Time accuracy, reliability and performance are the key words of Steriline customer satisfaction
Figure 1-The bess pro factory in Berlin, Germany, chooses Steriline as a guarantee of reliability
Figure 1-bess pro factory in Berlin, Germany
bess pro gmbh is a Berlin-based company of the bess group that produces and distributes high-quality equipment and medical products "Made in Germany". It has contacted Steriline, a highly specialized manufacturer of complete aseptic processing lines for injections Drugs in order to increase its production volume and stabilize the process to further open up to the international market.
bess pro is committed to a series of packaging and R&D processes (including sterilization, aseptic packaging and secondary packaging), as well as product innovation and further development in the fields of head and neck surgery, pulmonology and gastroenterology, and is committed to approximately 1,000 small batches of medical treatment Types of devices and pharmaceutical products.
Customer requirements include replacing manual and laboratory machines with automation solutions with better performance, more reliability, and a very small footprint. Steriline was chosen mainly because the company focused on producing small-volume machines for complete automatic lines (including washing machines and depyrogenation tunnels). The two companies started a successful cooperation with the goal of fundamentally enhancing the existing manufacturing process of bess pro, and it was a success.
The brief introduction of Steriline by bess pro includes a new complete production line, which includes a rotary washing machine (RA-V4), a depyrogenation tunnel (ST0), a new powder filling, plugging and capping machine under laminar flow (PVFCM50), All of them are equipped with customized specific modifications.
The most significant challenge is accuracy: Considering limited resources, customers need to produce small batches at a reasonable cost and always clearly meet the international regulatory requirements for medical devices and pharmaceutical products (such as FDA and GMP).
RA-V4 is designed to process vials and ampoules with a capacity of up to 7,200 per hour using intermittent motion. All fluid handling components in contact with the inside of the container are made of AISI 316L stainless steel. Other elements, such as frames, shafts and bearings, are AISI 304 stainless steel. The glassware is loaded on the rotating table, and each piece of glassware is automatically picked up by the pliers and repositioned to obtain the best cleaning and drainage effect during the passage through the washing and drying station. These workstations are equipped with lifting needles for penetrating glassware and spraying appropriate washing liquid and compressed air. After cleaning and drying, the glassware is automatically unloaded onto the sterilization tunnel conveyor belt. The integrated control system including PLC and HMI automatically controls all functional parameters of the machine according to various glassware sizes and types. Parameter data is stored in different menus, protected by a password, and only supervised and authorized personnel can access it.
ST0 is currently the smallest laminar flow depyrogenation tunnel on the market. It is designed to depyrogenate vials, ampoules, cartridges and other glassware, maintaining an ISO5 environment throughout the length of the tunnel through a continuous process. It consists of three chambers. The air inlet chamber has a laminar flow device, which can ensure the clean transfer of glassware from the washing machine to the hot chamber, dry and preheat the glassware to protect it from the backflow of hot air from the hot chamber; the hot chamber sends the glassware to the thermal cycle device Remove pyrogen; the cooling chamber cools the glassware to a temperature suitable for discharge into a sterile room or isolator. ST0 has a compact design and can adapt to the most compact production space specifically required by bess pro, and is especially suitable for R&D laboratories.
Due to the compact design, the rotating washing machine and the pyrogen removal tunnel with laminar flow hood have a very small footprint (approximately 1,500 x 2,900 cm), which fully meets the customer's initial requirements.
The design of the PVFCM50 with laminar flow hood takes into account the latest requirements of the filling process, including in-line transportation and small width, reduces the volume to be monitored and disinfected, and allows the operator to reach any point in front of the machine through gloves. In addition, the tight mechanism driven by the mechanical volume meets the sealing requirements of the closed RABS and the isolator; the design of the rotating table can easily achieve unidirectional and laminar airflow, reducing the presence of particles on the table. Provide continuous monitoring of active and inactive particles, as well as 100% IPC (process control) of the weight and weight check system, and feed back to the powder filling station. The stoppering process is performed by a vacuum-assisted pick and place system, and the capping is performed by a particle-free rotating blade system. The sensor detects the presence of bottle stoppers and bottle caps, so the machine rejects unstopped vials and vials with unqualified product weight. Steriline PVFM can handle vials up to 200 ml with minimal specification changes and production speeds of up to 200 vials per minute, depending on the size of the vial and the filling volume.
