Packaging Today - Battle of the bulge

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Battle of the bulge

April 2003
Blister packs for pharmaceuticals is an emotive subject, understandably so when it is related to child protection.
This method of packaging was first used in the US in the early 70s but it is still far from perfect. Rodney Abbott
reports
Consumer watchdogs and the lawmakers have been pretty demanding over the years. Both suppliers and
users have had a tough time of it but, with fresh EC legislation on the horizon, it is going to get a lot tougher.
According to Uhlmann's Dieter Janek, who was one of the pioneers of blister packing, the concept of child
resistance to blisters began in the US in 1970 with the Poison Prevention Packaging Act.
This produced many variations of the blister, including some that were complex to produce and open. As a
result, only 20% of products in the US are packed in blisters.
In the UK the pharmaceutical blister is far more ubiquitous. Why? "Because it has never needed to be child
resistant and has always been cheaper than reclosables," asserts Stephen Wilkins of the Child-Safe Packaging
Group.
Others argue that the blister pack offers improved patient compliance, notably calendar packs, product stability
and protection, convenience, tamper evidence, hygiene and low cost, especially for small packs.
But, when fresh EC legislation materialises, many fear that costs could soar all the way down the packaging
chain. Why? Because, whatever solutions for child resistance are implemented, the probability is that blister
sizes will increase and be based on the German model involving higher gauge or different substrates and
perforation of lidding foil.
Accordingly, the minimum workable space between pockets will be doubled and, for some, base substrates the
pocket angle will need to be shallower, contributing to a significant increase in overall blister size.
Materials' costs downstream as well as on the blister machine will increase, with larger cartons and cases
required.
This will impact right through the supply chain, affecting transport, storage and distribution functions for both
suppliers and retailers.
Another challenge facing the industry is how to achieve child-resistance and limit the frustration of those said to
be in the third age [55-70].
No provision is made for the over 70s but there are many who believe that medication after this age should be
supervised by a responsible adult!
Pago has solved this problem by deadening the adhesive in the centre and putting a perforation around the
pocket. When the perforation is burst, a tab is exposed and peeled back so that the pill is accessible.
Outside of prescription drugs, the American market is still very much a bottle market.
In the meantime the lawmakers are busy tightening up the rules. In the UK the Medicines Control Agency
updated guidelines on blister labelling at the beginning of last month.
And these guidelines make it clear that, where practicable, the name and strength of the product should appear
over each blister pocket or be oriented centrally across the pack.

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Why? Because it is important that the particulars remain available to the user up to the point at which the last
dose is removed from the blister pack.
It is not possible to apply all the information over each blister pocket but, where a random display of the
information is proposed, it should frequently appear across the pack.
In all cases it is acceptable to apply the batch number and expiry date to the end of the blister strip. If
technically possible this should be applied to both ends of the strip.
Blister foils should be printed to ensure maximum legibility of the statutory information using a sufficiently large
font.
Colour for the text and the font style should be chosen carefully as the legibility of the text on the foil is already
impaired due to the nature of the material.
Non-reflective material or coloured foils should be considered to enhance the readability of the information
presented and the correct identification of the medicine.
Only a month or two ago machinery maestro Romaco staged a conference in a bid to put together an overall
picture of the effects of fresh legislation on the industry.
At that meeting it became apparent that current moves towards further legislation within BS8404 [currently best
practice] were prompted by a child poisoning which took place over two years ago.
It was suggested that BS8404 could be implemented as early as October of this year, with transitional
arrangements running for a 12-month period thereafter. Pharmaceutical industry representatives reported
serious reservations about this timeframe, given the amount of development and testing required.
When amendments are incorporated in EU legislation, the re-licensing process could become unnecessarily
complicated.
EU legislation or not, there are some who feel that the moment of truth where standardisation is concerned has
arrived, albeit to the detriment of innovation.
Leading the charge is Pago managing director Mike Cooper who is convinced that, unless the following criteria
is met, much of the stream of innovation that is currently flooding the marketplace will fail to meet the required
standards.
"We need to establish a benchmark where surface tension, adhesive and mechanical configuration parameters
fall within a range that will automatically pass the child test," he says.
"The child test is expensive and encourages children to open blisters. For this reason it is not generally liked. A
less flexible standard could reduce these costs.
"To some extent such a move will stifle innovation but this philosophy works in the States. Admittedly, it will
slow blister lines down and it may affect profitability.
"The advantage of such a label lies in short runs and, unfortunately for the industry, orders are getting smaller
and smaller and lead times are getting shorter and shorter.
"The label industry has an opportunity to offer a solution but it needs one of the major blister machinery players
to agree to a joint development programme."
Not everyone in the industry believes that standardisation is the market requirement. "There has recently been
a vast increase in the variations of pack formats and styles," says Electro-Mec managing director Ron
Garwood.

