The production of prefillable syringes and cartridges, made from premium plastics such as COC and COP, which are to be filled e.g. with parenteral drugs demands a great deal of precision and cleanliness. In order to warrant the quality and stability of the filling medium, it is imperative that already during the production process, the packaging be free from contamination with germs or particles.
The manufacture of your products along the lines of cGMP is carried out in strictly monitored class D cleanrooms (ISO 14644, class 8); in specificially identified production areas, considerably higher standards are attained. The focus our tight monitoring, while obviously addressing visible particles, is on sub-visible particles which are a crucial and quality-relevant criterion for the filling of parenteral drugs.
To achieve this, the development and implementation of our production processes is aimed at scrupulously avoiding particles. This is done through a meticulous choice of adequate production equipment and cleanroom garments and also by strict monitoring. Furthermore, we strive for a high degree of automation in order to minimise particle and germ contamination through personnel.
Your products are manufactured on injection moulding machines of renowned producers which are equipped to specifically meet the needs of cleanroom production. The same is true for the corresponding peripheral and assembly equipment. All production equipment is comprehensively qualified and the corresponding production processes are validated. Our continuous recording and statistical analysis of quality-relevant parameters in the production processes ensures a constantly high product quality.
Our patented production technology, specifically designed to address these needs, allows constant shielding of the freshly moulded product from possible particle contamination by isolating the moulded body from the environment throughout the entire manufacturing process all the way up to packaging. The fully automated process is basically non-contact which further aids us in minimizing cosmetic defects.
Every moulded part is subjected to a visual 100% inspection to identify possible defects such as embedded particles, siliconisation flaws or blemishes caused by the injection moulding process.
The combination of these actions enables us to manufacture first-class prefillable products that also comply with Japanese quality standards.