Shanghai Yinghua, a Chinese supplier of packaging systems for the pharmaceutical industry, responds to the trend towards powdered pharmaceuticals with an innovative generation of machines. Key design features include an
An increasing number of pharmaceutical preparations, including injectables, are being manufactured in powder form for the specific benefits they offer. This method is suitable even for many heat-sensitive substances, since the powder production takes place at low temperatures. Proteins and microorganisms do not lose their biological viability during the freeze-drying process, nor do they denature or lose their effectiveness when dissolved in sterile water. Therefore, sterile and lyophilized powders for injections have become a popular option in clinical practice, and show a continuing upward trend.
In this context, pharmaceutical manufacturers need efficient, flexible and GMP-compliant equipment for dosing and packaging injectable powders. Shanghai Yinghua is one of the leading manufacturers of injectable powders in China, and is implementing these systems in its current packaging lines with the XTS linear conveying system.
The packaging process of sterile powder for injection essentially comprises the following stages:
Shanghai Yinghua has overcome multiple challenges when developing the new generation of equipment: tight competition and constant technological advances in pharmaceutical equipment forced it to offer cost advantages over the competition. In addition, there were many demanding technical tasks to deal with, such as turning vials upside down and accurately dosing powder at a higher filling rate, which was essential to increase the efficiency and quality of dosing and to reduce costs. of raw materials. Regulatory requirements were a third obstacle; One of them proposed how to implement online weighing to meet GMP traceability requirements, instead of weighing individual samples as was usually done until then.
To meet these requirements, it was not enough to simply improve the traditional machine design. Conventional transport using conveyor belts would make it difficult to meet dosing process specifications, especially because it is easy for vials to tip over on the belts, which would impose the need to discard the entire batch and clean the machine. Such an event would have a serious impact on productivity, since the system would be out of service for a long time. The relatively low precision of the conveyor belt would make it difficult to accurately position the vials under the filling needles. There would always have been a risk of powder residue remaining around the mouth of the vial during the filling process, which is another rejection criterion.
By moving to the XTS linear conveyor system, Shanghai Yinghua has been able to eliminate these process problems and set new industrial standards in terms of performance and quality: any number of movers can be mounted on the guide rails of the linear conveyor system. with minimal mechanical effort. This modality offers the necessary flexibility to adjust the filling line to the required production capacities. The movers can move individually, in groups or in sync with each other. When dosing powders, for example, movers can hold vials to prevent them from falling. This not only speeds up the production cycle and reduces the error rate, but also eliminates downtime for cleaning, which is an essential requirement for the facility to operate without personnel.
In terms of high dynamics and precision, the PC-based control allows the movers to be precisely guided and synchronized with the filling and packaging process. The precision of the magnetically driven movers is up to 50 µm, ensuring a perfect powder filling process, with no residue around the neck of the vial. Travel speeds of up to 4 m/s and accelerations of up to 10 g guarantee the effectiveness of the system. The combination of these specific properties of the XTS (precision, speed and dynamics) results in an increase in production rate of up to 450 vials per minute, providing Shanghai Yinghua with a clear competitive advantage.
The company manufactures several machines in tandem to produce sterile and lyophilized powders, which can be assembled into production lines complete with dispensers, vial washers, multifunctional cappers and sterilization and drying machines. Its clients include more than 200 pharmaceutical factories around the world.
Advantages include the online weighing system and the ability to record all operator interventions with an audit trail, meaning the systems meet GMP compliance requirements. For Shanghai Yinghua and other Chinese manufacturers, the XTS linear conveyor system sets a trend that takes pharmaceutical packaging technology to a whole new level.