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Pharmaceutical Manufacturing and Packing Sourcer

Always Read the Label

Mark Beauchamp of Citizen Systems Europe highlights the latest labelling technology enabling more efficient processes in the manufacture of medical equipment and devices

In recent years, labelling legislation such as that released by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA), which affects the packaging and labelling of pharmaceuticals and medical devices, presented both a commercial and technical challenge for some companies. Accordingly, a new generation of labelling systems has been developed to help manufacturing and packaging companies meet the latest legislation, while also improving productivity and quality in a rapidly changing marketplace.

CHALLENGING LEGISLATION

There is a large volume of legislation that affects the packaging and labelling of pharmaceutical products and medical devices, which includes a vast array of products, from first aid bandages and tongue depressors through to x-ray equipment, heart valves and dental materials. For example, in the US, the FDA released publication 89-4203 that outlines the regulatory requirements for labelling medical devices. Although released in 1989, this publication covers labelling requirements that are still effective today, which device manufacturers, reconditioners, re-packers and re-labellers must consider when a product requires labelling. Essentially, the document states that such labelling must include sufficient instructions for operation and servicing, adequate warnings against uses that may be dangerous to health, and information that may be necessary for the protection of users.

In particular, general labelling provisions include the name and place of the business of the manufacturer, packer and distributor. With regards to the use of the device, this must be labelled clearly, especially if the product is to be used for conditions or purposes other than for which it was intended. For example, manufacturers of dental x-ray equipment routinely sell their products to podiatrists; therefore, the label must clearly indicate that the device is being used for this alternative purpose.

The FDA document also requires that the labels on medical devices must include adequate directions for use, which are essentially instructions under which the layman can use the device safely and for the purposes intended. This includes, where applicable:

  • Statements of all purposes and conditions in which the device can be used
  • Quantity of dose for each use and usual quantities for persons of different ages and physical conditions
  • Frequency of administration
  • Time of administration in relation to other factors
  • Route or method of application
  • Any preparation necessary for use

In addition, the publication gives extra guidelines for the labelling requirements of over-the-counter non-prescription devices. In this instance, the regulations specify the size of the label or principal display panel, as it is called, in relation to the packaging of the product. For example, in the case of a rectangular package, the label should be the height by the width of one side; for cylindrical packaging it must be the percentage of the height by the circumference; for any other shapes it must be 40 per cent of the total surface area of the container, unless a more prominent site exists.

Extensive guidelines are also given for the labelling of in vitro diagnostic products (IVDs), including reagents, instruments and systems intended for use in the diagnosis of a disease or other condition and those products used in the collection, preparation and examination of specimens taken from the human body. In particular, each label must carry the following information:

  • The established and proprietary names of the product, for example cholestrolometers
  • The intended use or uses, for example pregnancy detection and diabetes screening
  • A statement of warnings and precautions for users
  • Name and address of the manufacturer, packer or distributor
  • Lot or control number traceable to the production history

For reagents additional information is required, including the quantity, proportion or concentration of all active ingredients, and for reagents derived from biological materials the source and measure of its activity – for example bovine. Labels must also include storage instructions, instructions for products requiring mixing or reconstitution, the net quantity of the product and all appropriate warnings and cautions.

Most critically, the FDA guidelines state that all the required information must appear on the immediate container or wrapper and be easily legible, even through an outside container or wrapper. Equally, the document states that all labels must be designed and applied to devices and containers so that the labels will remain in place, be resistant to smearing and will not be abraded during use. As a result, high definition print quality is vital, as is the use of a substrate that can withstand various liquids and cleaning chemicals.

In the EU, a revised version of the Medical Device Directive (MDD) (93/42/EEC) was released earlier this year. This directive applies to medical devices and their accessories (accessories are treated as medical devices in their own right). In this instance, a medical device is defined as any instrument, apparatus, appliance, software or material used specifically for diagnostic or therapeutic purposes, as well as the prevention, monitoring, treatment or alleviation of disease.

The directive dictates that every medical device must be accompanied by the information needed to use it safely and properly, taking into account the training and knowledge of the potential users, as well as information to identify the manufacturer. As far as practically possible and appropriate, this information must be set out on the device itself and/or on the packaging for each unit, typically in the form of a label.

In particular, the label must bear the following:

  • The name or trade name and address of the manufacturer
  • The details necessary to identify the device and the contents of the packaging especially for the users
  • Where appropriate, the word ‘sterile’
  • Where appropriate, the batch code, preceded by the word ‘lot’, or the serial number
  • Where appropriate, an indication of the date by which the device should be safely used, expressed as the year and month
  • Where appropriate, an indication that the device is for single use
  • If the device is custom made, the words ‘custom made device’
  • If the device is intended for clinical investigation, the words ‘exclusively for clinical investigations’
  • Any special storage or handling conditions
  • Any special operating instructions
  • Any warnings or precautions to take
  • Year of manufacture for active devices (this may be included in the batch or serial number)
  • Where applicable, the method of sterilisation
  • Where applicable, an indication that the device contains a human blood derivative

These examples highlight the increasing complexity of legislation and the potential impact it has on labelling practices adopted by manufacturers and packers of medical devices. Consequently, labelling technology has come under scrutiny as a potential area where production gains and cost savings can be made, while still ensuring compliance with all legislation.

