Automatic improvement – optimising manufacturing processes3 April 2017
How can manufacturing processes be automated cost-effectively with no compromises to quality and security? World Pharmaceutical Frontiers seeks the solution with Graham McCurdy, director, technical solution design, EMEA, at Abbott Diagnostics.
The age-old fear of humans being replaced by machines recently stepped up a gear. A 2016 report by market researcher Forrester predicted that robots will have eliminated 6% of all jobs in the US by 2021, starting with customer service representatives and eventually moving on to truck and taxi drivers.
Last year, The Bank of America calculated that robots would be performing 45% of all manufacturing roles within a decade, and shaving $9 trillion off labour costs. The Bank of England, meanwhile, warned last year that as many as 15 million (nearly half of all available positions) jobs would eventually be threatened by ‘smart’ technology, and a left-wing candidate in France’s 2017 presidential election, Benoît Hamon, even included a ‘robot tax’ – intended to shame employers into retaining human resources – in his manifesto.
Whatever the final outcome, huge changes are on the way and many pharma firms are already preparing for them. Labs are investing heavily in time and labour-saving machines, but are they safe, secure and reliable?
Healthcare systems are under increased pressure to cut costs. According to experts, the reasons for this include an ageing population – which has ongoing and complex problems that require not just a one-off hospital visit, but years of care – subsidised prescriptions and social care outside of hospitals.
Pharmaceutical budgets have been slashed, so how do labs, drugs companies and healthcare sector employees ensure they can continue to produce high-quality, dependable products?
Lab support systems have been considered particularly uneconomical. Companies have launched streamlined high-tech services for back-office labs in hospitals that will enable medical companies to marry low-cost/high-usage equipment with modern machinery in order to save money and resources.
“Consolidation is the big trend,” announced Michael Clayton, Abbott’s managing director for diagnostics (Northern Europe) at a recent product launch. “Users need more data and more action in their workplaces.”
Abbott’s new products represent a trend for pharma companies that serve public providers. Alinity, for example, crams a full pathology suite into something that fits into a corner of a room; the company claims to have developed it in response to the premium placed by its customers on lab space.
According to Clayton, industry and public health practitioners were required to cut costs as budgets for pharmaceutical services were being squeezed. “What’s being offered now is a suite of unified systems that will introduce uniformity to the machinery used in lab,” Clayton explains, noting that one of the biggest problems for goods in labs is the lack of compatibility between products of varying ages, or from different suppliers, as well as a host of other frustrating issues.
An example of the squeeze on resources was the recent revelation that the average lab in a UK hospital was recommended to be running at a cost of no more than 1.6% of a hospitals’ entire operating budgets. Dr Catherine Bailey, clinical scientist and head of the pathology labs at the Aneurin Bevan Health Board, a large NHS trust in South Wales, and an expert on lab systems, highlighted the issue at the Abbott launch, pointing out that some hospital unit were running at up to 2.4%. With a recommended budget of a third lower than that from the government, it’s clear why her cost-cutting is a concern for medical staff.
Bailey added that machinery and pharma products must be able to adapt to what the sector can afford and accommodate. “The future?” she asks, “A flexible, responsive sector that is able to be scaled up or down.” According to Bailey, new technology is vital, but it must be smart and economical.
Pharma products and machinery are becoming increasingly intertwined as one-stop shops that offer staff everything they need to ascertain patients’ well-being. Hardware is being streamlined and, at the sector’s behest, made as simple and small as possible, as the space no longer exists for bulky equipment (as Bailey explains, this is often because hospitals and other places have neither the physical space, nor the budget, to renovate or extend facilities). Pharma firms must therefore recognise budget constraints and listen to customers in order to optimise their offerings. In this case, small is good. Value for money is even better.
Graham McMurdy, Abbott’s director of technical solution design for EMEA, says that products like automation track systems will be a fantastic boon for pharma: “They can process large volumes of samples per hour, handling multiple tube sizes and types simultaneously.
By automating routine, manual tasks, automation systems may help labs reduce error, improve turn-around times and improve productivity.” But how is this accomplished?
At pharma manufacturing factories, the emphasis shifts from saving money and space, to guaranteeing security and quality despite issues such as budget constraints and automation.
Quality assurance is now automated; continuous process verification (CPV) helps companies improve product quality and optimise manufacturing.
One of the main trends McCurdy has noticed in pharma manufacturing is a decline in the number of qualified technicians in laboratories. The result is that labs are “looking for automated alternatives to help them do more with less”, he says.
“Automation means different things to different people, and can vary from something as small as removing the tops from tubes to installing a laboratory automation system in which all steps of the laboratory process are automated.”
More for less
McCurdy thinks a reduction in skilled, qualified staff, plus an increasing and ageing population, are combining to put pressure on healthcare, requiring labs to process more diagnostic test results than ever.
“At the same time,” he continues, “labs are being asked to do more with their existing resources, while undergoing changes as a result of consolidation. The combination of these new demands means that automation systems can play an important role in maintaining and improving laboratory services.”
In comes the regulator
The European Medicines Agency (EMA) believes that CPV should monitor product quality; ensure a state of control; provide assurance of the continued capability of the process, relevant process trends and non-conformances; and collect and assess defect reporting. The regulator sees the process as a means of ensuring that periodic reviews are performed, making producers consider the level of process understanding and performance in their practices and submitting to a possible period of enhanced sampling/monitoring. All of this should be against a backdrop of training and education.
“Many labs have successfully tried using ‘lean’ techniques to reduce waste,” McCurdy says, “thus reducing the variation in their processes, and removing as many non-value-added steps as possible. These improvements allow them to reduce their turnaround time.” Does using smaller production facilities with lower building and capital costs, minimising waste, energy consumption, and raw material use help keep costs down and standards up?
McCurdy thinks so, because real-estate always comes at a cost. “As cost pressures mount within a healthcare system, there may be a need to secure space from other departments or areas,” he says. “If the lab can release some of this space and then reduce its costs, then it is more likely to fulfil its required budget constraints.”
When it comes to the debate around security versus quality, has the automated CPV improved product quality and the manufacturing process?
McCurdy says that as with all processes, increasing the number of manual steps involved increases the likelihood of variation and human error. With greater automation, quality should improve while turnaround time becomes more reliable and confidence in test results builds.
By focusing on delivering timely, accurate test results the industry will be able to demonstrate that products are being produced to the same standard of quality as before. As for the areas in which companies are falling behind, McCurdy thinks the goal is to find ways of improving processes and methods of delivery so that “we provide the best actionable information as quickly as possible”.
What this all means for pharmaceuticals manufacturing and the equipment is that vigilance will be key in order to ensure that standards continue to be met.
With budgets slashed, new types of machinery being used and new plans made in order to highlight security and quality assurance, all parts of the chain of the products from the lab, production line and users must be sure that they are ticking every box on regulation, safety and good manufacturing practices.
The backlash from any missteps in terms in terms of output or quality could be immense, so it is in every company’s best interests to ensure that what it does becomes as streamlined and economical as possible, while remaining as safe and reliable as ever.