Trends in pharmaceutical packaging

It also remains abreast of legislative and regulatory trends. In this article some of the results of recent observations are considered, along with predictions about future developments in the pharmaceutical sector and their implications for packaging machinery.

The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five per cent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves (such as prefilled syringes, blow fill seal vials, powder applications and others) also have a direct impact on the packaging.

Traditionally, the majority of medicines (51%) have been taken orally by tablets or capsules, which are either packed in blister packs (very common in Europe and Asia) or fed into plastic pharmaceutical bottles (especially in the USA). 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%), inhalation (17%), and transdermal (3%) methods. Oral tablets themselves are also now available in a wide range of different shapes and sizes.

These changes have made 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.

Packaging of oral medicines generally conforms to requirements for easy dispensing, child resistance but senior-friendliness, but packs must also be identifiable, functional and very often hermetically sealed. 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 and the need to take medication on the go and, as a result, there has been a large increase in their use. Indeed, blister packaging has provided the best worldwide growth among all pharmaceutical packaging products, with demand increasing 6.2 per cent annually to over $4 billion in 2006.

However, alongside increased hygiene and convenience, the medicine still has to be child resistant and identifiable. Not many blister packs are child resistant and this goes 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.

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 should be hermetically sealed for higher product safety. 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% 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 cost 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 a challenge to cover all aspects at once.

The ongoing globalization trend with extended competitive landscape 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 often not designed for quick changeovers and flexibility. New packaging lines will have to offer high flexibility while maintaining production levels.

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 and line clearance should be able to be performed within a few minutes. To cope with this, the whole packaging process, which includes all modules and machines used in the entire system, must be completely harmonized. 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, very small batch sizes 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 1-2 hours to less than 30 minutes, and also offers much greater flexibility for use with various pack types and packing patterns.

To meet validation requirements, pharmaceutical companies increasingly demand that machinery is modularised and standardised. This includes a standardised operating interface and control systems for all components. Such systems also have monitoring systems for maximum production safety. With standardisation and modularity, profitability can also be increased, as the lines allow rapid changeover to cater for different dosages of the same medicine in different pack types. The increased profitability is additionally supported by lower maintenance cost.

It is not only the technology and its standardisation 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, in many cases, will be automated within the next few years. Sigpack Systems has already delivered many such automated robotic solutions to handle blister packs, drug delivery devices, medical devices, IV-bags, blow-fill-seal bottles, tubes and other products.