STERILIZATION

Strictly following the national standards and industry standards, we have formulated two sterilization requirements:
Validation of sterilization processes – A procedure must be developed to address validation of sterilization processes. Validation will be necessary if there is a change or addition to a process or a product. 
Validation of sterile barrier system – sterile barrier systems need to be validated with a defined procedure; for example, devices are tested for micro-biological contamination after going through these systems as part of the validation process. The sterile barrier system should be validated again if there is a change to any control of the barrier system, or a change in the design of system (for example, changes to the bio-sensors).

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