bess pro products that require a highly accurate dosing process means very gentle handling and metering of powder for vial filling. Steriline designed and manufactured a special spiral filling head equipped with a custom screw shape added to PVFCM50, allowing extremely gentle handling of the product and protecting its integrity. In this way, the extraordinary precision required for this particular filling process can be achieved without compromising in any way when handling very sensitive products. Prove that the spiral feeding system is suitable for the customer's purpose, and product processing is the main problem faced by the entire project. Multiple tests in Steriline's laboratory are essential to prove the reliability and safety of the proposed solution. Dose tolerance checking involves finding the level of accuracy achieved given a specific dose ratio. Because the required precision and tolerances are very strict, the powder filling machine is equipped with a 100% weight inspection system. In the one-week test, several screw filling heads of different sizes were used to actually test the filling of vials, and hundreds of samples were produced to evaluate product stability. They are all within the measurement range of the accuracy standard. In the end, the results unexpectedly show that the new spiral metering head is even more accurate than the products currently running on the bess pro production line.
Figure 2-Steriline's new spiral metering head, specially manufactured for bess pro
Figure 3-Steriline powder filling machine with outlet stacking table
Thanks to this solution, small batch production is possible, while always maintaining a low average consumption and procurement costs. The previous semi-automatic filling process has been fully automated, and the glass vials have been cleaned and depyrogenated. The entire production line cycle can be run independently and automatically without any manual intervention. In addition, the process has been proven to comply with GMP standards, and the production yield has increased significantly.
The entire project, from order placement to line installation, from technical discussions, pre-tests and trials, to the order stage, lasted about 10 months.
There are several reasons why bess pro chooses Steriline as its supplier, except that very small equipment is required to accommodate the limited number of available clean rooms. This Italian company can meet this requirement (because it usually provides the smallest machine on the market), but most importantly, it can provide a turnkey, fully operational production line. The production line is ready to run at full capacity, including training and verification assistance. This turnkey complete package, including the first year of maintenance, is the most important reason for bess pro's decision to purchase the Steriline project and development advice.
Experience is another key factor. It takes considerable experience to manufacture and execute powder processing machines, and Steriline has been doing this for a long time. The Italian company also studied the customer's complete packaging process, connecting the entire production line with the secondary packaging equipment, thanks to a special belt system and a rotating table used as a vial buffer system.
Even if the entire process is slightly delayed due to the COVID-19 emergency, Steriline provides two alternative solutions for the factory acceptance test (FAT) virtual program, which can be used in live streaming mode or recorded and released for later Customer modification and approval. Nonetheless, after the Italian lockdown and the first wave of coronavirus, bess pro customers are confident that a week of FAT testing will take place in Como, rather than a virtual test.
Last but not least, language also played a key role. Having engineers, project managers and sales managers who speak German and English helps to build stronger relationships with German customers and avoid the risk of cultural barriers.
This complete package ensures excellent quality, and the price is very affordable.
"Without Steriline, we would never be able to implement our best clean room production layout. Whether it's longer, shorter, rotating or mirrored, Steriline engineers tirelessly adjust their modules to customize the production line according to our production layout , Without incurring cost drivers. No competitor can show such a flexible performance. The collaboration with the Steriline project team is incredibly inspiring, and is always responsive and solution-oriented. Therefore, despite the pandemic , But it’s no surprise that the project was completed without any major delays,” said Sven Lange, project manager at bess pro gmbh.
"As early as the supplier selection stage, Steriline stood out from the crowd with its fast and binding communication method, and never let us down in the whole project. Especially customer-oriented special solutions, such as powder hopper The special container, integrated with the professional upstream manufacturing process of the API, has been excellently implemented. I am already looking forward to Steriline's future projects!" said Martin Gördes, CTO of bess pro gmbh.
"The field of R&D is very challenging and customers seek support when developing new drugs. Sometimes language can be an obstacle, especially when working with German customers who like German-speaking contacts. We usually work on customizing our standard solutions or New solutions are developed according to specific requirements, and this is the case with bess pro," commented Mirko Ebeling, managing director of Ebetech GmbH, the sales and service organization of Steriline in the German territory.
“Thanks to the close cooperation with the bess pro team, we have successfully developed a tailor-made solution, just like the auger filling head. This experience in particular shows the critical importance of the pre-sales trial and proves the Steriline Lab’s Effective methods ensure the most suitable solution in terms of process reliability," adds Stefano Albusceri, Steriline Project Manager.
Steriline robot nest filling machine tour