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"Its flexibility, particularly in terms of artwork to indicate varying time periods, is one of its greatest advantages.
Nevertheless, as products have become increasingly sophisticated so the variety of blister pack layouts has
continued to grow.
"The chevron-shaped blister packs, where forms are at an angle, enable more product to be packed into one
blister, a useful benefit for larger sized tablets and capsules.
"Some packs now have to accommodate two or more different products which can also be different shapes
that need to be taken on specific days.
"There are also certain drugs where there is one tablet that must be taken first and which needs to be isolated
and highlighted on the pack.
"Products do not come in standard shapes or sizes. These can vary from standard round bi-convex products
that roll easily during the packing process to flat or elliptical and multi-faceted shapes that need a degree of
agitation to aid feeding.
"Indeed, many products manufactured today can be quite brittle or fragile, causing them to shingle or break if
not handled carefully during the packing process. This can lead to unacceptably high reject rates."
While products and pack layouts are continually developing, one pharmaceutical packaging requirement that
has not changed is the need for accuracy.
Meeting these new challenges, while maintaining speed and efficiency and minimising rejects, have all but
changed the face of blister packing and filling.
Increased speeds and throughput on the packing lines have necessitated the development of bulk feed
systems to keep product moving through the feeders.
Dusty products have provided a new challenge with many tablets leaving a fine residue on the blister pack. This
causes problems in sealing, presentation and the perceived quality of the product. A means of extracting the
dust during the packing and filling process has had to be devised.
Large or awkward shaped capsules and caplets have been prone to stand upright rather than lie down in the
blister form. A special caplet orientation unit that gently pushes each caplet into the forms solves this problem
and can be used equally effectively with brush box feeding methods.
Machines are also now being designed that can alternate easily between different filling methods, depending on
the product being packed.
Product trials are an essential part of bringing a new product to the market place and again this can often
involve complicated or challenging packing requirements.
Clinical trials, for example, not only mean short packing runs but can very often involve different products in
different combinations on different days.
This requires placing a number of tablets or capsules into one blister form while a different combination may be
needed for the one immediately adjacent.
It may not always be possible, because of space restrictions, to dedicate an individual feeder to each product
and so machines have to be adapted to handle more than one product at the same time.
In ever-developing markets, new blister packaging challenges will constantly emerge. The packaging industry
has proved itself very capable of responding in the past and doubtless will continue to work with customers to
devise appropriate solutions in the future.

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Postscript :
Further information is available from: Uhlmann, 6 Lakeside Business Park, Swan Lake, Sandhurst, Berks GU47
9DN, tel: 01252 743120. Pago Labels and Labelling Systems, Centenary House, Gilberd Court, Severalls
Industrial Park, Colchester CO4 4WN, tel: 01206 755206. Romaco UK, Lakeview Court, Ermine Business Park,
Huntingdon, Cambridgeshire PE29 6WD, tel: 01480 435050 Electro-Mec, 28 Portman Road, Reading,
Berkshire RG30 1EA, tel: 0118 958 2035.

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12/27/2009