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DeutschVosfox Medical can organise the sterilisation process for you when your product must be sterile. We support all types of sterilisation processes and work with trusted partners. We can also arrange the transportation of your products to you or your customers, and when needed, also in a controlled environment.
Sterilisation Process
We support all types of sterilisation, such as irradiation (gamma, beta, x-ray), ethylene oxide, or steam. First step is the validation of the sterilisation process. When the process is validated we ensure the correct method/protocol is used by the subcontractor and issue the purchase order. But before we send products to be sterilised, we make sure the products are of good quality and released by QA.
Upon receiving the confirmation that the products are treated, we will check the sterilisation certificate to ensure the requirements are met. The products can be shipped directly to the customer or to Vosfox Medical when we take care of the logistics to your customers. When the products are sent directly to our the customer, we will ensure you receive the sterilisation certificate for the final release of the product.
When the products are returned to Vosfox Medical, we will visually inspect the boxes and the indicators. We will then release the goods after sterilisation. Ultimately, you, as the legal manufacturer, are responsible for the final release of the goods. Of course, we will provide all required documentation.
Monitoring of the process
When the sterilisation validation is completed, the frequency of monitoring the process is determined. Monitoring by just checking the sterilisation certificate is not sufficient. Several monitoring tests must be performed per year. This number is often 4x per year but depends on the risk assessment and is determined during the validation, and is subject to non-conformities.
Logistics
After the final release of the products, we can organise the shipment to you or to your customers. You provide us with the orders, and we will ensure the boxes are sent to the required locations.
If we send the products to your customer, repackaging them into smaller transport boxes might be necessary.
When transportation in a controlled environment (temperature and humidity) is required, we can use transport companies specialising in fully controlled, monitored transporting with documentation.