The pharmaceutical packaging market is constantly advancing and is expected to experience annual growth of at least four per cent, to US$18.2 billion, by 2005. As with most other packaged goods, the combined concerns of profitability and product protection means that pharmaceuticals need trouble-free and speedy packaging solutions.
Constant innovations in the pharmaceuticals themselves also have a direct impact on the packaging. Traditionally, just over half of medicines (51 per cent) have been taken orally by tablets or capsules, that are either packed in blister packs (very common in Europe and Asia) or fed into plastic pharmaceutical bottles (especially in the US). Powders, pastilles and liquids also make up part of the oral medicine intake.
However, other methods for taking medicines are now becoming more widely used. These include parenteral or intravenous (29 per cent), inhalation (17 per cent) and transdermal (three per cent) methods. Oral tablets themselves are also now available in a wide range of different shapes and sizes. These changes have had a big impact on the packaging industry and there is an increasing need to provide tailored, individual packaging solutions, which guarantee the effectiveness of medicines. Due to degradation from environmental factors, such as light and humidity, there is often a direct link between packaging and a remedy's effectiveness.
In recent years, the introduction of new laws concerning the supply of medicines has had a serious impact on the packaging of oral medicines.
Legislation now ensures that packages are easy to dispense, child-resistant but senior-friendly, identifiable, functional and hermetically sealed.
The standard packaging forms of oral medicines generally conform to these requirements. However, some innovations provide added benefits in one area, but may not conform to the expected standards governing another. For instance, blister packs provide convenience and ensure hygiene. They are ideal for our fast-paced lifestyles recognising the need to take medication on the go and, as a result, there has been a large increase in their use.
Indeed, blister packaging provides the best worldwide growth prospects among all pharmaceutical packaging products, with demand increasing 6.2 per cent annually to US$4 billion in 2005. However, alongside increased hygiene and convenience, the medicine still has to be childresistant and identifiable. Not many blister packs fulfil this requirement, going against recent government proposals to ensure that medicines containing aspirin, paracetamol and iron are supplied in child-resistant packaging, to cut the number of accidental poisonings.
In fact, the proposed legislation particularly targets blister packs. Identifiable packaging is also now being given more attention than in the past. The advantages of being able to trace a tablet, pill or capsule back to the time, day and factory where it was produced have obvious health and safety implications. The UK's Committee on Safety of Medicines (CSM) is proposing that the packaging of all medicines should carry information in a standard format, or 'number plate', to allow patients and health care professionals to check drug and dosage details quickly.
The CSM also wants the packaging and labels of medicines to be redesigned so that products are more individually identifiable. It believes pharmaceutical companies should undertake user testing of labelling to ensure that it is understandable.
Linked to this is the increasing trend to change the status of traditional, prescription-only medicine to overthe-counter medication. Labelling and instructions on the medicine need to be clearer than before, as less doctor guidance will have been given concerning the safety of the medicine.
Advances in the packaging machines themselves has seen the incorporation of precise filling mechanisms, as the wrong dosage of a medicine could be life threatening. Gentle handling is also essential and packs have to be hermetically sealed. A solution to achieve hermetically sealed packs for blister, blow-fill-seal pouches, vials and other products is to overwrap them into a horizontal flow wrap. These flow wraps consist of a foil laminate that is able to increase the shelf life of the product as well as to ensure 100 per cent tightness.
Some packaging needs are not driven by the need for hygiene, safety or traceability. The increased focus on marketing of pharmaceutical products will become even more important in the future and will drive factors such as the need for flexibility in terms of various pack types and sizes. Other needs are simply driven by costs as pharmaceutical manufacturers face increased financial pressures throughout the entire production and packaging process. As a result, packaging machines have to become more efficient and user-friendly, offering flexibility, easy operation, robustness, intelligence and protection from interference. It is not easy to cover all these aspects at once.
The continuous concentration of production locations in the pharmaceutical industry will lead to smaller batch sizes. If existing packaging equipment is used, this will have a negative effect on productivity, as older machines are not designed for quick changeovers and flexibility. New packaging lines will have to offer high flexibility while maintaining production levels. At present, only about 10 per cent of all packaging lines are run in high-speed areas, with another 10 per cent working at low speed.
The largest share, 80 per cent of pharmaceutical applications, are running at 100 to 300 packs per minute. This performance range demands complete systems that are decoupled and very flexible. Availability is an absolute must in the pharmaceutical industry, which necessitates the highest possible packaging speeds combined with minimal waste and high flexibility. High-speed lines can produce the requested small batch sizes within a few hours, but then resetting formats needs additional hours, which has a negative impact on the overall efficiency of the packaging line.
Format changes should be able to be performed within 20 to 30 minutes. To cope with this, the whole packaging process, which includes all modules and machines used in the entire system, must be completely harmonised. It is of no use if the majority of machines can be changed to handle a new batch within 15 minutes, but it then takes more than two hours to do the line clearance because some areas suffer from poor accessibility.
One area in which changes are taking place to accommodate quick changeover times is in the increasing use of robotic toploading solutions, which are replacing sideloader technology in the packaging of cartons. With smaller and smaller batch sizes - in some cases, batch sizes of 20 packs or less are already a reality - toploaders increase the overall efficiency of the line. When compared to sideloading, toploading provides a significant reduction of the format change time, from two hours to less than 30 minutes, and also offers much greater flexibility for use with various pack types and packing patterns.
To ensure product quality and consistency, pharmaceutical companies are now increasingly demanding that all the machinery is modularised and standardised. This includes a standardised operating interface and a standar-dised control system for all components. Such systems also now incorporate sophisticated monitoring systems for maximum production safety. With standardisation and modularity, profitability is increased, as the packaging lines now allow rapid changeover times to provide different dosages of the same medicine in different pack types.
It is not only the technology and its standardization that is sufficient to produce high efficiencies. The entire packaging process needs to be harmonised and there is a huge optimisation potential in this area. Within the pharmaceutical production and packaging process, there are many operations and interfaces between process steps that are still performed manually. In the future, many of these tasks will be taken over by flexible robotics technology. For example, the entire feeding process of products coming from batch production and fed to the packaging line is, in most cases, still a manual process which will be automated within the next few years.
Having looked at packaging, the pharmaceutical industry is starting to demand that equipment suppliers should not just sell a packaging machine or line, but should look at the entire production process and consult the customer over optimizing the whole process. This includes material flow, labour utilisation, production planning, format changes and many other aspects. There is also now a growing trend for packaging companies to supply not only the packaging hardware but also the software to accompany the machines.
Some packaging companies offer on-going training to ensure that strict packaging regulations are met. As the evolution of the pharmaceuticals industry quickens, packaging systems providers must remain nimble to keep pace with the industry's needs. Diversified methods of drug delivery, new products and increasingly stringent standards all impact on the variety and complexity of the packages. Volumes too are increasing, placing greater emphasis on speed and reliability. The market is cogent and valuable, but the packaging industry has to embrace continuous development to exploit it.
- (Source : sig-group.com)