Our packaging machines are qualified (IQ/OQ/PQ); tightest tolerances are guaranteed
Monitoring of temperature, force, time and vacuum/pressure, all parameters qualified
Conformity to all international medical technology standards
Requalification by trained VC999 Service Team
The packaging material is available with a packaging validation for EO and gamma sterilization and has a shelf life of up to 10 years (EO does not apply to PA/PE).
The packaging material meets the requirements of DIN EN ISO 11607.
All processes are documented so that their validation will endure in the audit cycle.
Audit-Trail: Machine and process data acquisition
VC999® (Medical Division) is certified to DIN EN ISO 13485:2016
as a manufacturer of packaging machines for the medical product industry
VC999® (Medical Division) has validated a process that includes the machine, packaging material and its validation. This validated process can be adopted directly by you and allows you to quickly implement a flexible, cost-optimized medical packaging solution. And all of this is "state of the art" with a shelf life of up to 10 years and for the commonest materials such as PA/PE, Tyvek® and paper/film.
With the adoption of our packaging validation, you have a sterile packaging solution with which the requirements of the new MDR and thus currently also the FDA can be met.
The VC999 Medical C6 machine is extremely flexible and covers a multitude of possible applications. A change of packaging size does not necessitate the conversion of a format set – simply choose a different bag size and continue working. The machine size allows very different products to be packaged – large and long articles, complete sets, high products or many smaller articles in one cycle. Thanks to the high speed, even large numbers of items can be packaged cost-effectively. The VC999 C6 usually replaces several sealing machines, which considerably reduces requalification costs and maintenance work.
The packaging validation is dispensed with.
VC999® recognized the need of many customers as well as the sign of the times and has executed its own packaging validation with a shelf life of up to 10 years.
As the user, you save high costs for checking and documentation as a result.
As the customer, you also save yourself the time-consuming artificial aging tests.
You don't have to wait 18 months – you can submit our base validation to your notified body and start packaging very quickly.
The documentation effort and the requisite know-how is extremely expensive for a packaging validation. With our process solution, our effort is reduced to submission to the notified body. Our team of experts with its many years of experience has taken care of this labor-intensive task for your company.
Qualified vacuum packaging machine + pre-validated packaging material = sterile packaging solution
We provide our customers with security in dealing with the new regulatory requirements for sterile packaging.
We have dealt with the risks involved in certification and maintain a large network of different partners.
You've got the product? We've got the right validated packaging for it.
There has been an important change in the medical technology sector: with the MDR, the cleaning and packaging has been upgraded to a critical part of the product, as a result of which many manufacturers are facing challenges. VC999® in Herisau has not only developed the machine, but in fact the complete packaging process, including its own packaging validation and a shelf life of ten years for PA/PE as well as Tyvek® and paper/film.
Customer statement: "Why did we choose the C6 from VC999®? FProcess reliability is important to us, as well as the variety that the machine offers across different materials and its speed. We simply need validated processes in our cleanroom and also well-qualified machines"
Head of Cleaning and Packaging
The right machine for every product. Our packaging machines ensure that you reach your goals efficiently.
Our recommendations for the packaging of medical products:
You can reach us on +41 71 353 59 00 or using the contact form:
