Working with needle guards
"Holding one's own as a German company in the international contract packaging sector is not primarily a matter of price", explained Burkhard Hunold, head of project management at GP-Grenzach Produktions-GmbH (GP) which belongs to Bayer AG. It is far more a matter a providing the customer with the best overall service for his particular product.
This means taking on work steps and processes which others cannot provide at all or not at this high quality. Part and parcel of such expertise is the appropriate technical equipment. "For new and innovative products the existing production lines often require modifications", Burkhard Hunold said. In cooperation with the special machine manufacturer Bausch+Ströbel, a new machine model was developed in 2008 to label syringes, insert the plunger rods and assemble the needle guards (safety devices to prevent needlestick injuries). As the demand on the market is high and the machine design is successful, GP has decided to invest in a second machine of the same type from Bausch + Ströbel.
GP formerly belonged to Hoffmann-La Roche AG but since 2005 it is an independent subsidiary of Bayer Health Care, which in turn is part of Bayer AG. High-quality medicines, cosmetics, dietary supplements and medical products are produced and packed here daily for national and international distribution. Bayer products are processed here; one of the most famous is the Bepanthen product line. Further renowned pharmaceutical companies also have their products produced, packed and distributed by GP.
Processing single-use syringes is a major mainstay of the company; several million syringes left the factory in 2011 filled with chemical or biotechnological products and the trend is rising. 70 percent of the single-use syringes are equipped with a needle guard which is a safety device to protect the user from needlestick injuries after administering the injection. "When one of our customers wanted his syringes equipped with a needle guard in 2007, this meant that GP had to convert the production line completely in a short time to ensure that there was no interruption in the market supply. We managed to make the changes to the production to meet this requirement in record time and so we were able to guarantee the market supply for our customer", remembered Burkhard Hunold not without pride. "Due to the constantly rising demand for single-use syringes with needle guards, the capacity had to be increased. We also wanted to improve the machine design for the new packaging line even further and to adapt it to the current GMP standards", explained Markus Korneli, responsible for Packaging & Services at GP-Grenzach.
"Bausch + Ströbel was then the only supplier providing labeling, plunger rod insertion and the application of the new needle guards not as several machines but integrated in a single, compact, high-capacity machine", Burkhard Hunold said, "The production area at GP is limited and therefore precious." As the cooperation had been positive in the past, GP wanted the machines for the new production line designed by B+S engineers, too, taking the special requirements requested by GP into account. Generally, GP is not in favor of installing prototypes, but trusted Bausch+Ströbel's long experience in the construction of special machines. Basically it was a matter of integrating an additional working step into the syringe assembly and labeling machine, type SME 2018, that GP already had on order. "After labeling the syringe and applying the plunger rod, the syringe was to be inserted into the new needle guard", explained Martin Müller, in charge of the project on behalf of Bausch+Ströbel. And so Bausch+Ströbel developed the new machine type NSM 9060 and implemented the requirements specified by GP. Especially the details demonstrate the machine manufacturer's technical know-how and long experience: both the plunger rods and the needle guards have a special shape that must be taken into account in the processing. The machine has two vision systems: one to check the variable data printed on the label and the other to check from two angles that the needle guards have been assembled correctly and are intact. In addition, the usual check stations on B+S labeling machines are integrated. As an option, further cameras can be installed, for example to check the syringes for damage.
No adaptions necessary
At FAT it became clear that the decision had fallen on the right machine manufacturer: the new machine model passed all performance tests at the first go. Burkhard Hunold remembered that no adaptations were necessary after FAT. The NSM 9060 could also apply a label to the needle guards themselves as a final step. "We haven't used that option yet", said Markus Korneli. The NSM 9060 can process up to 24 000 containers per hour. However, there is more to it than speed. It is, of course, important that the machine runs trouble-free and produces the lowest possible reject rate. Markus Korneli elucidated with the example of a costly, high-grade product requiring refrigeration. "This product may only be outside the cool store for a strictly defined period of time", Markus Korneli explained. If the machine is down for some time, it must be cleared completely and the product returned to the cool store to be on the safe side. The machine must also suit the complete production process. Downstream of the NSM 9060 is a blister packaging machine. As this machine runs at a lower output than the NSM 9060, a buffer was inserted in between by Bausch+Ströbel. The buffer SPE 8090 works on the First in / First out principle and compensates fluctuations in the process so that the blister machine runs continuously.
In the meantime the NSM 9060 runs in Grenzach round the clock in five shifts - virtually trouble-free. The operating staff are very pleased with the machine and praise its clear layout. Thanks to the gentle transport system using suction wheels, damaged containers are kept to a minimum. If malfunctions should occur or if settings need modification. The contract manufacturer is highly satisfied with the quick and reliable service provided by theier supplier.