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Horizontal innovation - what is it and why is it important?

Date Published 10.06.21

If you search the internet for “horizontal innovation” chances are that one of the top five search results will reference 3P innovation. Indeed our founding director, Dr Dave Seaward, has presented at the IET event focused on the subject on June 10th 2021. So what is “horizontal innovation”, why is it important and why are UK engineering institutions, such as the IET, championing it? Horizontal innovation is simply defined as 'the effective transfer of knowledge and technology from one sector to another'. One could argue, and we do, that most innovation falls under the horizontal innovation banner. The UK has a reputation for punching bigger than its weight when it comes to invention and innovation. Throughout industry there are ideas that are tried and tested in one sector, that are crying out to be used elsewhere. There is a genuine opportunity for horizontal innovation to drive growth and create fulfilling jobs for future generations of engineers – more importantly solutions that already exist can be used to address some of the world’s pressing challenges. The IET Past President, Jeremy Watson CBE, summarised it well in 2017 when he said “The UK is internationally renowned for its creativity, research and innovation, but often technologies or processes can get locked into one sector or industry. We want to break down barriers to sharing ideas to enable innovations to be used where they are needed, and not just in the sector in which they are created.” It could be argued that most innovation is “horizontal”. Anyone who has used the “theory of inventive problem solving” or Triz for short, is likely to agree to this. Triz is an abbreviation from the Russian "theory of the resolution of invention-related tasks" and was developed in the late 1940’s, 50’s and 60’s by Soviet inventor Genrich Altshuller. He analysed over 40,000 patent abstracts...
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Micromorts: predicting your risk of sudden death

Date Published 22.04.21

Today, 28th April, is World Day for Health and Safety at Work and we want to celebrate it by talking about Micromorts. Here we explain what these are and how we've used them during the pandemic to predict our risk of death when carrying out our day-to-day activities at 3P. At the start of the pandemic it was very difficult to obtain trusted data on Covid19. At 3P, our engineers love data. What we did have access to was the limited data from the cruise ship, the Diamond Princess, that was quarantined off the Japanese coast for two weeks in early February 2020.  It provided those who could interpret the data with an insight into what was to come. A 16-year-old luxury vessel, that cost half a billion dollars to build, was stuck in quarantine in Japan with more than 3,700 people on board. Hundreds of them had become sick with Covid19 and were confined to their cabins. There was a total of 712 confirmed cases among passengers and crew, around half of whom were asymptomatic at the time of testing. 18% of the positive tests turned out to be true asymptomatic. That is they had no symptoms at all. Unfortunately 9 died (just over 1% of the positive cases). The fact there were a significant number of asymptomatic cases and potentially a 1% mortality caught the attention of the 3P management team, and in particular, our Health and Safety Officer. In many respects, 3P were ahead of the curve in implementing no-touch hand sanitiser, buying PPE and implementing social distancing during early March 2020. What became very clear was that different staff had a very different view on the risks associated with Covid. Some staff became very anxious whilst others continued as if nothing was happening. This is not uncommon as humans have a hard time dealing with what are known as “Black Swan Events”: these are low probability, but high impact events. The problem with rare events is that they’re almost impossible to predict by looking...
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Has Pharma finally found its 'skunk'?

Date Published 20.04.21

Welcome to part 2 of 2 of this blog covering some topics around developing new products quickly. 'In part one, I posited that reconfiguring a problem so that you could fail often, fail rapidly and fail at little cost was a means to rapid success – the so called “fail early fail fast” motto. I certainly have examples within my career where this has proven correct. With the unprecedented speed of the development and roll out of Covid19 vaccines, in this second part I ask the question “has the pharma industry finally found its “Skunk””? Confused? Let me explain! Having worked in and around the development of pharmaceutical and MedTech products for several decades, I came to the view that the industry needed a “skunk works” mentality, especially during early phase development. By any industry standards, the heavily regulated pharmaceutical industry traditionally takes significant time to make any changes. The industry has long accepted this as the norm. Indeed, during the early 2000’s, when a significant “patent cliff” threatened years of enviable big pharma profits, there was a lot of talk of “agile”. This didn’t, however, appear to generate much in the way of tangible change. Having come from an agile SME engineering automation background, I was struck by how much could be achieved by a small highly focused and highly skilled team of engineers, and how little was often achieved by large corporate teams in our big pharma client base. Many clients (only the ones known well) have heard me remark “so you want me to significantly improve this process and you don’t want me to change anything!”. Wasn’t it Einstein that is quoted as saying “Insanity is doing the same thing over and over again and expecting different results”? Rewind to around 1990, and I had my team described as a “Skunk Works” by a senior exec...
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Why you should embrace failure: from human-powered airplanes to anti-HIV vaginal rings

