MeHow has a completed sterile medical device manufacturing system and capacity, with the production of class II sterile medical devices and class III implanted sterile medical devices experience, able to meet the needs of different clients for GMP manufacturing.
GMP Site Management System
The most important aspect of sterile and implanted medical devices is the control of contamination, including particles, microorganism, chemical contamination, etc. A set of qualified manufacturing system is the basis to ensure medical devices are not polluted, so as to ensure the safety and effectiveness of medical devices.
- GMP workshop hygiene management system
- Cleaning and disinfection management system
- Identification and traceability management system
- Clearance management system
- Batch record management system
- Product release management system
Advanced GMP Workshop
Hardware facilities are the basis of quality assurance for medical device manufacturing. MeHow has a completed GMP workshop facilities to meet the requirements of class II and class III implanted medical devices manufacturing.
- Class 10k & Class 100k clean workshop
- Purified water production workshop
- Ethylene oxide (EO) sterilization workshop
Laboratory Testing Capability
Clean room needs to check and and monitor the environment regularly to ensure the production environment meets the requirements. Medical device products must be tested before production release, to ensure the medical device meets the registered technical requirements and the requirements of laws and regulations.
- Environmental detection capability (particle, temperature and humidity, number of ventilation, pressure difference, sedimentation bacteria or planktonic bacteria)
- Physical performance test (size, welding strength, flow rate, leakage, heat sealing strength, etc.)
- Chemical performance test (EO residue, heavy metals, etc.)
- Microbiological performance test (initial contamination test, sterilization test)
- Reliability test (validity test, simulated transportation test)
