Sterile Packaging Process

Medical devices delivered in a sterile state should be designed, manufactured and packed to ensure that they are sterile, under documented storage and transportation conditions, until the barrier system is damaged or opened. To be compliant with ISO 11607 part 2, medical device companies must have a validation program to demonstrate repeatability and reproducibility of the sealing process. At Mavajan Packaging Solutions, LLC we have the expertise to work closely with equipment manufacturers and sterile packaging component suppliers to develop the right process and validate a perfect seal.