Validation is the second step, after development on the road towards clinical production. Vosfox Medical can perform the below-listed validation steps for you.
Validation is required when the production or a production step cannot be 100% verified. The process validation consists of three steps Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). These steps increase the chance that the products or components fulfilled the agreed Product Specifications.Read more
Test Method Validation
All tests done for monitoring and releasing products, a.k.a QC testing, must be validated. That includes analytical testing but also visual inspections. Analytical testing can include testing of solvent residues, mass, dimensions, or tensile strength.
Both analytical testing and visual inspection require validation. For example, with a visual inspection, you want a PASS from one operator to be also a PASS from another operator.Read more
Packaging & Transportation Validation
The integrity of medical devices is partly dependent on the packaging because it functions to protect the product when transported from the manufacturer to the user. Therefore, finishing the packaging validation before commercial use is essential. The packaging validation tests should test all defined functionalities of the packaging. This could be a sterile barrier, mechanical protection etc.
We do the packaging validation together with our trusted partners.Read more
When the appropriate packaging is selected, and your medical device needs to be sterile, we can fully do the validation for you or support you in any way required. The following steps are an example of what is required for a radiation sterilisation validation process;
- Validate the bioburden and sterility testing methods
- Define the sterilisation protocol.
- Determine bioburden level and determine the verification dose
- Sterilise samples at the verification dose and perform a sterility test
- Perform a dose-mapping study
For ETO or steam sterilisation, these steps are different.Read more
Cleaning validation is important to prevent (cross) contamination of the products during manufacturing. All types of contamination must be identified (during the Risk Analysis). Most often, contamination happens when more than one material is used on a piece of equipment. This equipment must be cleaned before starting the new production run and this cleaning process must be validated.Read more
Shelf Life Testing
It is a requirement that the expiry date of medical devices and pharma products is on the label. The shelf life must, therefore, first be determined. The customer chooses the preferred shelf life (e.g., two years), and we will write the protocol and perform the accelerated and real-time shelf life testing.Read more