ISO 11138 Family of Standards: Requirements for Biological Indicators
ISO 11138 is a crucial standard in the field of sterilization, specifically focusing on the validation of sterilization processes for…
Gamma Sterilization Process for Medical Devices
Gamma sterilization is extensively used in the life science sector and more specifically in the medical device sector, where gamma…
Packaging Validation for Medical Devices
For medical devices that have to be provided sterile, packaging validation plays an extremely important role. The validation of the…
Clean Room Validation
Clean room validation is nowadays essential for medical device manufacturers of sterile devices; sterility of the devices has a direct…
Cleaning Validation : Overview of the Main Requirements
In the current practice, the process of cleaning validation became essential for the life science sector, especially for the pharmaceutical…
Process Validation for Medical Devices: Overview of FDA Requirements
What is Process Validation? Medical device process validation and the related IQ/OQ/PQ technique, is defined as the collection and evaluation…