easyFairs Packaging Innovations Show

Anti-Counterfeiting in the pharma industry – Latest Packaging Trends & Technologies

easyFairs, the trade show specialists, are launching a new pharmaceutical workshop which will be making its debut at the easyFairs  packaging shows @ NEC, Birmingham, UK this February. The event will be organised and delivered by Design Cognition and an array of experts from the anti-counterfeiting & packaging industries.

The new ‘Pharma counterfeiting workshop’ will help delegates identify the key issues, and look at emerging packaging trends and technologies, including all sorts of overt (visible) solutions such as holograms and covert (hidden) solutions including various printing, coating and forensic technologies.

Leading thinkers and experts in the industry, will provide an unbiased and independent overview to help attendees see the ‘wood from the trees’. Taking place on 29 February (9.30am – 1.30pm) the workshop is being billed as one of the main highlights of the easyFairs event, which last year attracted over 4,500 visitors.

Amongst the speakers, Anne Dallison, Fellow of the Packaging Society and CTO at Design Cognition commented: “In a dynamic market, as well as providing a fantastic opportunity to get the latest perspective from industry experts such as the MHRA & PAGB on packaging implications of legislation such as the Falsified Medicines Directive and what it could mean for Brand Owners, this workshop will also provide an unrivalled and cost-effective means of networking with industry peers and leading-edge experts from the world of anti-counterfeiting. So if you want to stay one step ahead – you can’t afford to miss this!”

Also speaking at the show will be Jeremy Plimmer, Editor/Publisher at Product & Image Security Foundation and Chairman of West Midlands Packaging Society, who will be focusing on ‘Security Packaging – Is it a necessity or unnecessary expense.’  James Bevan, Director at Vandagraf and Agent for NetEnforcers in Europe will be looking at Internet Security and how to catch the fakers and identify fake sites.

Counterfeiting of products and packaging has become a multi-billion business, toys, dietary supplements, wine and iPhones are among the tens of thousands of counterfeit items seized every year. The speakers will bring the topics to life with real-life, hands-on examples and are encouraging delegates to bring their own packs along for a free counterfeit – audit, which can be conducted separately in a confidential environment if necessary.

Matt Benyon, Managing Director at easyFairs, comments: “Fake goods are certainly big business, especially in all this economic gloom. Intellectual property crime is estimated to be worth around £1.3bn in the UK each year and the Anti-Counterfeiting group, estimate that 12% of toys for sale in the UK are fakes. With ‘fake’ goods being such a hot topic we saw the importance of providing a comprehensive workshop concentrating just on this area, it is vital that packaging companies  help protect brands and retailers against counterfeiting with holograms or covert printing solutions.”

If you are interested in attending the Anti-Counterfeiting workshop you can register for the event here: Online Registration Form

Or for further information and a full list of speakers please contact Chris Penfold, CEO of Design Cognition, on +44 (0)115 846 1914 or email chris@designcognition.com

Delegate Fee: £149 – Fee includes full set of course documentation as well as refreshments and lunch. Places are limited and expected to go very quickly, so book early to avoid any disappointment.

We look forward to seeing you there.

Brazil’s law requiring serialisation for pharmaceuticals gains pace

At Design Cognition we believe that the following legislation will have a major impact on any pharmaceutical company manufacturing and/or selling medicinal products in Brazil. In a major drive to eliminate counterfeited medicinal products; unique labels are to be supplied by the Brazilian Government’s ‘National Mint’ for medicines registered with the Brazilian Authorities.

All medicines will be required to have labels applied to their packaging before January 15th 2012. It will be illegal to sell products without these labels in place. Pharmacies throughout Brazil will have label readers installed to verify the labels on the products in time for this deadline.

This initiative is far more controlled and constraining than other anti-counterfeit measures put in place by Governments in other country, for example in France, where 2D data matrix codes are to be incorporated on all medicines by the end of this year.

The  introduction of this legislation, although delayed from June, has taken a ‘new turn’ recently, as emphasised in September by Peter Schmitt of Montesino Associates, who provided an update on the impending law in the live Webcast, “Update: Brazil Law 11.903—An “Emerging” Regulation for Traceability & Serialization.”

ANVISA is the Brazilian National Health Surveillance Agency and was established in 1999. The law and the original ANVISA guidelines detailed a program of serialized code in 2-D Data Matrix format on a security label printed by the national mint that was to be rolled out in June 2010. Subsequent ANVISA announcements delayed the timeline, but in November, ANVISA indicated that it will require all pharmaceuticals sold in Brazil to comply with its program by January 2012.

On November 3, ANVISA posted a Normative Instruction to the Daily Journal (Brazil’s equivalent to the United States’s Federal Register) detailing its decision to move forward with the self-adhesive security labels supplied by the Brazilian Mint (known by its Portuguese initials: CMB-Casa da Moeda). According to Schmitt’s translation, ANVISA states in the Instruction that “the self-adhesive labels shall contain an individual, unique, and non-repetitive identifier, called the IUM (Brazilian Initials for Unique Drug Identifier), printed in legible characters, and consisting of a two dimensional bar code. . . . The other specifications of self-adhesive labels are the responsibility of the Mint of Brazil and will be published by that entity.”

