Valdamark’s range of medical sealers is comprehensive. The devices we supply are market leading, built only to the highest standards required by the medical, pharmaceutical and healthcare sectors.
Healthcare is one of the most fundamental parts of our lives. In recent times it has witnessed an unprecedented level of investment. This has translated to more sophisticated and efficient packaging solutions.
Our machines focus on the sterile packaging standard EN 868. This has become the ‘gold standard’ when it comes to sealer machine requirements and packaging systems in general.
Part to 2 to 10 refers to the testing procedures required for the various packaging materials that are used.
Previously IS0 11607 was used as the international standard for sterilized medical packaging. This was combined with EN 868-1. Both these standards have been jointly revised under ISO 11607.
Part 1 of the new standards focuses on requirements and testing procedures for sterile packaging whereas part 2 focusses on the medical device validation requirements and processes themselves.
Medical Pouch Sealers and Vacuum Impulse Sealers
When sealing sterile bags our range of medical pouch sealers & vacuum impulse sealers are all validatable and conform to the strict standards specified in EN 868 section 1.
Each validatable heat sealer have built in parameter controls which monitor pre-defined acceptable sealing conditions.
In order to ensure sealer accuracy calibration services can be provided by ourselves in conjunction with a certified laboratory.
This choice selection can complement a wider packaging solution with each machine designed to work in sync with particular flexible packaging products.
Contact us or take a look at our heat sealer guide for more advice on suitable machines.