Project Referencies
Consultancy and Legal Manufacturing Services
Legal Manufacturing
To date, Shin-Etsu silicone produces over 5,000 kinds of versatile silicone products. Decision has been taken by the management of the company to design and develop medical device and sell the device under own brand. The company had and established facility in Hungary which was focused on production of components for automotive and food segment.
Challenge
Because the company had no previous experience with medical device manufacturing and new upcoming regulations in the industry, the company decided to use silicone production expertise and build related infrastructure for production of Enteral feeding products in Hungary and use Sky Medical as the legal manufacturing partner.
Solution
Shin-Etsu engaged Sky Medical to plan and establish a medical device cleanroom production facility and infrastructure. Sky Medical was selected because of its ability to deliver a turnkey project - from planning to realization and validation of cleanroom and knowhow in establishing a Quality Management System (QMS) to MDR compliant technical file creation and management, assembly, packaging development and all related regulatory affairs concerning legal manufacturers.
Results
Production Facility: Planning, establishment and validation of a ISO 8 Clean room infrastructure for the production of medical products in Hungary.
Quality Management System: Integration of ISO 13485 requirements into existing QMS of Hungarian the facility.
Ongoing legal manufacturing services: MDR compliant technical file creation and submission to the notified body, skin level feeding G-button kit supplier establishment, packaging design and integrity validation, shelf life studies, sterilization validation, full responsibility for post market activities.
Product: Skin level feeding G-button of Shin-Etsu kit packed in Sky Medical. Shin-Etsu brand on the label, Sky Medical takes over full range of legal manufacturer’s responsibility.
Cleanroom facility establishment
Sky medical designs and establishes iso class 8, 250 square meter cleanroom facility for clever medical in almaty, Kazakhstan.
Challenge
Create a facility for the local, in-house production of sterile medical devices and products in Kazakhstan.
Solution
Engage Sky Medical in a turnkey project for the planning, realization, validation and the provision of consultant services for ongoing operation of the facility and establishment of a Quality Management System.
Results
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ISO-certified facility and infrastructure.
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Quality Management System for the production of sterile medical devices and products.
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Facility for the production of a range of sterile products.
Thermoforming packaging machine
Sky Medical is investing in a new Multivac thermoforming packaging machine. The Multivac R145 enables high output and quick format change to be achieved, as well as making individual pack design possible.