The self-adhesive labels, often called “Safety Labels” or “Stamps” by ANVISA, “will be supplied by the CMB to each company with drug registration in Brazil, regularized with ANVISA.”

The labels will feature an “invisible marker” for authentication that can only be recognized by the special readers. Measuring 19 × 25 mm, the labels will feature “micro fibers and coloured beads visible only under ultraviolet light” along with “micro cuttings to protect against attempted tampering,” Schmitt reports.

Over the next seven months, ANVISA will be supplying readers to pharmacies at no cost to them, which will enable them to authenticate the labels.

“Data from the security labels will be connected via the IUM and Brazil’s Electronic Invoice system and will be the responsibility of the Treasury Secretary of Brazil,” Schmitt explains.

“Pharmaceutical companies have 60 days to enroll in the program (not to implement) by signing a contract with the CMB,” Schmitt adds. “Shipment of the labels to the pharmaceutical company must begin within 60 days after the contract has been signed.”

Companies will have six months to start using the label for products produced in Brazil and 12 months for products imported into Brazil, Schmitt reports. After January 15, 2012, all pharmaceutical products sold in Brazil are required to have the safety label on their packaging.

Watch this space for further updates. You can read other pharmaceutical & healthcare-based packaging articles by following this link to Design Cognition Pharmaceutical Posts

Or follow this one to read the full Brazilian serialisation PMPNews article

Chris  Penfold

Medical device packaging

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

EC Packaging Project Funding available

Later this year (July) it is expected that the EC will publish a call for proposals to support the packaging industry to find new ways of adding value to its products. Large companies (>250 employees) can receive a grant of 50% towards their costs whilst SMEs can receive grants up to 75%.  The European Commission is looking for proposals that produce packaging concepts exhibiting the following properties:

· superb barrier properties in terms of durability and protection capabilities utilizing e.g. nanocoatings or thin films for enhancing consumer safety and to extend the shelf life of packaged, perishable goods;

· smart features incorporating nanotechnology such as indicators, sensors, protection against counterfeit and tampering, product traceability indicators, interactive components or biometric components which can be added to packaging  using low cost printing technologies, such as roll-to-roll printing;

· utilisation of materials derived from a sustainable and renewable source, recyclability or biodegradability, and the applicability of resource-efficient (material, energy, water) package production processes.

Maybe you are part of a large corporation that has identified some opportunities but don’t have the finance or resource to take them forward  (e.g. a sustainability or technology project that has the potential to ‘add value’)
or on the other hand, you could be part of an academic institution, Knowledge Transfer Network or SME who has a technology that is looking for a ‘home’.

Either way – I am looking for opportunities to help match you up, build a ‘value case’ and try and get our hands on some of this funding. So if you are interested – please get in touch: enquiries@designcognition.com (putting ‘EC Funding’ in the title)

Chris Penfold

Planet Earth

I found it interesting to read Incpen director Jane Bickerstaffe’s argument against the introduction of single measures to assess packaging’s impact on the environment. There is so much ‘green wash’ and ‘hogwash’ out there, that it’s not surprising people are confused.

I totally agree that a holistic approach needs to be  adopted, considering all supply chain implications. Companies need to aim for overall resource efficiency and work towards sustainability balancing economic, environmental and social considerations. This may sound ‘easier said than done’, but as Jane points out “it isn’t if it is based on actual information about product damage and spoilage rates and a good dose of common sense. After all, that’s what we all do when we go shopping – we look at financial cost, quality, quantity, aesthetic appeal, life-span and, increasingly, many of us look at environmental information. We balance them all out and decide what we want.”

So take a ’step back’ and think again about your corporate ‘carbon footprint’ policy or your move to make all of your packaging ‘lightweighted’, ‘recyclable or ‘reusable’. You may be ‘hitting the right’ buttons in terms of government policies and legislation, but are you really doing what’s best for the planet and a sustainable future?

Let’s have some common-sense here. With a little thought, a multi-faceted approach can be justified and work. Let us know what you think!

Chris Penfold

To read Jane’s full article just follow the link to our friends at Packaging News

Blister Packaging

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 appears to be coming as a surprise but the French government seem very keen on bringing environmental labelling on packaging into force by January 2011, that’s only 11 months away now, so not much time to implement any changes to existing product packaging. 

Whilst I understand the motives behind the French move and admire them for trying to make a difference I’m not sure this is the best way to encourage manufacturers to lower their environmental impact, I’d be interested to hear your opinions. (Jane Bear)

Interesting article  – within the Grenelle Law for the environment, the French government would like to make the labelling of a number of environmental indicators on certain products a legal requirement from January 2011.  For the full article visit cosmeticsdesign-europe

As we move into the second week following the Haitian earthquake, things have been fraught for the local population, most of whom have been without food, water, electricity, or a roof over their heads. During that period dead bodies have been piling up all over the place, including hospital car parks where medical supplies have been in short supply and many of the surgical operations that have been carried out, have been done without anaesthetic.

