Imagine a world where medical devices such as pacemakers could be implanted into the body, without the need for traditional batteries and cables and powered simply by body fluids. Well, it might not be as far away as you think. There have been some exciting and fascinating developments recently. Researchers have started to utilise a unique property of some materials, known as piezoelectricity, to generate electricity from kinetic energy….the same technology that is used in ‘wind-up torches’ to convert kinetic energy to electricity. Read more about this fascinating topic by following this link.

We are proud to announce an updated and improved one day intensive training course on pharma packaging!

Pharmaceutical packaging is a very specialised area with its own unique issues and problems. This introductory course will provide delegates with a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products – both Prescription Only Medicines (POM) and Over The Counter (OTC) and will have relevance in other affiliated areas such as Veterinary and, to some extent, Medical Devices too.

Whether you know nothing or have a basic understanding, this course will provide you with useful knowledge and insights from experts who have worked in the industry for over 25 years.

For more information – Follow this link to our Training Page to download a PDF flyer

With an ageing population and the growth of emerging economies across the world, the pharmaceutical sector is booming. Research business IMS predicts that the global pharmaceutical industry will reach sales of as much as $1.2tn by 2017 – representing annual growth of 3%-6% and, crucially, a growing market for pharmaceutical packaging suppliers and contract packers.

Yet it is a market that brings particular challenges, and particular opportunities, to those packaging suppliers and packers operating within it, not least the regulatory environment, which is complex and becoming more so. New regulations – notably the EU Falsified Medicines Directive, which requires every individual pack to carry a unique serial number – are posing new challenges to the supply chain both for product and packaging.

Chris Penfold, CEO of Design Cognition, along with a number of other industry experts recently took part in a Packaging News and Essentra roundtable discussion looking at the wide range of issues facing players in the pharmaceutical packaging segment.

You can find a more in-depth transcript of the discussion here:

Packaging News – Tough Talking – Pharmaceutical Packaging

or a short video ‘taster’ by clicking on the photo of Chris to take you to the YouTube video.

If you would like help and advice on any of these or other issues further and would like to contact Chris, please send an email via enquiries@designcognition.com or via phone on +44 (0)115 846 1914.

There are an ever-increasing number of ‘medical device’ products coming to market or existing products changing their classification to ‘medical device’ to give greater flexibility in the market. The boundary between Medical Devices and packaging is becoming ever-more blurred as the followng areas converge: smartphone technology, materials technology, internet capabilities & bandwidth, Wi-Fi and Near Field Communications (NFC). This is particularly evident in the area of patient compliance (adherence) and to a lesser extent, also in the areas of anti-counterfeiting and Track & Trace.

The route to CE marking depends on the risk classification of your device and also on how many you manufacture. The development of a device is heavily regulated and various criteria need to have been checked and decisions/design routes justified and recorded.

The Manufacturers or their authorised representative must follow one of several routes in order to CE mark their devices and legally sell or distribute them on the European market.
The Brand owner for the device will also have some of the responsibilities of the manufacturer.

The Team at Design Cognition have been involved in many successful device developments and understand what is required to develop a device/product that will meet the stringent criteria laid down by the various authorities. We can provide support for your project from concept through development, authorisation and commercialisation or even for the reviews. We are here to help, so give us a call!

Chris Penfold

Do you work in the pharmaceutical industry on the ‘periphery’ of packaging, working for example in Marketing, Purchasing, Design or QA etc , and have always wanted to find out more about packaging, but without having to attend a lengthy 3 day training course? Or perhaps you are a Packaging Technologist working on toiletries or cosmetics and want to gain a better understanding pharma issues and opportunities?

If so, then this ONE DAY TRAINING COURSE could be for you!

It’s being held on 14th October 2010 in Nottingham, UK

Pharmaceutical packaging is a very specialised area with its own unique issues & problems. This one day course will provide delegates with a good basic grounding & appreciation of what is required for the packaging of pharmaceutical & healthcare products. Whether you know nothing, have a basic understanding or are familiar with the area, this course will provide you with useful knowledge and insights from experts who have each worked in the industry for over 25 years.

What will be covered:

1.Packaging component & material selection Key product requirements (Consumer, Barrier, Shelf Life & Regulatory – Child resistance, Tamper evidence, Dosing & Stability. Marketing expectations.

2. Key properties of various materials / systems Main barriers & benefits of various packaging materials, Key drivers for pack performance, Supply chain implications on the packs

3. Pack testing & evaluation Mandatory requirements for Consumer testing & Transit testing.

4. Packaging component specifications Key requirements for a specification, Control of the documents.

5. Artwork generation & control Establishing processes suitable to your business needs – Wording & Templates, Creation, Version control & authorisation.

