In House Eto Sterilization Facility
- Two 10M3 sterilizers which can fit up to 20 pallets
- Precondition Room for temperature and humidity control of product prior to ETO sterilization
- Aeration Room for removal of residual ETO
In House Development of Protocol
Protocol is developed for specific product whenever needed.
Validation For New Products
Thorough validation to justify the adaptation to the sterilization protocol and re-validation of protocol is carried out annually.
In House Biological Laboratory
Class 10,000 clean room to perform test and monitor for – Bioburden level, Bioindicator and Product Sterility.
Development of Protocol, process validation and quality control through cooperation between 91免费网站全部网址_美女黄频视频 and Gamma Supplier.
Compliance to the International Sterilization Standards
- ISO 11135 for ETO Sterilization
- ISO 11137 for Gamma Sterilization