Medical, food & water supplies packaged to survive a harsh environment

Although of no consolation to those that have perished over the past week, luckily the logistical situation is improving now that US ships have arrived and helicopters are finally getting to the places they are needed with those essential supplies. It is at times like this that we are reminded of the true worth of packaging,  in an environment where there are no fridges to keep things cool and packaging has to perform an even more essential role than normal in a very hostile environment. The packaging contains, avoiding spillage. It protects against crushing, vermin & pilfering. It preserves, providing protection for the products within and extended shelf life. It enables ease of transport, whether by plane, truck or onwards by hand and lastly it informs, providing vital information on contents, storage, dosage and application.

In summary, it provides a lifeline where, without it, medical supplies would arrive dirty and non-sterile, food would ’spoil’ within hours and water would become contaminated, leading to dysentery and further distress and trauma. So, packaging, where on earth would we be without it? Chris Penfold

Confusion still reigns over the use of food packaging containing Bisphenol A.

The food standards agency in Australia and New Zealand seem to think that the risk is ‘very low and does not pose a significant health risk’

The Food and Drug Administration in America announced on Friday last week that they feel it’s use is ‘now of some concern’ – they would like to see it’s used phased out in the food and drink area.

The European Food Safety Authority has said that it wants to discuss the FDA’s announcement and the UK Food Standard Agency says that it’s position remains unchanged and feels that the amount of BPA in food packaging “is well below levels considered harmful.”

Looks like this subject could carry on rumbling for quite a while before a consensus is reached – in the meantime, it might be best to ensure any new food and drink products you develop/launch have packaging that doesn’t contain BPA (Jane)

via EFSA to evaluate FDA decision on bisphenol A.

via Bisphenol A (BPA) and food packaging (January 2010) – Food Standards Australia New Zealand.

PACKAGING AND LABELING HELP FIGHT DRUG COUNTERFEITS

In the U.S.Food and Drug Administration’s ongoing battle against counterfeit drug products, the latest FDA guidance is aimed directly at packaging techniques.In a July guidance document to industry, the FDA set forth some suggestions for incorporating so called “physical-chemical identifiers” PCIDs into solid oral dosageform drug products and paid particular attention to those that might migrate from packaging or container labeling.The FDA defines a PCID as a product with some unique physical and or chemical characteristic that is added to the dosage form of a drug product and which “makes it possible to detect and authenticate legitimate dosage forms and identify counterfeits.”These so-called PCIDs can include inks, pigments, flavors, or molecular taggants, says the FDA. And the agency expects that many of them would be made of existing substances used in food additives, colorants, or drug products’ excipients.The FDA’s guidance document, entitled “Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products For Anticounterfeiting,” is primarily concerned with helping drug makers and applicants for new drug approvals incorporate relevant information about their PCIDs into new drug applications, supplemental applications, and annual reports submitted to the FDA.The guidance does not attempt to address radio frequency identification RFID.Counterfeits have tended to be a bigger problem overseas than in the U.S., though it is a concern here, and not just when drugs are imported. The FDA has always recognized the importance of packaging technologies as potential solutions, including but not limited to RFID.Confirming the authenticity of any individual package of drugs, or, when possible, even an individual dosage, is the essence of thwarting counterfeits. In the complex distribution network through which drug products travel, opportunities abound to introduce counterfeit product into the mix.Counterfeits can come in many forms. For example, they might be products that are just imitations, and literally lack the right ingredients, or are out-of-date versions of the real thing, or are otherwise diverted from the ordinary authorized distribution pathways. It is a recognized phenomenon that authentic and appropriate products are often mixed with inauthentic counterfeits, meaning the confirmation of authenticity often involves measures going to the individual dosage level. Hence, ideas like PCIDs.As for PCIDs that are added to packaging or labeling of drug products in solid oral dosage form, the FDA makes specific recommendations on how to evaluate toxicological concerns and offers guidance on when and how to report or request approval of the addition of a PCID. The agency points out that, as expected, its “toxicological concerns are mitigated if the added substances is a permitted direct or indirect food additive,” or listed in the FDA’s Inactive Ingredient Guide.If the substance you want to use as a PCID in packaging is not the subject of known toxicological information, the packager should, says the FDA, determine that there won’t be migration of the substance into the products. If some interaction of the PCID with the product is expected, and toxicological concerns may result, the FDA suggests packagers contact the agency to discuss the issues. If the toxicology of the substance hasn’t been established, and the potential for its migration exists, the FDA says the drug product with that PCID in it would require a prior approval supplement before marketing.When it comes to PCIDs in solid oral dosage-form products, the FDA is hoping to help industry follow one of its key pieces of advice: Use a multifaceted approach to counterfeiting in order to stay at least one step ahead of counterfeiters.

via Healthcare Packaging – December 2009 : ANTI-COUNTERFEITING: WHEN PACKAGING AND LABELING HELP FIGHT DRUG COUNTERFEITS.