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'How I Learnt to Stop Worrying and Love the Lathe'

Date Published 17.08.21

In previous blog posts, Dr. Dave Seaward has written about the importance of a fail-fast mentality. He emphasised the importance of failure as a 'fast-track' to success by encouraging rapid testing of hypotheses and a tight feedback loop of learning & improvement.  In this blog, one of our Project engineers has written about getting over their fear of failure. Studying at University, I calculated cutting forces using Merchant’s circle long before I ever touched a machine tool. I should point out that there were plenty of opportunities to do so in the labs, but there’s a lot going on at University and I can’t say I ever made the most of this access. The thrust of University study is typically in a very academic direction; aiming to equip us with the knowledge needed to understand mechanical processes at a fundamental level, even if we have no experience of them in practice. This makes sense of course; Engineering graduates go in to a broad range of careers, and even subtracting those traitorous souls who enter finance, those who end up working within the field have no guarantees of ever going near a machine tool ever again. Merchant’s Circle of Cutting Forces ©EngineeringTribe https://www.engineeringtribe.com/2020/11/what-is-merchants-circle-diagram.html The Lathe The Lathe holds a sort of collective reverence amongst Engineers, and if it doesn’t, it certainly should! Whilst lathes have existed in some form or other since Ancient Egyptian times, the invention of a screw-cutting lathe enabled the standardisation of screw threads, which allowed for interchangeable parts and arguably birthed the development of mass production. They are a mainstay of every engineering workshop, and I don’t think it’s an exaggeration to say they’ve probably been used at some point in the manufacture of virtually...
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Have CAD packages neglected the 2D Drawing?

Date Published 04.08.21

In this blog, one of our mechanical engineers discusses how CAD packages have changed engineering drawing. He talks about the importance of drawings and how modern-day CAD packages could further improve the design process. Is engineering drawing dead? I’ve been using various CAD packages over the last 25+ years of my engineering career, from starting out using an old version of AutoCAD 10 with the puck and tablet, through various iterations of AutoCAD, before moving into the now with the all-singing, all-dancing parametric CAD packages. Over the years there has been a quantum jump in what you are able to do with these CAD packages (animations, structural analysis, CFD, parametric modelling to list just a few), but one area that seems to have been left behind is the ability of the designer to produce a top notch 2D engineering drawing. What is a drawing? There are a number of drawing types associated with the mechanical design process. The two main types are assembly drawings, and detail drawings. An assembly drawing shows, in quite some detail, how the various components fit together. It should include the overall dimensions of the assembly, any setting dimension once built, a parts list, and corresponding identification balloons. An engineering, or detail drawing, is used to clearly and accurately convey all of the geometric features of a component, so that the manufacturer or engineer can produce it. Things such as the required material, surface finish, and any secondary process requirements such as heat treatments and coatings would be specified on here. Why do I need a drawing? ‘Why do I need a drawing?’ is a commonly asked question in this day and age. Yes, you can send a model file directly to the manufacturer who can load it into their CNC machine and accurately manufacture the required part. But how do you specify surface finish, and any secondary finishing processes such as anodizing?...
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Understanding the ‘three P’s’: Why process definition is important to achieve ultimate performance

Date Published 28.07.21

In this blog, Ian Hayto, Project Engineer at 3P, discusses the importance of understanding the 'three P's' and how he himself uses them for project success. A few years ago, while watching a video of one of the machine projects I’ve worked on I was asked by a non-engineer friend ‘how do you end up with a machine like this?’ He was struggling to understand how we got from a product to the fully working machine he was watching. At the time, I’d never really given it much thought so I could only think to reply with ‘well, you just start with the thing you are making and work outwards from there. After a while you end up with a machine like that one. It seemed an overly simple answer to a complicated process, but in reality I’ve found that is exactly what happens. I have been fortunate to meet and work with some very talented engineers during my career, and I’ve tried to learn as much as possible from every one of them. I’m also fortunate that I have found myself working on a wide variety of design and machine projects covering a range of industries and having very different requirements. But the one thing I learnt while working alongside those more experienced engineers is that their approach to problem solving was actually quite similar: for the project to be a success you have to really understand what you are making and how you are going to do it. In other words understanding the ‘Product’ and the ‘Process’ is key to the ‘Production’ success of the solution. What’s in a name? It’s no coincidence that the three ‘P’s’ in 3P innovation’s name stand for 'Product', 'Process' and 'Production'. Some of those talented engineers I mention are now directors of the business and they know and understand that the relationship between the three elements is a key requirement to a successful outcome for the...
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The devil is in the detail

