Vosfox 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 when required.
Before we send your products for sterilisation, QA must first release the products to ensure only quality products are sent. We can support all types of sterilisation, such as irradiation (gamma, beta, x-ray), ethylene oxide, or steam. We ensure the correct method/protocol is used and issue the purchase order.
Upon receiving the confirmation that the products are treated, we will check the sterilisation certificate when the products are sterilised to ensure the requirements are met. The products can be shipped directly to the customer. We will provide the customer with the serialisation certificate, and the customer will need to do the product’s final release.
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.
After the final release of the products, we can organise the shipment for you or 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.