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

Design Cognition are offering a limited number of FREE product and packaging advisory sessions.  Are you worried about the non-compliance of any of your products?  Do you know what regulations your products need to comply to? – Why not book yourself one of these limited sessions and come for a chat?

 If you are attending easyFairs Packaging Innovations show at the NEC (UK 24-25 Feb) then why not take advantage of this fantastic FREE offer?  To book one of the limited 15 minute sessions simply email packagingsurgery@designcognition.com

 Places are limited though, so if you aren’t quick enough to book one, why not visit us on STAND 582 – right by the main entrance – to leave us your details and arrange a follow-up chat after the show.

If you’ve not already registered for the show why not do it now by following this link and becoming a Design Cognition visitor.

As we hurtle towards the end of January (already you say????) it is time to focus the mind again on packaging legislation.

We are routinely coming across pharma companies (small & large) who just don’t keep up with or monitor changes in packaging legislation, that will have a major impact on their businesses.

A good example is Braille legislation which is now MANDATORY for ALL pharma packs sold in Europe and has to be in place (i.e. on packs on the market) within the next 7 MONTHS.

As a consequence of non-compliance, an estimated 20% of pharma companies could have their products de-listed and taken off the market. So why do companies ignore it?

The following link will take you to a very interesting and comprehensive article on the European Pharmaceutical Manufacturer (EPM) magazine website: Braille labelling on medicines packaging

This article will give you some good tips on how to ensure that you comply and a summary of it has been printed in the latest version of the EPM printed magazine. Chris Penfold

A recent Los Angeles Times article examines how an increase in counterfeit condoms in China has health officials fearing the worst — the products “may in fact spread infectious diseases, tarnishing the axiom that condoms mean safe sex.”

The newspaper continues, “Authorities estimate that up to a third of the contraceptives used in some parts of China are counterfeits, despite improvements in state food and drug oversight. None of the counterfeits are properly sterilized, and others are of such inferior quality that they could rupture during use.”

The article details how authorities are attempting to track down what they estimate are more than one million condoms distributed throughout China, and notes how the knock-off condoms were uncovered in discount stores in New York, Texas and Virginia in 2008.

Thanks to @TheBodyGlobal for bringing our attention to this article via Twitter. More articles like this can be read at: www.thebody.com

We thought this article was worth communicating further as the issues McNeil have experienced may be impacting the packaging/products for other companies.

Annie Dallison

FDA has issued a warning letter to McNeil Healthcare stating that its Jan. 8 inspection of the company’s Las Piedras, Puerto Rico, location identified significant cGMP violations. Since 2008, McNeil has received odor complaints regarding certain Tylenol products. In 2009, McNeil began recalling bottled OTC products after discovering that packaging may have been contaminated with a pallet pesticide. The recall now numbers 60 million bottles.

http://bit.ly/7OeQMT

The development of both the BSI & CEN standards for Braille on Pharmaceutical Packaging have taken years of dedication from the Working Groups with clear commendation coming from the RNIB for the support they have received from the Packaging Industry.

The following article provides an interesting insight into the issues encountered from the RNIB perspective. It clearly demonstrates the amount of work and angst that has taken place over the past few years to make this happen and reach this breakthrough milestone. Three years ago many people thought that this initiative would never happen. It demonstrates what can be achieved by a common focus and working as a team to overcome all of the hurdles and we at Design Cognition Ltd (DCL) are proud to have been involved in these Working Groups at ‘the cutting edge’ and having been personally involved myself, wish to offer my thanks to all involved for their support and mutual respect.

 As I’m sure you will appreciate, to implement successful Braille packaging solutions for the client there is a lot of work involved from a technical & aesthetic point of view, requiring much ‘horse-trading’ to ensure that the needs of all stakeholders are met. Luckily at DCL we have the skills to understand & empathise with these juxtaposed issues and for many of our clients have delivered Braille solutions inclusive of artworks in a timely, efficient and sympathetic manner that delighted them. If you’d like any further information on Braille or ‘hands on’ help from people that have practical experience and have been through the loop, check out: www.thepharmagateway.com/about and get in touch. (Anne Dallison)

 

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.

Drug approvals from the Food and Drug Administration were flat last year compared with 2008 and warnings fell, even as the agency’s new leadership struck a tougher stance on safety.

The FDA approved 26 first-of-a-kind prescription drugs last year, up slightly from 25 in 2008, according to figures from Washington Analysis, an investment research group. New drugs cleared in 2009 included Novartis’ kidney cancer drug Afinitor and Bausch and Lomb’s pink eye medicine Besivance.

Chris Penfold – there are a number of reasons froi this trend, one of them being a reduced number odf applications – so we can’t read too much in to this report.

Sourced from Pharmaceutical & Medical News, 6th January 2010 – Washington, USA

Read the full article at: Pharmaceutical & Medical Packaging News

States News Service, 29th December 2009 via www.packagingdigest.com

(Relating to information released by the National Association of Convenience Stores in the US)

With the growing popularity of caffeinated foods and beverages – recent years have seen the introduction of caffeine-infused chewing gum, drinks and potato chips. The Los Angeles Times has reported that, due to health concerns, some health experts have proposed introducing labelling standards for caffeine.

It is believed that there is a need to educate consumers about caffeine’s effects on the body, which according to  James Lane, a professor of medical psychiatry at Duke University Medical Center, can lead to problems such as attention deficit disorder, hyperactivity, high blood pressure, and insomnia.

Personally I think that this is a sound initiative, being proposed for the right reasons, although it will inevitably lead to further problems of text fit onto already cramped packs. What do you think? Chris Penfold

You can read the full article at: The Packaging Digest