Vosfox Medical offers Services to all customers. These services can be from consulting to complete execution. That’s up to you.
Production Development Services
Our engineers at Vosfox Medical have experience in the development of fabrication processes of polymer based medical devices and components. We can also support you with processes like;
- Defining an URS
- Equipment selection
- Design reviews
- FAT / SAT
we are keen to provide support on. The level of our involvement is up to you. This means, we can also help with selecting the suppliers for raw materials of parts, packaging materials, labels, etc.
If you are not sure what the best packaging for your medical device is, Vosfox Medical can support you with finding the right packaging and labels. This includes the selection of materials and creating the right design.
Together, we will define the packaging requirements, such as oxygen and/or moisture barrier properties, mechanical integrity and sterilization method. Then, the appropriate materials for blisters, pouches and boxes are selected and a packaging design is created. The packaging must be suitable for the chosen sterilization method and pass the sterilization and transportation validation. Subsequently, the labels are selected and designed. Labels need to be designed according to the Medical Device Regulations with the right symbols and the UDI numbers.
When the appropriate packaging is selected and your medical device needs to be sterile at use, we have the knowledge to give support on, or do the sterilization validation for you. The following steps are an example of what is required for a radiation sterilization validation process;
- Determine bioburden level
- Determine your sterilization protocol (e.g. use VDmax 25)
- Validate the bioburden and sterility testing methods
- Test bioburden samples to determine the verification dose
- Sterilize samples at the verification dose and perform a sterility test
- Perform a dose mapping study
The integrity of medical devices is party dependant on the packaging because it functions as a protective layer between packaging and use and during transport. It is therefore important to finish the packaging validation before commercial use. It is also important that the packaging validation tests all the functions of the packaging, including the transportation. The following tests are part of a medical device packaging validation;
- Packaging integrity testing
- Packaging shelf life testing
- Transportation testing according to ISTA (e.g. 2A)
- Conditioning testing
- Compression testing
- Vibration testing
- Shock testing
We give support in setting up a packaging validation, however, we can also do it for you!