Prototyping

work on the manufacture of medical products in liquid form (preparation of substances) in the cleanroom module (ISO class 7), 
at least 1 day of work of a team of one specialist and quality control engineer

work on the manufacture of medical products in liquid form (preparation of substances) in the clean room module (ISO class 7), clean zone of ISO class 5, sterile by the aseptic filling method, 
at least 1 day of work of a team of one specialist and quality control engineer

work on the manufacture of medical products in liquid form (packing in syringes with capping) in the cleanroom module (ISO class 7), clean zone of ISO class 5, sterile by aseptic filling method, 
at least 200 samples

work on the manufacture of medical products in liquid form (packaging in bottles with closures) in the cleanroom module (ISO class 7), clean zone of ISO class 5, sterile by aseptic filling method, 
at least 200 samples

work on the manufacture of medical products in liquid form (packing in syringes with closures) in the cleanroom module (ISO class 7), followed by sterilization, 
at least 200 samples

works on the manufacture of medical products in liquid form (packaging in bottles with closures) in the cleanroom module (ISO class 7), followed by sterilization, 
at least 200 samples

Sterilization of closed containers with liquid. Sterilization method - Wet steam, with the impact of back pressure and rapid cooling, in order to prevent leakage of the container. The ability to sterilize prefilled syringes. Camera 85 liters. No more than 300 items per cycle.

Sterilization of medical devices. Sterilization method - Wet steam, the cost of 1 cycle, full load of the camera 100l. 
No more than 100 prototypes per pack per cycle.

Manufacturing of medical devices: with prototyping blister packaging for prototypes of medical devices in syringes and bottles with fixtures for fixation. According to the rules, prototypes of medical devices are submitted to the laboratory for technical and toxicological tests for registration in the Federal Service for Health and Social Development in exactly the type of packaging in which they will be put on the market in the future. The cost of work includes the manufacture of a pre-fabric blister package with a lid from Tyvek, packing products in the primary packaging, welding the cover to the blister, packaging in the secondary packaging, labeling, sterilization)

Validation of steam sterilization of medical products in liquid form 
(Preparation of PQ, PP protocols, conclusion processing, quality control. Work package: preparation of medical devices for monitoring indicators, for bioburden, sterility, package integrity, generation of reporting documentation for the registration dossier)