Date Published 28.07.21

In this blog, Graham Shirley, Senior Mechanical Engineer at 3P, talks about his passion for heritage engineering and how the heritage sector can play a major role in training and inspiring tomorrow’s engineers. A blast from the past Heritage engineering is something that grips me; we love visiting the past. Having travelled around Europe, I think I can safely say it is something we excel at in the UK. Many engineers will be familiar with the saying ‘The devil is in the detail’. Some heritage centres recreate scenes where actors play characters of the past in their heritage working and living environment. They tell you a story and you can converse with them and explore their thoughts and reasoning for doing things the way they did in the set time period. They may remind some of Eagle comic, Meccano, or a book for Christmas. Some may say their best teacher is their determination to get something done. Being an engineer, it is the detail that drives me. I love to look at old engineering photographs. There is a new invention on display, but what interests me is the tools and parts lying in the background. Why are they there? What were they used for? My visit to a heritage railway centre a few years ago triggered a meeting with a group restoring some 1950’s heritage. Richard Heenan and Hammerley Froude formed an engineering company in Manchester in 1881. You will know of their best-known creation – Blackpool Tower 1. Before me was another creation, not so widely known, but it had been an exhibit on Heenan & Froude’s stand at the 1951 Festival of Britain exhibition on the South Bank in London, next to the Royal Festival Hall. It was a box of mechanical parts, linkages and cams with two inputs and it generated 4 outputs. An analogue computer, when computers were mechanical devices rather than digital electronic. The group explained that the original was in the Science Museum, Kensington, London. I had probably seen...
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3D Printing: A new paradigm for design engineers

Date Published 20.07.21

In this blog, Dr. Dave Seaward (Director of Projects at 3P) discusses the way that modern CAD systems and 3D printers have changed forever the workflow for mechanical design engineers, and he posits that 3D printers are the ultimate in delivering “fail early, fail fast”.  This follows on from his previous two blogs ('Why you should embrace failure: from human-powered airplanes to anti-HIV vaginal rings' and 'Has Pharma finally found its 'skunk'?'). Humble beginnings When I entered industry in the early 1980’s Computer Aided Design (CAD) had just arrived. Large organisations had invested in huge blacked out rooms full of green monochrome screens driven by CAD stations costing more than a family car. The drawings were basic 2D and the workflow “clunky” to say the least, but CAD had arrived. In parallel there were traditional drawing offices full of row upon row of drawing boards populated by engineers, designers and detailers working with pencil and rubber in equal measure. Each drafter owned their own set of propelling pencils, French curves, inking pens, protractors, rules, dividers, trig tables, calculators, rubbers, set-squares, compasses (with extensions for those big circles), letter and number stencils etc. Indeed, I was given my father’s “precious” set of Staedtler drawing instruments that were bought in the early 1950’s during his father’s time as an apprentice draftsman. Tools of the trade These drawing offices (DO’s) felt old fashioned even to a fledgling engineer: the air hung with the smell of ammonia from the A0 copying machines of the day, mingled with stale cigarette smoke. The once white walls were browned by decades of nicotine exposure – these were the days before smoking in work environments was outlawed. The work flow reflected the technology of the day. The design authority was either a senior...
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A Passion for Steam: Cutting Edge Technology?

Date Published 06.07.21

In this blog, Carl Jones, Project Group Manager at 3P, talks about his passion for steam railway locomotives and how this links to some of the projects he's worked on at 3P. Man’s greatest piece of engineering? I’ve had an absorbing interest in and passion for steam railway locomotives for as long as I can remember. A career in Mechanical Engineering was the obvious choice for somebody who had always sought out as much technical information as possible about man’s greatest piece of engineering. Man’s greatest piece of engineering? Is this an outrageous claim? No! Let me explain why… My colleagues at 3P innovation will happily rib me mercilessly of course. Even our Managing Director will lower himself and join in! However, rather than rise to their friendly jibes, I can only pity their ignorance – sorry Tom… I am of course able to explain why the steam locomotive contains all of the fundamental points of engineering which have driven mankind’s progress since the Enlightenment and for all that is the closest man has ever come to creating a living machine. A steam locomotive at speed under power is a brilliant manifestation of the conversion of raw energy. It performs a type of alchemy by combining the basic elements of fire and water to produce motion and ‘poetry of motion’ at that. As a well-designed and finished machine, a locomotive can be very pleasing to look at – equal to any famous artwork - and yet it has the advantage over a painting or sculpture of being animated and has a sound and presence that makes onlookers step back in awe when it passes. Jet engines of yesteryear In my spare time, I am a qualified fireman at the preserved Severn Valley Railway which is a former Great Western Railway line on the border of Shropshire and Worcestershire and is now a significant tourist attraction, remaining so even through the current pandemic. The steam...
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The Properties of Liquids and Their Impacts on Engineering

