Medical Device Link.

Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published March 2000

CASE HISTORY

Packaging Line Dries the Tears

Laboratoires Alcon S.A. (Kayserberg, France) was faced with so much business that it couldn't see straight. The French affiliate of Alcon Laboratories (Fort Worth, TX), Laboratoires Alcon was responsible for packaging a range of eye care pharmaceuticals. To meet increased demand for its products, the firm needed to upgrade its production line that produced, filled, and packaged ampules for its eyedrops.

To accomplish this, the company needed a line integration partner that could obtain all the components needed for the project while utilizing equipment that Alcon already employed. One such piece of equipment was its Rommelag Bottelpack 4010 filling machine.

The firm packaged its eyedrops into blow-fill-seal ampule strips, each containing five ampules and ranging in ampule volume from 0.25 to 0.7 ml. To meet future demand, Alcon needed to be able to produce 12 layers of ampule strips. Also, output had to match that of the filling machine, which operated at the rate of 100 five-piece packs per minute. Alcon set a goal of 130 five-piece packs per minute.

Alcon decided to hire International Packaging Systems (IPS; Crailsheim, Germany), an engineering and consulting firm with 25 years' experience that sets up and maintains packaging lines around the world. IPS also performs personnel training as well as complete line qualification and validation.

Because Alcon used a batch-oriented filling process, no interruption could occur during filling. IPS chose to compensate for any short-time disturbances by integrating a buffer system by Eisenmann & Kraft (Kirchberg, Germany). During production the buffer system can refeed up to 30% of the capacity back into the packaging line.

After the filled ampule strips exit a cooling tunnel that carries them out of the sterile blow-fill-seal area, they enter the packaging line. It is at this point that the ampule strips enter the buffer system, which not only serves as an intermediate storage area but also as a product-orientation verification station.

Next, IPS designed the line so that the ampules pass beneath a dual-head hot-foil printer from Pago (Grabs, Switzerland) that recognizes the correct identification number for the label and provides it with a batch number, best-before date, and a print registration mark. In addition, this station incorporates a stand-by labeler as well as a reject station for the discharge of unlabeled or incorrectly labeled products.

In the new system, after labeling, the ampules move to a cartoning station where they await a Schubert SKA cartoner to erect cartons in any one of a number of formats. The unit erects and glues flat, die-cut blanks and then, using an Allen printer, imparts a batch number, best-before date, and print registration mark onto the formed cartons. At a separate station, product information leaflets are folded and inserted into the still-empty cartons. A bar code reader ensures insert conformity with the carton and product.

After the cartons are erected and filled with inserts, a Schubert SMB-F2 top-loading machine places labeled ampules into cartons by simultaneously picking up three five-piece packs. The cartons are then automatically checked to verify product presence and number.

At the next station the carton flaps are folded over, and the lid is sealed by a Nordson hot-melt gluing unit, creating a tamper-evident closure. At this stage, machinery is available to apply hanging tabs for the retail industry. After successful closure and weight checks, the filled and packaged ampules exit the line.

IPS engineered Alcon's new line to comply with FDA's good manufacturing practices. Setup, commissioning, and preacceptance of the line took place at IPS's facility so that the system could be optimized and calibrated before installation in Kayserberg.

Installation took only 10 days. IPS also trained Alcon employees at the IPS facility for one week. IPS remains on call to provide after-sales support as well as to satisfy any warranty claims.

The entire project, from engineering and supply through installation, took only seven months. Both IPS and Alcon engineers say that this accomplishment alone brought tears of joy to their eyes.