About the company
PASCAL MEDICAL LTD (former name, before October 07, 2016, was Signatum LTD) was registered on December 23, 2014. The company obtained the status of a resident of Dubna special economic zone, whereof the respective agreement was signed with the Ministry of Economic Development of the Russian Federation.
The goal of the project is to create a state-of-the-art Russian high tech production facility to manufacture sterile single-use medical devices. Implementation of this project is a contribution to solving one of the most important problems faced by Russia: substitution of imported medical devices with Russian made ones. In order to implement the project about 2 billion Russian rubles are planned to be invested in construction of a facility in the territory of Moscow region, intended for manufacture of single-use medical devices. The respective investment partnership agreement was signed with the governor of Moscow region, mr. Andrey Vorobyev, at the Saint Petersburg International Economic Forum.
The project comprises of several stages, and at the first stage it is planned to start production of the full range of single-use injection syringes, including insulin and tuberculin syringes. The production capacity is 450 million units per year. In future it is planned to enhance production lines and expand the range of produced medical devices. At the next stage we plan to start production of infusion and transfusion sets. Next, we plan to start production of vacuum blood and urine sampling systems, intravenous catheters which currently are not manufactured in Russia and syringes pre-filled with normal saline to rinse the intravenous catheters.
The production will be supported by modern manufacturing facilities and state-of-the-art technologies that will ensure that the cost of production of final products will be optimal due to efficient use of raw materials, as well as durability and high reliability of utilized equipment. Our production is a complete production cycle, including in-house sterilization and in-house manufacture of medical needles. These factors will allow us to produce medical devices compliant with all requirements of national and international standards of good manufacturing practices (GMP).
This statement is based on the fact that even now, at the stage of design and initial stages of project implementation we have a team of highly skilled specialists with great experience in that industry, capable to develop, implement and ensure performance of necessary measures. In contrast to quality control through testing selected samples of such products, which can only guarantee that those selected samples (and maybe batches of products manufactured immediately before or after the selected batch) are suitable for their intended use, GMP standards represent an integrated approach and actually regulate and evaluate parameters of manufacture and laboratory testing.
Implementation of this project will allow us to introduce a product of stable and consistent quality on the market. Its high quality will be guaranteed by implementation of project decisions with strict compliance with requirements of applicable good manufacturing practices (GMP). The quality assurance system to be used for our production is intended to prevent errors and deviation by taking into account all factors capable to have an impact on quality of finished products from the very beginning (incoming inspection of raw materials, in-process control, finished products inspection) and to the completion of the production cycle. Quality control of both raw materials and components and finished products will be carried out using most advanced testing equipment. Testing laboratories of our facility will carry out over 100 types of tests each shift.