6.Regulatory requirements Packaging data for the MA , Braille, barcodes, Child Resistance, Tamper Evidence, Readability & others – including emerging requirements (e.g. 2D data matrix barcodes). Key packaging data for the MA/Dossier (Specifications & data, Supplier details). Key requirements for Braille etc.

7. Transit packaging Considerations of risk, Establishing test programmes, Specific requirements for palletisation etc.

8. Trade /supply chain requirements Understanding the various markets & their particular requirements, Understanding trade requirements (e.g. Barcodes, Shelf Ready Trays etc).

A full set of documentation will be provided.

You can find out more and register for this event by clicking: More information on Packaging of Pharmaceuticals – a One Day Introductory Course 14th October 2010

Chris Penfold

Traditionally medical products, devices and their related packaging has been ’sidelined’ in much of the debate around the environment, where the major focus has been on retail products. However, it is estimated (Mulligan) that medical packaging contributes between 30% to 50% (or more) of the medical waste stream. There is a lot of work going on in the background, within the National Health Service (NHS) in the UK, and further afield globally, as healthcare practitioners are put under increasing pressure to ‘go green’, become more ’sustainable’ and reduce their ‘carbon footprint’.  These initiatives go right to the core of their infrastructure, looking at everything from operating theatre furniture and equipment, through to medical devices and all related packaging.

However, there are wider ramifications, as it apparent that these sustainability initiatives will also enable huge cost benefits, improved regulatory compliance, and enhanced corporate social responsibility (CSR) when done correctly. So no pressure then !

On the face of it, this looks like a huge and daunting task, but with the aid of modern modelling techniques, such as those used by Walmart and by Marks & Spencer (M&S) in their ‘Plan A’, data and issues can be quite easily ‘chunked-down’ into manageable bite-size segments. This can help prioritisation and enable ‘quick wins’ on the highest ‘value creating’ initiatives.

It is important that suppliers and medical device manufacturers think about these sweeping changes and, if not already doing so, start to design and develop medical devices & healthcare packaging to meet these more stringent requirements. Next-generation packaging must be: 1) easy to manufacture; 2) meet stringent regulatory requirements; 3) meet the needs of distributors, healthcare institutions, and medical practitioners; and 4) minimize impact on the environment.

Mulligan talks in greater detail about all of this in an interesting article ‘Using a Life Cycle Analysis approach in medical packaging‘ recently published on the Healthcare Packaging website. Have a read and let us know what you think!

Chris Penfold

It is interesting to read that the focus of active and intelligent (A&I) packaging has shifted from “manufacturer concerns” such as shelf-life and spoilage to “consumer concerns such as freshness, quality and information”, according to recently published research.

The report – ‘The Future of Active and Intelligent Packaging in Food and Drinks’ said that industry leaders had identified “freshness indicators as the most important innovations in the field over the next five years. A development on quality was listed as the next most important field followed by temperature and time indicators.”

However, with over 30% of all food that we buy being wasted, I would hardly call “shelf-life and spoilage” just “manufacturing concerns”. They are huge and global concerns for everyone, much of which is to do with education and the role that packaging can play to save costs for everyone in the supply chain (very important in the present economic situation) but also, ultimately, to help save the planet’s finite resources.

I’m not sure how the research was conducted, what questions were asked, or how they were asked, but apparently, consumers ranked “health, convenience, safety and enhancing product attributes” as the most important attributes that would make them willing to pay more for A&I-packaged products. “Longer shelf-life and packaging that communicates product information” were also seen as important, but consumers perhaps see these as a ‘given’ and wouldn’t necessarily want to pay extra for them.

It is my feeling that the growth of A&I packaging has been primarily technology-led, by developments in sensor technology including nanosensors and biosensors. This is highlighted by the emerging trend of the incorporation of scavenging functions into packaging with bottles, labels or films. This is great technology, but I’m not sure that most consumers would understand what these are or what benefits they bring and therefore they would certainly not want to pay for their incorporation.

It is true that “Delivery of efficiencies in the value chain and the opportunity for manufacturers to differentiate their products and boost their efficiency by reducing product losses” will be major benefits for manufacturers and retailers – but what about consumers? There is a huge consumer-led marketing ‘trick’ being missed here, especially when “High production costs, compliance with food safety regulations and consumer mistrusts” are being highlighted in the report as “potential challenges”.

So, it is good to see that the consumer perspective is taking greater prominence (to some degree at least), in the New Product developments (NPD) that will help meet consumer needs in the expanding drinks and ready-meals segments. I agree, that the current focus for A&I has to be on luxury goods initially, and that it will move to lower-end products as the technology becomes more widely available and costs fall, but maybe it’s time to take a large ’step back’, flip this around completely and look at it from a consumers’ point-of-view. It is up to us all to educate consumers – highlight the wider issues of food (and water) waste & spoilage, get them to understand the more holistic effects of these on their daily ‘wants & (real) needs’ and ultimately get their ‘buy-in’ to the ‘real’ benefits.
Chris Penfold

You can read the full article at www.foodproductiondaily.com

Many thanks to @PhilCyLaw in Brussels for bringing this to our attention via Twitter.

