Blister packaging machine | The effect of materials on blister packaging

Blister packaging machine

The first blister is made of transparent PVC and covered with aluminum foil for sealing. While this combination is still used in some products today, most licensed drugs are now packaged in different combinations. There are two drivers for this: on the one hand, the use of new materials that offer a higher degree of product protection, and, on the other hand, regulatory and legislative pressures, which will continue to have a significant impact on drug manufacturers.
The importance of product protection varies depending on the product's sensitivity to moisture and the climate of the supply area. PVC will show bleed over time and is therefore not suitable for sensitive products in wetter parts of the world. Alternatives developed over the years include PVC/PVDC combinations, multi-layer and proprietary films, PET and PP, and ultimately aluminum-aluminum blister. Most combinations are in use now, some need specially adapted forming stations: for example, PP requires special handling because it has specific characteristics when heated, while aluminum must be formed with care to avoid stress points that can lead to pinholes .
By far the biggest influence on material selection has been increasingly stringent regulatory controls, especially with regard to the child-resistant properties of blisters. This started with The Poison Prevention Packaging Act of 1970 in the US, which led to the production of a wide variety of blister packs, including some extremely complex blister packs, both for the production of blister packs and for patient use. Open when packing. As a result, only 20% of products in the U.S. are packaged in blisters, the vast majority of which are oral contraceptives and rarely, if ever, associated with accidental poisoning.
Since 1979, Germany has developed the DIN standard for pharmaceutical packaging, which has a more user-friendly solution. These are mainly based on the variety of covering materials and the use of easy tear holes. There are specifications for both push-open and peel-away blisters (see Table 1), and they appear to have achieved their goals, suggesting a more lenient approach than what is being done in the United States. In fact, despite the increased use of sachets and blisters, the incidence of accidental poisoning has not increased over the years, according to the UK OTC Medicines Council.
Many EU countries are considering or are introducing legislation, and the EU will soon introduce its own blister specification, which will replace existing legislation in all member states. At the same time, manufacturers must try to find a compromise solution for affected products while ensuring child safety, without compromising the accessibility of blister packs for seniors, and with minimal impact on operating procedures and costs.
As with every business area, cost is a key factor. In many parts of the world, life expectancy is increasing — an ideal situation that inevitably puts pressure on health care budgets. Therefore, governments have put pressure on drug manufacturers to reduce the cost of drugs - as early as the early 1990s, Hillary Clinton, the wife of US President Clinton, made a commitment to the US Health Insurance to reduce costs. Consideration . The debate continues to this day, with some major changes in the way companies operate over the past few decades. New business models have had a considerable impact on the role of blister devices, breaking the industry's traditional preconceptions and boundaries.
The biggest change is the level of resource utilization. Traditionally, due to the need to avoid product cross-contamination, the pharmaceutical industry justified lower equipment utilization than other industries: many production lines, dedicated to producing specific products.
However, under pressure to cut prices, manufacturers will have to find ways to cut costs if they want to remain profitable. In this case, it is not feasible to leave valuable production space and production tools idle waiting for the next batch of products. As a result, production lines are increasingly being used for different products, exposing the issue of downtime for cleaning and changeovers to the spotlight. According to the old scheme of the main line, the time it takes to replace the product is roughly irrelevant, as it is unlikely that it will be necessary to proceed to the next batch immediately. Another complicating factor is that batch sizes are often decreasing as buyers employ just-in-time strategies to reduce costs, while different regulations in different markets affect factors such as the number of products in a package and the number and location of markets.