NewsSTERILINE & BESS PRO TOGETHER FOR A NEW POWDER FILLING LINE: WHEN THE IDEAL
SOLUTION COMES FROM DEEP SPECIALIZATION AND LONG EXPERIENCE
A turnkey solution to radically improve production volumes provided in only 10 months despite
COVID‐19 pandemic.
Steriline, a highly specialized manufacturer of complete lines for the aseptic processing of injectabledrugs, recently successfully delivered a new line to bess pro gmbh, a Berlin located company part of thebess group, manufacturing and distributing high-quality devices and medical products ‘Made inGermany’.
bess pro works on a range of packaging and R&D processes, including sterilization, sterile packaging,secondary packaging and also on innovations and further developments of products in the fields of head& neck surgery, pneumology and gastroenterology, working on about 1,000 different types of medical
devices and pharmaceutical products with very small batch sizes.
The request for Steriline included then the substitution of manual and laboratory machines with more
performing and reliable automatic solutions with an extremely small footprint. They specificallyneeded a new complete line including a new Powder Filling, Stoppering and Capping Machine(PVFCM50) under Laminar Flow but also a Rotary Washing Machine (RA‐V4) and a Depyrogenation
Tunnel (ST0).
Steriline provided a turnkey line, fully operating and ready to perform at full capacity, including training
and validation assistance in approximatively 10 months, from the order to the line installation, startingwith technical discussions, pre‐testing, and trials until the order placement phase.
One of the major challenges was the design of the PVFCM50 under Laminar Flow Hood, taking into
consideration the newest filling process requirements: in line transport and small width, reduced
volume to be monitored and sterilized, and the need for operators to reach any point of the machine bygloves.
After the final agreed layout, the continuous monitoring of the viable and non‐viable particles isprovided, together with a 100% IPC (In Process Control) of the weight and a check weighing system withfeedback to the powder filling station. The stoppering process is performed by a vacuum assisted Pick &Place system while the capping by a particle less rotary blade system. A sensor detects stopper and cap
presence and consequently the machine rejects all un‐stoppered vials as well as those withnonconforming product weight. Steriline PVFM can handle to 200ml vials with minimal format changes
and production speeds up to 200 vials/min, according to vial size and filling volume.

Furthermore, a highly accurate dosing process was needed to handle and dose powder extremely gently
for vials’ filling. Steriline projected and designed then a special Auger Filling Head equipped with acustomized screw shape added to the PVFCM50 to protect product integrity. In this way, theextraordinary accuracy requested for the specific filling process could be achieved notcompromising at all the very sensitive product handled.
The Powder Filling Machine was also equipped with a 100% check weight system. Several trials wereperformed, practically testing filling vials with several different Auger Filling Heads dimensions, andhundreds of samples were produced to understand product stability. In the end, unexpected results
showed that the new Auger Dosing Head was definitely even accurate than expected.
«Steriline distinguished itself already during the supplier’s selection by fast and binding communicationand never let us down in this respect, during the further course of the project. – affirmed Martin Gördes,
Chief Technical Officer at bess pro gmbh – Special customer‐oriented solutions, such as a special
receptacle for the powder hopper to integrate specialized upstream manufacturing processes of the drug
substance, were implemented excellently».
Thanks to this solution, small batch sizes production is now possible, while always keeping low average
consumption and purchase costs. The entire line cycle can now run automatically, without any humaninterfering. Furthermore, the process has been demonstrated as secure according to GMP and theoutput, in terms of production, has been significantly increased.
«The area of R&D is very challenging with clients asking for support when there are new drugs todevelop – commented Mirko Ebeling, Managing Director at Ebetech GmbH, Steriline Sales and Service
Organisation for German territory – We usually work to customize our standard solutions or to develop
new ones following specific requirements and this was exactly the case with bess pro».
«The collaboration with the Steriline project team was incredibly motivating, always responsive andsolution oriented – concluded Martin Gördes – and it is therefore hardly surprising that this project wascompleted without any significant delay despite the pandemic».
In this regard, Steriline provided two alternative solutions for Factory Acceptance Test (FAT) virtual
procedure, always available in live streaming mode or also recorded and released later for client revision
and acceptance. Despite all this, after the lockdown and pandemic’s first wave in Italy, bess pro
technical team felt confident in performing FAT tests in person, not virtually, for one week in Como.