XTS linear transport system creates competitive advantages
Shanghai Yinghua, a Chinese pharmaceutical packaging system supplier, is responding to the trend toward powdered pharmaceuticals with an innovative generation of machines. The main features of the design include the XTS linear transport system and PC-based control, which engineers used to boost system output to 450 units per minute.
An increasing number of pharmaceutical preparations, including those designed for injection, are now being produced as powders due to the specific process advantages this offers. This method is even suitable for many heat-sensitive substances, since powder production is carried out at low temperatures. Proteins and microorganisms do not lose their biological viability during the freeze-drying process, nor do they become denatured or lose their effectiveness when dissolved in sterile water. Sterile and freeze-dried powders for injection purposes have therefore become a popular option in clinical practice, and the trend is continuing to rise.
Against this backdrop, manufacturers of pharmaceuticals need efficient, flexible, and GMP-compliant equipment for dosing and packaging injection powders. Shanghai Yinghua is a leading manufacturer of injection powder in China and is implementing these systems in its current packaging systems with the XTS linear transport system.
The process for packaging sterile powder for injection essentially comprises the following steps:
- washing, drying, and sterilizing the vials
- treating and sterilizing the rubber stoppers
- washing and sterilizing the aluminum caps
- packaging and sealing the powder in a sterile environment
- sealing, labeling, boxing, and packaging
Shanghai Yinghua faced several challenges when developing the new generation of equipment: fierce competition and constant technological advances in pharmaceutical equipment meant that they needed to offer cost advantages over their competitors. There were also many demanding technical tasks to contend with, such as turning the vials upside down and accurately dosing the powder at a higher filling speed, which are key to higher dosing efficiency and quality as well as lower raw material costs. Regulatory requirements presented a third hurdle, which included establishing how to implement inline weighing in order to meet GMP traceability requirements, instead of weighing individual samples, which was previously the usual method.
Specifications call for complete design overhaul
These requirements could not be met by simply upgrading the traditional machine design. Conventional transport by conveyor belts would make it difficult to meet the specifications of the dosing process, especially since the vials can easily tip over on the belts. If that were to happen, the entire batch would have to be scrapped and the machine would need to be cleaned. This would be a real blow to productivity, as the system would be out of action for quite some time. The relatively low accuracy of the conveyor belt means it would be difficult to position the vials under the filling needles with any kind of precision. There would always have been a risk of powder residue remaining around the mouth of the vial during the filling process, which constitutes yet another criterion for rejection.
By switching to the XTS linear transport system, Shanghai Yinghua was able to eliminate these typical process problems and set new standards in the industry in terms of performance and quality: almost any number of movers can be mounted on the guide rails of the linear transport system with minimal mechanical effort. This offers the flexibility to adjust the filling line to the required production capacities. The movers can be moved individually, in groups, or in sync with each other. When the powders are dosed, the vials can be clamped by the movers, for example, to prevent them from falling. Not only does this speed up the production cycle and reduce the error rate, it also eliminates any downtime for cleaning – an essential prerequisite for achieving unmanned operation.
Dynamics and precision are essential for faster machine cycles
In terms of high dynamics and precision, PC-based control enables the movers to be guided with precision and synchronized with the filling and packaging process. The accuracy of the magnetically driven movers is up to 50 µm, guaranteeing a perfect powder filling process without residue around the vial neck. Mover speeds of up to 4 m/s and up to 10 g acceleration assure the efficiency of the system. The combination of these specific XTS properties – precision, speed, and dynamics – results in an increased output rate of up to 450 vials per minute and gives Shanghai Yinghua a clear competitive advantage.
The company produces various tandem machines for producing sterile powder and freeze-dried powder, which can be assembled into complete production lines with dosing machines, vial washing machines, multifunctional capping machines, and sterilization and drying machines. Customers include more than 200 pharmaceutical factories worldwide.
Notable advantages here include the inline weighing system and the ability to record all operator interventions with an audit trail, which means the systems meet the compliance requirements in accordance with GMP. For Shanghai Yinghua and other Chinese manufacturers, the XTS linear transport system sets a trend that takes pharmaceutical packaging technology to a whole new level.