Date Published 06.07.21

Everyone knows what liquids are, and is familiar with their basic properties, but there are many behaviours and characteristics of liquids you may have noticed but not understood or acknowledged. Some of these properties can have practical implications when it comes to engineering, for example in liquid pumping and liquid filling machines. The properties of a liquid are largely defined by its molecular structure, where its molecules are tightly packed together, but are not fixed to each other. This means that liquids are almost incompressible, but can change their shape to suit the container they are held in. Cohesion and Adhesion There are two main molecular forces which are responsible for some of the unusual properties liquids can exhibit, cohesion and adhesion. Cohesion is the attractive force between molecules of the same type, and adhesion is the attractive force between different types of molecules. The molecules within a liquid can either be polar, or non-polar; a polar molecule is one where one end of the molecule is negatively charged and the other end is positively charged, whereas a non-polar molecule does not have a separation of charges across the molecule – it has an even distribution of charge. This polarity is what causes the attraction of the cohesive properties of liquids. Some of the effects of these properties are described below: Surface Tension The phenomenon of surface tension is where the cohesive bonds between the liquid molecules at a liquid-gas boundary are stronger than the cohesive bonds in the bulk of the liquid. This is because in the bulk of the liquid, each molecule has a neighbouring molecule to share a bond with, however the molecules at the surface have fewer adjacent molecules to bond with, and therefore the bonds between the molecules at the surface are stronger as they have fewer surrounding molecules to share the bonds with. The result of this effect is that the surface of the liquid has a greater...
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Is Employee Ownership the UK’s answer to the Mittelstand?

Date Published 24.06.21

Today we are celebrating our very first Employee Ownership day and, to do so, we've put together an interesting blog where we draw a parallel between Germany's 'Mittelstand' companies and employee-owned businesses in the UK. This interesting spin on Employee Ownership explores whether EO businesses are the equivalent to Germany's 'Mittelstands'. And if so, will employee-owned businesses drive a similar success for UK exporters?' In 2006, a group of six like-minded engineers formed automation company, 3P innovation. A lot of the “DNA” built into 3P from the start came from what they had observed within successful German Mittelstand companies. They formed an “open” company with high quality engineering at the heart of everything they did. It is probably no accident that 15 years later 3P is an employee-owned business that looks and feels like a Mittelstand company.. ‘Mittelstand’ is a German term that defines a long-term business mindset and ethos within business. In theory, it covers companies of less than 500 employees, but some larger firms (e.g. Robert Bosch) are also deemed to be part of the Mittelstand. Typically, they at the forefront of innovation, often regarded as world leaders and they focus on a niche, which they then typically export around the world. Germany is an exporting power house due to having 48% of these smaller niche world market leaders… the Mittelstand! They tend to be multi-generational family owned or, in some cases, they have a trust ownership structure. They also tend to integrate vertically to ensure they maintain control of the quality of their products throughout manufacturing. They have flat structures and also take decisions for the long term (meaning 10-20 years), such as their investment in training staff, buildings and capital equipment. It has been described by some authors as “patient capitalism”. This is not about a...
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International Women in Engineering Day 2021

Date Published 21.06.21

Today we're celebrating Women in Engineering and we are interviewing one of our female project engineers at 3P, Hayley. In this interview, Hayley tells us about why she chose a career in Engineering, what a typical day in the life of a female engineer at 3P looks like and we discuss current industry challenges. Q: Hi! Tell us a bit about yourself and how you got into Engineering? A: Hello, my name is Hayley and I’ve worked at 3P as a Project Engineer for nearly 3 years. I grew up in Bracknell and first became interested in Engineering through watching episodes of Scrapheap Challenge with my family. I didn’t realise at the time that the teams on the show were ‘engineers’, I just thought that making things that worked (or didn’t!) and solving problems as a team looked fun. After A-levels, I knew I wanted an engaging degree that would give me transferrable skills and make me employable, which is why I chose to study Mechanical Engineering at Bath. University was hard work, but I met some great people (including my future husband!) who supported me, and were able to celebrate with me when I graduated in 2018.   Q: Why is being an Engineer an interesting career? A: Engineering is interesting because it is so varied. Everything you interact with on a daily basis, from the mobile in your pocket to the cars and trains you use to get around has been designed or influenced by an Engineer. At 3P, we design bespoke automated machines for the pharmaceutical and FMCG sectors, which gives you a real appreciation for how much we consume relies on engineers to be created. Next time you tuck into a pack of biscuits from a supermarket or take some paracetamol for a headache, have a think about the engineers that enabled that to happen. Q: What does a typical day in your life look like? A: As the work we do at 3P is bespoke and covers every part of the design process from early concept to...
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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...
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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 workers with the help of the Warwick local business community. You can find the full story here. We are now about to introduce daily lateral flow tests, available to employees and visitors (once we're allowed to have visits!) to further minimise the risk of being exposed to asymptomatic...
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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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