Andrew Jackson

Worldwide pharmaceutical packaging demand is anticipated to reach an annual growth rate of 5.3% making the world pharmaceutical packaging industry worth $24.3 billion in 2009.

  More than 80% of revenues will be absorbed by the 10 largest drug-producing countries.  

Growth of the pharmaceutical packaging industry is expected to follow upward trends in global medication consumption, which will expand at a strong pace as aging demographic patterns lead to an increasing number of diseases and disorders. Furthermore, the adoption of stricter regulations and standards governing the production, storage, distribution and labelling of pharmaceuticals will boost global growth opportunities for packaging products and accessories.  

Historically, pharmaceutical packaging requirements focused exclusively on preserving the quality of the enclosed medication and increasing the products' shelf lives. These requirements are now being extended to cover such criteria as the prevention of product tampering and counterfeiting, the assurance of product dispensing accuracy, child protection and the promotion of patient compliance with product dosage schedules.  

Pharmaceutical noncompliance is a tremendous problem in the US, resulting in an estimated $100 billion expense every year while being blamed for the deaths of over 125000 Americans annually (342 people every day). Ten percent of all hospital admissions are the result of pharmaceutical noncompliance and 23% of all nursing home admissions are as a result of people's inability to take their medications as prescribed.

In February 2004, FDA published the final version of 21 CFR Parts 201, 606 and 610 to reduce the number of medication errors in hospitals and healthcare settings. The rule specifies that the packaging of all human drugs be labelled with a linear bar code containing the National Drug Code (NDC) number that serves as a universal product identifier. This 10-digit code identifies the labeller/vendor, product, trade package size, the specific strength, the dosage and the formula for a specific firm. 

According to the Healthcare Compliance Packaging Council (HCPC), the National Quality Forum (NQF) and FDA, the implementation of unit dose blister and strip packaging places a further restraint on the intentional or accidental misuse of pharmaceuticals. Furthermore, the EU specifies that all prescription drugs dispensed directly to patients be in a unit dose packaging. FDA describes unit dose packaging as the only packaging format that can accommodate bar codes on packaging labels for each dosage of medication dispensed to patients.

Coding and marking technologies for the primary packaging of pharmaceuticals must constantly evolve to meet the emerging industry trends and associated regulations. Bar coding methods have been traditionally chosen according to three main criteria: 					

the kind of data required to appear on the bar code (numeric symbols, alpha-numeric or special characters).  

the amount of available space on which to print and the specific location of the bar code. 

Where the bar code needs to be placed near an edge, there is a considerable risk of misreads (when a scanner cannot read the bar code). 

There is a wide variety of printers available for coding and marking pharmaceutical primary packaging including thermal transfer, inkjet, dot-matrix, laser, flexographic and colour change. It is not easy for companies to choose the appropriate technology that would suit their specific needs. The right choice depends upon the company's top priorities regarding legibility, cost, speed, ease-of-use, cleanliness and security.  

 These are more appropriate for production line bar code printing. Specifically, thermal transfer printers produce high quality, legible and clear bar codes, as well as other types of codes. Because ink is not involved, there is never any quality degradation during the process. Moreover, such printers are virtually maintenance free while they can also be connected to a software network for record-keeping purposes, which helps with validation. The main drawback of this technology is that although it can be set up quickly, it lacks printing speed. 

 These are the fastest and least expensive units available on the market. Unfortunately, there are considerable limitations to what they can print. In addition, they require frequent maintenance and can be quite messy. Another major downfall is that the print fades after successive use. Water-based inkjet fluids tend to streak and blur, while nonwater, soluble inkjet fluids produce a shine that reflects to the scanner and affects how the bar code is read. 

 These printers produce low-quality codes with low contrast, although this depends on the ribbon used. 

 These are off-line devices requiring a separate label applicator. A further disadvantage is that they are subject to toner flaking, meaning that they are unreliable for long-term bar code printing. 

 This more recent method uses a high powered beam to ablate the bar code onto the label by burning away a black ink patch to form the white spaces by exposing the underlying substrate material. However, this method results in high emission levels and can also create problems for bar code resolution levels. 

