Working With the Pharmaceutical Industry

Every time I open a box of aspirin, I'm amazed. First, it takes me a half an hour to figure out how to get the top off. Then I have to pull out miles of cotton wadding. I have to get out my magnifying glasses to read the mouse type on the product information sheets. And, finally, it takes what seems like an hour to unfold the directions. This is what amazes me most. (Could it be because it's one of my company's specialties?). It's incredible that such large sheets of paper can be folded down to such tiny sizes.

It's also interesting that, according to industry pundits, these sheets will continue to get larger and the type will continue to shrink as the FDA requires more and more information to go on these so-called labels.

Government regulations are no where more stringent than in the pharmaceutical industry, and they get stricter every day. To succeed as a vendor to this industry, packagers, printers and finishers have to be extraordinarily diligent in monitoring production of these items. Hence, the attention to quality control, such as SOPs, GMPs, ISO 9000 and TQM methods, and the importance of partnering.

These are labels? The FDA technically defines those micro-type instruction sheets as labels. However, we call them inserts and outserts. These production information sheets (P.I.s, for short) can be one of the most complex pieces we manufacture: They have to contain volumes of legally required information and be small enough to fit into even the smallest package. Quite a challenge.

So, how do we meet the challenge? Having the right equipment is essential, since we must be able to not only guarantee accuracy in production, we have to do so at a competitive price. For example, I know a printer who specializes in the pharmaceutical industry who has a Rotoflex that automatically, and at high speed, 100% inspects and certifies printing throughout the press run. This press can find faults in missing copy, barcode placement as well as in ink density.

While inserts and outserts are nearly synonymous with pharmaceutical printing, there are a number of other products that are just as specialized and FDA-regulated. For instance, one product my firm sees a lot of are the 20"-long tabbed and varnished pieces that are folded down to 3" x 5" file cards. Physicians are required to keep these on file for any medication they prescribe.

Although my company doesn't produce outserts, these are generally handled by companies specialized in pharmaceutical folding, the fact that we have a pharmaceutical folder enables us to manufacture a large volume of inserts, for the pharmaceutical industry and others.

Mini-pharmaceutical folders. This piece of equipment is remarkable for its versatility. Not only can it fold an 8.5" x 11" sheet down to a size enabling it be inserted into a tiny box of Visine, it can fold a full press sheet into a miniature booklet that's outserted onto wine bottle-necker. While these folders are most commonly used for pharmaceutical products, they are also widely used for product information and promotional literature for other industries, such as cosmetics, high-tech and electronics. For example, my company uses our two pharmaceutical folders to fold miniature brochures, catalogs and directories to fit inside CD-ROM jewel cases and cosmetic packages or to be glued onto point-of-purchase displays.

Glues and outserts. As folding is to inserts, gluing is to outserts. Here, too, your finisher must have the right equipment and know the right glue to use on substrates. Hot melt removable glues are the most commonly used to adhere outsert medical instructions. These can stick paper to paper and paper to plastic, most metals and glass. My company just finished a project, all done automatically, that used a removable glue to adhere a 20" x 13" product information sheet, folded to 6.5" x 5", to the uncoated back of an 11" x 15" card stock dosage chart. Spot applied to the back panel of the folded sheet, the glue kept the instruction sheet from getting separated from the dosage chart, yet allowed the physician to easily fold out and read the instructions. This particular job also required removable adhesive strips on the top and bottom of the back of the dosage chart so it could be adhered to a wall or bulletin board for easy reference by the physician and administering staff. All gluing and folding was performed automatically.

Hot melt removable glues are also widely used to affix prescription instruction sheets to plastic and glass containers. A latex-based glue, they have the consistency of rubber cement and can be applied in spots or in a continuous line, enabling documents to be easily peeled off without leaving a sticky residue or damaging the information.

Custom equipment can automatically apply, or tip, these glues to outserts and topserts onto a wide range of packaging. For example, our Attacher can affix decals, magnets, pencils, tokens, embossed or thin-mil cards, coins, keys, brochures, liquid packs and reply devices to sheets, signatures, envelopes and other host documents.

Fugitive glues are sometimes used for spot gluing product information to paper host substrates. This glue holds long enough for folding and other operations to take place, but later evaporates, leaving no damage to either surface and no residue.

With the right equipment, both removable and fugitive glues can be applied in line, an important time- and cost-saving factor.

Quality assurance and the importance of partnering. Next to having the right equipment, having well-established and compatible quality control systems is vital to a successful pharmaceutical client-supplier relationship. Printer and finisher must not only have their own internal controls, they also have to be able to meld these systems so their respective operations are seamless and flawless.

One printer I know employs what he calls a "problem prevention" total quality management process. Standard operating procedures (SOPs) include segregating all work areas and purging each one of everything having to do with one job before another is brought in. All materials are identified with tags, at the time of receipt, through all work stages and as finished product ready for shipping. He also has a quality auditor on staff to ensure SOPs are continually followed.

Since these clients hold their suppliers to the same rigid standards to which they themselves must adhere, pharmaceutical houses often prequalify vendors. In some instances, they even send out their own quality control teams to inspect a supplier's premises. Generally accepted as the standard for measuring quality in production systems, the ISO 9000 series is fast being adopted both by pharmaceutical houses and their suppliers and is becoming a determining factor in prequalification. Because of our work with the industry, my company is well into the certification process.

Bottom line... in no other industry, with the possible exception of high-tech, is the concept of partnering more important than in the pharmaceutical industry. Printer and finisher must be perfectly tuned to each other's production methods and quality management processes. If not, the relationship is likely to be as difficult as trying to open that aspirin bottle.