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Pharmaceutical Labeling



Servicing the pharmaceutical industry’s labeling needs requires a healthy mix of dedication and flexibilty.



Published August 27, 2010
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Pharmaceutical Labeling

Servicing the pharmaceutical industry’s labeling needs requires a healthy mix of dedication and flexibilty.



An extended content label from Cortegra
Pharmaceutical labeling is an area of the industry in which a label’s function – its role in identifying and explaining what a product is and does – is of the utmost importance. Regulations must be adhered to, because a text slip-up in dosing instructions, expiration dates, or ingredient lists could amount to dire consequences. End users of these products trust that their medicines are labeled accurately, and they also trust that the integrity of the package has not been comprised. Again, dire consequences.

Converters that manufacture pharmaceutical labels must be up on the latest regulations, as well as have certain capabilities, particularly in the areas of inspection and quality control. Pharmaceutical labeling can be considered a specialized area, as some converters print only pharmaceutical labels and other products for the broader healthcare markets. There are others, however, that list pharmaceuticals among the many PS products they offer. Regardless of how a label printer positions itself within the market, pharmaceutical labeling requires versatile, quality-driven capability.

HP Mile, Syracuse, NY, USA specializes in pharmaceutical labels. Trevor Richardson, the company’s VP of sales, provides a concise but comprehensive overview of the topic: “Pharmaceutical label printing can be a complex mix of functional performance requirements, specific application demand, business process compliance and on-press converting challenges. Legislative requirements, multilingual demands and brand security are all taken into consideration when designing or printing a label,” he says.

Extending content and capability
With pharmaceutical labels, and the healthcare packaging market in general, it’s function over form. End users are less concerned with graphics that pop, and more concerned with straight facts and information, as well as adherence to regulations.

“The most effective pharma labeling designs usually have very clean, basic artwork,” says David Puopolo, VP of Axiom Label Group, Compton, CA, USA. “And the artwork is usually positioned so that as much room is made as possible for the various information now required on pharmaceutical labels. As we now see on all of these products, not only ingredients, but also warning statements and drug facts have to be clearly visible on each label. The consumer’s ability to find what he’s looking for on a label is the key to an effective placement,” he adds.

An important factor to consider, in regard to all of the necessary text these labels must include, is just how much of it there is. Not only do there a need to be the instructions, warnings and ingredient information, but it often has to be in a number of different languages.

With space at a premium, distinct converting and printing trends have developed. For starters, the ability to legibly print very small fonts has become an extremely important capability to have.

Cortegra, a Fairfield, NJ, USA, based label and packaging converter for the pharmaceutical and related industries, has leveraged the latest in prepress technology in order to tackle the small font challenge. “The capability to print very small fonts with the highest level of precision require CTP (computer to plate) graphic capability, quality printing materials and the ability to inspect with vision systems where needed,” says Leslie Love, national sales manager for Cortegra.

Love also notes the move toward booklets and other constructions to accommodate the need for more space. “More copy on smaller bottle labels has created a whole market for the multi-layer, multi-language and multi-page booklets. In addition, innovation in providing multi-layer labels for patient records continues to be of interest to many pharmaceutical companies,” she says.


The ability to legibly print small fonts is crucial, as seen in this OTC label from Axiom.
Axiom’s David Puopolo emphasizes that the most important thing for pharmaceutical label printing is legibility of text. But confounding this, he says, are frequent changes being made by the brand owners. To overcome this challenge, Axiom has invested in digital print technology. “Many OTC marketers change ingredients frequently. We also found the quantities reduced on runs because of these ingredient changes. In response, we invested in HP digital presses. The print quality for one- and two-point type is superb, and also, with the reduction in quantity, we can through-put more SKUs in a just-in-time fashion without fighting the print quality or remake of plates,” Puopolo says.

Keller Crescent, a pharmaceutical packaging specialist headquartered in Greensboro, NC, USA, has also taken note of what digital can do. Ernie Chaplin, VP Marketing, says the company has recently made a deal with digital press maker Xeikon. “There’s been a significant shift in embracing digital print technology, and a move away from flexo and letterpress. In the late fourth quarter of this year we will be producing digitally printed labels. We’ve spent the last four years researching the technology, and we decided to go with Xeikon. It’s going to allow us to address market requests for lower volume, and quicker turns, and it’s also going to help in reducing waste and spoilage of paperstock,” says Chaplin.

