Working on CDMO for Macromolecular Target Drugs
Preparation production in multiple specifications and dosage forms can be performed. With strict B+A clean area design and online particle monitoring system, IPC system installed on the filling line, product quality and accuracy of filled volume can be effectively assured.
◆ We own the automatic preparation production line of Germany Bosch, which can perform the liquid preparation production of 2ml、6ml、15ml、25ml, and 50ml vials, as well as the lyophilized preparation production of 6ml, 15ml, and 50ml;
◆ The filling speed can reach 24000 vials/h, and IPC monitoring of multiple modes can be set, thus ensuring that the filled volume of the product meets the process requirements;
◆ The large freeze dryer of 15 m2 was installed, with automatic feed-in/ feed-out and CIP/SIP systems to avoid the effect of human factors and ensure the sterility and stable quality of products;
◆ The filling line has installed an online monitoring system to ensure the whole filling is under control and the clean environment of production meets the requirement;
◆ The filling of the pre-filled syringe can be performed and the product can be directly filled into the syringe of 1.0ml (slender) and 2.23ml syringes. The patient can use the medicine directly to avoid introducing risk during medicine extraction and transferring at a later stage.