The following article is one that I’ve recently written for the Packaging Professional magazine, which details a fascinating 25 year transformation in the way we work and do business in the pharmaceutical packaging industry. Over that period the industry itself has undergone huge change and with recent economic pressures and the rise of generic competition is likely to continue unabated.

Back in the 1980’s, before the days of email and the internet, working in packaging could sometimes be a lonely business, especially in an area like pharmaceuticals where regulatory requirements, standards and process were constantly being updated as authorities, such as the US Food and Drug Administration (FDA) and the UK Medicines Control Agency (MCA), evolved  increasing powers and rules. A situation where ‘fit for purpose’ packaging could be a matter of life and death.

Pharma companies are strictly regulated and need to work to tight and common standards and most companies were running similar, machinery, quality systems and packaging materials. So learnings from one company could greatly help another and save having to ‘reinvent the wheel’. It was also important for the industry to provide a collective view to positively influence proposed legislation and regulations, with a common and pragmatic ‘voice’.

So back in 1984, the ‘seed’ of an idea for a group was ‘sown’ by Alan Haskins of Roussel Laboratories and Roy Gray of ICI Pharmaceuticals, after Roy’s boss had visited the USA and seen a successful American group working in the same sector. This was a defining moment and the group would not have happened without their collective vision and proactive approach. The first Pharmaceutical Common Interest Group (PCIG) meeting took place on 16^th October 1984 at Sysonby Lodge, which was the head office of The Institute of Packaging (IOP) at the time). The meeting was chaired by Alan Haskins, with Roy Gray as Secretary and an attendance of 18 people from 15 pharmaceutical companies from across the industry. There were 37 questions raised & discussed at that meeting on a range of topics, including: a New British Standard for aluminium flexible tubes, label adhesives, Tamper Evidence and EAN bar codes – themes that would arise again and again over the years.

It was agreed that there would be three meetings per year and venues would rotate across the various company sites, but over the years most were actually hosted by the IOP.

One of the original members, Mike Shorten, who worked for Boots Pharmaceuticals at the time and is now retired, recalls:

“The PCIG soon became my most important network. Forty pharmaceutical practitioners across all sectors of the industry provided a powerful resource that could offer practical experience about most issues and without any consultants’ fees! A great strength of the group was the willingness of its members to talk openly about issues and share best practice and then to collectively influence new regulations and standards”

How the CIG has changed over the years

I have myself have been a member of the group for over 18 years (since 1991) and over that time can recall a great deal of camaraderie, focused help for each other and pragmatism having helped us all deal with issues as diverse as use of high barrier blister materials, bar coding issues and leeching of preservative through polyethylene bottles.

As issues became apparent, some common themes evolved and a number of dedicated ‘sub groups’ were set up to focus on specific topics. Four of these were Working Groups for Digital Artwork & Reprographics (DAR), Validation, Child Resistance and Quality Standards. The DAR subgroup was set up at a time when ‘desktop publishing’ was a buzz word being used as artwork generation moved from ‘old fashioned’ layout board, to a digitised computerised system.  At the time there was no common standard. There was a range of hardware (PC & Mac based), a number of operating systems, and various artwork creative software packages on each platform. The ease by which artwork could be generated and manipulated raised its own issues in terms of artwork version control and (in the early days) data going ‘missing’ sometimes between approval and print – which had the potential to cause a catastrophic result. So the group played a critical role in sharing ‘best practice’ and setting appropriate standards.

The Validation subgroup was formed in 1992, the founding Chairman being Mike Harwood of The Wellcome Foundation, Dartford. A subsequent Chairman (1993-98) John Cooper (of Pfizer at the time) recalls “The original intent was to develop a set of guidelines for validating pharmaceutical packaging equipment and then issue to IOP members, but as the guideline developed and the information was shared informally with machine manufacturers it became obvious that it would be of a wider benefit to publish a ‘book’. As I was a member both of the PCIG and Institute of Quality Assurance Pharma Quality Group (IQA PQG), I suggested that this was published jointly as a monograph in the series which was already established by the PQG. The monograph was published in 1998 and launched at a joint meeting of PCIG and PQG at the Royal Pharmaceutical Society in Lambeth with over 200 people in attendance, including the MCA Head of Inspection and Enforcement, Gordon Munro!” That was another defining moment in the ‘life’ of the PCIG and evidence of the esteem with which the group was held within the pharmaceutical industry. The third edition of that monograph is presently due for print.