Tom Spina, president, Luminer Converting, Lakewood, NJ, USA, a converter that specializes in expanded content and extended text labels, feels the most impactful trend is the increased regulations and the language requirements that go with it. “With the government requiring many different languages, but the containers getting no bigger, there is only one solution – and that is multi-page labels. This trend is the same in chemicals, lubricants and other potentially dangerous products. And it means presses have to become more sophisticated and the companies that run them more inventive to be able to find solutions,” he says.

Having the capability and know-how to create these multi-page, extended content constructions is a key asset for printers of pharmaceutical labels. And as marketers try and make do with less packaging, being creative is critical.

“Due to economics, many OTC pharmaceutical companies have eliminated the box or insert to create a two ply or three ply extended text label to include all the pertinent information now required – including bi-lingual and tri-lingual drug facts, and ‘how-to-use’ statements,” says Puopolo. “These two or three ply constructions can allow a consumer to peel the top ply of the label and read text on the back panel of the label or an extra panel below. At Axiom, we have a proprietary 16-color press with dual webs that allows us to print this construction (called Twin-pack) in one complete pass.

“We also can laminate a coated one-side sheet and fold it accordian style onto a clear carrier for a three panel onsert called Promo Pack. This is perfect for drug facts info. The print methods for most of these labels are usually flexo because flexo presses can have the integrated folding equipment and dual webs,” he says.

Having the right equipment is crucial, and equally as crucial is not pigeonholing oneself as just one specific type of converter, according to Tom Spina. He says that with pharma labeling, challenges create opportunity. “Many companies are still caught up in the ‘label business’ or ‘flexo business.’ If you do that, you may be out of business. We use all different types of equipment including digital sheetfed, offset, inline fold, offline fold, sheetfed gluing machines, narrow web flexo presses, digital web, inline gluing, etc. It is by having this great flexibility that allows you to take on challenges whether by pharma companies, or any others. But of course, in pharma, you must be able to control not only the equipment, but the record keeping and procedural activity as well.

“Our business revolves around multi-web constructions. So both purchasing outside, and building equipment internally to do this is the backbone of our business. In our plant you would see several processes which include multiple presses working as one, single presses with multi-web capability, re-registration presses, booklet presses, and latest and best inspection equipment,” says Spina.

Designed for drug trials, Schreiner MediPharm’s new film disguises differences in color, while preserving the view of the fill level.
Gene Dul, president, Schreiner MediPharm L.P., Blauvelt, NY, USA, a developer of specialty labels for the pharmaceutical and medical industries, says pharma companies’ requirements are diverse and challenging. “A label manufacturer should have an extensive expertise in materials, adhesion technologies as well as dispensing and printing technologies. Thanks to its long tradition as a supplier to the pharma industry, and its extensive expertise combined with in-house R&D, Schreiner MediPharm can cope with demanding customer requests. Flexibility and speed are key as well, since pharma customers expect not only high quality products, but also an excellent delivery performance,” Dul says.

HP Mile is seeing more opportunities in flexible packaging, and it’s providing additional options for the company’s customers. “The services we provide for labeling are a direct fit for our customers that are looking to package products in multi-layer, high barrier film/foil structures,” says Trevor Richardson.
“Flexible packaging has incredible benefits in the supply chain versus rigid packaging, and we proactively approach our customers with innovative flexible packaging structures that could work for their product lines. It just makes sense for us to also provide short run or multiple SKU flexible packaging roll stock, and our customers tend to agree when they have seen the model work so well for other printed materials we supply. It is an exciting market to have a focus for, and we’ve found a specific niche and value proposition that fits this market and allows us to participate at a very competitive level.”

Functional forms
But there’s more than just booklets, extended content, and flexible packaging that’s trending in the pharmaceutical labeling space these days. It’s hard to imagine a better candidate for security measures than a pharmaceutical label, and 2D bar coding is another area that’s become prevalent. Also, some companies have developed labels that add value by providing specific functions. And whatever the function, whether it’s security or something smart, quality is paramount.

