A reliable feed system for “top-heavy” vials and secure packaging for complex sets

Among other things, Bayer HealthCare LLC in Berkeley USA manufactures the drug Kogenate; the product, which is administered intravenously, is used either prophylactically or for acute haemostasis. Bayer packages the convenience set in which Kogenate is provided for use at home on a Dividella NeoTOP 804 machine.

Drugs which are intended for intravenous application at home or in emergency situations must be readily to hand with all the components needed to administer the product. This is why Bayer HealthCare LLC offers Kogenate, its medication for haemophiliacs supplied in filled vials, in a set with a swab, a blister with the infusion set, a syringe and a booklet. Until two months ago, the various components were packaged by hand. "We did have a cartoner, which erected and glued the boxes for the sets automatically before they were filled manually, but the market could not provide an automated solution for inserting the various components which would meet our requirements. The erected folding boxes were therefore brought by conveyor belt to a station where employees inserted the components into the boxes. However, the sealing, quality control and packaging of the sets in shipping cartons was again automated," reports Jürgen Danner, project manager at Bayer Technology Services GmbH. Bayer Technology Services carried out the project as owners' engineers for the Bayer HealthCare LLC division, part of the Bayer Group, at the Berkeley site in California.

The manual process was reaching its limits

As time went by, this solution, which included a purely manual packaging stage, was no longer adequate: demand for Kogenate grew as a result of its successful launch in more and more countries; a fast, cost-effective packaging solution had to be found to cope with increasing sales. "Another important reason for looking for an automated solution was the fact that fully automated processes can be validated; however, if there is manual intervention in the packaging process, organising validation is difficult. Of course, even if manual interventions are necessary within a process, we ensure that patient safety is absolutely guaranteed at all times, thanks to tough quality control of our products and extensive employee training. But the costs are high, and in any case, given the increasing sales figures, it was clear that we had to find an automated packaging solution as quickly as possible", says Jürgen Danner.

Safe handling of the vials

In June 2008, for the reasons outlined above, Bayer HealthCare LLC decided to invest in a NeoTOP 804 from Dividella AG, Grabs, Switzerland. The machine is modular in construction and was tailored to meet the exact requirements of the Bayer plant in Berkeley. The greatest challenge in designing the installation was to implement the feed and transport systems. "The vials with the drug have a seal which makes them 'top-heavy'. i.e. the products tend to fall over on the conveyor belt. For this reason we designed the entire feed and transport system so that secure and stable product handling is guaranteed - at a production rate of 80 cycles per minutes", says Stefan Ehrne, who was responsible for the project at Dividella.

Diversion ensures accessibility

The automated packaging process, with the Dividella machine at its heart, now operates as follows: first of all the vials pass through a labeller and after the labelling process they are routed to the rear of the NeoTOP machine; from there they are conveyed through the inserter module to the operator side of the machine. "This diversion is necessary on the one hand to save space and especially, on the other hand, because the machine has to be highly accessible on the operator side; conveying the products to the opposite side of the machine and feeding them from behind the machine enabled us to solve the space problem and also ensures good accessibility throughout", says Stefan Ehrne, describing another special feature of the customised machine solution for Bayer HealthCare in Berkeley.

A fully automated process with a manual option

After being conveyed to the opposite side of the machine, the labelled vials reach the NeoTOP 804 cartoner. The cartoner erects the toploading folding box blanks, specially designed for packaging the convenience sets, inserts the customised cardboard inserts and fills them with the vials and the other products, which are also fed automatically, to complete the set.

However, Bayer wanted to retain the option to intervene manually in the fully automated packaging process and if necessary to fill the NeoTOP cartoner manually. "This option is important for us because we would also like to package other products on the machine if necessary. Then we can manually channel the products on the module provided into the process, and as soon as the products are conveyed to the machine the packaging process continues automatically, as usual", explains Jürgen Danner.

Once the products have been inserted into the toploading folding boxes, they are checked for completeness, sealed with a tamper-evident label and conveyed to a balance, which weighs the boxes; here a camera also checks the presence and correctness of the barcodes and a variable data printing check is carried out. Finally, the boxes are conveyed to a shipping cartoner, which packs the boxes in shipping cartons.

Toploading folding boxes with many advantages

Bayer in Berkeley are not only impressed by the machine solution, they are equally enthusiastic about the toploading folding boxes: the contents of the set are clearly visible, and the glass vials are securely fixed and optimally protected in the cardboard inserts which are designed and manufactured individually for each customer project; in addition, thanks to their folding lid, the folding boxes are easy to open and the set components can be seen at a glance and removed easily. In conjunction with detailed instructions and pictograms, which can be printed on the inside of the large folding lid, the toploading packaging concept makes an important contribution to the greatest possible convenience in use and to clear, comprehensible communication.

The folding boxes, which are erected on the NeoTOP 804, also have outstanding features in terms of simplified logistics: the external dimensions of the boxes are always identical - regardless of the product format inside, as only the internal cardboard inserts are adapted to the product, to fix them securely in the boxes and to protect them. This means - as Bayer in Berkeley intend - that other products can also be packaged on the line without having to carry out format conversion on the machines and equipment which are located downstream of the NeoTOP 804. The shipping cartons themselves can therefore be ordered in the future in just one size, and charging/securing of pallets then becomes a matter of routine - without any format conversion being required.

Professional cooperation right from the start

In conclusion, Jürgen Danner comments: "Right from the highly professional presentation, the Dividella machine solution ran very smoothly, and the detailed preparations soon convinced us that Dividella was the right partner for our project. The professionalism continued as the project progressed and now, after the machine has been in operation for two months in the commissioning phase, we are sure that our decision to carry out this challenging project with Dividella was absolutely correct."