It was not uncommon in the early days for PCIG meeting attendance to be around 35-40 people, with standing room only. Questions would be collated by the Secretary and shared at each meeting. It would sometimes take 3 or 4 hours to go through them all, one-by-one. As the years have gone by and we have moved in to a digital age, email has enabled members to converse more easily and questions can be asked and answered sometimes within minutes. So the focus and frequency of face-to-face meetings changed to providing more of an opportunity for discussing in more depth, processes, procedures, technology and impending legislation, and to keep in touch with old colleagues and friends. Together with the myriad of mergers among the pharma companies, this has meant attendances have dropped.

Where we are going with it in future
The PCIG (now called the Pharmaceutical Packaging Forum – PPF) is still active, with a core of ‘stalwart’ members and a new voluntary Secretary, David Pethick, former Director of Packaging Development at GSK. David is upbeat about future for the group and says “the pharma landscape, increasing demands and changing regulations on packaging present as much, if not more of, a challenge as when the PCIG was first established. I see both a need and role for a vibrant PCIG to help the pharma packaging professional meet those challenges, whether that be from simply providing networking among its members, to wider influencing, technical leadership, training needs or whatever”.

Pharma packaging legislation/regulation has changed enormously, and the Society recently received an enquiry about training courses on this. Feedback from PCIG members showed a high level of similar interest. Whether or not such a course could be developed is still a work in progress, but both David (for PPF) and Ian Morris, Training Manager at IOM3, would be interested in readers’ feedback.

Ultimately, the future and utility of PCIG, as over its past history, is reliant on the members who actively value and contribute to it.

Chris Penfold

If you work in Pharma and are interested in knowing more or in joining the PPF group, you can contact David Pethick (the Secretary) at dppk@btinternet .

On my own part (Chris), as well as continuing to be an active member of the PPF and a consultant, I am also the External Relations Officer of the East Midlands Packaging Society, for which you can find more information at: East Midlands Packaging Society.

You can find more help and advice on various aspects of pharmaceutical packaging at our sister site: The Pharma Gateway

This is a fantastic example of materials innovation by Queen’s University Belfast in the growing area of drug-device combination products, moving beyond just the drug component by adding some stimulus-sensitive property to allow the catheter to respond to a potential infection. Watch this space to keep up with any further developments in this area. Chris Penfold

A polymer that combines drug-eluting and self-cleansing agents could reduce the risk of bacterial infection through urinary catheters, say researchers at the University.

The material, derived from esters of acrylic and methacrylic acid, is melt-extruded in a confidential multilayer extrusion mechanism to produce a catheter surface that continuously delivers antimicrobial agents over prolonged periods, minimising bacterial colonisation.

‘Although medical device technology has made significant advancements, the inherent problems associated with implanted urinary devices and the significant role microbial biofilms play in device-related infection are now widely recognised as major disadvantages of an otherwise highly effective treatment strategy’, says Dr Gavin Andrews, who is leading the project at the University’s School of Pharmacy.

Via Materials World Magazine, 01 Jan 2010

Click on the following link to read the full article Self-cleansing medical devices

NOTTINGHAM science companies will lead a delegation of UK firms pitching for business during one of the biggest events in the American pharmaceutical industry’s calendar.

Businesses from the city account for one-third of the firms in the English delegation attending a reception during the American Association of Pharmaceutical Sciences (AAPS) annual meeting in Los Angeles.

They will meet potential customers and investors next week at an event hosted on their behalf by the British Consul in LA, Dame Barbara Hey.

The Nottingham firms taking part in the 20-strong delegation are Critical Pharmaceuticals, Design Cognition, Food and Drug Analytical Services, Molecular Profiles, Pharmaceutical Development Services and R5 Pharmaceuticals.

The US pharmaceutical market is the biggest and most lucrative in the world, with companies bidding for work in a field where the biggest firms routinely outsource research, development and service work to smaller companies.

Some of the Nottingham firms will be going to link-up with existing contacts, while others, such as specialist packaging and product development firm Design Cognition, are first- timers. Chris Penfold, the company’s chief executive, said: “We are on a fact-finding mission, to learn as much as possible about the US market and assessing where and how we can add value for US pharmaceutical companies looking to export, through our understanding of packaging requirements and regulations of global markets.”

His company is working closely with Pharmaceutical Development Services, which already has an office in the US state of South Carolina, another industry hotspot.

“Making a move into the US requires a great deal of market as well as regulatory intelligence,” said managing director Michael Gamlen.

“Close working relationships and collaboration are key to success and our respective consultancy services dovetail perfectly to add potential value for US companies.”

To read the full article, click here: http://bit.ly/Ox0hr

Watch this space for further information as I will be following up with This is Business- East Midlands (Nottingam Evening Post) after the AAPS event.