“Certainly the accountability and traceability through the entire manufacturing process has increased over the years, although the pharma industry has always been the most strict for obvious reasons,” says Tom Spina. “Also, the need for individual label numbering has grown over the years, therefore requiring that label companies be proficient in several different methods of variable imaging.”

Gene Dul says that, in general, a label manufacturer has to meet the high quality demands of the pharmaceutical industry. “Schreiner MediPharm strictly complies with the cGMP (current Good Manufacturing Practice) rules to ensure maximum product quality and to meet the requirements imposed by health authorities for bringing products to market. This includes in-process controls and 100 percent camera inspections. Of course, post-printing capabilities, printing of variable data, backside printing and special varnishes, for example – for the printing of tactile elements – are important aspects as well,” Dul says, adding, “Current trends in pharmaceutical labeling include 2D barcoding and serialization as well as the integration of anti-counterfeiting features. Pharma companies are constantly striving to optimize and secure the supply chain while becoming increasingly sensitive to the dangers of counterfeit drugs. Also, there is a growing demand to integrate functional elements, for instance, such as label-integrated safety devices like our Needle-Trap label which helps prevent needlestick injuries.”

Schreiner also recently introduced a translucent, self-adhesive film designed for use in clinical trials to neutralize color differences between placebo and drug solutions. Here’s a case where the label is designed for the research and development of the pharmaceuticals themselves. Before being approved, every drug must successfully pass the test of clinical trials. And in many of these trials, participants are not permitted to know whether an effective drug or a placebo is being administered. Often, these trials involve liquid substances that obviously differ in color and such visual differences must be reliably neutralized. However, the person dispensing the substance must still be able to see how much liquid is contained in the vial or syringe.

The new film by Schreiner MediPharm reliably disguises any differences in color, while preserving the view of the fill level. “We are very excited to bring this product to market,” says Dul, “It is a unique, effective product that we believe will play a major role in clinical trials.” The new film can be adapted to suit the color of the liquids. In addition, it can be printed with graduation lines and product information, and a “proof-of-first-opening” element can be integrated as well.

Dedication
Targeting the pharmacuetical and medical industry’s specific labeling needs is a healthy business model, and its needs make it a good for Lean practices. “At HP Mile we utilize Lean Manufacturing principles from the very front end of the business and throughout the supply chain,” says Trevor Richardson. “Specific, dedicated work cell teams – trained in cGMP, ISO and Lean Manufacturing procedures become integrated into our customer’s business. Our team becomes a literal extension of the customer from sales through to shipping.

“Dedicating and integrating a work cell to a customer allows us to bypass many traditional hurdles and costs that are found in other label printer structures. We find that aligning our assets and resources gets our customers immediate responses and levels of service that they do not normally see. Dedicated resources also provide direct waste improvement results and lower fixed cost association. At HP Mile the customer is not paying for other assets that we do not use to produce their packaging. Many of our competitors offer kanban or pre-printed label stocking programs. Some even go so far as to offer consignment – at the end of the day, someone pays for the items produced that are not used or are aging due to changes in forecasting demand.

“At HP Mile, the dedicated work cell fits into our customers schedule – not the other way around. This negates the need for pre-printing of materials and consequently any forms of obsolescence,” adds Richardson.

Cortegra is another converter that leverages its dedication to the pharmaceutical industry with strong customer service and value. “With the consolidation of some major pharmaceutical companies and the challenging economic times, Cortegra has stood out through its strong value proposition to the pharmaceutical customer,” says Leslie Love. “Financial strength through our parent company – Menasha Packaging, expertise in the broader healthcare market such as medical device, biotech, and clinicals, and broad solutions-based product support have allowed us to stay strong. Through our Cortegra Express execution of new product launches and our close partnerships with many pharmaceutical companies, Cortegra will continue to be strong in the healthcare marketplace.

And the market remains strong. “The global pharma market will certainly continue to grow, considering demographic development, the growing number of elderly people, and emerging markets like China, India and South America,” notes Gene Dul. “However, there is also a growing trend to stricter regulations in many countries, cost pressure and consolidation trends within the healthcare market that confront the pharmaceutical industry with a lot of challenges.”


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