, whether you sweep the floor or build a sophisticated low humidity, nitrogen enriched isolator.”