About Healthcare and Pharma Packaging

The history of pharmaceutical packaging follows the general trends and technological advances of other sorts of packaging, but places emphasis on a variety of issues that are only relevant to medicinal and nutritional products and their respective industries, including product security and anti-counterfeiting measures.

The primary function of any sort of packaging, including pharmaceutical packaging is to protect the product contained within, as well as providing a simple and efficient way to take the product about. Traditionally, glass has been the medium of choice for pharma packaging, as it provides excellent barrier protection from gasses, light, and contaminants. With the advent of modern materials (plastic, in all its myriad forms) pharmaceutical companies now have more options for providing excellent packaging in lightweight, easy-to-use containers.

New forms of packaging have sprung up that have led to different ways to take medicines and other health-related products. Blister packs are now far more common than paper powder envelopes and plastic pill bottles have generally replaced cork-stopped apothecary flasks. As consumers tend to be more and more mobile, the packaging produced has to keep up, such that more and more we're seeing pills and liquids packaged as single-serve items, with the added benefit of having components remaining sterile longer. Also, multiple packaging elements need to work together in pharma packaging - a medicine bottle, for example, is usually sold within a cardboard box that may also contain a product prospectus, complements such as measuring spoons or cups, and application attachments.

Thousands of medicines and health products are sold worldwide today, with most being produced by first-world nations spearheaded by the USA. Most contemporary pharmaceutical production plants are highly automated. Milling and micronizing machines, which pulverize substances into extremely fine particles, are used to reduce bulk chemicals to the required size. These finished chemicals are combined and processed further in mixing machines. The mixed ingredients may then be mechanically capsulated, pressed into tablets, or made into solutions. One type of machine, for example, automatically fills, seals, and stamps capsules. Other machines fill bottles with capsules, tablets, or liquids, and seal, label, and package the bottles. Some of the more common techniques used in pharmaceutical packaging include foil and heat sealing, olefin and polyester package printing, polyethylene or polypropylene printing, and flat bed die cutting.

The primary concerns of pharma packaging, apart from those related to packaging in general, are:

Tamper resistance

The purpose of tamper resistance is twofold. First, tamper evidence (the most common form of tamper resistance) prevents the product from being taken out without a visible indication, deterring the theft of costly medications. Second, and just as important, it provides a visual test for someone about to purchase a product, such that a package that indicates tampering may also suggest that a harmful substance has been added and therefore should be avoided. Most bottles feature a screw cap lid with a breakaway plastic ring that detaches from the cap once twisted, though other more elaborate methods include packaging which require some sort of tool to open, packaging with built-in chips that indicate tampering through an LED or other indicator, and products that can simply not be resealed after use (such as blister packs, ampoules, and others), ensuring one use per customer.

Counterfeiting

The process for releasing a new pharmaceutical product on the market is an incredibly lengthy and costly one. From the initial recognition of a market need to the release of the product in pharmacies (either over the counter or by prescription), takes over a decade. Each year, pharmaceutical industry testing involves millions of compounds, yet may eventually yield fewer than 50 new prescription medicines. The compounds must be researched, isolated, and screened, which is a lengthy process beginning with simulations, then cultures, then animals, with each step monitored rigorously for developments prior to actual human trials. Once all the testing has taken place, the results are passed on to a national agency such as the USA's Food and Drug Administration (the FDA) for review. As mentioned above, the entire process can take ten years or more, and cost a pharmaceutical firm hundreds of millions of dollars in R&D, manufacturing, and marketing, so its no wonder that firms want to control counterfeiting and ensure they recoup their investment. New measures such as radio frequency identification assign individual serial numbers to specific product containers, ensuring a reader can identify the source. Other methods rely on checking the drug itself to ensure authenticity, like Energy Dispersive X-Ray Diffraction (EDXRD) which uses a focused ray to gauge the exact density and composition of a substance within its packaging.

Child resistance

Much like tamper resistance, the means are similar, but the focus is on safety for a particular group of people, in this case, kids. Companies don't want children getting into "candy" than can prove harmful, and make sure that a certain amount of skill is required to open the packaging. Hence, blister packs need to put up some resistance rather than simply pop out with little effort. Bottles often have pressure caps that require simultaneously pushing in on both sides or down while unscrewing. Yet, the packaging can't be so complex that it can't be opened intuitively by a normal adult or by a senior with limited visibility or dexterity. Companies spend millions on making sure they strike the perfect balance.

Validation

The concept of having process and facility certification in business is not necessarily a new one, but the fact that companies can boast certification through international standards within a specific category certainly is. Companies now have the ability to say "we are ISO 9001 certified", which conveys volumes of meaning in a very short phrase. The certification indicates that the company has processes and facilities in place that ensure quality management, management responsibility, resource management, and other elements that back the product as a safe purchase for both distributors and consumers. Pharmaceutical companies even have their own specific category of packaging certification to ensure their packaging meets the standards required for processes and materials prior to having to pass local or regional compliance testing. The set of ISO 15378:2006 standards clearly details the hoops that have to be jumped through in order to foster GMP (good manufacturing processes) of pharmaceutical packaging. The standard gives guidance on both risk management and validation and contains guidance annexes on both these aspects. The standard is applicable to all primary packaging materials (glass, rubber, plastic, aluminium, etc.) and enables companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors through process perfection and auditing.

Where is pharma packaging headed?

Look for more "wow" packaging. Consumers have seen the same pharma packaging forever, and are looking for better ways to get things done with regard to medicines and health products. Some examples of innovative, "wow" pharma packaging:

Products are moving away from weighty and bulky, and are moving more towards single-serve, convenient, and portable.

Lots of products will begin to feature Braille on them, due to new international standards on pharma packaging requiring that products be sold with the blind in mind. Check this out.

Buzz words for 2012 and beyond: extemporaneous, travel, compliant, certified, Braille, dosing.

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