 These produce high-quality images, thereby being most suitable for printing small characters but they can be costly to use and maintain because a plate change is required for every coding change. 

 This is a noncontact, high resolution, low emission technique that generates high definition data, bar codes and graphics to an infinite array of materials. Combining chemistry, substrate conversion and laser energy, this process uses very low power laser light for the high speed, on-demand printing of variable information on primary packaging. The subsequent laser imaging process provides a means of marking without ablation and it does not require any ink or ribbons. Additionally, the technology is virtually maintenance free, non-toxic and environmentally friendly. 

Colour change technology is equally suitable for any type of primary packaging substrate including flexible packaging, paper, board and plastics. The technology's versatility makes it ideal for a wide range of applications relating to coding, marking, and tracking and tracing. Because of the stability of the image produced, this solution provides extreme protection for brand integrity. 

In summary, scientists working in the pharmaceutical packaging industry should base their choice of printing technology on three main criteria — first, the regulations governing pharmaceutical practice, second, their company's specific coding and marking needs, and third, the benefits and downfalls each particular method involves. 

is applications marketing manager, DataLase (formerly Sherwood Technology), UK. 

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Articles

The right choice [of coding and marking technology] depends upon the company's top priorities regarding legibility, cost, speed, ease of use, cleanliness and security.

Coding and marking technologies for the pharmaceutical industry

Packaging and labelling play a vital role in the pharmaceutical industry. Labelling provides pharmaceutical companies the opportunity to incorporate anticounterfeiting and brand identification measures on products. It is also a necessity since FDA and the EU introduced legislation governing pharmaceutical labelling. 

The increasing importance of pharmaceutical labelling has forced companies to look for suitable label materials that feature all of the information required by regulation, and include branding and anticounterfeiting measures. In addition, the labels must not take up too much space on the packaging and, most importantly, not be expensive. 

February 2004 saw FDA launch the final version of rule 21 CFR Parts 201, 606 and 610. These regulations aim to reduce the number of medication errors in hospitals and healthcare environments through stricter pharmaceutical packaging and labelling control.  

The rule, part 201, requires that human drug and biological product labels include linear barcodes containing the national drug code (NDC) number. Additionally, hospitals are required to use medication administrations recording (MAR) systems (patient drug regimen in a computerized database) so that healthcare professionals can verify that the right drug, dose and route of administration is given to the right patient at the right time. The NDC number also enables the industry to track the drug throughout the manufacturing process. 

In addition, EU Directive 2001/20/EC, which was implemented in May 2004, applies to the way in which clinical trials involving human subjects are conducted within the European Community. One of its objectives is to impose regulations on the labelling of clinical trials supplies. These rules require investigational products to be labelled with increasing amounts of information such as  					

sponsor, clinical research organization (CRO) or investigator contact details

the name/identifier, strength/potency and batch/code number in open trials.

Adding to the ruling's complexity, the labelled information should be printed in the language of the country where the product is to be used. Furthermore, the information should appear on both the immediate container (such as a blister pack) and outer packaging (e.g., outer carton). The need to include so much information on a label presents a significant challenge to the pharmaceutical company, both in terms of label size and practicality, and cost. 

Various types of labels have been employed to attempt to address the challenges outlined above. Traditionally, pressure sensitive adhesive labels have been the preferred choice, however these require a time-consuming process of printing and then being applied (often manually) to the packaging. This presents the problem of continuous stop/starting on the production line, which, in turn, has cost implications.  

 The combination of information levels and limited packaging space on which a label is applied means that print-and-apply labels are starting to fall short. The label can also be peeled off the packaging at any stage during production.  

Counterfeiters use a wide range of methods to get their products into the supply chain. One of the principle ways is by removing the labelling and replacing it with false data; for example, expired drugs are relabelled and resold. Print-and-apply labels also fall short where 'parallel packaging' occurs — when drugs destined for one country are repackaged to be sold in another and so need to be in a different language. Counterfeiters tamper with the labelling, often by complete replacement, and sell on at a much higher price than would be the case in the original destination country. 