Date Published 12.04.21

In this blog, Dr. Dave Seaward (Director of Projects at 3P) discusses the importance of 'failing early and fast' and how embracing failure can be very positive.  'Throughout a career some conversations are significantly more influential than others. I recall discussing technology development over lunch with a senior big pharma executive back in the early 2000’s. The big pharma company in question was trying to become more agile. They sent me an article about the Gossamer Condor human-powered plane. The mantra of finding success from “Fail early – Fail fast”, has stayed with me. Let’s rewind to 1959, when a British industry magnate Henry Kremer offered the then eye-watering sum of £50,000 for the first person to build a human-powered plane that could fly a figure eight around two markers half a mile apart. He offered a further £100,000 to fly across the English Channel. Henry made his money from inventing special wood products such as the plywood that went into the WWII wooden Mosquito light bomber (incidentally the Mosquito carried special 57mm 6lb guns developed by one of my previous employers). Lots of teams tried and failed to win the prizes. It was looking increasingly impossible, until serial inventor Paul MacCready, decided to get involved. He reframed the problem when he realised that people were solving the wrong problem. “The problem is,” he said, “that we don’t understand the problem.” His insight was that everyone was trying to solve the problem of trying to design a light weight human-powered airplane – not unreasonable you might think? Typically, failing teams would spend a year designing and building a plane based on some basic concept and lots of theoretical calculations. Following a year’s worth of work, planes would typically smash into the ground or a pilot would be exhausted after just a few hundred metres of flight. With just...
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How we joined in the fight against Covid-19

Date Published 10.03.21

Today marks one year since the first lockdown was announced in England. We wanted to take this opportunity to reflect on how we reacted to the pandemic and the measures we took to join in the fight against Covid-19. As a business we decided, before the UK national lock-down, to go hard and go early with Covid related mitigations. Thus far our response has meant that, to date, we have had no known incidences of transmission within the business. This is despite a few of our staff contracting the disease within the wider community. We have also seen significantly lower incidence of Covid cases within our staff than the UK national averages. Shortly after the UK national lockdown, the Government issued advice for businesses to mitigate risks in the workplace. We carefully read through the ~250 suggestions made available for businesses, selected the outstanding actionable steps that applied to our industry and implemented them. A year on, we have taken a look back at when it all started and put together a list of the preventative actions we took to protect our employees, our suppliers and our clients at 3P. Here's how we reacted to Covid-19 and the measures we implemented during the first three months of the pandemic:                                                                     These health and safety measures allowed us to really understand the importance of acting quickly and being flexible to the constant changes in Goverment guidance, as a way of protecting both our employees and our customers. The silver lining of the pandemic for us, was our visor initiative. We manufactured and donated over 30,000 visors to frontline and care...
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Have You Forgotten To Consider The ‘Ergo’ Bit?

Date Published 26.10.20

In our previous blog post, we discussed the importance of flexibility in aseptic fill-finish production equipment, giving customers the ability to fill multiple container types and different formulations on the same equipment.  Rapid changeover and cost-effective change tooling, combined with scalable processes that can be applied in a commercial setting are some of the key success factors to judge how flexible a new production solution really is.   Our fourth blog post will discuss how manufacturers can increase efficiency and productivity by optimising operator comfort and ease of interaction with the machine through ergonomic design and consideration of human factors. Ergonomics is an applied science concerned with designing or modifying workplaces to fit the worker’s needs, creating an optimal working environment. The term ‘Ergonomics’ emerged as a scientific discipline during the late 1940’s after the innovations of World War II. The introduction of more complex technologies and military equipment during the war highlighted the issues between the demands of the human operator and the technical equipment – specifically aircraft and their illogical cockpit designs which led to numerous accidents. Whilst military psychologists and physiologists were attempting to resolve the conflict between the lack of human capabilities and complex machinery, the need to study and understand the interactions between humans, equipment and the environment was established. As a result, the Ergonomics Research Society (ERS) was formed in 1949, which later evolved into the Chartered Institute of Ergonomics & Human Factors. Today, ergonomics has become a fundamental part of the design processes in aseptic manufacturing. Improving efficiency and productivity As the demand for more advanced aseptic manufacturing technologies increases, manufacturers are faced with the challenge of creating new and more complex designs that...
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Future-Proofing Aseptic Manufacturing

