The medical market has two unique requirements compared with other manufacturers that use packaging machinery; the first it that it operates in a tough regulatory environment and the second is that it typically has a large range of products that dictates regular changeover of the packaging process.

In the pharmaceutical and medical industry, packs are part of the product, rather than just a vehicle to get the product to market. The pack maintains sterility and is vital for the product's functionality. Since the big and bulky products such as drapes, tubing sets, tracheal tubes and syringes, cannot be automatically packed on a pouching machine (four side seal flat pack), the thermoform technique of packaging has become a vital part of sterile packaging as the only form of automatic packaging that can satisfactorily generate a 3D pack. The pack is constructed with two materials; the lid, from a film, paper or foil, and the base (the formed part), from a thermo plastic (melts when it gets hot) laminate. This technique can produce a cavity in a pack typically up-to 6 inches in depth. Not only is a thermoform pack advantageous with bulky products, but the pack seal generated provides the high integrity peel/seal required by the industry. With the correct choice of lidding material, the thermoform pack can be sterilized in all the normal ways required by the industry (Gamma, ETO or steam in some cases).

In order to meet the medical market requirements, the thermoforming machine has to be of an exceptional standard. The medical market has inherited the thermoform technique from the food industry and in so doing the machines have hitherto been a compromise. As a specialist packaging machinery manufacturer for the medical industry, Doyen felt a need to design a Thermoformer to meet the requirements of the industry. There are a number of key factors that need to be built-in to a medical grade Thermoformer. The first is that it must be easily validated. The second is that it must be able to accommodate regular changes and sometimes even fundamental alteration in application. With conventional machines this can be a contradiction in terms since regular changeovers often corrupt machine validation. A major operational issue is also that the changeovers should require minimal skill, so the use of memory based recipes and servo controls is mandatory in the design of modern machines.

Cavity formed from a Thermo Plastic Laminate (MT2500 - Tool-less Changeover Thermoform Packaging Machine)

Filling the gap in the market for a medical grade Thermoformer is significant enough, but now Doyen has gone one step further. Thermoform packaging machines are not inherently versatile. Unlike a four side seal poucher, they do not allow different pack sizes to be produced on one machine without tool changes, due to the need to change or adapt the forming and sealing stations as applications vary. Conventional machine suppliers have two answers to the problem. The first is to supply sets of change parts, which are then used to change the machine. Extra tooling is not only costly for the customer, but it will take up to 2 hours for a machine fitter to changeover the machine. The second option is to invest in one machine that has multiple sets of tooling built into it. This can be costly and usually means larger machines, and even then the machine is limited in its changeover capability to the number of tooling sets that have been supplied.

Doyen have now patented a unique way around the problem. The new system is a hybrid machine that can be changed from one product size to another in a matter of minutes and without changing the seal head tooling. The new Tool-less Changeover Thermoformer (MT2500) is revolutionary to the industry, and it will reduce costs, increase flexibility and reduce machine downtime. Most importantly, manufacturers can now achieve their goal to mass-produce a large number of different products on one machine! So what does the future hold for Medical Thermoforming? Medical Thermoforming will continue to grow as an important component of medical device manufacturing. The flexibility and adaptability now being offered by Doyen machines mean that Medical device manufactures now have a wider commercially justifiable scope in the choice of their packaging medium, and can at the same time benefit from Doyen's huge experience in the supply of validated systems into the medical market.

Paper Lid Sealed and then cut with flying Knife (MT2500 - Tool-less Changeover Thermoform Packaging Machine)