Mentor Media cleanroom services are ISO certified, with temperature and humidity-controlled facilities that are monitored on particles and bioburden levels.
An efficient sterile packaging process protects the devices from contaminants during transportation and storage, ensure non-toxic, is compatible to the sterilization process, compliance to international standards and maintain the devices with an active shelf life of up to 10 years or until the point of use.
In the light of pandemics, Healthcare and its services are of paramount importance. The need to deliver sterile packaged medical devices is especially crucial for reduction of Healthcare Associated Infections (HAIs).
What makes Mentor Media unique in sterile packaging:
- State of the Art Quality Management System (TUV SUD certified)
- Complete packaging process consultation:
- Utilization of a variety of pre-validated packaging materials. (certified Shelf life of up to 10 years.)
- Research on conducive concept flow / packaging for clients
- Consultation on required validation
- Incoming inspections
- Assembly of small parts medical devices in the cleanroom environment
- Use of Ultrasonic bath (IPA 70%) or (high purified water system) to clean for final disinfection or removal of potential bio-contamination and particles.
- Cleanroom for packaging of post-processed products (utilizing rotary sealers or high-speed chamber machine)
- Collaboration with leading sterilization company for Gamma or EO sterilization
CASE STUDIES