Date Published 02.10.20

In our previous blog post, ‘4 Factors to Consider During the Design Process in Aseptic Manufacturing’, we discussed the objectives that the design process should set out to achieve for new aseptic manufacturing challenges. For our third blog post, we will be discussing the importance of developing flexible solutions that can support next-generation formulations, accommodate different filling environments and fulfil changes in production volumes for years to come. Pharmaceutical manufacturers are becoming increasingly active in the search for evolving technologies that can provide flexible, future-proof aseptic solutions. Although flexible systems may cost more initially and take longer to develop, they have the ability to support the total life-cycle from early-stage manufacturing to commercial production and handle challenging drug properties to eliminate the need to purchase new technologies. As with any automation investment, the goal should also be to ensure improved labour productivity and safety, manufacturing reliability, product quality and, where required, faster throughout to achieve the overall goal of shortening product development lead times. This makes for a cost-effective and robust investment. The increasing complexity of new drugs The increasing complexity of manufacturing new drugs has stimulated a growing demand for flexible solutions. Many traditional filling systems are unable to handle changing drug properties, which impacts the accuracy of doses. As mentioned in our previous blog, it is highly important to specify and design flexible equipment that can accommodate changing properties of the drug quickly (e.g. viscosity of liquids, powder flow properties etc). This agility and flexibility will, for example, be a major enabler for low dose and potent drug handling to support next-generation powders and formulations of the future. This includes the ability to fill very low dose weights of pure API or higher concentrations of...
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4 Key Factors to Consider During the Design Process in Aseptic Manufacturing

Date Published 08.09.20

Demand for the design and development of specialist aseptic manufacturing solutions is being driven by the significant growth in biological drug pipelines, the trend towards personalised medicines, increased out-sourcing of drug development and manufacturing and an ageing population with increasing life-expectancy. In addition, customers are experiencing increasing competition and growing pressures to find cures for cancer, dementia and other diseases which drive significant cost and pressures on our global health services. Consequently, there are growing demands for new manufacturing processes to develop and produce sterile drugs faster and at lower cost. In this 2nd article in our series on Aseptic Manufacturing, we talk about the Design Process, and encourage the reader to consider what wider objectives the design process should set out to achieve for a new aseptic manufacturing challenge, whether for liquid filling, powder filling or device development, the same questions apply.  1.     Design for De-Risking One of the most critical objectives during the design process is to develop and de-risk the core aseptic processes involved in manufacture. From a machine and equipment perspective, it is important to specify and design equipment which will provide agility and flexibility to quickly accommodate changes in the properties of the drug (e.g. viscosity of liquids, powder flow properties etc) and in the design of the primary drug container (PDC) itself (e.g. size, shape, material selection etc). The machine must be capable of supporting the definition of the ‘Critical Quality Attributes’ (CQA) of a medical device or PDC, then based on this must perform aseptic processes that can be measured, with ability to define and record the ‘Critical Process Parameters’ (CPPs) necessary to achieve the CQA’s of the product. An important requirement directly related to the...
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A Brief History of Aseptic Processing

Date Published 08.09.20

What is Aseptic Processing? Aseptic processing is the method of producing a sterile product in which sterile bulk drugs or other sterile materials are filled and enclosed in sterile packaging containers, in a controlled environment where the supply of air, materials, equipment and operators are carefully regulated and controlled to control microbial and particulate contamination within acceptable levels. Aseptic processing is a term which describes the multiple tasks and processes involved in the manufacturing method, which may be completed manually or by semi-automated or fully-automated equipment. One of the most critical processes is the filling of sterile drugs in the Grade A environment, whether in liquid or powder form. The Evolution of Aseptic Processing The aseptic processing market was valued at over $56 trillion in 2018 and is expected to grow to $124 trillion by 2027, with a CAGR growth of 9.18%. The industry has seen many changes over the last century due to a number of challenges including changing regulations, the pressure to develop drugs and devices more quickly and cost-effectively, advances in technologies and the need for customised and adaptable solutions to suit specific manufacturers’ needs in sterile production.  Regulations Sterilisation processes have substantially developed since their methods involved the use of Bunsen burners and boiling water. In the 1920s, sterility requirements for injectables were introduced. These requirements along with mass demand for sterile injectables in WWII began the evolution of fill-finish aseptic processing.   Aseptic processing methods were revolutionised following the lethal contamination of plasma products in 1940. The ‘Blood for Britain’ programme saw mass biological manufacturing of blood and plasma to treat wounded soldiers during WWII. However, the plasma collection process was a haven for bacterial contamination and many vaccines were...
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