+7 (495) 728-15-87
In the sphere of medical devices production, manufacturing companies solve a large number of tasks, including those related to packaging, and, in the case of sterile products manufacturing, with sterilization. In order to fulfill all these tasks, producers need considerable investments for equipment purchases, office rents and payroll fund. One of the opportunities to organize this effectively - their outsourcing to specialized companies engaged in contract manufacturing (Contract Manufacturing Organizations, CMO). SteriPaсk Service is one of such companies and is ready to offer you a set of services for the development, assembly, packaging, sterilization of medical devices, and validation of production processes in Moscow.
The sterilization of medical devices, primarily sterilization with ethylene oxide, is in constant demand among manufacturers. It is so popular because gas ethylene oxide sterilization allows you to sterilize products that are sensitive to moisture and high temperatures and require special care. In addition to EO sterilization, we also provide radiation sterilization services that allow to sterilize a wide range of medical products, including pharmaceutical ones. SteriPaсk Service is a specialized sterilization center in Russia using sterilization equipment and sterilization quality control systems of 3M company (USA). You can read more about this in the sections:
We can also offer you a service for the assembly and packaging of medical devices. If the solutions for primary and secondary packaging have not yet been found - we will help you in its development. Read more about this: Assembling medical devices
The validation of the sterilization process and the validation of medical devices packaging, as one of the measures to improve the quality and safety of medical devices, is becoming the norm in the medical devices manufacturing in Russia. Validation is documentary evidence that after the sterilization process we get really sterile products that meet all the requirements in accordance with GOST ISO 11135-2012. The validation of the sterilization process is a key component of the quality control and management system. The validation procedures significantly improve the quality of the products. The validation of the sterilization process and the packaging of medical products became especially important since January 2015, after Roszdravnadzor introduced the requirements for the validation protocols control when submitting a set of registration documents. Nevertheless, the importance of validation procedures is much higher than compliance with the requirements of the law. The quality control of the products is the obligation of each manufacturer of medical products, primarily to clients, patients and to themselves. More detailed information about this service you can find here: Validation of gas, radiation and steam sterilization
Call us on the phone +7 (495) 728-15-87 and we will calculate the cost of contract manufacturing of the medical device at the production facilities of SteriPaсk Service as soon as possible.