One solution would be to create a labelling system by which the destination language and all variable data are indelibly formed directly within the packaging material. More information could be incorporated with this method without being confined to a small label. 

 Colour change technology is a novel solution that can be used in a wide range of applications, including 'virtual' labelling. The technique eradicates the need to use adhesive labels on inner and outer pack materials by incorporating a laser responsive coating (a 'virtual label') into packaging materials such as cartons, cases and overwraps. 

Integrating high quality virtual labels into the base material or printing process is simple. The colour change chemistry is incorporated into, or coated onto, the substrate during its manufacture. Alternatively, the converter can introduce the laser responsive chemistry by either a patch printing or flood coating process, as the solution is compatible with the majority of printing and coating processes. The resulting laser responsive surface becomes an integral part of the packaging and, unlike conventional labels, will not peel or fall off. Then, on the packaging line high reliability, low power CO

 lasers rapidly produce images such as barcodes, graphics and instructions for use (often in multiple languages) directly onto the pretreated surface. 

Information can be spread over a larger area because the virtual label is integrated into the design of the packaging. Manufacturers can, therefore, include more text, barcodes and graphics on the packaging. Additionally, the resultant image can be embedded beneath an overlaminate or shrinkfilm making it resistant to abrasion and tamperproof, thereby providing an extra defence against counterfeiters. 

Virtual labels eliminate the need for troublesome transfer ribbons or inkjet fluids, which are inherent with traditional labelling technologies. Colour change technology makes it possible to create a label that incorporates a wide range of information and encoding capabilities, and remains secure throughout the life cycle of the package — this is not viable with conventional adhesive labels. By removing the need for the additional consumables, virtual labels offer manufacturers considerable cost savings. 

				 The virtual labelling process uses very low power laser light at high speed, which provides a number of substantial advantages compared with other commercially available methods, including 									

compliance with environmental regulations.

The contrast and image clarity benefit from the laser imaging process, as an extremely small spot size laser beam is used. If the virtual label requires a barcode for product tracking, then the fine laser beam provides a precise code with no line-width 'spreading'. A distinguishing feature of this technology is the ability to produce extremely high-resolution images.  

Virtual labelling provides a means of information printing that uses a change of colour in the substrate on the application of laser energy on which the printing is to appear, rather than transfer ribbons or fluids. The chemistry offers a viable alternative to traditional printing and labelling methods by abolishing the problems associated with the apparatus (i.e., ribbons, fluids, solvents, maintenance, unreliability etc.), which are particularly undesirable for sensitive pharmaceutical products. 

A German diagnostic device company is moving beyond production trials to implementation with a virtual labelling application. Switching to virtual labelling replaces thermal-transfer print-and-apply labels. The company employs two levels of virtual labelling — one for inner blister packs containing syringes or ampoules, and another on secondary cartons. The blisters are flood-coated with the laser responsive material and laser-marked with alphanumeric product name, expiration data, and traceability information. This is done immediately after sealing the blisters.  

The blister packs are then packed into a 58 cm

  paperboard carton with product identification and barcode printed by the colour change technique while the carton is stationary. Information that was printed on a label is now coded directly on the carton into a white area that matches the previous label's dimensions. 

Because the new technique eliminates consumables, the customer can enjoy significant overall cost savings. 

In an industry that faces increasing cost pressures and regulatory compliance, pharmaceutical companies have been striving for a new labelling technique that satisfies all requirements. Virtual labelling is a viable solution to today's challenges, offering a system that deters counterfeiters, increases productivity, is cheaper than traditional technologies and enables a high volume of data to be displayed clearly on the packaging.  

  is applications marketing manager at Sherwood Technology Ltd, UK. 

Virtual labels eliminate the need for troublesome transfer ribbons or inkjet fluids, which are inherent with traditional labelling technologies.

A Virtual Future

How important will anticounterfeiting measures become to protect the European pharma industry?