EXPLOITING BARCODES

Barcoding is an established method of recording, tracking and marking products throughout the supply chain, with a humble barcode holding a great deal of vital information on a relatively small surface area. Today, medical device manufacturers have the choice of a wide selection of Automatic Identification and Data Capture (AIDC) technologies. These have been developed to enable detailed product specific data to be stored on labels, identified and communicated around the world. Solutions range from printed linear barcodes to radio frequency identification (RFID) tags, but all essentially fulfil the same purpose: to provide a smarter, more versatile way of storing and sharing data.

In particular, we have seen the 2D barcode grow hugely in popularity, especially in medical applications. This two-dimensional barcode is a development on the EAN (1D) barcode, offering a more sophisticated level of data handling, while being considerably cheaper and easier to implement than completely new technologies. Similarly, DataMatrix codes are also proving to be extremely popular within the sector, offering greater data capacity than traditional barcodes.

While DataMatrix codes work in a similar way to conventional barcodes, their appearance couldn’t be more different. These codes comprise a pattern of black and white cells, typically in a square format. This makes them extremely space-efficient and scaleable depending on the amount of information that needs to be stored. Following years of development, DataMatrix codes are now a viable labelling solution for medical device manufacturers.

One of the key benefits of DataMatrix codes is the ability to store detailed product specific and logistical data, such as Global Trade Item Numbers (GTIN), batch numbers and expiration dates. The GTIN is a globally recognised unique identification number allocated to an individual product. With the GTIN accessible from the product label, retailers and manufacturers can easily verify a device at the point of use.

Perhaps just as importantly, DataMatrix codes can play a vital role in the prevention of counterfeiting and grey importing within the pharmaceutical sector. As the codes allow labels to carry product or batch specific information, it becomes much easier to spot cloned barcodes, as no two genuine barcodes are ever the same. As a result, labelling a counterfeit product for the retail market would prove extremely difficult. Additionally, the superior level of data management makes it much easier to trace the route a product has taken from the manufacturer to the shelf, minimising the potential for grey market imports. A product being sold in a market that it wasn’t intended for can be identified quickly and the correct action can be taken.

Furthermore, these latest barcoding technologies also allow companies to realise an improved level of information and the ability to manage stock more effectively. With more detailed product data, manufacturers can make informed decisions about when and where to move products around the globe to maximise profits.

Combined with the latest legislation, the use of these barcodes can increase the consistency in the labelling of medical devices for the benefit of patients and clinicians alike. However, in order for these desired benefits to be realised, it is vital to ensure that the printer technology being used is capable of producing consistently accurate and high quality results.

PIONEERING PRINTER TECHNOLOGY

The latest generation of barcode and label printers have been specifically developed to offer a cost-effective method of achieving the high degree of performance and reliability needed to optimise production levels.

These dedicated label printers are particularly easy to use thanks to their vertically opening design, and feature a far more robust construction than conventional machines, due to an all-metal mechanism. As all major components, including power supply, Ethernet connection and wireless LAN, are housed within the printer casing, the reliability concerns associated with external boxes are eliminated. Additionally, the health and safety issues relating to trailing cables on the factory floor are also minimised.

In addition, these new printers are compatible with a wide range of sizes and types of media. Labels of between 12.5mm and 118mm can be printed easily and in many different formats – including metallic, polyethylene or antimicrobial labels – for use in cleanroom environments.

By implementing a flexible and simple to use label printing solution, productivity and profitability can be increased significantly. Indeed, many new machines feature easy access side loading for ribbons, eliminating the need to feed the media through a complicated path and avoiding problems such as ribbon tangling. As the latest generation of printers feature standardised functionality, design, operation and maintenance are simplified considerably, reducing the need for staff training and cutting down on human error.

To minimise the risk of error further still, inline validation systems can be incorporated that automatically check and validate all printed labels featuring barcodes for accuracy and possible degradation. As a result, quality control and compliance with standards can be carried out quickly and reliably as each label is printed.

With these inline validation systems, an alarm is raised automatically if print quality drops – for example, as a result of contamination entering the printer’s casing and obstructing the print head. Likewise, if the print head needs replacing, staff are made aware sooner rather than later, allowing the production line to keep running.

CONCLUSION

The current regulations governing medical devices make labelling a critical element in the production process as a mechanism for delivering a wide range of vital information. With ever-increasing demands for label performance and functionality, leading printer manufacturers have developed their offerings, resulting in the introduction of technology that is simple to operate and robust. Most importantly, these developments are enabling companies within the medical devices sector to improve both productivity and profitability, as well as enabling them to be fully compliant with the latest regulations, representing a considerable commitment to improving patient and consumer safety.


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Mark Beauchamp is European Marketing Manager for Citizen Systems Europe. With over 20 years’ experience at the company and a wealth of technical knowledge, he is adept at helping channel partners and end users alike to understand the latest printing technology. In addition to working with clients across Europe, the Middle East and Africa, Mark regularly visits the company’s head offices in Japan as a leading driver in product development. Mark is Chairman of AIM UK, the British chapter of the Auto-ID Manufacturers’ Association.
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